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Sample records for therapy medicinal products

  1. Regulation of Cell and Gene Therapy Medicinal Products in Taiwan.

    Science.gov (United States)

    Lin, Yi-Chu; Wang, Po-Yu; Tsai, Shih-Chih; Lin, Chien-Liang; Tai, Hsuen-Yung; Lo, Chi-Fang; Wu, Shiow-Ing; Chiang, Yu-Mei; Liu, Li-Ling

    2015-01-01

    Owing to the rapid and mature development of emerging biotechnology in the fields of cell culture, cell preservation, and recombinant DNA technology, more and more cell or gene medicinal therapy products have been approved for marketing, to treat serious diseases which have been challenging to treat with current medical practice or medicine. This chapter will briefly introduce the Taiwan Food and Drug Administration (TFDA) and elaborate regulation of cell and gene therapy medicinal products in Taiwan, including regulatory history evolution, current regulatory framework, application and review procedures, and relevant jurisdictional issues. Under the promise of quality, safety, and efficacy of medicinal products, it is expected the regulation and environment will be more flexible, streamlining the process of the marketing approval of new emerging cell or gene therapy medicinal products and providing diverse treatment options for physicians and patients.

  2. European regulatory tools for advanced therapy medicinal products.

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    Flory, Egbert; Reinhardt, Jens

    2013-12-01

    Increasing scientific knowledge and technical innovations in the areas of cell biology, biotechnology and medicine resulted in the development of promising therapeutic approaches for the prevention and treatment of human diseases. Advanced therapy medicinal products (ATMPs) reflect a complex and innovative class of biopharmaceuticals as these products are highly research-driven, characterised by innovative manufacturing processes and heterogeneous with regard to their origin, type and complexity. This class of ATMP integrates gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineering products and are often individualized and patient-specific products. Multiple challenges arise from the nature of ATMPs, which are often developed by micro, small and medium sized enterprises, university and academia, for whom regulatory experiences are limited and regulatory requirements are challenging. Regulatory guidance such as the reflection paper on classification of ATMPs and guidelines highlighting product-specific issues support academic research groups and pharmaceutical companies to foster the development of safe and effective ATMPs. This review provides an overview on the European regulatory aspects of ATMPs and highlights specific regulatory tools such as the ATMP classification procedure, a discussion on the hospital exemption for selected ATMPs as well as borderline issues towards transplants/transfusion products.

  3. Cell therapy medicinal product regulatory framework in Europe and its application for MSC based therapy development

    Directory of Open Access Journals (Sweden)

    Janis eAncans

    2012-08-01

    Full Text Available Advanced therapy medicinal products (ATMPs, including cell therapy products, form a new class of medicines in the European Union. Since ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT has been established at European Medicines Agency (EMA for centralized classification, certification and evaluation procedures, and other ATMP related tasks. Guidance documents, initiatives and interaction platforms are available to make the new framework more accessible for small and medium-sized enterprises, academia, hospitals and foundations. Good understanding of centralised and national components of the regulatory system is required to plan product development. It is in the best interests of cell therapy developers to utilise provided resources starting with the preclinical stage. Whilst there have not been mesenchymal stem cell (MSC based medicine authorisations in the EU, three MSC products have received marketing approval in other regions since 2011. Information provided on regulatory requirements, procedures and initiatives is aimed to facilitate MSC based medicinal product development and authorisation in the EU.

  4. Advanced therapy medicinal products: current and future perspectives.

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    Hanna, Eve; Rémuzat, Cécile; Auquier, Pascal; Toumi, Mondher

    2016-01-01

    Advanced therapy medicinal products (ATMPs) are innovative therapies that encompass gene therapy, somatic cell therapy, and tissue-engineered products. These therapies are expected to bring important health benefits, but also to substantially impact the pharmaceuticals budget. The aim of this study was to characterise the ATMPs in development and discuss future implications in terms of market access. Clinical trials were searched in the following databases: EudraCT (EU Drug Regulating Authorities Clinical Trials), ClinicalTrials.gov, and ICTRP (International Clinical Trials Registry Platform of the World Health Organization). Trials were classified by category of ATMP as defined by European regulation EC No. 1394/2007, as well as by development phase and disease area. The database search identified 939 clinical trials investigating ATMPs (85% ongoing, 15% completed). The majority of trials were in the early stages (Phase I, I/II: 64.3%, Phase II, II/III: 27.9%, Phase 3: 6.9%). Per category of ATMP, we identified 53.6% of trials for somatic cell therapies, 22.8% for tissue-engineered products, 22.4% for gene therapies, and 1.2% for combined products (incorporating a medical device). Disease areas included cancer (24.8%), cardiovascular diseases (19.4%), musculoskeletal (10.5%), immune system and inflammation (11.5%), neurology (9.1%), and others. Of the trials, 47.2% enrolled fewer than 25 patients. Due to the complexity and specificity of ATMPs, new clinical trial methodologies are being considered (e.g., small sample size, non-randomised trials, single-arm trials, surrogate endpoints, integrated protocols, and adaptive designs). Evidence generation post-launch will become unavoidable to address payers' expectations. ATMPs represent a fast-growing field of interest. Although most of the products are in an early development phase, the combined trial phase and the potential to cure severe chronic conditions suggest that ATMPs may reach the market earlier than

  5. Risk of discontinuation of Advanced Therapy Medicinal Products clinical trials.

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    Hanna, Eve; Rémuzat, Cecile; Auquier, Pascal; Toumi, Mondher

    2016-01-01

    Advanced therapy medicinal products (ATMPs) constitute a class of innovative products that encompasses gene therapy, somatic cell therapy, and tissue-engineered products (TEP). There is an increased investment of commercial and non-commercial sponsors in this field and a growing number of ATMPs randomized clinical trials (RCT) and patients enrolled in such trials. RCT generate data to prove the efficacy of a new therapy, but the discontinuation of RCTs wastes scarce resources. Our objective is to identify the number and characteristics of discontinued ATMPs trials in order to evaluate the rate of discontinuation. We searched for ATMPs trials conducted between 1999 to June 2015 using three databases, which are Clinicaltrials.gov, the International Clinical Trials Registry Platform (ICTRP), and the EU Drug Regulating Authorities Clinical Trials (EudraCT). We selected the ATMPs trials after elimination of the duplicates. We identified the disease areas and the sponsors as commercial or non-commercial organizations. We classified ATMPs by type and trial status, that is, ongoing, completed, terminated, discontinued, and prematurely ended. Then, we calculated the rate of discontinuation. Between 1999 and June 2015, 143 withdrawn, terminated, or prematurely ended ATMPs clinical trials were identified. Between 1999 and June 2013, 474 ongoing and completed clinical trials were identified. Therefore, the rate of discontinuation of ATMPs trials is 23.18%, similar to that for non-ATMPs drugs in development. The probability of discontinuation is, respectively, 27.35, 16.28, and 16.34% for cell therapies, gene therapies, and TEP. The highest discontinuation rate is for oncology (43%), followed by cardiology (19.2%). It is almost the same for commercial and non-commercial sponsors; therefore, the discontinuation reason may not be financially driven. No failure risk rate per development phase is available for ATMPs. The discontinuation rate may prove helpful when assessing the

  6. Regulatory structures for gene therapy medicinal products in the European Union.

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    Klug, Bettina; Celis, Patrick; Carr, Melanie; Reinhardt, Jens

    2012-01-01

    Taking into account the complexity and technical specificity of advanced therapy medicinal products: (gene and cell therapy medicinal products and tissue engineered products), a dedicated European regulatory framework was needed. Regulation (EC) No. 1394/2007, the "ATMP Regulation" provides tailored regulatory principles for the evaluation and authorization of these innovative medicines. The majority of gene or cell therapy product development is carried out by academia, hospitals, and small- and medium-sized enterprises (SMEs). Thus, acknowledging the particular needs of these types of sponsors, the legislation also provides incentives for product development tailored to them. The European Medicines Agency (EMA) and, in particular, its Committee for Advanced Therapies (CAT) provide a variety of opportunities for early interaction with developers of ATMPs to enable them to have early regulatory and scientific input. An important tool to promote innovation and the development of new medicinal products by micro-, small-, and medium-sized enterprises is the EMA's SME initiative launched in December 2005 to offer financial and administrative assistance to smaller companies. The European legislation also foresees the involvement of stakeholders, such as patient organizations, in the development of new medicines. Considering that gene therapy medicinal products are developed in many cases for treatment of rare diseases often of monogenic origin, the involvement of patient organizations, which focus on rare diseases and genetic and congenital disorders, is fruitful. Two such organizations are represented in the CAT. Research networks play another important role in the development of gene therapy medicinal products. The European Commission is funding such networks through the EU Sixth Framework Program. Copyright © 2012 Elsevier Inc. All rights reserved.

  7. Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development

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    Ancans, Janis

    2012-01-01

    Advanced therapy medicinal products (ATMPs), including cell therapy products, form a new class of medicines in the European Union. Since the ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT) has been established at the European Medicines Agency (EMA) for centralized classification, certification and evaluation procedures, and other ATMP-related tasks. Guidance documents, initiatives, and interaction platforms are available to make the new framework more accessible for small- and medium-sized enterprises, academia, hospitals, and foundations. Good understanding of the centralized and national components of the regulatory system is required to plan product development. It is in the best interests of the cell therapy developers to utilize the resources provided starting with the pre-clinical stage. Whilst there have been no mesenchymal stem cell (MSC)-based medicine authorizations in the EU, three MSC products have received marketing approval in other regions since 2011. The information provided on the regulatory requirements, procedures, and initiatives is aimed at facilitating MSC-based medicinal product development and authorization in the EU. PMID:22912639

  8. Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

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    Renner, Matthias; Anliker, Brigitte; Sanzenbacher, Ralf; Schuele, Silke

    2015-01-01

    In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.

  9. [Translational/regulatory science researches of NIHS for regenerative medicine and cellular therapy products].

    Science.gov (United States)

    Sato, Yoji

    2014-01-01

    In 2013, the Japanese Diet passed the Regenerative Medicine Promotion Act and the revisions to the Pharmaceutical Affairs Act, which was also renamed as the Therapeutic Products Act (TPA). One of the aims of the new/revised Acts is to promote the development and translation of and access to regenerative/cellular therapies. In the TPA, a product derived from processing cells is categorized as a subgroup of "regenerative medicine, cellular therapy and gene therapy products" (RCGPs), products distinct from pharmaceuticals and medical devices, allowing RCGPs to obtain a conditional and time- limited marketing authorization much earlier than that under the conventional system. To foster not only RCGPs, but also innovative pharmaceuticals and medical devices, the Ministry of Health, Labour and Welfare recently launched Translational Research Program for Innovative Pharmaceuticals, Medical Devices and RCGPs. This mini-review introduces contributions of the National Institute of Health Sciences (NIHS) to research projects on RCGPs in the Program.

  10. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.

    Science.gov (United States)

    Salmikangas, Paula; Schuessler-Lenz, Martina; Ruiz, Sol; Celis, Patrick; Reischl, Ilona; Menezes-Ferreira, Margarida; Flory, Egbert; Renner, Matthias; Ferry, Nicolas

    2015-01-01

    With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a centralised marketing authorisation became mandatory. The European Medicines Agency (EMA) together with its Committee for Advanced Therapies, Committee for Human Medicinal Products and the network of national agencies is responsible for scientific evaluation of the marketing authorisation applications. For a new application, data and information relating to manufacturing processes and quality control of the active substance and the final product have to be submitted for evaluation together with data from non-clinical and clinical safety and efficacy studies. Technical requirements for ATMPs are defined in the legislation, and guidance for different products is available through several EMA/CAT guidelines. Due to the diversity of ATMPs, a tailored approach for regulating these products is considered necessary. Thus, a risk-based approach has been introduced for ATMPs allowing flexibility for the regulatory requirements. Since the regulatory framework for ATMPs was established, five products have been licenced in the European Union. However, the pipeline of new ATMPs is much bigger, as seen from the significant numbers of different products discussed by the CAT in scientific advice and classification procedures. In 2013, a public consultation on the ATMP Regulation was conducted by the European Commission, and the results were published in 2014. The report proposes several improvements for the current framework and established procedures for the regulation of ATMPs.

  11. Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe

    Directory of Open Access Journals (Sweden)

    Andreas M. Farkas

    2017-05-01

    Full Text Available In 2008, the European Union introduced the Advanced Medicines Regulation aiming to improve regulation of advanced therapy medicinal products (ATMPs. We applied the ATMPs classification definitions in this Regulation to understand the link of this emerging group of medicinal products and the use of the Orphan Regulation. A total of 185 products that can be classified as ATMPs based on this Regulation have been submitted for orphan designation. Prior to its introduction in 2008, 4.5% of the products submitted for orphan designation met these criteria. This percentage went up to 15% after 2008. We analyzed several parameters associated with active ATMP ODDs focusing on sponsor type and EU-Member State origin, therapeutic area targeted, and ATMP classification [i.e., somatic cell therapy medicinal product, tissue-engineered product (TEP, or gene therapy medicinal product (GTMP] and the use of regulatory services linked to incentives such as the use of protocol assistance (PA and other Committees [Committee for Advanced Therapies (CAT and the Pediatric Committee]. The aim here was to gain insight on the use of different services. The UK submits the largest number of ATMPs for ODD representing ~30% of the total to date. Few submissions have been received from central and Eastern European Member States as well as some of the larger Member States such as Germany (3.6%. ATMPs ODDs were primarily GTMPs (48.7% and SCTMPs (43.3%. TEPs only represented 8% of all submissions for this medicinal class. This is different from non-ODDs ATMPs where GTMPs make only 20% of ATMPs. A total of 11.7% of ATMP ODDs had received formal CAT classification. A total of 29.8% of all orphan drug (OD ATMPs requested PA. A total of 71.8% did not have an agreed pediatric investigation plan (PIP. Four products (Glybera one PA; Zalmoxis two; Holoclar one; Strimvelis three have received a marketing authorization (MAA and a 10-year market exclusivity. Strimvelis also completed their

  12. Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe.

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    Farkas, Andreas M; Mariz, Segundo; Stoyanova-Beninska, Violeta; Celis, Patrick; Vamvakas, Spiros; Larsson, Kristina; Sepodes, Bruno

    2017-01-01

    In 2008, the European Union introduced the Advanced Medicines Regulation aiming to improve regulation of advanced therapy medicinal products (ATMPs). We applied the ATMPs classification definitions in this Regulation to understand the link of this emerging group of medicinal products and the use of the Orphan Regulation. A total of 185 products that can be classified as ATMPs based on this Regulation have been submitted for orphan designation. Prior to its introduction in 2008, 4.5% of the products submitted for orphan designation met these criteria. This percentage went up to 15% after 2008. We analyzed several parameters associated with active ATMP ODDs focusing on sponsor type and EU-Member State origin, therapeutic area targeted, and ATMP classification [i.e., somatic cell therapy medicinal product, tissue-engineered product (TEP), or gene therapy medicinal product (GTMP)] and the use of regulatory services linked to incentives such as the use of protocol assistance (PA) and other Committees [Committee for Advanced Therapies (CAT) and the Pediatric Committee]. The aim here was to gain insight on the use of different services. The UK submits the largest number of ATMPs for ODD representing ~30% of the total to date. Few submissions have been received from central and Eastern European Member States as well as some of the larger Member States such as Germany (3.6%). ATMPs ODDs were primarily GTMPs (48.7%) and SCTMPs (43.3%). TEPs only represented 8% of all submissions for this medicinal class. This is different from non-ODDs ATMPs where GTMPs make only 20% of ATMPs. A total of 11.7% of ATMP ODDs had received formal CAT classification. A total of 29.8% of all orphan drug (OD) ATMPs requested PA. A total of 71.8% did not have an agreed pediatric investigation plan (PIP). Four products (Glybera one PA; Zalmoxis two; Holoclar one; Strimvelis three) have received a marketing authorization (MAA) and a 10-year market exclusivity. Strimvelis also completed their PIP

  13. [Scientific advice by the national and European approval authorities concerning advanced therapy medicinal products].

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    Jost, Nils; Schüssler-Lenz, Martina; Ziegele, Bettina; Reinhardt, Jens

    2015-11-01

    The aim of scientific advice is to support pharmaceutical developers in regulatory and scientific questions, thus facilitating the development of safe and efficacious new medicinal products. Recent years have shown that the development of advanced therapy medicinal products (ATMPs) in particular needs a high degree of regulatory support. On one hand, this is related to the complexity and heterogeneity of this group of medicinal products and on the other hand due to the fact that mainly academic research institutions and small- and medium-sized enterprises (SMEs) are developing ATMPs. These often have limited regulatory experience and resources. In 2009 the Paul-Ehrlich-Institut (PEI) initiated the Innovation Office as a contact point for applicants developing ATMPs. The mandate of the Innovation Office is to provide support on regulatory questions and to coordinate national scientific advice meetings concerning ATMPs for every phase in drug development and especially with view to the preparation of clinical trial applications. On the European level, the Scientific Advice Working Party (SAWP) of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicinal Agency (EMA) offers scientific advice. This article describes the concepts of national and EMA scientific advice concerning ATMPs and summarizes the experience of the last six years.

  14. [Report from the Committee for Advanced Therapies (CAT). Pitfalls on the way from concept to medical treatment with advanced therapy medicinal products].

    Science.gov (United States)

    Reiss, M; Büttel, I C; Schneider, C K

    2011-07-01

    Advanced therapy medicinal products (ATMP) are highly innovative and complex medicines. They comprise gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products (TEP). With the European Regulation on ATMP that came into force in 2008, a consolidated regulatory framework was created, where the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA) plays a central role. This article discusses pitfalls and challenges that the CAT has experienced in its discussions of various procedures. Often ATMPs are developed by small and medium-sized enterprises (SME) which also face nonscientific challenges. The CAT wishes to meet these challenges on a scientific and regulatory level during its 2010-2015 work program.

  15. Advanced Therapy Medicinal Products in type I diabetes mellitus: technological and regulatory challenges

    Directory of Open Access Journals (Sweden)

    Camila Leal-Lopes

    2018-02-01

    Full Text Available Introduction: Type 1 Diabetes mellitus (T1DM is an autoimmune disorder which arises from the destruction of insulin-producing pancreatic β-cells. Currently, Brazil’s advanced therapy medicinal products (ATMP, developed for clinical research and therapeutic purposes, take place in the so-called Cellular Technology Centers (CTC, according to the Resolution nº. 9/2011 of the Collegiate Board of Directors (RDC, enacted by the National Health Surveillance Agency (Anvisa. Objective: This study was conducted with the main objective of describing and discussing the development of ATMP for T1DM treatment. Method: A qualitative research, narrative review and critical discussion of the literature were under taken. Results: ATMP promote new therapeutic approaches for Diabetes, holding great potential to restore the patients’ endogenous insulin secretion, improving their life quality, overcoming the chronic complications of Diabetes and reducing the socioeconomic burden. Nowadays, ATMP in T1DM comprise: a cell therapy; b gene therapy products; c tissue engineering and d ATMPassociated to biopharmaceutical products. Conclusions: Further research should contribute to stimulate public and private organizations to effectively act towards reducing the impact of Diabetes on individuals and the society as a whole. It is essential that Brazilian legislation closely follows the biotechnological developments, supporting the scientific progress and benefiting T1DM patients with modern and cutting-edge therapies.

  16. Access to advanced therapy medicinal products in the EU: where do we stand?

    Science.gov (United States)

    Mahalatchimy, A

    2011-05-01

    The European Union has a public health strategy and will generally ensure in all its policies and activities a "high level of human health protection". The new Regulation (EC) n 1394/2007 on advanced therapy medicinal products (ATMP), stems from this global policy and aims to harmonise access to the ATMP market. A real will for the harmonisation is clearly expressed in legal texts and enforced in the implementable procedures and requirements. However, several barriers remain. On the one hand, the scope of the ATMP Regulation is limited. On the other hand, Member States benefit from a wide margin of action.

  17. From discovery to approval of an advanced therapy medicinal product-containing stem cells, in the EU.

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    Pellegrini, Graziella; Lambiase, Alessandro; Macaluso, Claudio; Pocobelli, Augusto; Deng, Sophie; Cavallini, Gian Maria; Esteki, Roza; Rama, Paolo

    2016-06-01

    In 1997, the human corneal epithelium was reconstructed in vitro and transplanted on patients. Later, it became a routine treatment, before regulations considered advanced therapy medicinal products and drugs on the same lines. Manufacturing, before and after good manufacturing practice setting, was established in different facilities and the clinical application in several hospitals. Advanced therapy medicinal products, including stem cells, are unique products with different challenges than other drugs: some uncertainties, in addition to benefit, cannot be avoided. This review will focus on all recent developments in the stem cell-based corneal therapy.

  18. The early career researcher's toolkit: translating tissue engineering, regenerative medicine and cell therapy products.

    Science.gov (United States)

    Rafiq, Qasim A; Ortega, Ilida; Jenkins, Stuart I; Wilson, Samantha L; Patel, Asha K; Barnes, Amanda L; Adams, Christopher F; Delcassian, Derfogail; Smith, David

    2015-11-01

    Although the importance of translation for the development of tissue engineering, regenerative medicine and cell-based therapies is widely recognized, the process of translation is less well understood. This is particularly the case among some early career researchers who may not appreciate the intricacies of translational research or make decisions early in development which later hinders effective translation. Based on our own research and experiences as early career researchers involved in tissue engineering and regenerative medicine translation, we discuss common pitfalls associated with translational research, providing practical solutions and important considerations which will aid process and product development. Suggestions range from effective project management, consideration of key manufacturing, clinical and regulatory matters and means of exploiting research for successful commercialization.

  19. Regulation of advanced therapy medicinal products in Europe and the role of academia.

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    Pearce, Kim F; Hildebrandt, Martin; Greinix, Hildegard; Scheding, Stefan; Koehl, Ulrike; Worel, Nina; Apperley, Jane; Edinger, Matthius; Hauser, Andrea; Mischak-Weissinger, Eva; Dickinson, Anne M; Lowdell, Mark W

    2014-03-01

    Advanced therapy medicinal products (ATMP) are gene therapy, somatic cell therapy or tissue-engineered products regulated under (EC) No. 1394/2007 to ensure their free movement within the European Union while guaranteeing the highest level of health protection for patients. Academic good manufacturing practice (GMP) centers are major contributors in the development of ATMPs and this study assessed the impact of regulations on them. European academic and non-industrial facilities (n = 747) were contacted, and a representative sample of 50 replied to a detailed questionnaire. Experienced centres were further selected in every Member State (MS) for semi-structured interviews. Indicators of ATMP production and development success were statistically assessed, and opinions about directive implementation were documented. Facilities experienced in manufacturing cell therapy transplant products are the most successful in developing ATMPs. New centres lacking this background struggle to enter the field, and there remains a shortage of facilities in academia participating in translational research. This is compounded by heterogeneous implementation of the regulations across MS. GMP facilities successfully developing ATMPs are present in all MS. However, the implementation of regulations is heterogeneous between MS, with substantial differences in the definition of ATMPs and in the approved manufacturing environment. The cost of GMP compliance is underestimated by research funding bodies. This is detrimental to development of new ATMPs and commercialization of any that are successful in early clinical trials. Academic GMP practitioners should strengthen their political visibility and contribute to the development of functional and effective European Union legislation in this field. Copyright © 2014 International Society for Cellular Therapy. All rights reserved.

  20. [The certification of advanced therapy medicinal products. A quality label for product development in small and medium-sized enterprises].

    Science.gov (United States)

    Berger, A; Schüle, S; Flory, E

    2011-07-01

    Advanced therapy medicinal products (ATMPs) are gene therapy, cell therapy, and tissue engineered products. To gain access to the market within the European Union, ATMPs must be authorized by the European Commission (EC). Especially for small and medium-sized enterprises (SMEs), the European centralized procedure of marketing authorization that is conducted by the European Medicines Agency (EMA) constitutes a major challenge, because SMEs often have little experience with regulatory procedures and many have limited financial possibilities. To tackle these challenges, a certification procedure exclusively for SMEs and their ATMP development was introduced by the EC. Independently from a marketing authorization application, development and/or production processes can be certified. An issued certificate demonstrates that the respective process meets the current regulatory and scientific requirements of the EMA, representing a valuable milestone for putative investors and licensees. This article highlights the background, the detailed procedure, the minimum requirements, as well as the costs of certification, while giving further noteworthy guidance for interested parties.

  1. Advanced Therapy Medicinal Products (ATMPand exemptions to the Regulation 1394/2007: how confident can we be? An exploratory analysis.

    Directory of Open Access Journals (Sweden)

    Philippe eVan Wilder

    2012-02-01

    Full Text Available The market authorisation procedure for medicinal products for human use is relying on their demonstrated efficacy, safety and pharmaceutical quality. This applies to all medicinal products whether of chemical or biological origin. Since October 2009, the first advanced therapy medicinal product (ATMP has been authorised through the centralized procedure. ATMPs are gene therapy medicinal products, somatic cell therapy medicinal products or tissue-engineered products.An appropriate ATMP- Regulation is dealing with ATMP requirements.Two exemptions are foreseen to the ATMP-Regulation: a. Products, which were legally on the Community market when the Regulation became applicable, should comply to the Regulation by 30 December 2012. b.the hospital exemption rule for non routine products for an individual patient. In this work we explored whether the actual application of the Regulation on ATMPs is in line with the aim of the Regulation in terms of guaranteeing the highest level of health protection for patients. Based on the analysis of the relative efficacy of the only EC authorized ATMP and its exempted alternatives, there is evidence against this Regulation 1394/2007 assumption.

  2. Advanced Therapy Medicinal Products and Exemptions to the Regulation 1394/2007: How Confident Can We be? An Exploratory Analysis.

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    Van Wilder, Philippe

    2012-01-01

    The market authorization procedure for medicinal products for human use is relying on their demonstrated efficacy, safety, and pharmaceutical quality. This applies to all medicinal products whether of chemical or biological origin. Since October 2009, the first advanced therapy medicinal product (ATMP) has been authorized through the centralized procedure. ATMPs are gene therapy medicinal products, somatic cell therapy medicinal products or tissue-engineered products. An appropriate ATMP - Regulation is dealing with ATMP requirements. Two exemptions are foreseen to the ATMP Regulation: (a) Products, which were legally on the Community market when the Regulation became applicable, should comply to the Regulation by December 30, 2012. (b) The hospital exemption rule for non-routine products for an individual patient. In this work we explored whether the actual application of the Regulation on ATMPs is in line with the aim of the Regulation in terms of guaranteeing the highest level of health protection for patients. Based on the analysis of the relative efficacy of the only EC authorized ATMP and its exempted alternatives, there is evidence against this Regulation 1394/2007 assumption.

  3. Three-Dimensional Printing of Medicinal Products and the Challenge of Personalized Therapy.

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    Zema, Lucia; Melocchi, Alice; Maroni, Alessandra; Gazzaniga, Andrea

    2017-07-01

    By 3-dimensional (3D) printing, solid objects of any shape are fabricated through layer-by-layer addition of materials based on a digital model. At present, such a technique is broadly exploited in many industrial fields because of major advantages in terms of reduced times and costs of development and production. In the biomedical and pharmaceutical domains, the interest in 3D printing is growing in step with the needs of personalized medicine. Printed scaffolds and prostheses have partly replaced medical devices produced by more established techniques, and more recently, 3D printing has been proposed for the manufacturing of drug products. Notably, the availability of patient-tailored pharmaceuticals would be of utmost importance for children, elderly subjects, poor and high metabolizers, and individuals undergoing multiple drug treatments. 3D printing encompasses a range of differing techniques, each involving advantages and open issues. Particularly, solidification of powder, extrusion, and stereolithography have been applied to the manufacturing of drug products. The main challenge to their exploitation for personalized pharmacologic therapy is likely to be related to the regulatory issues involved and to implementation of production models that may allow to efficiently turn the therapeutic needs of individual patients into small batches of appropriate drug products meeting preset quality requirements. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  4. EU decision-making for marketing authorization of advanced therapy medicinal products: a case study.

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    de Wilde, Sofieke; Coppens, Delphi G M; Hoekman, Jarno; de Bruin, Marie L; Leufkens, Hubert G M; Guchelaar, Henk-Jan; Meij, Pauline

    2018-03-21

    A comparative analysis of assessment procedures for authorization of all European Union (EU) applications for advanced therapy medicinal products (ATMPs) shows that negative opinions were associated with a lack of clinical efficacy and identified severe safety risks. Unmet medical need was often considered in positive opinions and outweighed scientific uncertainties. Numerous quality issues illustrate the difficulties in this domain for ATMP development. Altogether, it suggests that setting appropriate standards for ATMP authorization in Europe, similar to elsewhere, is a learning experience. The experimental characteristics of authorized ATMPs urge regulators, industry, and clinical practice to pay accurate attention to post-marketing risk management to limit patient risk. Methodologies for ATMP development and regulatory evaluations need to be continuously evaluated for the field to flourish. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  5. Hurdles in clinical implementation of academic advanced therapy medicinal products: A national evaluation.

    Science.gov (United States)

    de Wilde, Sofieke; Veltrop-Duits, Louise; Hoozemans-Strik, Merel; Ras, Thirza; Blom-Veenman, Janine; Guchelaar, Henk-Jan; Zandvliet, Maarten; Meij, Pauline

    2016-06-01

    Since the implementation of the European Union (EU) regulation for advanced therapy medicinal products (ATMPs) in 2009, only six ATMPs achieved marketing authorization approval in the EU. Recognizing the major developments in the ATMP field, starting mostly in academic institutions, we investigated which hurdles were experienced in the whole pathway of ATMP development towards clinical care. Quality interviews were executed with different stakeholders in The Netherlands involved in the ATMP development field, e.g. academic research groups, national authorities and patient organizations. Based on the hurdles mentioned in the interviews, questionnaires were subsequently sent to the academic principal investigators (PIs) and ATMP good manufacturing practice (GMP) facility managers to quantify these hurdles. Besides the familiar regulatory routes of marketing authorization (MA) and hospital exemption (HE), a part of the academic PIs perceived that ATMPs should become available by the Tissues and Cells Directive or did not anticipate on the next development steps towards implementation of their ATMP towards regular clinical care. The main hurdles identified were: inadequate financial support, rapidly evolving field, study-related problems, lacking regulatory knowledge, lack of collaborations and responsibility issues. Creating an academic environment stimulating and planning ATMP development and licensing as well as investing in expanding the relevant regulatory knowledge in academic institutions seems a prerequisite to develop ATMPs from bench to patient. Copyright © 2016 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  6. Nuclear medicine therapy

    CERN Document Server

    Eary, Janet F

    2013-01-01

    One in three of the 30 million Americans who are hospitalized are diagnosed or treated with nuclear medicine techniques. This text provides a succinct overview and detailed set of procedures and considerations for patient therapy with unsealed radioactivity sources.  Serving as a complete literature reference for therapy with radiopharmaceuticals currently utilized in practice, this source covers the role of the physician in radionuclide therapy, and essential procedures and protocols required by health care personnel.

  7. Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market - Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014.

    Science.gov (United States)

    Celis, Patrick; Ferry, Nicolas; Hystad, Marit; Schüßler-Lenz, Martina; Doevendans, Pieter A; Flory, Egbert; Beuneu, Claire; Reischl, Ilona; Salmikangas, Paula

    2015-05-01

    On September 11, 2014, a workshop entitled 'Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Product Successfully to the Market' was held at the 47th annual meeting of the German Society for Transfusion Medicine and Immunohematology (DGTI), co-organised by the European Medicines Agency (EMA) and the DGTI in collaboration with the German Stem Cell Network (GSCN). The workshop brought together over 160 participants from academia, hospitals, small- or medium-sized enterprise developers and regulators. At the workshop, speakers from EMA, the Committee for Advanced Therapies (CAT), industry and academia addressed the regulatory aspects of development and authorisation of advanced therapy medicinal products (ATMPs), classification of ATMPs and considerations on cell-based therapies for cardiac repair. The open forum discussion session allowed for a direct interaction between ATMP developers and the speakers from EMA and CAT.

  8. Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market – Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014

    Science.gov (United States)

    Celis, Patrick; Ferry, Nicolas; Hystad, Marit; Schüßler-Lenz, Martina; Doevendans, Pieter A.; Flory, Egbert; Beuneu, Claire; Reischl, Ilona; Salmikangas, Paula

    2015-01-01

    On September 11, 2014, a workshop entitled ‘Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Product Successfully to the Market’ was held at the 47th annual meeting of the German Society for Transfusion Medicine and Immunohematology (DGTI), co-organised by the European Medicines Agency (EMA) and the DGTI in collaboration with the German Stem Cell Network (GSCN). The workshop brought together over 160 participants from academia, hospitals, small- or medium-sized enterprise developers and regulators. At the workshop, speakers from EMA, the Committee for Advanced Therapies (CAT), industry and academia addressed the regulatory aspects of development and authorisation of advanced therapy medicinal products (ATMPs), classification of ATMPs and considerations on cell-based therapies for cardiac repair. The open forum discussion session allowed for a direct interaction between ATMP developers and the speakers from EMA and CAT. PMID:26195933

  9. COMPARATIVE EFFICACY AND SAFETY OF HYPOLIPIDEMIC THERAPY WITH GENERIC AND ORIGINAL MEDICINAL PRODUCTS OF SIMVASTATIN

    Directory of Open Access Journals (Sweden)

    E. I. Tarlovskaya

    2011-01-01

    Full Text Available Aim. To compare efficacy , safety and pharmacoeconomical characteristics of generic and original medicinal products of simvastatin in achievement of cholesterol and low density lipoprotein target levels. Material and methods. 38 patients with arterial hypertension accompanied by type 2 diabetes with dyslipidemia were included into the study. They had no clinically obvious ischemic heart disease and did not receive hypolipidemic pharmacotherapy for a month before the study start. The patients were randomized into group A or group B. Patients of group A (n=18 received original simvastatin, patients of group B (n=20 received generic simvastatin. Initial simvastatin dose was 20 mg daily. Lipid plasma profile, liver enzymes, creatine phosphokinase were evaluated every 4 weeks. Cost-effectiveness ratio was calculated. Results. 11 patients (61% in group A and only 5 patients (25% in group B (χ2=5.05; р<0.05 achieved cholesterol target level with simvastatin in dose of 20 mg daily in 3 months of the treatment. Creatine phosphokinase blood level did not increase significantly. Achievement of cholesterol target level cost 814 and 952 RUB per patient in groups A and B, respectively , in 1 month of simvastatin treatment. These costs were 643 and 417 RUB per patient in groups A and B, respectively , in 3 months of treatment. Conclusion. The original simvastatin in comparison with generic one has advantages in hypolipidemic effect. Safety profile is similar for both medications. Original simvastatin therapy has lower cost than this for generic simvastatin therapy in achievement of cholesterol target level in 1 month of treatment. In 3 months the cost of treatment per patient is 227 RUB higher for original medication in comparison with this for generic medication.

  10. The early career researcher's toolkit:translating tissue engineering, regenerative medicine and cell therapy products

    OpenAIRE

    Rafiq, Qasim A.; Ortega, Ilida; Jenkins, Stuart I.; Wilson, Samantha L.; Patel, Asha K.; Barnes, Amanda L.; Adams, Christopher F.; Delcassian, Derfogail; Smith, David

    2015-01-01

    Although the importance of translation for the development of tissue engineering, regenerative medicine and cell-based therapies is widely recognized, the process of translation is less well understood. This is particularly the case among some early career researchers who may not appreciate the intricacies of translational research or make decisions early in development which later hinders effective translation. Based on our own research and experiences as early career researchers involved in...

  11. Current advanced therapy cell-based medicinal products for type-1-diabetes treatment.

    Science.gov (United States)

    Cañibano-Hernández, Alberto; Del Burgo, Laura Sáenz; Espona-Noguera, Albert; Ciriza, Jesús; Pedraz, Jose Luis

    2018-03-27

    In the XXI century diabetes mellitus has become one of the main threats to human health with higher incidence in regions such as Europe and North America. Type 1 diabetes mellitus (T1DM) occurs as a consequence of the immune-mediated destruction of insulin producing β-cells located in the endocrine part of the pancreas, the islets of Langerhans. The administration of exogenous insulin through daily injections is the most prominent treatment for T1DM but its administration is frequently associated to failure in glucose metabolism control, finally leading to hyperglycemia episodes. Other approaches have been developed in the past decades, such as whole pancreas and islet allotransplantation, but they are restricted to patients who exhibit frequent episodes of hypoglycemia or renal failure because the lack of donors and islet survival. Moreover, patients transplanted with either whole pancreas or islets require of immune suppression to avoid the rejection of the transplant. Currently, advanced therapy medicinal products (ATMP), such as implantable devices, have been developed in order to reduce immune rejection response while increasing cell survival. To overcome these issues, ATMPs must promote vascularization, guaranteeing the nutritional contribution, while providing O 2 until vasculature can surround the device. Moreover, it should help in the immune-protection to avoid acute and chronic rejection. The transplanted cells or islets should be embedded within biomaterials with tunable properties like injectability, stiffness and porosity mimicking natural ECM structural characteristics. And finally, an infinitive cell source that solves the donor scarcity should be found such as insulin producing cells derived from mesenchymal stem cells (MSCs), embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs). Several companies have registered their ATMPs and future studies envision new prototypes. In this review, we will discuss the mechanisms and etiology of

  12. Therapy in nuclear medicine

    International Nuclear Information System (INIS)

    Eftekhari, M.; Sadeghi, R.; Takavar, A.; Fard, A.; Saghari, M.

    2002-01-01

    Although there have been very significant development in the field of radionuclide therapy within the past 10 years, radionuclide therapy in the form of 131 I, 33 P,.... have been in use for over 46 years. Palliation of bone pain is a good example for radionuclide therapy. It has an especial role in advanced metastatic cancer. 32 P, 89 Sr-Cl, 186 Re-HEDP, 133 Sm-EDTMP, and 117 mSn-DTPA are used in these patients. They are usually effective and help to maintain a painless life for patients with advanced cancer. Although this kind of therapy is not as rapid as radiotherapy, its effect lasts longer. In addition re-treatment with these agents is safe and effective. Radioimmunotherapy is a new exciting technique in the radionuclide therapy. In this technique monoclonal antibodies or their fragments are labeled with a suitable radionuclide, these antibodies can irradiate tumor cells over a distance of some fraction of a millimeter. Bulky tumors are obviously unsuitable targets for Rit. Several antibodies specific for Cd 20 (B1 and 1 F 5) and CD 37 (Mb-1) labeled with 131 I have been used for hematologic malignancies with good response. Several antigens associated with carcinomas of various histologic types have been targeted for therapeutic purposes by antibodies labeled with different radionuclides. Other routes of administration like intraperitoneal, intrathecal, and intravesical have been used with different rates of success. Pre targeting techniques can be used to reduce unwanted radioactive concentration in normal tissues. The avidin-biotin system is an example, which exploits the high-affinity binding between avidin and biotin, and was first used with anti-Cea antibody. Radiation synovectomy is another aspect of radionuclide therapy 198 Au colloid, 90 Y resin colloid, and 165 Dy-FHMA are some of the radionuclides used in the field of hematology. There has been significant advances in the field of therapy in nuclear medicine in recent years, which are briefly

  13. Good Manufacturing Practices (GMP) manufacturing of advanced therapy medicinal products: a novel tailored model for optimizing performance and estimating costs.

    Science.gov (United States)

    Abou-El-Enein, Mohamed; Römhild, Andy; Kaiser, Daniel; Beier, Carola; Bauer, Gerhard; Volk, Hans-Dieter; Reinke, Petra

    2013-03-01

    Advanced therapy medicinal products (ATMP) have gained considerable attention in academia due to their therapeutic potential. Good Manufacturing Practice (GMP) principles ensure the quality and sterility of manufacturing these products. We developed a model for estimating the manufacturing costs of cell therapy products and optimizing the performance of academic GMP-facilities. The "Clean-Room Technology Assessment Technique" (CTAT) was tested prospectively in the GMP facility of BCRT, Berlin, Germany, then retrospectively in the GMP facility of the University of California-Davis, California, USA. CTAT is a two-level model: level one identifies operational (core) processes and measures their fixed costs; level two identifies production (supporting) processes and measures their variable costs. The model comprises several tools to measure and optimize performance of these processes. Manufacturing costs were itemized using adjusted micro-costing system. CTAT identified GMP activities with strong correlation to the manufacturing process of cell-based products. Building best practice standards allowed for performance improvement and elimination of human errors. The model also demonstrated the unidirectional dependencies that may exist among the core GMP activities. When compared to traditional business models, the CTAT assessment resulted in a more accurate allocation of annual expenses. The estimated expenses were used to set a fee structure for both GMP facilities. A mathematical equation was also developed to provide the final product cost. CTAT can be a useful tool in estimating accurate costs for the ATMPs manufactured in an optimized GMP process. These estimates are useful when analyzing the cost-effectiveness of these novel interventions. Copyright © 2013 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  14. [Requirements for long-term follow-up on efficacy and safety of advanced therapy medicinal products. Risk management and traceability].

    Science.gov (United States)

    Klug, B; Reinhardt, J; Schröder, C

    2010-01-01

    Advanced therapy medicinal products (ATMPs) are an innovative treatment option. To promote timely access of the innovative medicinal product and to safeguard public health, new elements have been introduced into legislation. A key element of the ATMP regulation is the requirement for long-term follow-up on safety and efficacy of patients enrolled in clinical trials with ATMPs, which is beyond the routine requirements on pharmacovigilance. For gene therapy medicinal products, a guideline on long-term follow-up, which lays down the technical requirements, is available. A further key element of the ATMP regulation is the traceability of the starting materials used to manufacture the ATMP. A common European coding system is imperative to ensure the traceability of starting materials, especially across the borders of European Member States.

  15. Comparison of advanced therapy medicinal product gingiva and skin substitutes and their in vitro wound healing potentials.

    Science.gov (United States)

    Boink, Mireille A; Roffel, Sanne; Breetveld, Melanie; Thon, Maria; Haasjes, Michiel S P; Waaijman, Taco; Scheper, Rik J; Blok, Chantal S; Gibbs, Susan

    2018-02-01

    Skin and oral mucosa substitutes are a therapeutic option for closing hard-to-heal skin and oral wounds. Our aim was to develop bi-layered skin and gingiva substitutes, from 3 mm diameter biopsies, cultured under identical conditions, which are compliant with current European regulations for advanced therapy medicinal products. We present in vitro mode of action methods to (i) determine viability: epithelial expansion, proliferation (Ki-67), metabolic activity (MTT assay); (ii) characterize skin and gingiva substitutes: histology and immunohistochemistry; and (iii) determine potency: soluble wound healing mediator release (enzyme-linked immunosorbent assay). Both skin and gingiva substitutes consist of metabolically active autologous reconstructed differentiated epithelium expanding from the original biopsy sheet on a fibroblast populated connective tissue matrix (donor dermis). Gingival epithelium expanded 1.7-fold more than skin epithelium during the 3 week culture period. The percentage of proliferating Ki-67-positive cells located in the basal layer of the gingiva substitute was >1.5-fold higher than in the skin substitute. Keratins 16 and 17, which are upregulated during normal wound healing, were expressed in both the skin and gingiva substitutes. Notably, the gingiva substitute secreted higher amounts of key cytokines involved in mitogenesis, motogenesis and chemotaxis (interleukin-6 > 23-fold, CXCL8 > 2.5-fold) as well as higher amounts of the anti-fibrotic growth factor, hepatocyte growth factor (>7-fold), compared with the skin substitute. In conclusion, while addressing the viability, characterization and potency of the tissue substitutes, important intrinsic differences between skin and gingiva were discovered that may explain in part the superior quality of wound healing observed in the oral mucosa compared with skin. Copyright © 2017 The Authors. Tissue Engineering and Regenerative Medicine published by John Wiley & Sons, Ltd.

  16. Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving?

    Science.gov (United States)

    Boráň, Tomáš; Menezes-Ferreira, Margarida; Reischl, Ilona; Celis, Patrick; Ferry, Nicolas; Gänsbacher, Bernd; Krafft, Hartmut; Lipucci di Paola, Michele; Sladowski, Dariusz; Salmikangas, Paula

    2017-09-01

    The research and development of advanced therapy medicinal products (ATMPs) has been active in Europe and worldwide during recent years. Yet, the number of licensed products remains low. The main expected legal change in the near future in the European Union (EU) concerns the regulation on clinical trials (536/2014), which will come into force in 2018. With this new framework, a more harmonized and swift process for approval of clinical trials is anticipated, which is expected to support the entry of new innovations into the EU market. A survey on ATMPs in clinical trials during 2010-2015 in the EU was conducted in order to study the trends of ATMP development since the earlier survey published in 2012. According to the results, the number of clinical trials using ATMPs is slowly increasing in the EU. Yet, the focus is still in early development, and the projects are mainly carried out by small and medium-sized enterprises, academia, and hospitals. Oncology is the main area of clinical development. Yet, the balance between cell-based products and gene therapy medicinal products in this area may be changing in the future due to the new T-cell technologies. Many limitations and challenges are identified for ATMP development, requiring proportionate regulatory requirements. On the other hand, for such a novel field, the developers should be active in considering possible constraints and actively engage with authorities to look for solutions. This article provides up to-date information on forthcoming regulatory improvements and discusses the main challenges hampering the commercialization of ATMPs in the EU.

  17. Gene therapy and reproductive medicine.

    Science.gov (United States)

    Stribley, John M; Rehman, Khurram S; Niu, Hairong; Christman, Gregory M

    2002-04-01

    To review the literature on the principles of gene therapy and its potential application in reproductive medicine. Literature review. Gene therapy involves transfer of genetic material to target cells using a delivery system, or vector. Attention has primarily focused on viral vectors. Significant problems remain to be overcome including low efficacy of gene transfer, the transient expression of some vectors, safety issues with modified adenoviruses and retroviruses, and ethical concerns. If these issues can be resolved, gene therapy will be applicable to an increasing spectrum of single and multiple gene disorders, as the Human Genome Project data are analyzed, and the genetic component of human disease becomes better understood. Gynecologic gene therapy has advanced to human clinical trials for ovarian carcinoma, and shows potential for the treatment of uterine leiomyomata. Obstetric applications of gene therapy, including fetal gene therapy, remain more distant goals. Concerns about the safety of human gene therapy research are being actively addressed, and remarkable progress in improving DNA transfer has been made. The first treatment success for a genetic disease (severe combined immunodeficiency disease) has been achieved, and ongoing research efforts will eventually yield clinical applications in many spheres of reproductive medicine.

  18. Complementary Therapies and Medicines and Reproductive Medicine.

    Science.gov (United States)

    Smith, Caroline A; Armour, Mike; Ee, Carolyn

    2016-03-01

    Complementary therapies and medicines are a broad and diverse range of treatments, and are frequently used by women and their partners during the preconception period to assist with infertility, and to address pregnancy-related conditions. Despite frequent use, the evidence examining the efficacy, effectiveness, and safety for many modalities is lacking, with variable study quality. In this article, we provide an overview of research evidence with the aim of examining the evidence to inform clinical practice. During the preconception period, there is mixed evidence for acupuncture to improve ovulation, or increase pregnancy rates. Acupuncture may improve sperm quality, but there is insufficient evidence to determine whether this results in improved pregnancy and live birth rates. Acupuncture can be described as a low-risk intervention. Chinese and Western herbal medicines may increase pregnancy rates; however, study quality is low. The evaluation of efficacy, effectiveness, and safety during the first trimester of pregnancy has most commonly reported on herbs, supplements, and practices such as acupuncture. There is high-quality evidence reporting the benefits of herbal medicines and acupuncture to treat nausea in pregnancy. The benefit from ginger to manage symptoms of nausea in early pregnancy is incorporated in national clinical guidelines, and vitamin B6 is recommended as a first-line treatment for nausea and vomiting in pregnancy. The safety of ginger and vitamin B6 is considered to be well established, and is based on epidemiological studies. Acupuncture has been shown to reduce back pain and improve function for women in early pregnancy. There is little evidence to support the use of cranberries in pregnancy for prevention of urinary tract infections, and chiropractic treatment for back pain. Overall the numbers of studies are small and of low quality, although the modalities appear to be low risk of harm. Thieme Medical Publishers 333 Seventh Avenue, New

  19. [Personalized medicine in transplantation therapy].

    Science.gov (United States)

    Nakatani, Kaname

    2013-05-01

    Personalized medicine based on pharmacogenomics is being developed at the clinical stage. Various evidence is accumulating in transplantation therapy. Tacrolimus, a calcineurin inhibitor, is usually used for immunosuppressive therapy after transplantation. Tacrolimus is mainly metabolized by cytochrome P450 isozymes, CYP3A4 and CYP3A5, expressed in the intestine as well as in the liver. Recent studies of pharmacogenomics have reported that several single nucleotide polymorphisms (SNPs) of CYP3A5 are correlated with gene expression and enzyme activity. Phenotypes of CYP3A5 are typed as expressors (*1/*1 and *1/*3) or non-expressors (*3/*3) . In living-donor liver transplantation, CYP3A5 phenotypes could predict the blood concentration of tacrolimus. In particular, preoperative assessment of CYP3A5 genotypes in both recipients (intestine) and donors (graft liver) is required for predicting tacrolimus pharmacokinetics. In kidney transplantation, blood tacrolimus concentrations were significantly different between expressors and non-expressors. Genotyping and phenotyping of recipients were useful to predict blood tacrolimus levels in early phase of post-transplantation. Furthermore, phenotypes of CYP3A5 could predict the initial dose of tacrolimus. Combination therapy was performed after bone marrow transplantation to prevent complications. Genotyping and phenotyping of metabolic enzymes for combination dugs would be useful for predicting drug actions. In conclusion, phenotyping based on pharmacogenomics supports personalized medicine in transplantation therapy. In future, multiplex testing should be developed to support personalized medicine in various fields.

  20. Metabolic radiopharmaceutical therapy in nuclear medicine

    International Nuclear Information System (INIS)

    Reguera, L.; Lozano, M. L.; Alonso, J. C.

    2016-01-01

    In 1986 the National Board of Medical Specialties defined the specialty of nuclear medicine as a medical specialty that uses radioisotopes for prevention, diagnosis, therapy and medical research. Nowadays, treatment with radiopharmaceuticals has reached a major importance within of nuclear medicine. The ability to treat tumors with radiopharmaceutical, Radiation selective therapy has become a first line alternative. In this paper, the current situation of the different therapies that are sued in nuclear medicine, is reviewed. (Author)

  1. Food therapy and medical diet therapy of Traditional Chinese Medicine

    OpenAIRE

    Qunli Wu; Xiaochun Liang

    2018-01-01

    Food therapy of traditional Chinese medicine aims to maintain balanced nutrition through diet. Medical diet therapy, however, is to achieve the balance of Yin and Yang through the combination of nutrition and medicine. Either “food therapy” or “medical diet therapy” aims to keep health, prevent disease, remove illness and slow aging. In recent years, both food therapy and medical diet therapy have been increasingly applied in clinical nutrition therapy. In terms of traditional Chinese food th...

  2. Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133+ Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy

    Directory of Open Access Journals (Sweden)

    Daniela Belotti

    2015-01-01

    Full Text Available According to the European Medicine Agency (EMA regulatory frameworks, Advanced Therapy Medicinal Products (ATMP represent a new category of drugs in which the active ingredient consists of cells, genes, or tissues. ATMP-CD133 has been widely investigated in controlled clinical trials for cardiovascular diseases, making CD133+ cells one of the most well characterized cell-derived drugs in this field. To ensure high quality and safety standards for clinical use, the manufacturing process must be accomplished in certified facilities following standard operative procedures (SOPs. In the present work, we report the fully compliant GMP-grade production of ATMP-CD133 which aims to address the treatment of chronic refractory ischemic heart failure. Starting from bone marrow (BM, ATMP-CD133 manufacturing output yielded a median of 6.66 × 106 of CD133+ cells (range 2.85 × 106–30.84 × 106, with a viability ranged between 96,03% and 99,97% (median 99,87% and a median purity of CD133+ cells of 90,60% (range 81,40%–96,20%. Based on these results we defined our final release criteria for ATMP-CD133: purity ≥ 70%, viability ≥ 80%, cellularity between 1 and 12 × 106 cells, sterile, and endotoxin-free. The abovementioned criteria are currently applied in our Phase I clinical trial (RECARDIO Trial.

  3. Full GMP-compliant validation of bone marrow-derived human CD133(+) cells as advanced therapy medicinal product for refractory ischemic cardiomyopathy.

    Science.gov (United States)

    Belotti, Daniela; Gaipa, Giuseppe; Bassetti, Beatrice; Cabiati, Benedetta; Spaltro, Gabriella; Biagi, Ettore; Parma, Matteo; Biondi, Andrea; Cavallotti, Laura; Gambini, Elisa; Pompilio, Giulio

    2015-01-01

    According to the European Medicine Agency (EMA) regulatory frameworks, Advanced Therapy Medicinal Products (ATMP) represent a new category of drugs in which the active ingredient consists of cells, genes, or tissues. ATMP-CD133 has been widely investigated in controlled clinical trials for cardiovascular diseases, making CD133(+) cells one of the most well characterized cell-derived drugs in this field. To ensure high quality and safety standards for clinical use, the manufacturing process must be accomplished in certified facilities following standard operative procedures (SOPs). In the present work, we report the fully compliant GMP-grade production of ATMP-CD133 which aims to address the treatment of chronic refractory ischemic heart failure. Starting from bone marrow (BM), ATMP-CD133 manufacturing output yielded a median of 6.66 × 10(6) of CD133(+) cells (range 2.85 × 10(6)-30.84 × 10(6)), with a viability ranged between 96,03% and 99,97% (median 99,87%) and a median purity of CD133(+) cells of 90,60% (range 81,40%-96,20%). Based on these results we defined our final release criteria for ATMP-CD133: purity ≥ 70%, viability ≥ 80%, cellularity between 1 and 12 × 10(6) cells, sterile, and endotoxin-free. The abovementioned criteria are currently applied in our Phase I clinical trial (RECARDIO Trial).

  4. Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133+ Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy

    Science.gov (United States)

    Belotti, Daniela; Gaipa, Giuseppe; Bassetti, Beatrice; Cabiati, Benedetta; Spaltro, Gabriella; Biagi, Ettore; Parma, Matteo; Biondi, Andrea; Cavallotti, Laura; Gambini, Elisa; Pompilio, Giulio

    2015-01-01

    According to the European Medicine Agency (EMA) regulatory frameworks, Advanced Therapy Medicinal Products (ATMP) represent a new category of drugs in which the active ingredient consists of cells, genes, or tissues. ATMP-CD133 has been widely investigated in controlled clinical trials for cardiovascular diseases, making CD133+ cells one of the most well characterized cell-derived drugs in this field. To ensure high quality and safety standards for clinical use, the manufacturing process must be accomplished in certified facilities following standard operative procedures (SOPs). In the present work, we report the fully compliant GMP-grade production of ATMP-CD133 which aims to address the treatment of chronic refractory ischemic heart failure. Starting from bone marrow (BM), ATMP-CD133 manufacturing output yielded a median of 6.66 × 106 of CD133+ cells (range 2.85 × 106–30.84 × 106), with a viability ranged between 96,03% and 99,97% (median 99,87%) and a median purity of CD133+ cells of 90,60% (range 81,40%–96,20%). Based on these results we defined our final release criteria for ATMP-CD133: purity ≥ 70%, viability ≥ 80%, cellularity between 1 and 12 × 106 cells, sterile, and endotoxin-free. The abovementioned criteria are currently applied in our Phase I clinical trial (RECARDIO Trial). PMID:26495296

  5. Massage Therapy in Iranian Traditional Medicine

    Directory of Open Access Journals (Sweden)

    Amir-Mohammad Jaladat

    2012-10-01

    Full Text Available Background and Aim: Massage training and how the body is influenced by massage are common issues which are seriously under study and discussion in Iranian traditional medicine. Iranian physicians considered motion and massage as major principles of health maintenance.In this study, we examined the available literature of traditional medicine to evaluate location, purpose and use of massage therapy in Iranian medicine in comparison with other popular conventional styles.The aim of Iranian massage is to regulate the core body temperature and aid to eliminate the waste products from the body. This type of massage is divided into five categories including solid, soft, moderate, great and aggressive, based on the intensity, speed, duration and techniques of massage.Iranian physicians proposed general body massage or massage of a particular area based on subjective complaints. They recommended specific massages in particular groups including children, pregnant women, the elderly and athletes. In some cases, the effects of these recommendations have been studied in clinical trials.Conclusion: It seems that the major difference between Iranian massage and other styles of massage is special attention of Iranian massage to the individual circumstances, and the cause of the problem rather than technique of the massage.

  6. Molecular methods in nuclear medicine therapy

    International Nuclear Information System (INIS)

    Lee, Kyung Han

    2001-01-01

    Nuclear medicine has traditionally contributed to molecular oncology by allowing noninvasive monitoring of tumor metabolism, growth and genetic changes, thereby providing a basis for appropriate biology-based treatment planning. However, NM techniques are now being applied as an active therapeutic tool in novel molecular approaches for cancer treatment. Such areas include research on cancer therapy with radiolabeled ligands or oligonucleotides, and utilization of synergism between NM radiotherapy and gene transfer techniques. Here we will focus on novel aspects of nuclear medicine therapy

  7. The assessment and appraisal of regenerative medicines and cell therapy products: an exploration of methods for review, economic evaluation and appraisal.

    Science.gov (United States)

    Hettle, Robert; Corbett, Mark; Hinde, Sebastian; Hodgson, Robert; Jones-Diette, Julie; Woolacott, Nerys; Palmer, Stephen

    2017-02-01

    The National Institute for Health and Care Excellence (NICE) commissioned a 'mock technology appraisal' to assess whether changes to its methods and processes are needed. This report presents the findings of independent research commissioned to inform this appraisal and the deliberations of a panel convened by NICE to evaluate the mock appraisal. Our research included reviews to identify issues, analysis methods and conceptual differences and the relevance of alternative decision frameworks, alongside the development of an exemplar case study of chimeric antigen receptor (CAR) T-cell therapy for treating acute lymphoblastic leukaemia. An assessment of previous evaluations of regenerative medicines found that, although there were a number of evidential challenges, none was unique to regenerative medicines or was beyond the scope of existing methods used to conceptualise decision uncertainty. Regarding the clinical evidence for regenerative medicines, the issues were those associated with a limited evidence base but were not unique to regenerative medicines: small non-randomised studies, high variation in response and the intervention subject to continuing development. The relative treatment effects generated from single-arm trials are likely to be optimistic unless it is certain that the historical data have accurately estimated the efficacy of the control agent. Pivotal trials may use surrogate end points, which, on average, overestimate treatment effects. To reduce overall uncertainty, multivariate meta-analysis of all available data should be considered. Incorporating indirectly relevant but more reliable (more mature) data into the analysis can also be considered; such data may become available as a result of the evolving regulatory pathways being developed by the European Medicines Agency. For the exemplar case of CAR T-cell therapy, target product profiles (TPPs) were developed, which considered the 'curative' and 'bridging to stem-cell transplantation

  8. Nuclear medicine therapy of neuroblastoma

    International Nuclear Information System (INIS)

    Hoefnagel, C.A.

    1999-01-01

    Specific targeting of radionuclides to neuroblastoma, a neural crest tumor occurring predominantly in young children and associated with a relatively poor prognosis, may be achieved via the metabolic route (Mibg), receptor binding (peptides) or immunological approach (antibodies). The clinical role of 1 31 I -Mibg therapy and radioimmunotherapy in neuroblastoma is discussed. In recurrent or progressive metastatic disease after conventional treatment modalities have failed, 1 31 I -Mibg therapy, with an overall objective response rate of 35%, is probably the best palliative treatment, as the invasiveness and toxicity of this therapy compare favourably with that of chemotherapy, immunotherapy and external beam radiotherapy. In patients presenting with inoperable stage III and IV neuroblastoma, 1 31 I -Mibg therapy at diagnosis is at least as effective as combination chemotherapy but is associated with much less toxicity. In patients with recurrent disease 1 31 I -Mibg therapy in combination with hyperbaric oxygen therapy proved feasible and encouraging effects on survival have ben observed. Attempts to intensify the treatment in relapsed patients by combination of 1 31 I -Mibg therapy with high dose chemotherapy and/or total body irradiation have met with considerable toxicity. Developments in Mibg therapy aiming at improving the therapeutic index are mentioned. Early results of radioimmunotherapy using 1 31 I -UJ13A or 1 31 I -3F8 monoclonal antibodies have shown moderate objective response and considerable side effects in patients with stage IV neuroblastoma, who had relapsed or failed conventional therapy. New developments in radioimmunotherapy of neuroblastoma include the use of chimeric antibodies, the enhancement of tumor uptake by modulation of antigen expression or by increasing the tumor perfusion/vascularity/permeability, the use of other labels and multistep targeting techniques, e.g. using bispecific monoclonal antibodies

  9. Towards an advanced therapy medicinal product based on mesenchymal stromal cells isolated from the umbilical cord tissue: quality and safety data.

    Science.gov (United States)

    Martins, José Paulo; Santos, Jorge Miguel; de Almeida, Joana Marto; Filipe, Mariana Alves; de Almeida, Mariana Vargas Teixeira; Almeida, Sílvia Cristina Paiva; Água-Doce, Ana; Varela, Alexandre; Gilljam, Mari; Stellan, Birgitta; Pohl, Susanne; Dittmar, Kurt; Lindenmaier, Werner; Alici, Evren; Graça, Luís; Cruz, Pedro Estilita; Cruz, Helder Joaquim; Bárcia, Rita Nogueira

    2014-01-17

    Standardization of mesenchymal stromal cells (MSCs) manufacturing is urgently needed to enable translational activities and ultimately facilitate comparison of clinical trial results. In this work we describe the adaptation of a proprietary method for isolation of a specific umbilical cord tissue-derived population of MSCs, herein designated by its registered trademark as UCX®, towards the production of an advanced therapy medicinal product (ATMP). The adaptation focused on different stages of production, from cell isolation steps to cell culturing and cryopreservation. The origin and quality of materials and reagents were considered and steps for avoiding microbiological and endotoxin contamination of the final cell product were implemented. Cell isolation efficiency, MSCs surface markers and genetic profiles, originating from the use of different medium supplements, were compared. The ATMP-compliant UCX® product was also cryopreserved avoiding the use of dimethyl sulfoxide, an added benefit for the use of these cells as an ATMP. Cells were analyzed for expansion capacity and longevity. The final cell product was further characterized by flow cytometry, differentiation potential, and tested for contaminants at various passages. Finally, genetic stability and immune properties were also analyzed. The isolation efficiency of UCX® was not affected by the introduction of clinical grade enzymes. Furthermore, isolation efficiencies and phenotype analyses revealed advantages in the use of human serum in cell culture as opposed to human platelet lysate. Initial decontamination of the tissue followed by the use of mycoplasma- and endotoxin-free materials and reagents in cell isolation and subsequent culture, enabled the removal of antibiotics during cell expansion. UCX®-ATMP maintained a significant expansion potential of 2.5 population doublings per week up to passage 15 (P15). They were also efficiently cryopreserved in a DMSO-free cryoprotectant medium with

  10. The Traditional Medicine and Modern Medicine from Natural Products

    Directory of Open Access Journals (Sweden)

    Haidan Yuan

    2016-04-01

    Full Text Available Natural products and traditional medicines are of great importance. Such forms of medicine as traditional Chinese medicine, Ayurveda, Kampo, traditional Korean medicine, and Unani have been practiced in some areas of the world and have blossomed into orderly-regulated systems of medicine. This study aims to review the literature on the relationship among natural products, traditional medicines, and modern medicine, and to explore the possible concepts and methodologies from natural products and traditional medicines to further develop drug discovery. The unique characteristics of theory, application, current role or status, and modern research of eight kinds of traditional medicine systems are summarized in this study. Although only a tiny fraction of the existing plant species have been scientifically researched for bioactivities since 1805, when the first pharmacologically-active compound morphine was isolated from opium, natural products and traditional medicines have already made fruitful contributions for modern medicine. When used to develop new drugs, natural products and traditional medicines have their incomparable advantages, such as abundant clinical experiences, and their unique diversity of chemical structures and biological activities.

  11. The Traditional Medicine and Modern Medicine from Natural Products.

    Science.gov (United States)

    Yuan, Haidan; Ma, Qianqian; Ye, Li; Piao, Guangchun

    2016-04-29

    Natural products and traditional medicines are of great importance. Such forms of medicine as traditional Chinese medicine, Ayurveda, Kampo, traditional Korean medicine, and Unani have been practiced in some areas of the world and have blossomed into orderly-regulated systems of medicine. This study aims to review the literature on the relationship among natural products, traditional medicines, and modern medicine, and to explore the possible concepts and methodologies from natural products and traditional medicines to further develop drug discovery. The unique characteristics of theory, application, current role or status, and modern research of eight kinds of traditional medicine systems are summarized in this study. Although only a tiny fraction of the existing plant species have been scientifically researched for bioactivities since 1805, when the first pharmacologically-active compound morphine was isolated from opium, natural products and traditional medicines have already made fruitful contributions for modern medicine. When used to develop new drugs, natural products and traditional medicines have their incomparable advantages, such as abundant clinical experiences, and their unique diversity of chemical structures and biological activities.

  12. Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP).

    Science.gov (United States)

    Zscharnack, Matthias; Krause, Christoph; Aust, Gabriela; Thümmler, Christian; Peinemann, Frank; Keller, Thomas; Smink, Jeske J; Holland, Heidrun; Somerson, Jeremy S; Knauer, Jens; Schulz, Ronny M; Lehmann, Jörg

    2015-05-20

    The clinical development of advanced therapy medicinal products (ATMPs), a new class of drugs, requires initial safety studies that deviate from standard non-clinical safety protocols. The study provides a strategy to address the safety aspects of biodistribution and tumorigenicity of ATMPs under good laboratory practice (GLP) conditions avoiding cell product manipulation. Moreover, the strategy was applied on a human ATMP for cartilage repair. The testing strategy addresses biodistribution and tumorigenicity using a multi-step analysis without any cell manipulation to exclude changes of test item characteristics. As a safeguard measurement for meeting regulatory expectations, the project design and goals were discussed continuously with the regulatory authority using a staggered scientific advice concept. Subsequently, the strategy was applied to co.don chondrosphere® (huChon spheroid), a tissue-engineered matrix-free ATMP of human normal chondrocytes. In both the biodistribution and tumorigenicity studies, huChon spheroids were implanted subcutaneously into 40 immunodeficient mice. Biodistribution was studied 1 month after implantation. A skin disc containing the huChon spheroid, two surrounding skin rings and selected organs were analyzed by validated, gender-specific, highly-sensitive triplex qPCR and by immunohistochemistry (IHC). No human DNA was detected in distant skin rings and analyzed organs. IHC revealed no direct or indirect indications of cell migration. Tumorigenicity was assessed 6 months after huChon spheroid implantation by palpation, macroscopic inspection, histology and IHC. No mice from the huChon spheroid group developed a tumor at the implantation site. In two mice, benign tumors were detected that were negative for HLA-ABC, suggesting that they were of spontaneous murine origin. In summary, the presented strategy using a multi-step analysis was confirmed to be suitable for safety studies of ATMPs.

  13. Medicinal therapy of malignant lymphomas

    International Nuclear Information System (INIS)

    Aul, C.; Schroeder, M.; Giagounidis, A.

    2002-01-01

    Chemotherapy represents the most important therapeutic option in malignant lymphomas. Low to intermediate risk Hodgkin's disease is treated by a combination of chemotherapy and radiation. The new chemotherapy protocol BEACOPP has improved the outcome of advanced stages in comparison with the internationally accepted standard protocol COPP/ABVD. Dependent on the initial staging, cure rates between 50 and 95% can be achieved. Indolent non-Hodgkin's lymphomas usually present in advanced stages of disease. Chemotherapy in these cases has palliative character and aims at improving patients'quality of life and at avoiding complications due to the disease. In aggressive and very aggressive non-Hodgkin's lymphoma chemotherapy is curative and must be initiated immediately irrespective of the staging results. The efficacy of the standard protocol CHOP (cyclophosphamide,doxorubicin, vincristine and prednisone), that was established in the 1970s, has recently been improved by shortening of the therapy interval (CHOP-14 vs.CHOP-21),addition of etoposide (CHOEP) and combination with the monoclonal antibody rituximab (R-CHOP). The value of high dose chemotherapy with stem cell transplantation has been shown unequivocally only for aggressive non-Hodgkin lymphoma and relapsed Hodgkin's disease responsive to chemotherapy. The therapeutic strategy of malignant lymphomas is likely to be improved within the next years due to the introduction of novel cytostatic agents, the broadening application of monoclonal antibodies,upcoming new transplantation procedures and the development of substances with molecular targets.To rapidly increase our current knowledge on the topic it is mandatory to include patients into the large national and international multicenter studies. (orig.) [de

  14. Research Productivity of Sports Medicine Fellowship Faculty

    OpenAIRE

    Cvetanovich, Gregory L.; Saltzman, Bryan M.; Chalmers, Peter N.; Frank, Rachel M.; Cole, Brian J.; Bach, Bernard R.

    2016-01-01

    Background: Research productivity is considered an important factor in academic advancement in sports medicine. No study to date has evaluated academic productivity and correlates of academic rank for sports medicine fellowship faculty. Purpose: To describe the academic productivity of American Orthopaedic Society for Sports Medicine (AOSSM) fellowship program faculty and to determine the association between academic productivity, fellowship characteristics, and academic rank. Study Design: D...

  15. Nuclear medicine. Clinical value of the medicine methods. Nuklearmedizin. Klinische Bedeutung nuklearmedizinischer Diagnostik und Therapie

    Energy Technology Data Exchange (ETDEWEB)

    Schmidt, H A.E. [Evangelisches Krankenhaus Bethesda Gemeinnuetzige G.m.b.H., Duisburg (Germany, F.R.). Nuklearmedizinische Klinik und Poliklinik; Ortiz Berrocal, J [Universidad Autonoma de Madrid (Spain). Dept. of Nuclear Medicine; eds.

    1979-01-01

    This proceedings volume of the 16th International Annual Meeting of the Gesellschaft fuer Nuklearmedizin, which took place in Madrid on October 24-27, 1978, contains 183 compacts on the following subjects: Metrology and data processing, cyclotron products and radiopharmaceuticals, nuclear medicine as compared with computerized tomography and sonography, radioimmunoassay, haematology, thyreology, osteology, pulmonology, cardiology, angiology, nephrology, gastroenterology and hepatology, oncology, nuclear therapy methods and some free lectures and thus give a good picture of the state of the art in nuclear medicine at the time.

  16. New tools in regenerative medicine: gene therapy.

    Science.gov (United States)

    Muñoz Ruiz, Miguel; Regueiro, José R

    2012-01-01

    Gene therapy aims to transfer genetic material into cells to provide them with new functions. A gene transfer agent has to be safe, capable of expressing the desired gene for a sustained period of time in a sufficiently large population of cells to produce a biological effect. Identifying a gene transfer tool that meets all of these criteria has proven to be a difficult objective. Viral and nonviral vectors, in vivo, ex vivo and in situ strategies co-exist at present, although ex vivo lenti-or retroviral vectors are presently the most popular.Natural stem cells (from embryonic, hematopoietic, mesenchymal, or adult tissues) or induced progenitor stem (iPS) cells can be modified by gene therapy for use in regenerative medicine. Among them, hematopoietic stem cells have shown clear clinical benefit, but iPS cells hold humongous potential with no ethical concerns.

  17. Regulatory and clinical aspects of psychotropic medicinal products bioequivalence.

    Science.gov (United States)

    Bałkowiec-Iskra, Ewa; Cessak, Grzegorz; Kuzawińska, Olga; Sejbuk-Rozbicka, Katarzyna; Rokita, Konrad; Mirowska-Guzel, Dagmara

    2015-07-01

    Introduction of generic medicinal products to the market has increased access to modern therapies but also enabled significant reduction in their cost, leading to containment of public expenditures on medicinal products reimbursement. The critical assessment of bioequivalence of any reference medicinal product and its counterpart is based on comparison of their rate and extent of absorption. It is assumed that two medicinal products are bioequivalent when their rate and extent of absorption do not show significant differences when administered at the same dose under similar experimental conditions. Bioequivalent medicinal products are declared to be also therapeutically equivalent and can be used interchangeably. However, despite regulatory declaration, switching from reference to generic drugs is often associated with concerns of healthcare providers about decreased treatment effectiveness or occurrence of adverse drug reactions. The aim of this article is to provide a description of rules that guide registration of generic medicinal products in the European Union and to analyze specific examples from the scientific literature concerning therapeutic equivalence of reference and generic antidepressant and antipsychotic medicinal products. Copyright © 2015 Elsevier B.V. and ECNP. All rights reserved.

  18. Medicinal leech therapy-an overall perspective.

    Science.gov (United States)

    Sig, Ali K; Guney, Mustafa; Uskudar Guclu, Aylin; Ozmen, Erkan

    2017-12-01

    Complementary medicine methods have a long history, but modern medicine has just recently focused on their possible modes of action. Medicinal leech therapy (MLT) or hirudotherapy, an old technique, has been studied by many researchers for possible effects on various diseases such as inflammatory diseases, osteoarthritis, and after different surgeries. Hirudo medicinalis has widest therapeutic usage among the leeches, but worldwide, many different species were tested and studied. Leeches secrete more than 20 identified bioactive substances such as antistasin, eglins, guamerin, hirudin, saratin, bdellins, complement, and carboxypeptidase inhibitors. They have analgesic, anti-inflammatory, platelet inhibitory, anticoagulant, and thrombin regulatory functions, as well as extracellular matrix degradative and antimicrobial effects, but with further studies, the spectrum of effects may widen. The technique is cheap, effective, easy to apply, and its modes of action have been elucidated for certain diseases. In conclusion, for treatment of some diseases, MLT is not an alternative, but is a complementary and/or integrative choice. MLT is a part of multidisciplinary treatments, and secretes various bioactive substances. These substances vary among species and different species should be evaluated for both treatment capability and their particular secreted molecules. There is huge potential for novel substances and these could be future therapeutics.

  19. Nigerian Journal of Natural Products and Medicine

    African Journals Online (AJOL)

    Nigerian Journal of Natural Products and Medicine is published by the Nigerian Society of Pharmacognosy, a non profit organisation established in 1982 dedicated to the promotion of Pharmacognosy, Natural Products and Traditional Medicine. It has a current circulation of about 500 to scientists in Nigeria and abroad.

  20. Maggot Debridement Therapy in Disaster Medicine.

    Science.gov (United States)

    Stadler, Frank; Shaban, Ramon Z; Tatham, Peter

    2016-02-01

    When disaster strikes, the number of patients requiring treatment can be overwhelming. In low-income countries, resources to assist the injured in a timely fashion may be limited. As a consequence, necrosis and wound infection in disaster patients is common and frequently leads to adverse health outcomes such as amputations, chronic wounds, and loss of life. In such compromised health care environments, low-tech and cheap wound care options are required that are in ready supply, easy to use, and have multiple therapeutic benefits. Maggot debridement therapy (MDT) is one such wound care option and may prove to be an invaluable tool in the treatment of wounds post-disaster. This report provides an overview of the wound burden experienced in various types of disaster, followed by a discussion of current treatment approaches, and the role MDT may play in the treatment of complex wounds in challenging health care conditions. Maggot debridement therapy removes necrotic and devitalized tissue, controls wound infection, and stimulates wound healing. These properties suggest that medicinal maggots could assist health care professionals in the debridement of disaster wounds, to control or prevent infection, and to prepare the wound bed for reconstructive surgery. Maggot debridement therapy-assisted wound care would be led by health care workers rather than physicians, which would allow the latter to focus on reconstructive and other surgical interventions. Moreover, MDT could provide a larger window for time-critical interventions, such as fasciotomies to treat compartment syndrome and amputations in case of life-threatening wound infection. There are social, medical, and logistic hurdles to overcome before MDT can become widely available in disaster medical aid. Thus, research is needed to further demonstrate the utility of MDT in Disaster Medicine. There is also a need for reliable MDT logistics and supply chain networks. Integration with other disaster management

  1. Radionuclide Therapies in Molecular Imaging and Precision Medicine.

    Science.gov (United States)

    Kendi, A Tuba; Moncayo, Valeria M; Nye, Jonathon A; Galt, James R; Halkar, Raghuveer; Schuster, David M

    2017-01-01

    This article reviews recent advances and applications of radionuclide therapy. Individualized precision medicine, new treatments, and the evolving role of radionuclide therapy are discussed. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Music therapy and music medicine for children and adolescents.

    Science.gov (United States)

    Yinger, Olivia Swedberg; Gooding, Lori

    2014-07-01

    This article summarizes the research on music therapy and music medicine for children and adolescents with diagnoses commonly treated by psychiatrists. Music therapy and music medicine are defined, effects of music on the brain are described, and music therapy research in psychiatric treatment is discussed. Music therapy research with specific child/adolescent populations is summarized, including disorders usually diagnosed in childhood, substance abuse, mood/anxiety disorders, and eating disorders. Clinical implications are listed, including suggestions for health care professionals seeking to use music medicine techniques. Strengths and weaknesses of music therapy treatment are discussed, as well as areas for future research. Published by Elsevier Inc.

  3. Translational research: precision medicine, personalized medicine, targeted therapies: marketing or science?

    Science.gov (United States)

    Marquet, Pierre; Longeray, Pierre-Henry; Barlesi, Fabrice; Ameye, Véronique; Augé, Pascale; Cazeneuve, Béatrice; Chatelut, Etienne; Diaz, Isabelle; Diviné, Marine; Froguel, Philippe; Goni, Sylvia; Gueyffier, François; Hoog-Labouret, Natalie; Mourah, Samia; Morin-Surroca, Michèle; Perche, Olivier; Perin-Dureau, Florent; Pigeon, Martine; Tisseau, Anne; Verstuyft, Céline

    2015-01-01

    Personalized medicine is based on: 1) improved clinical or non-clinical methods (including biomarkers) for a more discriminating and precise diagnosis of diseases; 2) targeted therapies of the choice or the best drug for each patient among those available; 3) dose adjustment methods to optimize the benefit-risk ratio of the drugs chosen; 4) biomarkers of efficacy, toxicity, treatment discontinuation, relapse, etc. Unfortunately, it is still too often a theoretical concept because of the lack of convenient diagnostic methods or treatments, particularly of drugs corresponding to each subtype of pathology, hence to each patient. Stratified medicine is a component of personalized medicine employing biomarkers and companion diagnostics to target the patients likely to present the best benefit-risk balance for a given active compound. The concept of targeted therapy, mostly used in cancer treatment, relies on the existence of a defined molecular target, involved or not in the pathological process, and/or on the existence of a biomarker able to identify the target population, which should logically be small as compared to the population presenting the disease considered. Targeted therapies and biomarkers represent important stakes for the pharmaceutical industry, in terms of market access, of return on investment and of image among the prescribers. At the same time, they probably represent only the first generation of products resulting from the combination of clinical, pathophysiological and molecular research, i.e. of translational research. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  4. [Ethical aspects of human embryonic stem cell use and commercial umbilical cord blood stem cell banking. Ethical reflections on the occasion of the regulation of the European Council and Parliament on advanced therapy medicinal products].

    Science.gov (United States)

    Virt, G

    2010-01-01

    The regulation of the European Council and Parliament on advanced therapy medicinal products also includes therapies with human embryonic stem cells. The use of these stem cells is controversially and heavily discussed. Contrary to the use of adult stem cells, medical and ethical problems concerning the use of human embryonic stem cells persists, because this use is based on the destruction of human life at the very beginning. The regulation foresees, therefore, subsidiarity within the European Member States. Although there are no ethical problems in principle with the use of stem cells from the umbilical cord blood, there are social ethical doubts with the banking of these stem cells for autologous use without any currently foreseeable medical advantage by commercial blood banks. Also in this case subsidiarity is valid.

  5. Enriched cultures of lactic acid bacteria from selected Zimbabwean fermented food and medicinal products with potential as therapy or prophylaxis against yeast infections

    Directory of Open Access Journals (Sweden)

    Alec Chabwinja

    2017-10-01

    Full Text Available Objective: To investigate the antifungal activity of crude cultures of putative strains of lactic acid bacteria (LAB from a selection of Zimbabwean traditional and commercial food/ medicinal products against yeasts (strains of environmental isolates of Candida albicans and Rhodotorula spp.. Methods: Cultures of putative LAB from our selection of fermented products were enriched in de Man, Rogosa and Sharpe and isolated on de Man, Rogosa and Sharpe agar. Results: The crude microbial cultures from the products that showed high antifungal activities (zone of inhibition, mm were as follows: supernatant-free microbial pellet (SFMP from an extract of Melia azedarach leaves [(27.0 ± 2.5 mm] > cell-free culture supernatants (CFCS from Maaz Dairy sour milk and Mnandi sour milk [approximately (26.0 ± 1.8/2.5 mm] > CFCS and SFMP from Amansi hodzeko [(25.0 ± 1.5 mm] > CFCS from Parinari curatellifolia fruit [(24.0 ± 1.5 mm], SFMP from Parinari curatellifolia fruit [(24.0 ± 1.4 mm] and SFMP from mahewu [(20.0 ± 1.5 mm]. These cultures also showed high tolerance to acidic conditions (pH 4.0 and pH 5.0. However, culture from WAYA LGG (shown elsewhere to harbour antimicrobial activities showed no antifungal activity. The LAB could have inhibited yeasts by either competitive exclusion or the release of antimicrobial metabolites. Conclusions: Our cultures of LAB from a selection of Zimbabwean fermented products, especially Ziziphus mauritiana and fermented milk products have great potential for use as antifungal probiotics against yeast infections. Studies are ongoing to determine the exact mechanisms that are employed by the putative LAB to inhibit Candida albicans.

  6. traditional medicinal uses of small mammal products

    African Journals Online (AJOL)

    Dr. Nelson Boniface

    hunted small mammals mainly by dogs for cultural and ornamental reasons. Products of African ... (WHO) defines traditional medicine as ''health practices ... particularly in Asian countries. ..... Ntiamoa- Baidu Y 1992 Local Perceptions and.

  7. Medicinal plants: production and biochemical characterization

    International Nuclear Information System (INIS)

    Chunzhao Liu; Zobayed, S.M.A; Murch, S.J.; Saxena, P.K.

    2002-01-01

    Recent advances in the area of biotechnology offer some possibility for the development of new technologies for the conservation, characterization and mass production of medicinal plant species, (i.e. in vitro cell culture techniques for the mass production of sterile, consistent, standardized medicinal plant materials). This paper discussed the following subjects - plant tissue culture, de novo shoot organogenesis, de novo root organogenesis, somatic embryogenesis, large scale propagation in bioreactors and discovery of unique biomolecules

  8. [Classification of cell-based medicinal products and legal implications: An overview and an update].

    Science.gov (United States)

    Scherer, Jürgen; Flory, Egbert

    2015-11-01

    In general, cell-based medicinal products do not represent a uniform class of medicinal products, but instead comprise medicinal products with diverse regulatory classification as advanced-therapy medicinal products (ATMP), medicinal products (MP), tissue preparations, or blood products. Due to the legal and scientific consequences of the development and approval of MPs, classification should be clarified as early as possible. This paper describes the legal situation in Germany and highlights specific criteria and concepts for classification, with a focus on, but not limited to, ATMPs and non-ATMPs. Depending on the stage of product development and the specific application submitted to a competent authority, legally binding classification is done by the German Länder Authorities, Paul-Ehrlich-Institut, or European Medicines Agency. On request by the applicants, the Committee for Advanced Therapies may issue scientific recommendations for classification.

  9. Turning Regenerative Medicine Breakthrough Ideas and Innovations into Commercial Products.

    Science.gov (United States)

    Bayon, Yves; Vertès, Alain A; Ronfard, Vincent; Culme-Seymour, Emily; Mason, Chris; Stroemer, Paul; Najimi, Mustapha; Sokal, Etienne; Wilson, Clayton; Barone, Joe; Aras, Rahul; Chiesi, Andrea

    2015-12-01

    The TERMIS-Europe (EU) Industry committee intended to address the two main critical issues in the clinical/commercial translation of Advanced Therapeutic Medicine Products (ATMP): (1) entrepreneurial exploitation of breakthrough ideas and innovations, and (2) regulatory market approval. Since January 2012, more than 12,000 publications related to regenerative medicine and tissue engineering have been accepted for publications, reflecting the intense academic research activity in this field. The TERMIS-EU 2014 Industry Symposium provided a reflection on the management of innovation and technological breakthroughs in biotechnology first proposed to contextualize the key development milestones and constraints of allocation of financial resources, in the development life-cycle of radical innovation projects. This was illustrated with the biofuels story, sharing similarities with regenerative medicine. The transition was then ensured by an overview of the key identified challenges facing the commercialization of cell therapy products as ATMP examples. Real cases and testimonies were then provided by a palette of medical technologies and regenerative medicine companies from their commercial development of cell and gene therapy products. Although the commercial development of ATMP is still at the proof-of-concept stage due to technology risks, changing policies, changing markets, and management changes, the sector is highly dynamic with a number of explored therapeutic approaches, developed by using a large diversity of business models, both proposed by the experience, pitfalls, and successes of regenerative medicine pioneers, and adapted to the constraint resource allocation and environment in radical innovation projects.

  10. Behaviors of providers of traditional korean medicine therapy and complementary and alternative medicine therapy for the treatment of cancer patients.

    Science.gov (United States)

    Yu, Jun-Sang; Kim, Chun-Bae; Kim, Ki-Kyong; Lee, Ji-Eun; Kim, Min-Young

    2015-03-01

    In Korea, cancer is one of the most important causes of death. Cancer patients have sought alternative methods, like complementary and alternative medicine (CAM) together with Western medicine, to treat cancer. Also, there are many kinds of providers of CAM therapy, including providers of Korean oriental medicine therapy. The purpose of this study is to identify the behaviors of Korean oriental medicine therapy and CAM therapy providers who treat cancer patients and to provide background knowledge for establishing a new policy with the management and quality control of CAM. Structured and well organized questionnaires were made, and 350 persons were surveyed concerning the providers of CAM or Korean oriental medicine. The questionnaires were collected and analyzed. The questionnaires (182) were collected. The questionnaires identified a total of 73 known providers, such as medicinal professionals or other providers of CAM suppliers, 35.6% of whom had had experience with treating cancer patients (52.6% vs. 29.6%). The treatment methods were a little different: alternative therapy and nutritional therapy being preferred by medicinal professionals and mind body modulation therapy and alternative therapy being preferred by other CAM providers. Four patients (7.4%) experienced side effects, and 6 patients (12.5%) experienced legal problems. As the method for managing the therapy, CAM providers, medicinal professionals, and other CAM providers had different viewpoints. For example, some CAM providers stated that both legislation and an official education on CAM or a national examination were needed as a first step to establish the provider's qualifications and that as a second step, a license test was needed for quality control. To the contrary, medicinal professionals stated that a license test was needed before legislation. Adequate management and quality control of CAM providers is thought to involve both education and legislation.

  11. Alternative medicine: an update on cupping therapy.

    Science.gov (United States)

    Chen, B; Li, M-Y; Liu, P-D; Guo, Y; Chen, Z-L

    2015-07-01

    To know the research progress of cupping therapy all over the world, the authors analyze the research of cupping therapy in recent 5 years. It indicates that cupping therapy can be applied to extensive curable disease, but has poor clinical evidence. Some improvements in the mechanism research of cupping therapy have been made, but it needs further research. The adverse events of cupping therapy attract attention. The standardization of cupping therapy has emerged. © The Author 2014. Published by Oxford University Press on behalf of the Association of Physicians. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  12. Integrative Medicine and Complementary and Alternative Therapies

    Science.gov (United States)

    ... complementary therapies with your healthcare team: Are there complementary therapies that you would recommend? What research is available about this therapy’s safety and effectiveness? What are the benefits and risks of this ...

  13. Medicinal Product Regulation: Portugal׳s Framework.

    Science.gov (United States)

    Herdeiro, Maria Teresa; Bastos, Paulo D; Teixeira-Rodrigues, António; Roque, Fátima

    2016-09-01

    The pharmaceutical industry is one of the most tightly regulated sectors, and it is essential to know each country׳s legal framework to understand the regulation, approval, and marketing of medicinal products for human use. This article describes the main statutes and procedures governing medicinal products for human use in Portugal and the role of the country׳s National Medicines and Health Products Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; INFARMED). From the most recently available data, an update of requests and approvals concerning marketing authorizations, variations, pricing, and reimbursements is provided. Data were sourced from the INFARMED website, Infomed (database of medicinal products for human use), and periodic reports issued by national authorities. Organic laws, acts, and law decrees published in the government gazette (Diário da República) are cited and reproduced as required. In 2015 Portugal ranked fifth in the European System of Medicines Evaluation in terms of the number of completed procedures as a reference member state. Approximately 80% of all approved drug applications in Portugal in 2015 were for generic drugs, mostly pertaining to the nervous system. In Portugal, INFARMED monitors drug quality, safety profile, and efficacy in all stages of the drug life cycle, ensuring patients' safety. The Portuguese market for medicinal products for human use has been appreciably changed by the advent of generic drugs. There is an increased trend for new request applications for biological and biotechnological substances. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

  14. Advances in Precision Medicine: Tailoring Individualized Therapies.

    Science.gov (United States)

    Matchett, Kyle B; Lynam-Lennon, Niamh; Watson, R William; Brown, James A L

    2017-10-25

    The traditional bench-to-bedside pipeline involves using model systems and patient samples to provide insights into pathways deregulated in cancer. This discovery reveals new biomarkers and therapeutic targets, ultimately stratifying patients and informing cohort-based treatment options. Precision medicine (molecular profiling of individual tumors combined with established clinical-pathological parameters) reveals, in real-time, individual patient's diagnostic and prognostic risk profile, informing tailored and tumor-specific treatment plans. Here we discuss advances in precision medicine presented at the Irish Association for Cancer Research Annual Meeting, highlighting examples where personalized medicine approaches have led to precision discovery in individual tumors, informing customized treatment programs.

  15. Internal radiation dosimetry using nuclear medicine imaging in radionuclide therapy

    International Nuclear Information System (INIS)

    Kim, Kyeong Min; Byun, Byun Hyun; Cheon, Gi Jeong; Lim, Sang Moo

    2007-01-01

    Radionuclide therapy has been an important field in nuclear medicine. In radionuclide therapy, relevant evaluation of internally absorbed dose is essential for the achievement of efficient and sufficient treatment of incurable disease, and can be accomplished by means of accurate measurement of radioactivity in body and its changes with time. Recently, the advances of nuclear medicine imaging and multi modality imaging processing techniques can provide chance of more accurate and easier measurement of the measures commented above, in cooperation of conventional imaging based approaches. In this review, basic concept for internal dosimetry using nuclear medicine imaging is summarized with several check points which should be considered in real practice

  16. Gene mutation-based and specific therapies in precision medicine.

    Science.gov (United States)

    Wang, Xiangdong

    2016-04-01

    Precision medicine has been initiated and gains more and more attention from preclinical and clinical scientists. A number of key elements or critical parts in precision medicine have been described and emphasized to establish a systems understanding of precision medicine. The principle of precision medicine is to treat patients on the basis of genetic alterations after gene mutations are identified, although questions and challenges still remain before clinical application. Therapeutic strategies of precision medicine should be considered according to gene mutation, after biological and functional mechanisms of mutated gene expression or epigenetics, or the correspondent protein, are clearly validated. It is time to explore and develop a strategy to target and correct mutated genes by direct elimination, restoration, correction or repair of mutated sequences/genes. Nevertheless, there are still numerous challenges to integrating widespread genomic testing into individual cancer therapies and into decision making for one or another treatment. There are wide-ranging and complex issues to be solved before precision medicine becomes clinical reality. Thus, the precision medicine can be considered as an extension and part of clinical and translational medicine, a new alternative of clinical therapies and strategies, and have an important impact on disease cures and patient prognoses. © 2015 The Author. Journal of Cellular and Molecular Medicine published by John Wiley & Sons Ltd and Foundation for Cellular and Molecular Medicine.

  17. Gene and cell therapy for children--new medicines, new challenges?

    Science.gov (United States)

    Buckland, Karen F; Bobby Gaspar, H

    2014-06-01

    The range of possible gene and cell therapy applications is expanding at an extremely rapid rate and advanced therapy medicinal products (ATMPs) are currently the hottest topic in novel medicines, particularly for inherited diseases. Paediatric patients stand to gain enormously from these novel therapies as it now seems plausible to develop a gene or cell therapy for a vast number of inherited diseases. There are a wide variety of potential gene and cell therapies in various stages of development. Patients who received first gene therapy treatments for primary immune deficiencies (PIDs) are reaching 10 and 15 years post-treatment, with robust and sustained immune recovery. Cell therapy clinical trials are underway for a variety of tissues including corneal, retinal and muscle repair and islet cell transplantation. Various cell therapy approaches are also being trialled to enhance the safety of bone marrow transplants, which should improve survival rates in childhood cancers and PIDs. Progress in genetic engineering of lymphocyte populations to target and kill cancerous cells is also described. If successful these ATMPs may enhance or replace the existing chemo-ablative therapy for several paediatric cancers. Emerging applications of gene therapy now include skin and neurological disorders such as epidermolysis bullosa, epilepsy and leukodystrophy. Gene therapy trials for haemophilia, muscular dystrophy and a range of metabolic disorders are underway. There is a vast array of potential advanced therapy medicinal products (ATMPs), and these are likely to be more cost effective than existing medicines. However, the first clinical trials have not been without setbacks and some of the key adverse events are discussed. Furthermore, the arrival of this novel class of therapies brings many new challenges for the healthcare industry. We present a summary of the key non-clinical factors required for successful delivery of these potential treatments. Technological advances

  18. Gene and cell therapy for children — New medicines, new challenges?☆

    Science.gov (United States)

    Buckland, Karen F.; Bobby Gaspar, H.

    2014-01-01

    The range of possible gene and cell therapy applications is expanding at an extremely rapid rate and advanced therapy medicinal products (ATMPs) are currently the hottest topic in novel medicines, particularly for inherited diseases. Paediatric patients stand to gain enormously from these novel therapies as it now seems plausible to develop a gene or cell therapy for a vast number of inherited diseases. There are a wide variety of potential gene and cell therapies in various stages of development. Patients who received first gene therapy treatments for primary immune deficiencies (PIDs) are reaching 10 and 15 years post-treatment, with robust and sustained immune recovery. Cell therapy clinical trials are underway for a variety of tissues including corneal, retinal and muscle repair and islet cell transplantation. Various cell therapy approaches are also being trialled to enhance the safety of bone marrow transplants, which should improve survival rates in childhood cancers and PIDs. Progress in genetic engineering of lymphocyte populations to target and kill cancerous cells is also described. If successful these ATMPs may enhance or replace the existing chemo-ablative therapy for several paediatric cancers. Emerging applications of gene therapy now include skin and neurological disorders such as epidermolysis bullosa, epilepsy and leukodystrophy. Gene therapy trials for haemophilia, muscular dystrophy and a range of metabolic disorders are underway. There is a vast array of potential advanced therapy medicinal products (ATMPs), and these are likely to be more cost effective than existing medicines. However, the first clinical trials have not been without setbacks and some of the key adverse events are discussed. Furthermore, the arrival of this novel class of therapies brings many new challenges for the healthcare industry. We present a summary of the key non-clinical factors required for successful delivery of these potential treatments. Technological advances

  19. [Safety monitoring of cell-based medicinal products (CBMPs)].

    Science.gov (United States)

    Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

    2015-11-01

    Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.

  20. Storytelling as therapy: implications for medicine.

    Science.gov (United States)

    Lawlis, G F

    1995-05-01

    Storytelling is an art developed during the beginning of human history, probably to teach the wisdom of generations past, including basic mental and physical health principles. This approach, based on sound behavioral medicine principles, is explored here for use as an integral part of medical practice. Also, practical considerations are addressed concerning the conduct of storytelling, with emphasis on relaxation, imagery, and lifestyle change implementations.

  1. Social and cultural efficacies of medicines: Complications for antiretroviral therapy

    Directory of Open Access Journals (Sweden)

    Hardon Anita

    2006-11-01

    Full Text Available Abstract Using ethnographic examples of medicine use, prescription, distribution and production, the authors argue that social and cultural effects of pharmaceuticals should be taken into account. Non-medical effects deeply influence the medical outcome of medicine use. Complications around the advent of anti-AIDS medicines in poor countries are taken as a point in case. The authors are medical anthropologists specialised in the social and cultural analysis of pharmaceuticals.

  2. Complementary and alternative medicine therapies for chronic pain.

    Science.gov (United States)

    Bauer, Brent A; Tilburt, Jon C; Sood, Amit; Li, Guang-Xi; Wang, Shi-Han

    2016-06-01

    Pain afflflicts over 50 million people in the US, with 30.7% US adults suffering with chronic pain. Despite advances in therapies, many patients will continue to deal with ongoing symptoms that are not fully addressed by the best conventional medicine has to offer them. The patients frequently turn to therapies outside the usual purview of conventional medicine (herbs, acupuncture, meditation, etc.) called complementary and alternative medicine (CAM). Academic and governmental groups are also starting to incorporate CAM recommendations into chronic pain management strategies. Thus, for any physician who care for patients with chronic pain, having some familiarity with these therapies-including risks and benefits-will be key to helping guide patients in making evidence-based, well informed decisions about whether or not to use such therapies. On the other hand, if a CAM therapy has evidence of both safety and efficacy then not making it available to a patient who is suffering does not meet the need of the patient. We summarize the current evidence of a wide variety of CAM modalities that have potential for helping patients with chronic pain in this article. The triad of chronic pain symptoms, ready access to information on the internet, and growing patient empowerment suggest that CAM therapies will remain a consistent part of the healthcare of patients dealing with chronic pain.

  3. Evolution of magnetic therapy from alternative to traditional medicine.

    Science.gov (United States)

    Vallbona, C; Richards, T

    1999-08-01

    Static or electromagnetic fields have been used for centuries to control pain and other biologic problems, but scientific evidence of their effect had not been gathered until recently. This article explores the value of magnetic therapy in rehabilitation medicine in terms of static magnetic fields and time varying magnetic fields (electromagnetic). A historical review is given and the discussion covers the areas of scientific criteria, modalities of magnetic therapy, mechanisms of the biologic effects of magnetic fields, and perspectives on the future of magnetic therapy.

  4. Systematic reviews of complementary therapies - an annotated bibliography. Part 2: herbal medicine

    NARCIS (Netherlands)

    Linde, K.; ter Riet, G.; Hondras, M.; Vickers, A.; Saller, R.; Melchart, D.

    2001-01-01

    BACKGROUND: Complementary therapies are widespread but controversial. We aim to provide a comprehensive collection and a summary of systematic reviews of clinical trials in three major complementary therapies (acupuncture, herbal medicine, homeopathy). This article is dealing with herbal medicine.

  5. MicroRNAs and Chinese Medicinal Herbs: New Possibilities in Cancer Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Hong, Ming; Wang, Ning; Tan, Hor Yue [School of Chinese Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong (China); Tsao, Sai-Wah [Department of Anatomy, Li KaShing Faculty of Medicine, The University of Hong Kong, Hong Kong (China); Feng, Yibin, E-mail: yfeng@hku.hk [School of Chinese Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong (China)

    2015-08-24

    In recent decades Chinese medicine has been used worldwide as a complementary and alternative medicine to treat cancer. Plenty of studies have shown that microRNAs (miRNAs) play fundamental roles in many pathological processes, including cancer, while the anti-cancer mechanisms of Chinese medicinal herbs targeting miRNAs also have been extensively explored. Our previous studies and those of others on Chinese medicinal herbs and miRNAs in various cancer models have provided a possibility of new cancer therapies, for example, up-regulating the expression of miR-23a may activate the positive regulatory network of p53 and miR-23a involved in the mechanism underlying the anti-tumor effect of berberine in hepatocellular carcinoma (HCC). In this review, we survey the role of Chinese medicinal herbal products in regulating miRNAs in cancer and the use of mediating miRNAs for cancer treatment. In addition, the controversial roles of herb-derived exogenous miRNAs in cancer treatment are also discussed. It is expected that targeting miRNAs would provide a novel therapeutic approach in cancer therapy by improving overall response and survival outcomes in cancer treatment, especially when combined with conventional therapeutics and Chinese medicinal herbal products.

  6. MicroRNAs and Chinese Medicinal Herbs: New Possibilities in Cancer Therapy

    International Nuclear Information System (INIS)

    Hong, Ming; Wang, Ning; Tan, Hor Yue; Tsao, Sai-Wah; Feng, Yibin

    2015-01-01

    In recent decades Chinese medicine has been used worldwide as a complementary and alternative medicine to treat cancer. Plenty of studies have shown that microRNAs (miRNAs) play fundamental roles in many pathological processes, including cancer, while the anti-cancer mechanisms of Chinese medicinal herbs targeting miRNAs also have been extensively explored. Our previous studies and those of others on Chinese medicinal herbs and miRNAs in various cancer models have provided a possibility of new cancer therapies, for example, up-regulating the expression of miR-23a may activate the positive regulatory network of p53 and miR-23a involved in the mechanism underlying the anti-tumor effect of berberine in hepatocellular carcinoma (HCC). In this review, we survey the role of Chinese medicinal herbal products in regulating miRNAs in cancer and the use of mediating miRNAs for cancer treatment. In addition, the controversial roles of herb-derived exogenous miRNAs in cancer treatment are also discussed. It is expected that targeting miRNAs would provide a novel therapeutic approach in cancer therapy by improving overall response and survival outcomes in cancer treatment, especially when combined with conventional therapeutics and Chinese medicinal herbal products

  7. The clinical effects of music therapy in palliative medicine.

    Science.gov (United States)

    Gallagher, Lisa M; Lagman, Ruth; Walsh, Declan; Davis, Mellar P; Legrand, Susan B

    2006-08-01

    This study was to objectively assess the effect of music therapy on patients with advanced disease. Two hundred patients with chronic and/or advanced illnesses were prospectively evaluated. The effects of music therapy on these patients are reported. Visual analog scales, the Happy/Sad Faces Assessment Tool, and a behavior scale recorded pre- and post-music therapy scores on standardized data collection forms. A computerized database was used to collect and analyze the data. Utilizing the Wilcoxon signed rank test and a paired t test, music therapy improved anxiety, body movement, facial expression, mood, pain, shortness of breath, and verbalizations. Sessions with family members were also evaluated, and music therapy improved families' facial expressions, mood, and verbalizations. All improvements were statistically significant (Pmusic therapy. Objective data were obtained for a large number of patients with advanced disease. This is a significant addition to the quantitative literature on music therapy in this unique patient population. Our results suggest that music therapy is invaluable in palliative medicine.

  8. Nuclear medicine therapy: current status and future prospects

    International Nuclear Information System (INIS)

    Sharma, S.M.

    1990-01-01

    Radioisotope therapy began in 1942 with the use of 131 I for Graves disease and 32 P for polycythemia vera. Local therapy with radioisotopes includes radiocolloids for malignant pleural and peritoneal effusions, intra-articular radiocolloids for chronic synovitis, intra-arterial radioactive microspheres for liver metastases, and intralymphatic administration for malignancies of the lymphatic system. The most widely practised use of radioisotopes for therapy is for the management of hyperthyroidism by 131 I. 131 is also being used effectively for thyroid cancer, particularly at the Radiation Medicine Centre, BARC. There is hope that a new generation of radiolabelled compounds is round the corner for therapy. Radiolabelled monoclonal antibodies aimed against specific tumor antigens have already shown great promise. Another area of interest is the use of minute lipid spheroids (vesicles) enclosing the radioactive drug which can be targeted to the tumor. (author). 19 refs

  9. Low-Intensity Extracorporeal Shockwave Therapy in Sexual Medicine

    DEFF Research Database (Denmark)

    Fode, Mikkel; Lowenstein, Lior; Reisman, Yacov

    2017-01-01

    INTRODUCTION: Low-intensity extracorporeal shockwave therapy (LI-ESWT) has emerged as a treatment option for male sexual dysfunction. However, results have been contradictory. AIM: To investigate the knowledge, practice patterns, and attitudes regarding LI-ESWT among experts in sexual medicine....... METHODS: A study-specific questionnaire was handed out at the 18th Congress for the European Society for Sexual Medicine. Participants were queried on their knowledge about LI-ESWT and about their use of the equipment. MAIN OUTCOME MEASURES: Descriptive data on the knowledge of LI-ESWT and perception...... of treatment effects. RESULTS: One hundred ninety-two questionnaires were available for analysis. Most respondents were physicians (79.7%) and most of these specialized in urology (58.9%). Overall, 144 of 192 (75%) reported that they were familiar with LI-ESWT in sexual medicine. Twenty-seven (14.1%) had...

  10. Statutory instruments: 1984 No. 1261 Medicines - The Medicines (Committee on Radiation from Radioactive Medicinal Products) (Revocation) Order 1984

    International Nuclear Information System (INIS)

    1984-01-01

    This Order, which came into force on 6 September 1984, revokes the Medicines (Committee on Radiation from Radioactive Medicinal Products) Order 1978 thereby abolishing the Committee, which was established for the purpose of giving advice on safety, quality and efficacy in relation to radiation involving any substance or article for human use to which the Medicins Act 1968 is applicable. (NEA) [fr

  11. Medicinal therapy of malignant lymphomas; Medikamentoese Therapie maligner Lymphome

    Energy Technology Data Exchange (ETDEWEB)

    Aul, C.; Schroeder, M.; Giagounidis, A. [Medizinische Klinik II, St.-Johannes-Hospital Duisburg (Germany)

    2002-12-01

    Chemotherapy represents the most important therapeutic option in malignant lymphomas. Low to intermediate risk Hodgkin's disease is treated by a combination of chemotherapy and radiation. The new chemotherapy protocol BEACOPP has improved the outcome of advanced stages in comparison with the internationally accepted standard protocol COPP/ABVD. Dependent on the initial staging, cure rates between 50 and 95% can be achieved. Indolent non-Hodgkin's lymphomas usually present in advanced stages of disease. Chemotherapy in these cases has palliative character and aims at improving patients'quality of life and at avoiding complications due to the disease. In aggressive and very aggressive non-Hodgkin's lymphoma chemotherapy is curative and must be initiated immediately irrespective of the staging results. The efficacy of the standard protocol CHOP (cyclophosphamide,doxorubicin, vincristine and prednisone), that was established in the 1970s, has recently been improved by shortening of the therapy interval (CHOP-14 vs.CHOP-21),addition of etoposide (CHOEP) and combination with the monoclonal antibody rituximab (R-CHOP). The value of high dose chemotherapy with stem cell transplantation has been shown unequivocally only for aggressive non-Hodgkin lymphoma and relapsed Hodgkin's disease responsive to chemotherapy. The therapeutic strategy of malignant lymphomas is likely to be improved within the next years due to the introduction of novel cytostatic agents, the broadening application of monoclonal antibodies,upcoming new transplantation procedures and the development of substances with molecular targets.To rapidly increase our current knowledge on the topic it is mandatory to include patients into the large national and international multicenter studies. (orig.) [German] Die Chemotherapie stellt die wichtigste Behandlungsoption maligner Lymphome dar. Bei Hodgkin-Lymphomen niedrigen bzw. intermediaeren Risikoprofils wird eine kombinierte Behandlung

  12. [Review on community herbal monographs for traditional herbal medicinal products].

    Science.gov (United States)

    Zou, Wenjun; Qu, Liping; Ye, Zuguang; Ji, Jianxin; Li, Bogang

    2011-12-01

    This article discusses the characteristics of cmmunity herbal monographs for traditional herbal medicinal products and its establishment procedure. It also reviews the new development of cmmunity traditional herbal monographs. The purpose is to clarify the relationship between cmmunity herbal monographs and simplified registration for traditional herbal medicinal product in European Union and provide reference to the registration of taditional Chinese mdicinal products in Europe.

  13. North African Medicinal Plants Traditionally Used in Cancer Therapy.

    Science.gov (United States)

    Alves-Silva, Jorge M; Romane, Abderrahmane; Efferth, Thomas; Salgueiro, Lígia

    2017-01-01

    Background: Cancer is a major cause of mortality worldwide with increasing numbers by the years. In North Africa, the number of cancer patients is alarming. Also shocking is that a huge number of cancer patients only have access to traditional medicines due to several factors, e.g., economic difficulties. In fact, medicinal plants are widely used for the treatment of several pathologies, including cancer. Truthfully, herbalists and botanists in North African countries prescribe several plants for cancer treatment. Despite the popularity and the potential of medicinal plants for the treatment of cancer, scientific evidence on their anticancer effects are still scarce for most of the described plants. Objective: Bearing in mind the lack of comprehensive and systematic studies, the aim of this review is to give an overview of studies, namely ethnobotanical surveys and experimental evidence of anticancer effects regarding medicinal plants used in North Africa for cancer therapy. Method: The research was conducted on several popular search engines including PubMed, Science Direct, Scopus and Web of Science. The research focused primarily on English written papers published between the years 2000 and 2016. Results: This review on plants traditionally used by herbalists in North Africa highlights that Morocco and Algeria are the countries with most surveys on the use of medicinal plants in folk medicine. Among the plethora of plants used, Nigella sativa and Trigonella foenum-graecum are the most referred ones by herbalists for the treatment of cancer. Moreover, a plethora of scientific evidence qualifies them as candidates for further drug development. Furthermore, we report on the underlying cellular and molecular mechanisms. Conclusion: Overall, this review highlights the therapeutic potential of some medicinal plants as anticancer agents. The North African flora offers a rich source of medicinal plants for a wide array of diseases, including cancer. The elucidation of

  14. Complementary and alternative drug therapy versus science-oriented medicine

    Directory of Open Access Journals (Sweden)

    Anlauf, Manfred

    2015-06-01

    Full Text Available This opinion deals critically with the so-called complementary and alternative medical (CAM therapy on the basis of current data. From the authors’ perspective, CAM prescriptions and most notably the extensive current endeavours to the “integration” of CAM into conventional patient care is problematic in several respects.Thus, several CAM measures are used, although no specific effects of medicines can be proved in clinical studies. It is extensively explained that the methods used in this regard are those of evidence-based medicine, which is one of the indispensable pillars of science-oriented medicine. This standard of proof of efficacy is fundamentally independent of the requirement of being able to explain efficacy of a therapy in a manner compatible with the insights of the natural sciences, which is also essential for medical progress. Numerous CAM treatments can however never conceivably satisfy this requirement; rather they are justified with pre-scientific or unscientific paradigms. The high attractiveness of CAM measures evidenced in patients and many doctors is based on a combination of positive expectations and experiences, among other things, which are at times unjustified, at times thoroughly justified, from a science-oriented view, but which are non-specific (context effects. With a view to the latter phenomenon, the authors consider the conscious use of CAM as unrevealed therapeutic placebos to be problematic. In addition, they advocate that academic medicine should again systematically endeavour to pay more attention to medical empathy and use context effects in the service of patients to the utmost.The subsequent opinion discusses the following after an introduction to medical history: the definition of CAM; the efficacy of most common CAM procedures; CAM utilisation and costs in Germany; characteristics of science-oriented medicine; awareness of placebo research; pro and contra arguments about the use of CAM, not least

  15. Complementary and alternative drug therapy versus science-oriented medicine

    Science.gov (United States)

    Anlauf, Manfred; Hein, Lutz; Hense, Hans-Werner; Köbberling, Johannes; Lasek, Rainer; Leidl, Reiner; Schöne-Seifert, Bettina

    2015-01-01

    This opinion deals critically with the so-called complementary and alternative medical (CAM) therapy on the basis of current data. From the authors’ perspective, CAM prescriptions and most notably the extensive current endeavours to the “integration” of CAM into conventional patient care is problematic in several respects. Thus, several CAM measures are used, although no specific effects of medicines can be proved in clinical studies. It is extensively explained that the methods used in this regard are those of evidence-based medicine, which is one of the indispensable pillars of science-oriented medicine. This standard of proof of efficacy is fundamentally independent of the requirement of being able to explain efficacy of a therapy in a manner compatible with the insights of the natural sciences, which is also essential for medical progress. Numerous CAM treatments can however never conceivably satisfy this requirement; rather they are justified with pre-scientific or unscientific paradigms. The high attractiveness of CAM measures evidenced in patients and many doctors is based on a combination of positive expectations and experiences, among other things, which are at times unjustified, at times thoroughly justified, from a science-oriented view, but which are non-specific (context effects). With a view to the latter phenomenon, the authors consider the conscious use of CAM as unrevealed therapeutic placebos to be problematic. In addition, they advocate that academic medicine should again systematically endeavour to pay more attention to medical empathy and use context effects in the service of patients to the utmost. The subsequent opinion discusses the following after an introduction to medical history: the definition of CAM; the efficacy of most common CAM procedures; CAM utilisation and costs in Germany; characteristics of science-oriented medicine; awareness of placebo research; pro and contra arguments about the use of CAM, not least of all in terms

  16. Complementary and alternative drug therapy versus science-oriented medicine.

    Science.gov (United States)

    Anlauf, Manfred; Hein, Lutz; Hense, Hans-Werner; Köbberling, Johannes; Lasek, Rainer; Leidl, Reiner; Schöne-Seifert, Bettina

    2015-01-01

    This opinion deals critically with the so-called complementary and alternative medical (CAM) therapy on the basis of current data. From the authors' perspective, CAM prescriptions and most notably the extensive current endeavours to the "integration" of CAM into conventional patient care is problematic in several respects. Thus, several CAM measures are used, although no specific effects of medicines can be proved in clinical studies. It is extensively explained that the methods used in this regard are those of evidence-based medicine, which is one of the indispensable pillars of science-oriented medicine. This standard of proof of efficacy is fundamentally independent of the requirement of being able to explain efficacy of a therapy in a manner compatible with the insights of the natural sciences, which is also essential for medical progress. Numerous CAM treatments can however never conceivably satisfy this requirement; rather they are justified with pre-scientific or unscientific paradigms. The high attractiveness of CAM measures evidenced in patients and many doctors is based on a combination of positive expectations and experiences, among other things, which are at times unjustified, at times thoroughly justified, from a science-oriented view, but which are non-specific (context effects). With a view to the latter phenomenon, the authors consider the conscious use of CAM as unrevealed therapeutic placebos to be problematic. In addition, they advocate that academic medicine should again systematically endeavour to pay more attention to medical empathy and use context effects in the service of patients to the utmost. The subsequent opinion discusses the following after an introduction to medical history: the definition of CAM; the efficacy of most common CAM procedures; CAM utilisation and costs in Germany; characteristics of science-oriented medicine; awareness of placebo research; pro and contra arguments about the use of CAM, not least of all in terms of

  17. Medicinal Plants Useful For Malaria Therapy In Okeigbo, Ondo State ...

    African Journals Online (AJOL)

    There is increasing resistance of malaria parasites to chloroquine, the cheapest and commonly used drug for malaria in Nigeria. Artemisin, a product from medicinal plant indigenous to China, based on active principle of Artemisia annua, has been introduced into the Nigerian market. However not much has been done to ...

  18. The importance of clinical mistletoe cancer therapy and korean mistletoe pharmacopuncture preparation development and application possibility for oriental medicine

    Directory of Open Access Journals (Sweden)

    Ok-Byung Choi

    2009-03-01

    Full Text Available Objectives : Mistletoe extracts have been in use for around 85 years, predominantly in the area of cancer therapy. Today mistletoe preparations are among the most prescribed drugs in cancer medicine, thus constituting a standard biological therapy in the area of oncology. The purpose of this study is to analyze the practical implications of mistletoe cancer therapy, their clinical status, their preparation techniques and companies. Contents : Mistletoe therapy for cancer has been developed within the context of anthroposophical medicine. One major effect of mistletoe extract is that it stimulates the immune system and cancer defences. In Germany, a total of eight different mistletoe preparations are available, five developed by Anthroposophic Medicine and three evolved from research in phytotherapy. Therapy always consists of an introductory phase in order to test the patient′s tolerance, find the right dosage and choose the most suitable preparation. This paper covers the background of mistletoe medical plant materials, mistletoe therapy for cancer, the anthroposophical medicine and clinical research, the practical regulation of treatment, preparation of mistletoe drugs. Result & suggestion : Mistletoe extracts are a complementary teratment of cancer, widely used in intergrative cancer care. The study of the integration of korean mistletoe extracts to oriental cancer medicine, its development and feasibility in Korea are urgently needed. The products, substances, compositions of european mistletoe drugs are very similar to those of oriental medicine theory. Applying the mistletoe cancer therapy and its preparation techniques to oriental medicine, the herbal acupuncture preparation should be modernized and korean mistletoe products are to be developed. To this end, government and herbal acupuncture society need to interact each other for the development of oriental mistletoe cancer medicine.

  19. [Technology transfer to the facility for production of medicines].

    Science.gov (United States)

    Beregovykh, V V; Spitskiĭ, O P

    2013-01-01

    Innovation development of pharmaceutical industry is close connected to knowledge transfer going to each subsequent life cycle phase of medicinal product. Formal regulation of technology and knowledge transfer is essential for achievement high quality during production of medicines designed during development phase. Conceptual tools, approaches and requirements are considered that are necessary for knowledge and technology transfer across all the life cycle phases of medicines. They are based on scientific knowledge of medicinal products and take into account both international and Russian regulations in the area of development, production and distribution of medicines. Importance of taking into consideration all aspects related to quality of medicines in all steps of technology transfer is shown. An approach is described for technology transfer organization for Russian pharmaceutical manufacturers based on international guides in this area.

  20. New veterinary medicinal products authorised by centralised procedure

    Directory of Open Access Journals (Sweden)

    Simona Sturzu

    2012-06-01

    Full Text Available Veterinary medicinal products that are subject to authorization via the centralized procedure according to Regulation (EC no. 726/2004 are included in the Community register of veterinary medicines, that is published on the European Commission website and product information of them are published on the website of the European Medicines Agency. Each competent authority involved in the linguistic review process of product information annexed to the Marketing Authorization for medicinal products authorized centrally (SPC, leaflet, information about the marketing authorization holder, product labeling conditions, approve the version in the language mother of each Member State. In the second half of 2011 have received marketing authorization via the centralized procedure a total of four veterinary medicinal products, presented above.

  1. [Regulatory requirements regarding cell-based medicinal products for human and veterinary use - a comparison].

    Science.gov (United States)

    Kuhlmann-Gottke, Johanna; Duchow, Karin

    2015-11-01

    At present, there is no separate regulatory framework for cell-based medicinal products (CBMP) for veterinary use at the European or German level. Current European and national regulations exclusively apply to the corresponding medicinal products for human use. An increasing number of requests for the regulatory classification of CBMP for veterinary use, such as allogeneic stem cell preparations and dendritic cell-based autologous tumour vaccines, and a rise in scientific advice for companies developing these products, illustrate the need for adequate legislation. Currently, advice is given and decisions are made on a case-by-case basis regarding the regulatory classification and authorisation requirements.Since some of the CBMP - in particular in the area of stem-cell products - are developed in parallel for human and veterinary use, there is an urgent need to create specific legal definitions, regulations, and guidelines for these complex innovative products in the veterinary sector as well. Otherwise, there is a risk that that the current legal grey area regarding veterinary medicinal products will impede therapeutic innovations in the long run. A harmonised EU-wide approach is desirable. Currently the European legislation on veterinary medicinal products is under revision. In this context, veterinary therapeutics based on allogeneic cells and tissues will be defined and regulated. Certainly, the legal framework does not have to be as comprehensive as for human CBMP; a leaner solution is conceivable, similar to the special provisions for advanced-therapy medicinal products laid down in the German Medicines Act.

  2. CAR-T Cell Therapies From the Transfusion Medicine Perspective.

    Science.gov (United States)

    Fesnak, Andrew; Lin, ChieYu; Siegel, Don L; Maus, Marcela V

    2016-07-01

    The use of chimeric antigen receptor (CAR)-T cell therapy for the treatment of hematologic malignancies has generated significant excitement over the last several years. From a transfusion medicine perspective, the implementation of CAR-T therapy as a potential mainstay treatment for not only hematologic but also solid-organ malignancies represents a significant opportunity for growth and expansion. In this review, we will describe the rationale for the development of genetically redirected T cells as a cancer therapeutic, the different elements that are required to engineer these cells, as well as an overview of the process by which patient cells are harvested and processed to create and subsequently validate CAR-T cells. Finally, we will briefly describe some of the toxicities and clinical efficacy of CAR-T cells in the setting of patients with advanced malignancy. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Evidence from the Cochrane Collaboration for Traditional Chinese Medicine Therapies

    Science.gov (United States)

    Wieland, Susan; Kimbrough, Elizabeth; Cheng, Ker; Berman, Brian M.

    2009-01-01

    Abstract Background The Cochrane Collaboration, an international not-for-profit organization that prepares and maintains systematic reviews of randomized trials of health care therapies, has produced reviews summarizing much of the evidence on Traditional Chinese Medicine (TCM). Our objective was to review the evidence base according to Cochrane systematic reviews. Methods In order to detect reviews focusing on TCM, we searched the titles and abstracts of all reviews in Issue 4, 2008 of the Cochrane Database of Systematic Reviews. For each review, we extracted data on the number of trials included and the total number of participants. We provided an indication of the strength of the review findings by assessing the reviewers' abstract conclusions statement. We supplemented our assessment of the abstract conclusions statements with a listing of the comparisons and outcomes showing statistically significant meta-analyses results. Results We identified 70 Cochrane systematic reviews of TCM, primarily acupuncture (n = 26) and Chinese herbal medicine (n = 42), and 1 each of moxibustion and t'ai chi. Nineteen (19) of 26 acupuncture reviews and 22/42 herbal medicine reviews concluded that there was not enough good quality trial evidence to make any conclusion about the efficacy of the evaluated treatment, while the remaining 7 acupuncture and 20 herbal medicine reviews and each of the moxibustion and t'ai chi reviews indicated a suggestion of benefit, which was qualified by a caveat about the poor quality and quantity of studies. Most reviews included many distinct interventions, controls, outcomes, and populations, and a large number of different comparisons were made, each with a distinct forest plot. Conclusions Most Cochrane systematic reviews of TCM are inconclusive, due specifically to the poor methodology and heterogeneity of the studies reviewed. Some systematic reviews provide preliminary evidence of Chinese medicine's benefits to certain patient populations

  4. Metabolic radiopharmaceutical therapy in nuclear medicine; Terapia metabolica mediante radiofarmacos en medicina nuclear

    Energy Technology Data Exchange (ETDEWEB)

    Reguera, L.; Lozano, M. L.; Alonso, J. C.

    2016-08-01

    In 1986 the National Board of Medical Specialties defined the specialty of nuclear medicine as a medical specialty that uses radioisotopes for prevention, diagnosis, therapy and medical research. Nowadays, treatment with radiopharmaceuticals has reached a major importance within of nuclear medicine. The ability to treat tumors with radiopharmaceutical, Radiation selective therapy has become a first line alternative. In this paper, the current situation of the different therapies that are sued in nuclear medicine, is reviewed. (Author)

  5. Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

    Science.gov (United States)

    Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

    2010-01-01

    The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.

  6. Chinese medicine protein and peptide in gene and cell therapy.

    Science.gov (United States)

    Feng, Yinglu; Yin, Zifei; Zhang, Daniel; Srivastava, Arun; Ling, Chen

    2018-06-11

    The success of gene and cell therapy in clinic during the past two decades as well as our expanding ability to manipulate these biomaterials are leading to new therapeutic options for a wide range of inherited and acquired diseases. Combining conventional therapies with this emerging field is a promising strategy to treat those previously-thought untreatable diseases. Traditional Chinese medicine (TCM) has evolved for thousands of years in China and still plays an important role in human health. As part of the active ingredients of TCM, proteins and peptides have attracted long-term enthusiasm of researchers. More recently, they have been utilized in gene and cell therapy, resulting in promising novel strategies to treat both cancer and non-cancer diseases. This manuscript presents a critical review on this field, accompanied with perspectives on the challenges and new directions for future research in this emerging frontier. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  7. The Prohibition of Medicinal Claims: Food in Fact But Medicinal Product in Law?

    NARCIS (Netherlands)

    Bremmers, H.J.; Meulen, van der B.M.J.; Waarts, Y.R.

    2015-01-01

    Under EU medicinal law, any substance or combination of substances presented as having properties for treating or preventing disease in human beings is a medicinal product by virtue of its presentation. Under EU food law it is prohibited to attribute to any food the property of preventing, treating

  8. Role of Nuclear Medicine in the cardiac resinchronization therapy

    Energy Technology Data Exchange (ETDEWEB)

    Brandao, Simone Cristina Soares, E-mail: simonecordis@yahoo.com.br [Universidade Federal de Pernambuco (UFPE), Recife, PE (Brazil); Giorgi, Maria Clementina Pinto; D' Orio, Silvana Angelina; Meneghetti, Jose Claudio [Instituto do Coracao (InCor/FM/USP), Sao Paulo, SP (Brazil)

    2011-10-15

    Cardiac resynchronization therapy (CRT) emerged as one of the most promising approaches in the treatment of cardiac dyssynchrony in heart failure patients' refractory to medical treatment. However, despite very promising clinical and functional results, individual response analyses show that a significant number of patients do not respond to treatment. The role of nuclear medicine and molecular imaging in the selection of CRT candidates by the assessment of cardiac dyssynchrony, myocardial viability, myocardial perfusion and blood flow and sympathetic cardiac activity has been discussed in this review. The potential utilization of this tool to improve the comprehension of detrimental effects of dyssynchrony on cardiac function and the evaluation and monitoring of the response to CRT were also considered. Other molecular targets that characterize glucose and fatty acid metabolism, apoptosis, angiotensin converting enzyme activity and angiogenesis that can be evaluated with this technique were described. (author)

  9. Role of Nuclear Medicine in the cardiac resinchronization therapy

    Energy Technology Data Exchange (ETDEWEB)

    Brandao, Simone Cristina Soares, E-mail: simonecordis@yahoo.com.br [Universidade Federal de Pernambuco (UFPE), Recife, PE (Brazil); Giorgi, Maria Clementina Pinto; D' Orio, Silvana Angelina; Meneghetti, Jose Claudio [Instituto do Coracao (InCor/FM/USP), Sao Paulo, SP (Brazil)

    2011-10-15

    Cardiac resynchronization therapy (CRT) emerged as one of the most promising approaches in the treatment of cardiac dyssynchrony in heart failure patients' refractory to medical treatment. However, despite very promising clinical and functional results, individual response analyses show that a significant number of patients do not respond to treatment. The role of nuclear medicine and molecular imaging in the selection of CRT candidates by the assessment of cardiac dyssynchrony, myocardial viability, myocardial perfusion and blood flow and sympathetic cardiac activity has been discussed in this review. The potential utilization of this tool to improve the comprehension of detrimental effects of dyssynchrony on cardiac function and the evaluation and monitoring of the response to CRT were also considered. Other molecular targets that characterize glucose and fatty acid metabolism, apoptosis, angiotensin converting enzyme activity and angiogenesis that can be evaluated with this technique were described. (author)

  10. Laboratory research at the clinical trials of Veterinary medicinal Products

    OpenAIRE

    ZHYLA M.I.

    2011-01-01

    The article analyses the importance of laboratory test methods, namely pathomorfological at conduct of clinical trials. The article focuses on complex laboratory diagnostics at determination of clinical condition of animals, safety and efficacy of tested medicinal product.

  11. 75 FR 65293 - Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for...

    Science.gov (United States)

    2010-10-22

    ...] Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for... Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled ``Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data...

  12. Evidence - based medicine/practice in sports physical therapy.

    Science.gov (United States)

    Manske, Robert C; Lehecka, B J

    2012-10-01

    A push for the use of evidence-based medicine and evidence-based practice patterns has permeated most health care disciplines. The use of evidence-based practice in sports physical therapy may improve health care quality, reduce medical errors, help balance known benefits and risks, challenge views based on beliefs rather than evidence, and help to integrate patient preferences into decision-making. In this era of health care utilization sports physical therapists are expected to integrate clinical experience with conscientious, explicit, and judicious use of research evidence in order to make clearly informed decisions in order to help maximize and optimize patient well-being. One of the more common reasons for not using evidence in clinical practice is the perceived lack of skills and knowledge when searching for or appraising research. This clinical commentary was developed to educate the readership on what constitutes evidence-based practice, and strategies used to seek evidence in the daily clinical practice of sports physical therapy.

  13. PCMO L01-Setting Specifications for Biological Investigational Medicinal Products.

    Science.gov (United States)

    Krause, Stephan O

    2015-01-01

    This paper provides overall guidance and best practices for the setting of specifications for clinical biological drug substances and drug products within the framework of ICH guidelines on pharmaceutical development [Q8(R2) and Q11], quality risk management (Q9), and quality systems (Q10). A review is provided of the current regulatory expectations for the specification setting process as part of a control strategy during product development, pointing to existing challenges for the investigational new drug/investigational medicinal product dossier (IND/IMPD) sponsor. A case study illustrates how the investigational medicinal product specification revision process can be managed within a flexible quality system, and how specifications can be set and justified for early and late development stages. This paper provides an overview for the setting of product specifications for investigational medicinal products used in clinical trials. A case study illustrates how product specifications of investigational medicinal products can be justified and managed within a modern product quality system. © PDA, Inc. 2015.

  14. [Research strategies for feed additives and veterinary medicines from side products of Chinese medicine resources industrialization].

    Science.gov (United States)

    Zhao, Ming; Duan, Jin-Ao; Zhang, Sen; Guo, Sheng; Su, Shu-Lan; Wu, Qi-Nan; Tang, Yu-Ping; Zeng, Jian-Guo

    2017-09-01

    The global antimicrobial resistance has been a big challenge to the human health for years. It has to make balance between the safety of animal products and the use of antimicrobials in animal husbandry. Any methods that can minimize or even phase out the use of antimicrobials in animal husbandry should be encouraged. We herein describe the research strategies for feed additives and veterinary medicines from the side products of Chinese medicine resources industrialization. Killing two birds with one stone-besides the major purposes, the rational utilization of non-medicinal parts and wastes of industrialization of Chinese herbal medicines is also achieved under the proposed strategies. Copyright© by the Chinese Pharmaceutical Association.

  15. Conditional approval: Japan lowers the bar for regenerative medicine products.

    Science.gov (United States)

    Sipp, Douglas

    2015-04-02

    A new system for conditional approval of regenerative medicine products will allow products of undetermined efficacy to enter the Japanese market. The potential scientific, economic, and ethical implications of this program highlight the need for further discussion and refinement. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. Programme of Action for Cancer Therapy: Maximizing Investments in Radiation Medicine

    International Nuclear Information System (INIS)

    Enwerem-Bromson, N.; Nitzsche-Bell, A.

    2015-01-01

    In the presentation, Ms Nelly Enwerem-Bromson will present her work as Director of the Programme of Action for Cancer Therapy (PACT) and the crucial role of nuclear techniques in cancer control. She will review the key drivers for increasing demand for technical support on cancer control from low and middle income (LMI) Member States to the UN system in general, and the IAEA in particular. She will further elaborate on IAEA’s Programme of Action for Cancer Therapy (PACT) main products and services and how they are having a positive impact on assessing national capacities and needs, supporting Member States in identifying key priority interventions and translating them into action through the IAEA Technical Cooperation Programme. Ms Enwerem-Bromson will also address innovative approaches on distance learning and international collaboration to increase the quantity and quality of oncology related human resources as well as in the establishment of sustainable radiation medicines services in LMI countries. (author)

  17. Determination of impurities and degradation products from veterinary medicinal products by HPLC method

    Directory of Open Access Journals (Sweden)

    Elena Gabriela Oltean

    2014-06-01

    Full Text Available The organic or inorganic impurities in the veterinary medicinal product can derive from starting materials, manufacturing process, incomplete purification, inappropriate storage. The acceptable levels of impurities in pharmaceuticals are estimated by comparison with standard solutions, according to the appropriate monographs. Forced degradation studies determine the stability of the method of dosage for the active compounds and for the entire finished product under excessive accelerated degradation conditions. They also provide information on degradation pathways and selectivity of analytical methods applied. The information provided by the degradation studies on the active compound and finished pharmaceutical product should demonstrate the specificity of the analytical method regarding impurities. Forced degradation studies should demonstrate that the impurities and degradation products generated do not interfere with the active compound. The current forced degradation methods consist of acid hydrolysis, basic hydrolysis, oxidation, exposure of the medicinal product to temperature and light. HPLC methods are an integral analytical instrument for the analysis of the medicinal product. The HPLC method should be able to separate, detect and quantify various specific degradation products that can appear after manufacture or storage of the medicinal product, as well as new elements appearing after synthesis. FDA and ICH guidelines recommend the enclosure of the results, including the chromatograms specific to the forced degradation-subjected medicinal product, in the documentation for marketing authorization. Using HPLC methods in forced degradation studies on medicinal products provides relevant information on the method of determination for the formulation of the medicinal product, synthesis product, packaging methods and storage.

  18. Modern radioisotope production technologies for medicine

    International Nuclear Information System (INIS)

    Bechtold, V.; Schweickert, H.

    1989-01-01

    The advantages of the accelerator production of radioisotopes for medical purposes, are, above all, the high specific activity attainable as well as the possibility of the generation of nuclei with only a few neutrons which disintegrate due to β + emission or electron capture. It is, for example, possible to diagnostically utilize the developing long-range γ quanta by means of computerized tomography. The production of I-123 at the cyclotron of Karlsruhe (nuclear reaction, target, irradiation arrangement) as well as of ultra-pure I-123 with the help of compact cyclotrons, and the plant developed for this are described in brief. As another radioisotope which can be produced with the help of the compact cyclotron, Rb-81 is mentioned, the disintegration product Kr-81m of which is used in pulmonary diagnostics. (RB) [de

  19. Should Anthroposophic Medicinal Products Be Regulated in Europe?

    Science.gov (United States)

    Michaux, Geneviève

    2017-03-01

    European Commission’s reports suggest that the European Union should address the status of anthroposophic products, i.e. products that are developed, manufactured and prescribed in accordance with the holistic approach on which anthroposophic medicine is based. Anthroposophic products cannot be placed as such on the European market because they cannot meet the marketing authorisation or even registration requirements set out by European or national pharmaceutical law. Yet, the 95-year European tradition and good safety profile of anthroposophic products justify giving them an easier access to market. Such access can result from specific rules on anthroposophic products, but can be more efficiently achieved by encouraging the Member States to better apply the existing rules on marketing authorisation procedures or on registration of homeopathic and traditional herbal medicinal products, or by including anthroposophic substances, manufacturing methods or uses in monographs.

  20. MANUFACTURING NATURAL KILLER CELLS AS MEDICINAL PRODUCTS

    Directory of Open Access Journals (Sweden)

    Christian CHABANNON

    2016-11-01

    Full Text Available Natural Killer (NK cells are Innate Lymphoid Cells (ILC with cytotoxic and regulatory properties. Their functions are tightly regulated by an array of inhibitory and activating receptors, and their mechanisms of activation strongly differ from antigen recognition in the context of HLA presentation as needed for T-cell activation. NK cells thus offer unique opportunities for new and improved therapeutic manipulation, either in vivo or in vitro, in a variety of human diseases, including cancers. NK cell activity can possibly be modulated in vivo through direct or indirect actions exerted by small molecules or monoclonal antibodies. NK cells can also be adoptively transferred following more or less substantial modifications through cell and gene manufacturing, in order to empower them with new or improved functions and ensure their controlled persistence and activity in the recipient. In the present review, we will focus on the technological and regulatory challenges of NK cell manufacturing, and discuss conditions in which these innovative cellular therapies can be brought to the clinic.

  1. Comparison of Authorization/Registration/Notification Processes among Biocidal Products, Cosmetics, Plant Protection Products and Human Medicinal Products

    OpenAIRE

    Söyleriz, Yüksel

    2015-01-01

    In this study, comparison of the authorization/registration/notification processes of biocidal products, cosmetics, plant protection products and medicinal products are made and in this respect, the situation in EU is assessed.

  2. Brazilian scientific production on herbal medicines used in dentistry

    Directory of Open Access Journals (Sweden)

    R.D. Castro

    2014-09-01

    Full Text Available The objective of this study was to critically analyze the scientific production published in specialized Brazilian journals concerning the use of medicinal plants in dentistry. A literature review was carried out using an indirect documentation technique by means of a bibliographical study. Four examiners performed independent searches in Brazilian journals of medicinal plants indexed in the database SciELO (Brazilian Journal of Pharmacognosy; Brazilian Journal of Medicinal Plants; Brazilian Journal of Pharmaceutical Sciences; and Acta Botanica Brasilica using the descriptors "herbal medicine/phytotherapy" or "medicinal plants" and "dentistry ". The articles published from 2002 to 2012 addressing the use of medicinal plants in dentistry were included and analyzed. The searches based on the descriptors and reading of abstracts, resulted in 155 articles. Of these, 44 were read in full and a total of 16 publications met the eligibility criteria and were selected. Laboratory studies predominated (10 and were limited to the evaluation of antimicrobial properties by means of tests for determining inhibitory, fungicidal and bactericidal concentrations. Three literature reviews and only one clinical trial with no blinding and randomization were found. It is highlighted the need for better methodological designs in the researches and greater production of clinical or in vivo studies.

  3. Shielding estimation for nuclear medicine therapy ward: our experience

    International Nuclear Information System (INIS)

    Skopljak-Beganovic, A.; Kucukalic-Selimovic, E.; Beganovic, A.; Drljevic, A.

    2008-01-01

    Full text: The aim of this study was to calculate and estimate the shielding thickness for a new Nuclear Medicine Therapy Ward. Parameters available for shielding calculation were: ground plan of the ward, radionuclides planned for use, maximum administered activity of I-131, maximum delivered activity of I-131 to the ward per week, average time spent in the hospital after the treatment. The most hazardous and most commonly used radioisotope is I-131. The target dose that needs to be met for occupationally exposed workers is 0.3 mSv per year. There are several factors that could be changed in order to achieve this value: distance from the source, shielding thickness, angle of incidence, occupational and usage factors. The maximum dose rate at 1 meter from the thyroid gland of the patient was considered to be 100 mSv/h. The distances and incidence angles could not be changed since these vales were predetermined in the ground plan. Different usage and occupational factors were used for different rooms in the ward. We used occupational factor 1 for the bed and 1/6 for the bathroom, and usage factor 1 for nurses' room and patient room and 1/6 for the corridors, etc. The easiest way of calculating dose attenuation in material was by introducing the HVL and TVL for broad beams. TVL and HVL were taken from the graph.The results show that shielding thickness should be in the range of 3 mmPb for room doors to 30 mmPb for the wall adjacent to the nurse's office. Most of the walls are 20 mmPb thick. These values were calculated using conservative assumptions and are more then enough to protect staff, patients and public from external radiation. If the construction cannot support the weight of lead some rearrangements regarding patient positions could be made. (author)

  4. Fighting trafficking of falsified and substandard medicinal products in Russia.

    Science.gov (United States)

    Fayzrakhmanov, N F

    2015-01-01

    The trafficking of falsified and substandard medicinal products is a global socio-economic problem, which poses a serious threat to economy and health of populations of most countries, including the Russian Federation. To identify the main achievements and challenges in the fight against trafficking of falsified and substandard medicinal products in the Russian Federation, to formulate possible solutions to these problems. The study of criminal cases and statistical information about the level of crime in the Russian Federation; legal analysis of regulatory legal acts in the sphere of criminal law and turnover of medicinal products; review of scientific and practical publications. The problem of trafficking of falsified and substandard medicinal products in the Russian Federation was publicly discussed in the late 1990s - early 2000-ies, first in the media and special editions, later this phenomenon was the subject of extensive discussions at international conferences, in public authorities and public circles. However, the most significant results in tackling this problem were achieved only in the last 5 years.Thus, in 2010, the Russian Federation first joined the annual international police operation under the code name Pangaea, held since 2008 on the initiative of Interpol and the Medicines and Healthcare products Regulatory Agency of the World Health Organization (MHRA WHO). From year to year, the special operation Pangea unites the efforts of many countries from different continents and aims to eliminate transnational criminal groups operating through a global network the Internet. In 2010, as a result of large-scale international inspections 1 200 Internet sites were revealed, through which the fake medicines were spread and 10,000 boxes of medicines were seized, making more than a million falsified tablets in the amount of 2.6 million USA dollars. In 2011, in a special operation Pangea IV was attended by 165 different organizations from 81 countries

  5. Submerged cultivation of medicinal mushrooms: bioprocesses and products (review).

    Science.gov (United States)

    Elisashvili, Vladimir

    2012-01-01

    Medicinal mushrooms belonging to higher Basidiomycetes are an immensely rich yet largely untapped resource of useful, easily accessible, natural compounds with various biological activities that may promote human well-being. The medicinal properties are found in various cellular components and secondary metabolites (polysaccharides, proteins and their complexes, phenolic compounds, polyketides, triterpenoids, steroids, alkaloids, nucleotides, etc.), which have been isolated and identified from the fruiting bodies, culture mycelium, and culture broth of mushrooms. Some of these compounds have cholesterol-lowering, anti-diabetic, antioxidant, antitumor, immunomodulating, antimicrobial, and antiviral activities ready for industrial trials and further commercialization, while others are in various stages of development. Recently, the submerged cultivation of medicinal mushrooms has received a great deal of attention as a promising and reproducible alternative for the efficient production of mushroom mycelium and metabolites. Submerged cultivation of mushrooms has significant industrial potential, but its success on a commercial scale depends on increasing product yields and development of novel production systems that address the problems associated with this technique of mushroom cultivation. In spite of many researchers' efforts for the production of bioactive metabolites by mushrooms, the physiological and engineering aspects of submerged cultures are still far from being thoroughly studied. The vast majority of studies have focused on polysaccharide and ganoderic acid production in submerged cultivation of medicinal mushrooms, and very little has been written so far on the antioxidant and hemagglutinating activity of submerged mushroom cultures. The purpose of this review is to provide an update of the present state of the art and future prospects of submerged cultivation of medicinal mushrooms to produce mycelium and bioactive metabolites, and to make a

  6. Nontraditional Therapies (Traditional Chinese Veterinary Medicine and Chiropractic) in Exotic Animals.

    Science.gov (United States)

    Marziani, Jessica A

    2018-05-01

    The nontraditional therapies of Traditional Chinese Veterinary Medicine and chiropractic care are adjunct treatments that can be used in conjunction with more conventional therapies to treat a variety of medical conditions. Nontraditional therapies do not need to be alternatives to Western medicine but, instead, can be used simultaneously. Exotic animal practitioners should have a basic understanding of nontraditional therapies for both client education and patient referral because they can enhance the quality of life, longevity, and positive outcomes for various cases across multiple taxa. Copyright © 2018 Elsevier Inc. All rights reserved.

  7. Contamination of herbal medicinal products marketed in Kaduna ...

    African Journals Online (AJOL)

    The study aimed to evaluate the bacterial contamination of powdered herbal medicinal preparations sourced from identified herbal retail outlets in different parts of Kaduna metropolis. The assessments of the contamination of the herbal products were carried out using standard procedures: total aerobic bacterial plate count, ...

  8. HEAVY METAL CONTENT OF AYURVEDIC HERBAL MEDICINE PRODUCTS

    Science.gov (United States)

    Case reports of individuals taking Ayurvedic herbal medicine products (HMPs) suggest that they may contain lead, mercury, and/or arsenic. We analyzed the heavy metal content of Ayurvedic HMPs manufactured in India and Pakistan, available in South Asian grocery stores in the Bost...

  9. Complementary and alternative medicine therapies for the anesthesiologist and pain practitioner: a narrative review.

    Science.gov (United States)

    Woodbury, Anna; Soong, Stephen Neal; Fishman, David; García, Paul S

    2016-01-01

    This narrative review provides an overview of the complementary and alternative medicine (CAM) therapies that anesthesiologists and pain management practitioners commonly encounter along with recommendations for evaluation and implementation. A literature search of PubMed was performed using the comprehensive MeSH term, "Complementary Therapies OR Dietary Supplements", and a search was conducted of the various licensing organizations and books published on the topics of CAM and integrative medicine. In North America, the most commonly encountered CAM therapies include 1) manipulation and procedural therapies; 2) herbs, nutritional supplements (nutraceuticals), and dietary therapies; and 3) mind-body and energy therapies. Controversy exists regarding many of these therapies, particularly those with a higher risk of harm, such as chiropractic manipulation, acupuncture, and nutraceutical use. Several well-conducted studies were analyzed to show how research in CAM can control for placebo responses. Practical considerations are provided for patients and practitioners interested in pursuing or already employing CAM in perioperative and chronic pain management settings. Complementary and alternative medicine therapies in general may provide a useful adjunct in the management of chronic pain. Nevertheless, many patients are not aware of the risks and benefits of individual therapies. In the perioperative setting, the most concerning CAM therapy is the use of herbs and other supplements that may produce physiologic and metabolic derangements and may interact with prescription medications. Resources exist to aid pain specialists, anesthesiologists, and patients in the evidence-based utilization of CAM therapies.

  10. Economic aspects of radionuclide production for nuclear medicine

    International Nuclear Information System (INIS)

    Le Gallic, Y.; Prospert, J.

    1980-03-01

    In a difficult economic situation it was considered advisable to inform users of certain financial aspects of radionuclide production for nuclear medicine. Two aspects of this vast and many-sided problem are developed here: - The cost price structure of different products (radiopharmaceutical and radioimmunological) which defines the size of the market consistent with a balanced budget. This aspect of the economic analysis seems all the more important as ORIS, although a non profit-making organization, has to balance its production costs. - The effects on the national economy of the nuclear medicine supply market. From this viewpoint it seemed interesting to examine the share-out of the French market between ORIS which is practically the only national producer and importers, as well as the balance of payments situation in this respect [fr

  11. Readability assessment of package inserts of biological medicinal products from the European medicines agency website.

    Science.gov (United States)

    Piñero-López, Ma Ángeles; Modamio, Pilar; Lastra, Cecilia F; Mariño, Eduardo L

    2014-07-01

    Package inserts that accompany medicines are a common source of information aimed at patients and should match patient abilities in terms of readability. Our objective was to determine the degree of readability of the package inserts for biological medicinal products commercially available in 2007 and compare them with the readability of the same package inserts in 2010. A total of 33 package inserts were selected and classified into five groups according to the type of medicine: monoclonal antibody-based products, cytokines, therapeutic enzymes, recombinant blood factors and other blood-related products, and recombinant hormones. The package inserts were downloaded from the European Medicines Agency website in 2007 and 2010. Readability was evaluated for the entire text of five of the six sections of the package inserts and for the 'Annex' when there was one. Three readability formulas were used: SMOG (Simple Measure of Gobbledygook) grade, Flesh-Kincaid grade level, and Szigriszt's perspicuity index. No significant differences were found between the readability results for the 2007 package inserts and those from 2010 according to any of the three readability indices studied (p>0.05). However, there were significant differences (preadability scores of the sections of the package inserts in both 2007 and 2010. The readability of the package inserts was above the recommended sixth grade reading level (ages 11-12) and may lead to difficulties of understanding for people with limited literacy. All the sections should be easy to read and, therefore, the readability of the medicine package inserts studied should be improved.

  12. The Role of Medicinal Cannabis in Clinical Therapy: Pharmacists' Perspectives.

    Science.gov (United States)

    Isaac, Sami; Saini, Bandana; Chaar, Betty B

    2016-01-01

    Medicinal cannabis has recently attracted much media attention in Australia and across the world. With the exception of a few countries, cannabinoids remain illegal-known for their adverse effects rather than their medicinal application and therapeutic benefit. However, there is mounting evidence demonstrating the therapeutic benefits of cannabis in alleviating neuropathic pain, improving multiple sclerosis spasticity, reducing chemotherapy induced nausea and vomiting, and many other chronic conditions. Many are calling for the legalisation of medicinal cannabis including consumers, physicians and politicians. Pharmacists are the gatekeepers of medicines and future administrators/dispensers of cannabis to the public, however very little has been heard about pharmacists' perspectives. Therefore the aim of this study was to explore pharmacists' views about medicinal cannabis; its legalisation and supply in pharmacy. Semi-structured interviews with 34 registered pharmacists in Australia were conducted. All interviews were audio-recorded, transcribed ad verbatim and thematically analysed using the NVivo software. Emergent themes included stigma, legislation, safety and collaboration. Overall the majority of pharmacists felt national legalisation of a standardised form of cannabis would be suitable, and indicated various factors and strategies to manage its supply. The majority of participants felt that the most suitable setting would be via a community pharmacy setting due to the importance of accessibility for patients. This study explored views of practicing pharmacists, revealing a number of previously undocumented views and barriers about medicinal cannabis from a supply perspective. There were several ethical and professional issues raised for consideration. These findings highlight the important role that pharmacists hold in the supply of medicinal cannabis. Additionally, this study identified important factors, which will help shape future policies for the

  13. The Role of Medicinal Cannabis in Clinical Therapy: Pharmacists' Perspectives.

    Directory of Open Access Journals (Sweden)

    Sami Isaac

    Full Text Available Medicinal cannabis has recently attracted much media attention in Australia and across the world. With the exception of a few countries, cannabinoids remain illegal-known for their adverse effects rather than their medicinal application and therapeutic benefit. However, there is mounting evidence demonstrating the therapeutic benefits of cannabis in alleviating neuropathic pain, improving multiple sclerosis spasticity, reducing chemotherapy induced nausea and vomiting, and many other chronic conditions. Many are calling for the legalisation of medicinal cannabis including consumers, physicians and politicians. Pharmacists are the gatekeepers of medicines and future administrators/dispensers of cannabis to the public, however very little has been heard about pharmacists' perspectives. Therefore the aim of this study was to explore pharmacists' views about medicinal cannabis; its legalisation and supply in pharmacy.Semi-structured interviews with 34 registered pharmacists in Australia were conducted. All interviews were audio-recorded, transcribed ad verbatim and thematically analysed using the NVivo software.Emergent themes included stigma, legislation, safety and collaboration. Overall the majority of pharmacists felt national legalisation of a standardised form of cannabis would be suitable, and indicated various factors and strategies to manage its supply. The majority of participants felt that the most suitable setting would be via a community pharmacy setting due to the importance of accessibility for patients.This study explored views of practicing pharmacists, revealing a number of previously undocumented views and barriers about medicinal cannabis from a supply perspective. There were several ethical and professional issues raised for consideration. These findings highlight the important role that pharmacists hold in the supply of medicinal cannabis. Additionally, this study identified important factors, which will help shape future

  14. Date fruit: chemical composition, nutritional and medicinal values, products.

    Science.gov (United States)

    Tang, Zhen-Xing; Shi, Lu-E; Aleid, Salah M

    2013-08-15

    Date fruit has served as a staple food in the Arab world for centuries. Worldwide production of date fruit has increased almost threefold over the last 40 years, reaching 7.68 million tons in 2010. Date fruit can provide many essential nutrients and potential health benefits to the consumer. Date fruit goes through four ripening stages named kimri, khalal, rutab and tamer. The main chemical components of date fruit include carbohydrates, dietary fibre, enzymes, protein, fat, minerals, vitamins, phenolic acids and carotenoids. The chemical composition of date fruit varies according to ripening stage, cultivar, growing environment, postharvest conditions, etc. The nutritional and medicinal activities of date fruit are related to its chemical composition. Many studies have shown that date fruit has antioxidant, antimutagenic, anti-inflammatory, gastroprotective, hepatoprotective, nephroprotective, anticancer and immunostimulant activities. Various date fruit-based products such as date syrup, date paste, date juice and their derived products are available. Date by-products can be used as raw materials for the production of value-added products such as organic acids, exopolysaccharides, antibiotics, date-flavoured probiotic-fermented dairy produce, bakery yeasts, etc. In this paper the chemical composition and nutritional and medicinal values of date fruit as well as date fruit-based products are reviewed. © 2013 Society of Chemical Industry.

  15. Equine-Assisted Therapies: Complementary Medicine or Not?

    Science.gov (United States)

    Ratcliffe, Katherine T.; Sanekane, Cindy

    2009-01-01

    Equine-assisted therapies are interventions that use the unique qualities of a horse to assist persons with disabilities to improve their gross motor, language, social, and self-help skills. Programs offering these services are varied and operate on all major continents across the world. The effectiveness of equine-assisted therapies is generally…

  16. Preclinical imaging methods for assessing the safety and efficacy of regenerative medicine therapies

    Science.gov (United States)

    Scarfe, Lauren; Brillant, Nathalie; Kumar, J. Dinesh; Ali, Noura; Alrumayh, Ahmed; Amali, Mohammed; Barbellion, Stephane; Jones, Vendula; Niemeijer, Marije; Potdevin, Sophie; Roussignol, Gautier; Vaganov, Anatoly; Barbaric, Ivana; Barrow, Michael; Burton, Neal C.; Connell, John; Dazzi, Francesco; Edsbagge, Josefina; French, Neil S.; Holder, Julie; Hutchinson, Claire; Jones, David R.; Kalber, Tammy; Lovatt, Cerys; Lythgoe, Mark F.; Patel, Sara; Patrick, P. Stephen; Piner, Jacqueline; Reinhardt, Jens; Ricci, Emanuelle; Sidaway, James; Stacey, Glyn N.; Starkey Lewis, Philip J.; Sullivan, Gareth; Taylor, Arthur; Wilm, Bettina; Poptani, Harish; Murray, Patricia; Goldring, Chris E. P.; Park, B. Kevin

    2017-10-01

    Regenerative medicine therapies hold enormous potential for a variety of currently incurable conditions with high unmet clinical need. Most progress in this field to date has been achieved with cell-based regenerative medicine therapies, with over a thousand clinical trials performed up to 2015. However, lack of adequate safety and efficacy data is currently limiting wider uptake of these therapies. To facilitate clinical translation, non-invasive in vivo imaging technologies that enable careful evaluation and characterisation of the administered cells and their effects on host tissues are critically required to evaluate their safety and efficacy in relevant preclinical models. This article reviews the most common imaging technologies available and how they can be applied to regenerative medicine research. We cover details of how each technology works, which cell labels are most appropriate for different applications, and the value of multi-modal imaging approaches to gain a comprehensive understanding of the responses to cell therapy in vivo.

  17. Search for bioactive natural products from medicinal plants of Bangladesh.

    Science.gov (United States)

    Ahmed, Firoj; Sadhu, Samir Kumar; Ishibashi, Masami

    2010-10-01

    In our continuous search for bioactive natural products from natural resources, we explored medicinal plants of Bangladesh, targeting cancer-related tumor necrosis factor-related apoptosis-inducing ligand-signaling pathway, along with some other biological activities such as prostaglandin inhibitory activity, 1,1-diphenyl-2-picrylhydrazyl free-radical-scavenging activity, and cell growth inhibitory activity. Along with this, we describe a short field study on Sundarbans mangrove forests, Bangladesh, in the review.

  18. Implementation of Plasma Fractionation in Biological Medicines Production

    OpenAIRE

    Mousavi Hosseini, Kamran; Ghasemzadeh, Mehran

    2016-01-01

    Context The major motivation for the preparation of the plasma derived biological medicine was the treatment of casualties from the Second World War. Due to the high expenses for preparation of plasma derived products, achievement of self-sufficiency in human plasma biotechnological industry is an important goal for developing countries. Evidence Acquisition The complexity of the blood plasma was first revealed by the Nobel Prize laureate, Arne Tiselius and Theodor Svedberg, which resulted in...

  19. Current and future regenerative medicine - principles, concepts, and therapeutic use of stem cell therapy and tissue engineering in equine medicine

    DEFF Research Database (Denmark)

    Koch, Thomas Gadegaard; Berg, Lise Charlotte; Betts, Dean H.

    2009-01-01

    This paper provides a bird's-eye perspective of the general principles of stem-cell therapy and tissue engineering; it relates comparative knowledge in this area to the current and future status of equine regenerative medicine.The understanding of equine stem cell biology, biofactors, and scaffolds...... mesenchymal stromal cells, unless there is proof that they exhibit the fundamental in vivo characteristics of pluripotency and the ability to self-renew. That said, these cells from various tissues hold great promise for therapeutic use in horses. The 3 components of tissue engineering - cells, biological...... factors, and biomaterials - are increasingly being applied in equine medicine, fuelled by better scaffolds and increased understanding of individual biofactors and cell sources.The effectiveness of stem cell-based therapies and most tissue engineering concepts has not been demonstrated sufficiently...

  20. Medicinal and commercial uses of ostrich products in Tanzania.

    Science.gov (United States)

    Magige, Flora; Røskaft, Eivin

    2017-08-23

    Traditional communities have been utilizing animal products for numerous purposes and have for a long time contributed to the accumulation of world knowledge. Local people in Tanzania and elsewhere in Africa, have been using birds including ostriches as pets or their products such as meat, eggs as food; their body parts such as feathers, bones and hide for ornaments but more importantly have used such products in traditional medicine and rituals. Nevertheless, there is a general lack of information about the differences that exist between local people with different cultures, and the best use of such products to improve their livelihoods. This study aimed to determine the use of ostrich products among people residing around Serengeti National Park and explore the potential of improving livelihoods through game ranching. Use of the products was compared between that of agriculturalists with long hunting traditions in the Serengeti District to the west of Serengeti National Park (SNP) and the largely pastoral community in the Ngorongoro District to the east by using semistructured questionnaires in June 2006. A total of 115 respondents were interviewed, and the majority (74.5%) in the Serengeti district admitted that ostriches were mainly hunted for their products by snares, while in the Ngorongoro district, 98.2% of the respondents said that villagers only gathered products such as feathers and eggs. Ostriches were hunted for food, ornamentation, medical and economic purposes, and eggs and oil, which are believed to have medicinal properties, were used for the treatment of various ailments, including asthma. This indigenous knowledge of the medicinal value of ostrich products must be integrated with scientific knowledge to prove the supposed medical efficacy of the products. Ostrich products also had market value and were thus sold to the villagers. Since it has been found that ostrich products are commercially used, legal establishment of markets through game

  1. Medical application of nuclear science: nuclear medicine and production of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Cornet, L.

    1997-01-01

    Nuclear science in attendance on medicine or from Radium to Radiopharmaceuticals. By a brief historical reminder of the evolution of the radioactivity and development of nuclear science, we could see a very early interest and application of the radioactivity in the medical field. Main steps: Detection of natural radioactivity/Discovery of artificial radioactivity/First treatment of leukaemia and thyroid/First nuclear reactor/First radioisotope laboratory in hospital/First scintigraphy/First radiopharmaceutical/First cyclotron and cyclotron products/First immunoscintigraphy/Biotechnology and radioisotope/Evolution of technics [equipment for diagnosis (imaging, scintigraphy) and therapy]/Evolution of production technics and concept of products (generators of Technetium) and machines, reactor, cyclotron/Evolution of importance and interest of nuclear medicine/Creation of international association of nuclear medicine and producers (example ARPR)/Evolution of safety and pharmaceuticals regulation. After the sixties, period extremely rich in invention of products, characterized by a high fertility specially due to a non-restrictive regulation in terms of safety and pharmaceutical consideration, the evolution of technics, the importance of costs (investment, research, healthcare and the evolution of the regulations) have smoothly but continuously transformed the contexts and different actors. Consequences and facts: Rationalization and standardization of the catalogues, total integration of radiopharmaceuticals into the pharmaceutical laws, stop of nuclear research reactors, increase of number of cyclotrons, transformation of size and role of the producers and nuclear centers, risk in supply of some raw materials like Molybdenum, medical nuclear application as a worldwide business

  2. College of Science Magazine explores genetic medicine, cancer therapies

    OpenAIRE

    Doss, Catherine

    2010-01-01

    The newest issue of the College of Science Magazine features a host of scientific research projects underway at Virginia Tech. New avenues in genetic medicine, environmental links to breast cancer, and resistance training for diabetics are just a few of the topics.

  3. Optimizing the use of intravenous therapy in internal medicine.

    Science.gov (United States)

    Champion, Karine; Mouly, Stéphane; Lloret-Linares, Celia; Lopes, Amanda; Vicaut, Eric; Bergmann, Jean-François

    2013-10-01

    We aimed to evaluate the impact of physicians' educational programs in the reduction of inappropriate intravenous lines in internal medicine. Fifty-six French internal medicine units were enrolled in a nationwide, prospective, blinded, randomized controlled trial. Forms describing the patients with an intravenous line and internal medicine department characteristics were filled out on 2 separate days in January and April 2007. Following the first visit, all units were randomly assigned to either a specific education program on the appropriate indications of an intravenous line, during February and March 2007, or no training (control group). The Investigators' Committee then blindly evaluated the clinical relevance of the intravenous line according to pre-established criteria. The primary outcome was the percentage of inappropriate intravenous lines. During January 2007, intravenous lines were used in 475 (24.9%) of the 1910 hospitalized patients. Of these, 80 (16.8%) were considered inappropriate. In April 2007, 416 (22.8%) of the 1823 hospitalized patients received an intravenous line, which was considered in 10.2% (21/205) of patients managed by trained physicians, versus 16.6% (35/211) of patients in the control group (relative difference 39%; 95% confidence interval, -0.6-13.3; P = .05). Reduced intravenous administration of fluids, antibiotics, and analgesics accounted for the observed decrease. The use of a simple education program reduced the rate of inappropriate intravenous lines by almost 40% in an internal medicine setting (NCT01633307). Copyright © 2013 Elsevier Inc. All rights reserved.

  4. Quality of natural product clinical trials: a comparison of those published in alternative medicine versus conventional medicine journals.

    Science.gov (United States)

    Cochrane, Zara Risoldi; Gregory, Philip; Wilson, Amy

    2011-06-01

    To compare the quality of natural product clinical trials published in alternative medicine journals versus those published in conventional medicine journals. Systematic search and review of the literature. Randomized controlled trials of natural products were included if they were published in English between 2003 and 2008. Articles were categorized by their journal of publication (alternative medicine versus conventional medicine). Two independent reviewers evaluated study quality using guidelines from the Cochrane Collaboration. The results with respect to the primary outcome (positive or negative) were also assessed. Thirty articles were evaluated, 15 published in alternative medicine journals and 15 in conventional medicine journals. Of articles published in alternative medicine journals, 33.33% (n = 5) were considered low quality, and none were considered high quality. Of articles published in conventional medicine journals, 26.67% (n = 4) were considered low quality and 6.67% (n = 1) were considered high quality. Two thirds of all trials reviewed were of unclear quality, due to inadequate reporting of information relating to the study's methodology. Similar proportions of positive and negative primary outcomes were found in alternative and conventional medicine journals, and low-quality articles were not more likely to report a positive primary outcome (Fisher's exact test, two-tailed p = .287). The quality of natural product randomized controlled trials was similar among alternative and conventional medicine journals. Efforts should be made to improve the reporting of natural product clinical trials for accurate determinations of study quality to be possible.

  5. Ilaj bil hijamah (cupping therapy) in the Unani system of medicine: anecdotal practice to evidence based therapy.

    Science.gov (United States)

    Abbas Zaidi, S M; Jameel, S S; Jafri, Kehkashan; Khan, Shariq A; Ahmad, Ehsan

    2016-08-01

    Cupping (Hijamah) therapy is very well documented as a result of several thousand years of clinical experiences in Unani medicine. In this procedure, suction is created by various means either with or without bloodletting. Though this therapy is being widely practiced across the globe for treating many chronic and intractable ailments but many reports reveal its unscientific and improper practices which results in many complications. Therefore to develop standard operative procedures and to propose protocols of cupping therapy in various diseases is the need of hour. A thorough literature review of relevant journals and textbooks was performed to gather the maximum available data on cupping therapy. This paper seeks to introduce the general concepts of cupping therapy in Unani medicine and other traditional systems of medicine, shortcomings and limitations of the currently published studies and suggest ways to improve these technical/methodological flaws. In addition, the authors have also attempted to provide the cupping related materials, hypotheses, observations which will provide the researchers the base for evaluating their usefulness in future clinical trials.

  6. Radioactively labelled substances for in vivo and in vitro tests from the time of their production up to their use in nuclear medicine

    International Nuclear Information System (INIS)

    Riccato, M.T.

    1976-01-01

    Most important production steps and control tests applied to radionuclides and radioactive labelled compounds used in nuclear medicine are described. Radiopharmaceutical products are subdivided in products for therapy and for in vivo and in vitro diagnostics tests. (orig./HP) [de

  7. In-Patient Treatment of Fibromyalgia: A Controlled Nonrandomized Comparison of Conventional Medicine versus Integrative Medicine including Fasting Therapy

    Directory of Open Access Journals (Sweden)

    Andreas Michalsen

    2013-01-01

    Full Text Available Fibromyalgia poses a challenge for therapy. Recent guidelines suggest that fibromyalgia should be treated within a multidisciplinary therapy approach. No data are available that evaluated multimodal treatment strategies of Integrative Medicine (IM. We conducted a controlled, nonrandomized pilot study that compared two inpatient treatment strategies, an IM approach that included fasting therapy and a conventional rheumatology (CM approach. IM used fasting cure and Mind-Body-Medicine as specific methods. Of 48 included consecutive patients, 28 were treated with IM, 20 with CM. Primary outcome was change in the Fibromyalgia Impact Questionnaire (FIQ score after the 2-week hospital stay. Secondary outcomes included scores of pain, depression, anxiety, and well being. Assessments were repeated after 12 weeks. At 2 weeks, there were significant improvements in the FIQ (P<0.014 and for most of secondary outcomes for the IM group compared to the CM group. The beneficial effects for the IM approach were reduced after 12 weeks and no longer statistically significant with the exception of anxiety. Findings indicate that a multimodal IM treatment with fasting therapy might be superior to CM in the short term and not inferior in the mid term. Longer-term studies are warranted to assess the clinical impact of integrative multimodal treatment in fibromyalgia.

  8. Clinical proteomics-driven precision medicine for targeted cancer therapy: current overview and future perspectives.

    Science.gov (United States)

    Zhou, Li; Wang, Kui; Li, Qifu; Nice, Edouard C; Zhang, Haiyuan; Huang, Canhua

    2016-01-01

    Cancer is a common disease that is a leading cause of death worldwide. Currently, early detection and novel therapeutic strategies are urgently needed for more effective management of cancer. Importantly, protein profiling using clinical proteomic strategies, with spectacular sensitivity and precision, offer excellent promise for the identification of potential biomarkers that would direct the development of targeted therapeutic anticancer drugs for precision medicine. In particular, clinical sample sources, including tumor tissues and body fluids (blood, feces, urine and saliva), have been widely investigated using modern high-throughput mass spectrometry-based proteomic approaches combined with bioinformatic analysis, to pursue the possibilities of precision medicine for targeted cancer therapy. Discussed in this review are the current advantages and limitations of clinical proteomics, the available strategies of clinical proteomics for the management of precision medicine, as well as the challenges and future perspectives of clinical proteomics-driven precision medicine for targeted cancer therapy.

  9. Medicinal Plants from Near East for Cancer Therapy

    Science.gov (United States)

    Abu-Darwish, Mohammad S.; Efferth, Thomas

    2018-01-01

    Background: Cancer is one of the major problems affecting public health worldwide. As other cultures, the populations of the Near East rely on medicinal herbs and their preparations to fight cancer. Methods: We compiled data derived from historical ethnopharmacological information as well as in vitro and in vivo results and clinical findings extracted from different literature databases including (PubMed, Scopus, Web of Science, and Google Scholar) during the past two decades. Results: In this survey, we analyzed the huge amount of data available on anticancer ethnopharmacological sources used in the Near East. Medicinal herbs are the most dominant ethnopharmacological formula used among cancer’s patients in the Near East. The data obtained highlight for the first time the most commonly used medicinal plants in the Near East area for cancer treatment illustrating their importance as natural anticancer agents. The literature survey reveals that various Arum species, various Artemisia species, Calotropis procera, Citrullus colocynthis, Nigella sativa, Pulicaria crispa, various Urtica species, Withania somnifera, and others belong to the most frequently used plants among cancer patients in the Near East countries. Molecular modes of action that have been investigated for plant extracts and isolated compounds from Near East include cell cycle arrest and apoptosis induction with participation of major player in these processes such as p53 and p21, Bcl-2, Bax, cytochrome c release, poly (ADP-ribose) polymerase cleavage, activation of caspases, etc. Conclusion: The ethnopharmacology of the Near East was influenced by Arabic and Islamic medicine and might be promising for developing new natural and safe anticancer agents. Further research is required to elucidate their cellular and molecular mechanisms and to estimate their clinical activity. PMID:29445343

  10. Reliance on medicinal plant therapy among cancer patients in Jamaica.

    Science.gov (United States)

    Foster, Kimberley; Younger, Novie; Aiken, William; Brady-West, Doreen; Delgoda, Rupika

    2017-11-01

    Patients' perspective of their treatment regime plays a vital role in its success. Recognizing the high prevalence of medicinal plant usage among Jamaicans at large, we investigated the engagement of such remedies by cancer patients, with the aim of uncovering self-medicating habits, perceptions and details of utilized plants. A structured, interviewer-based questionnaire was administered to 100 patients attending the oncology and urology clinics at the University Hospital of the West Indies in Kingston, Jamaica. A method of convenience sampling was employed and the data were analyzed using summary statistics and statistical significance tests. A large proportion (n = 80, 80%) of interviewed patients, engaged medicinal plants in their treatment regimes. Such habits were independent of person's education, economic status and were higher among the 55-74 age groups (p Petiveria alliacea L. were the most commonly used plants for treating breast and prostate cancers, respectively. A large proportion of Jamaican cancer patients use medicinal plants in self-medicating practices and their perceptions and habits need to be considered by physicians, in the design of safe and effective care regimes.

  11. Anti-cancer natural products isolated from chinese medicinal herbs

    Directory of Open Access Journals (Sweden)

    Wu Guosheng

    2011-07-01

    Full Text Available Abstract In recent years, a number of natural products isolated from Chinese herbs have been found to inhibit proliferation, induce apoptosis, suppress angiogenesis, retard metastasis and enhance chemotherapy, exhibiting anti-cancer potential both in vitro and in vivo. This article summarizes recent advances in in vitro and in vivo research on the anti-cancer effects and related mechanisms of some promising natural products. These natural products are also reviewed for their therapeutic potentials, including flavonoids (gambogic acid, curcumin, wogonin and silibinin, alkaloids (berberine, terpenes (artemisinin, β-elemene, oridonin, triptolide, and ursolic acid, quinones (shikonin and emodin and saponins (ginsenoside Rg3, which are isolated from Chinese medicinal herbs. In particular, the discovery of the new use of artemisinin derivatives as excellent anti-cancer drugs is also reviewed.

  12. Regulating Medicines in Croatia: Five-year Experience of Agency for Medicinal Products and Medical Devices

    Science.gov (United States)

    Tomić, Siniša; Filipović Sučić, Anita; Plazonić, Ana; Truban Žulj, Rajka; Macolić Šarinić, Viola; Čudina, Branka; Ilić Martinac, Adrijana

    2010-01-01

    Aim To present the activities of the Agency for Medicinal Products and Medical Devices in the first 5 years of its existence and to define its future challenges. Methods Main activities within the scope of the Agency as a regulatory authority were retrospectively analyzed for the period from 2004-2008. Data were collected from the Agency’s database and analyzed by descriptive statistics. Results The number of issued medicine authorizations rose from 240 in 2004 to 580 in 2008. The greatest number of new chemical and biological entities was approved in 2005. The greatest number of regular quality controls (n = 5833) and special quality controls was performed in 2008 (n = 589), while the greatest number of off-shelf quality controls (n = 132) was performed in 2007. The greatest number of medicine labeling irregularities was found in 2007 (n = 19) and of quality irregularities in 2004 (n = 9). The greatest number of adverse reactions was reported in 2008 (n = 1393). The number of registered medical devices rose from 213 in 2004 to 565 in 2008. Conclusion Over its 5 years of existence, the Agency has successfully coped with the constant increase in workload. In the future, as Croatia enters the European Union, the Agency will have to face the challenge of joining the integrated European regulatory framework. PMID:20401952

  13. Microbial quality of some medicinal herbal products in Kashan, Iran

    Directory of Open Access Journals (Sweden)

    Mazroi Arani Navid

    2014-04-01

    Full Text Available Introduction: The use of medicinal plants has risen worldwide. In Iran, herbal waters and rose waters are of traditional medicinal products and as a result, they are widespreadly consumed. Therefore, diagnosis of microbial quality of these products is important. The aim of this study was to evaluate microbial quality of herbal extracts distributed in Kashan, Iran. Methods: In this descriptive study, 256 samples of herbal waters and 191 samples of rose waters (total samples of 447 distributed in Kashan during 2012 to 2013 were purchased and transferred to laboratory. Then microbial tests such as total aerobic bacterial count, mold and yeast count, total coliforms, and detection of Enterococcus, Pseudomonas and sulphite-reducing Clostridia were evaluated based on national standard of Iran. Results: Contamination with Pseudomonas and Enterococcus was observed in the herbal water samples. 196 cases (43.84% of the total samples, 113 cases (44.15% of the herbal waters and 83 cases (43.45% of the rose waters were usable based on the national standard of Iran. Neither herbal waters nor rosewater samples were contaminated by E.Coli and Sulphite-reducing clostridia. Additionally, none of the rosewater samples was contaminated by Coliforms and Pseudomonas. Conclusion: Based on the findings and due to the fact that these products are contaminated with aerobic mesophilic bacteria, mold and yeast, to minimize the risks we recommend to apply pasteurized temperature, high-quality packaging material and hygiene observance in processing time of herbal waters and rose waters.

  14. Case Study of Oriental Medicine Treatment with acupotomy Therapy of the Achilles Tendinitis

    Directory of Open Access Journals (Sweden)

    Jang Eun-ha

    2008-12-01

    Full Text Available Purpose : In order to estimate clinical effects of Oriental Medicine Treatment with acupotomy therapy of Achilles Tendinitis Methods : From 4th August, 2008 to 14th August, 2008, 1 female patient diagnosed as Chronic Achilles Tendinitis (clinical diagnosed was treated with general oriental medicine therapy(acupuncture, moxibustion, cupping, physical therapy, herbal medication and acupotomy. Results : The patient's chief complaints- Lt. heel pain and stiffness, dorsi-flexion limitation, nodules in the achilles tendon- were notably improved. Conclusions : This study demonstrates that oriental medical treatment with acuputomy therapy has significant effect in improving symptoms of achilles tendinitis. as though we had not wide experience in this treatment, more research is needed.

  15. Progressing a human embryonic stem-cell-based regenerative medicine therapy towards the clinic.

    Science.gov (United States)

    Whiting, Paul; Kerby, Julie; Coffey, Peter; da Cruz, Lyndon; McKernan, Ruth

    2015-10-19

    Since the first publication of the derivation of human embryonic stem cells in 1998, there has been hope and expectation that this technology will lead to a wave of regenerative medicine therapies with the potential to revolutionize our approach to managing certain diseases. Despite significant resources in this direction, the path to the clinic for an embryonic stem-cell-based regenerative medicine therapy has not proven straightforward, though in the past few years progress has been made. Here, with a focus upon retinal disease, we discuss the current status of the development of such therapies. We also highlight some of our own experiences of progressing a retinal pigment epithelium cell replacement therapy towards the clinic. © 2015 The Author(s).

  16. Paving the way to personalized medicine. Production of some theragnostic radionuclides at Brookhaven National Laboratory

    International Nuclear Information System (INIS)

    Srivastava, S.C.

    2011-01-01

    This paper introduces a relatively novel paradigm that involves specific individual radionuclides or radionuclide pairs that have emissions that allow pre-therapy low-dose imaging plus higher-dose therapy in the same patient. We have made an attempt to sort out and organize a number of such theragnostic radionuclides and radionuclide pairs that may potentially bring us closer to the age-long dream of personalized medicine for performing tailored low-dose molecular imaging (SPECT/CT or PET/CT) to provide the necessary pre-therapy information on biodistribution, dosimetry, the limiting or critical organ or tissue, and the maximum tolerated dose (MTD), etc. If the imaging results then warrant it, it would be possible to perform higher-dose targeted molecular therapy in the same patient with the same radiopharmaceutical. A major problem that remains yet to be fully resolved is the lack of availability, in sufficient quantities, of a majority of the best candidate theragnostic radionuclides in a no-carrier-added (NCA) form. A brief description of the recently developed new or modified methods at BNL for the production of four theragnostic radionuclides, whose nuclear, physical, and chemical characteristics seem to show great promise for personalized cancer therapy are described.

  17. Exploiting science? A systematic analysis of complementary and alternative medicine clinic websites' marketing of stem cell therapies.

    Science.gov (United States)

    Murdoch, Blake; Zarzeczny, Amy; Caulfield, Timothy

    2018-02-28

    To identify the frequency and qualitative characteristics of stem cell-related marketing claims made on websites of clinics featuring common types of complementary and alternative medicine practitioners. The involvement of complementary and alternative medicine practitioners in the marketing of stem cell therapies and stem cell-related interventions is understudied. This research explores the extent to which they are involved and collaborate with medical professionals. This knowledge will help with identifying and evaluating potential policy responses to this growing market. Systematic website analysis. Global. US and English-language bias due to methodology. Representations made on clinic websites in relation to practitioner types, stem cell therapies and their targets, stem cell-related interventions. Statements about stem cell therapies relating to evidence of inefficacy, limited evidence of efficacy, general procedural risks, risks specific to the mode of therapy, regulatory status, experimental or unproven nature of therapy. Use of hype language (eg, language that exaggerates potential benefits). 243 websites offered stem cell therapies. Many websites advertised stem cell transplantation from multiple sources, such as adipose-derived (112), bone marrow-derived (100), blood-derived (28), umbilical cord-derived (26) and others. Plant stem cell-based treatments and products (20) were also advertised. Purposes for and targets of treatment included pain, physical injury, a wide range of diseases and illnesses, cosmetic concerns, non-cosmetic ageing, sexual enhancement and others. Medical doctors (130), chiropractors (53) and naturopaths (44) commonly work in the clinics we found to be offering stem cell therapies. Few clinic websites advertising stem cell therapies included important additional information, including statements about evidence of inefficacy (present on only 12.76% of websites), statements about limited evidence of efficacy (18.93%), statements of

  18. Traditional Chinese medicine as adjunctive therapy improves the long-term survival of lung cancer patients.

    Science.gov (United States)

    Liao, Yueh-Hsiang; Li, Chia-Ing; Lin, Cheng-Chieh; Lin, Jaung-Geng; Chiang, Jen-Huai; Li, Tsai-Chung

    2017-12-01

    Traditional Chinese medicine is one of the popular alternative treatments for cancer, mainly enhancing host immune response and reducing adverse effect of chemotherapy. This study first explored traditional Chinese medicine treatment effect on long-term survival of lung cancer patients. This study evaluated whether traditional Chinese medicine combined with conventional cancer treatment improved overall survival of lung cancer patients. We had conducted a retrospective cohort study on 111,564 newly diagnosed lung cancer patients in 2000-2009 from National Health Insurance Program database. A total of 23,803 (21.31%) patients used traditional Chinese medicine for lung cancer care. Eligible participants were followed up until 2011 with a mean follow-up period of 1.96 years (standard deviation 2.55) for non-TCM users and 3.04 years (2.85) for traditional Chinese medicine users. Patients with traditional Chinese medicine utilization were significantly more likely to have a 32% decreased risk of death [hazard ratio = 0.62; 95% confidence interval = 0.61-0.63], compared with patients without traditional Chinese medicine utilization after multivariate adjustment. We also observed a similar significant reduction risk across various subgroups of chronic lung diseases. Qing Zao Jiu Fei Tang was the most effective traditional Chinese medicine agent for mortality reduction both in the entire lung cancer (0.81; 0.72-0.91) and matched populations (0.86; 0.78-0.95). This study demonstrated adjunctive therapy with traditional Chinese medicine may improve overall survival of lung cancer patients. This study also suggested traditional Chinese medicine may be used as an adjunctive therapy for cancer treatment. These observational findings need being validated by future randomized controlled trials to rule out the possibility of effect due to holistic care.

  19. Translating stem cell therapies: the role of companion animals in regenerative medicine

    OpenAIRE

    Volk, Susan W.; Theoret, Christine

    2013-01-01

    Veterinarians and veterinary medicine have been integral to the development of stem cell therapies. The contributions of large animal experimental models to the development and refinement of modern hematopoietic stem cell transplantation were noted nearly five decades ago. More recent advances in adult stem cell/regenerative cell therapies continue to expand knowledge of the basic biology and clinical applications of stem cells. A relatively liberal legal and ethical regulation of stem cell r...

  20. Contributions of nuclear medicine to the therapy of malignant tumors

    Energy Technology Data Exchange (ETDEWEB)

    Feinendegen, L.E. (Forschungszentrum Juelich GmbH (Germany). Inst. fuer Medizin Duesseldorf Univ. (Germany). Nuklearmedizinische Klinik)

    1991-11-01

    The diagnostic and therapeutic application of radionuclides on oncology has led to an increased efficiency in the treatment of malignant tumors. - Regarding diagnosis, measuring metabolic reactions in tumor tissue, especially by positron emission tomography, opened the potential for assaying tumor response to different treatment modalities and thus eventually for tailoring effective treatment of a given tumor in the individual patient. - Regarding treatment, attention is given to the choice of the radionuclide for optimal deposition of the desired radiation in tumor cells avoiding exposure of normal cells; in this context microdosimetric considerations are essential with respect to {beta}-emitters, {alpha}-emitters, the Auger-effect and neutron capture therapy. Examples of therapeutic uses of radionuclides in the inorganic form are 131-I for thyroid cancer and 32-P for polycythemia vera; organically bound radionuclides are employed with precursors for tumor cell metabolism or with receptor seeking agents, such as MIBG and monoclonal antibodies which presently enjoy a particular interest and bear great promise. Stable nuclides, if property accumulated within tumors, may be activated for therapy in situ, for example by thermal neutrons, as in neutron capture therapy using the 10-B (n, {alpha})7-Li reaction. - Treatment planning and execution with radionuclides have gained momentum over the past decade, yet much more needs to be done. (orig.).

  1. Leech therapy- a holistic approach of treatment in unani (greeko-arab) medicine.

    Science.gov (United States)

    Lone, Azad Hussain; Ahmad, Tanzeel; Anwar, Mohd; Habib, Shahida; Sofi, Gh; Imam, Hashmat

    2011-07-01

    The Unani System of Medicine also known as Greeko-Arab medicine, founded by Hippocrates is based on the concept of equilibrium and balance of natural body humours (blood, bile, black bile and phlegm). The imbalance in the quality and quantity of these humours leads to diseases whereas restoration of this balance maintains health of a person. The treatment methodology of diseases is based on four therapeutic modalities viz. Regimental therapy, Dieto-therapy, Pharmacotherapy and surgery. Irsale Alaq (Leech or Hirudo therapy) is one of the most important and widely practised methods of regimental therapy used for local evacuation of morbid humours. It is a procedure of treatment with the use of medicinal leeches. It has been suggested and successfully practised by Greeko-Arab physicians in the management of musculoskeletal diseases, gynaecological disorders, chronic skin diseases, thromboembolic diseases, varicose veins, ENT disorders etc since long. According to Unani doctrine, the efficacy of leech therapy is attributed to the analgesic and resolvent activities of leeches. However, from modern perspective, the saliva of leech contains about 100 pharmacologically active biological substances like Hirudin, hyaluronidase, vasodilators, anesthetics, antibacterial, fibrinases, collagenase etc. These substances are injected into human body while sucking of the blood and are responsible for the analgesic, anti inflammatory and anesthetic effects of leech therapy.

  2. Catalytic Therapy of Cancer with Ascorbate and Extracts of Medicinal Herbs

    Directory of Open Access Journals (Sweden)

    Nadejda Rozanova (Torshina

    2010-01-01

    Full Text Available Catalytic therapy (CT is a cancer treatment modality based on the generation of reactive oxygen species (ROS using a combination of substrate molecules and a catalyst. The most frequently used substrate/catalyst pair is ascorbate/Co phthalocyanine (PcCo. In the present work, herb extracts containing pigments have been studied as a catalyst in place of PcCo. Extracts from herbs are expected to have efficiency comparable with that of phthalocyanines but as natural products, to exhibit fewer side effects. The present studies demonstrate that a combined use of ascorbate and herbal extracts results in ROS production and a significant decrease in the number of cancer cells after a single in vitro treatment. Treatment with ascorbate in conjunction with extracts prepared from several medicinal herbs stimulated apoptosis and disrupted the cell cycle. The number of cells accumulating in the sub-G0/G1 stage of the cell cycle was increased 2- to 7-fold, and cells in G2/M increased 1.5- to 20-fold, indicating that the treatment protocol was highly effective in suppressing DNA synthesis and potentially reflecting DNA damage in the tumor cells. In addition, 20–40% of the cells underwent apoptosis within 24 h of completing treatment. Our results suggest that herbal extracts can function as CT catalysts in the treatment of cancer.

  3. The public production of medicines compared to the National Policy of Medicines and the burden of disease in Brazil

    Directory of Open Access Journals (Sweden)

    Tatiana Aragão Figueiredo

    2017-09-01

    Full Text Available Abstract: The public production of medicines in Brazil by Government Pharmaceutical Laboratories has once again become the object of incentives, and Industrial Development Partnerships are one of the mechanisms adopted for the production of strategic medicines for the Brazilian Unified National Health System (SUS. Considering that burden-of-disease studies have been used as a tool to define priority and essential medicines, the article compares the product portfolios of the country’s Official Pharmaceutical Laboratories (OPL and the list of strategic medicines for the SUS and burden of disease in Brazil in 2008. Of the 205 strategic medicines for the SUS and 111 from the portfolios, 73% and 89%, respectively, are on the National List of Essential Medicines (RENAME 2014. Some strategic medicines for the SUS are already produced by OPL and feature the selection of cancer drugs and biologicals. The current study contributes to the discussion on the public production of medicines in light of the country’s current industrial policy and highlights the need to define priority drugs and the role of OPL in guaranteeing access to them.

  4. Good manufacturing practices for medicinal products for human use.

    Science.gov (United States)

    Gouveia, Bruno G; Rijo, Patrícia; Gonçalo, Tânia S; Reis, Catarina P

    2015-01-01

    At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability.

  5. Good manufacturing practices for medicinal products for human use

    Science.gov (United States)

    Gouveia, Bruno G.; Rijo, Patrícia; Gonçalo, Tânia S.; Reis, Catarina P.

    2015-01-01

    At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability. PMID:25883511

  6. 78 FR 43889 - Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine...

    Science.gov (United States)

    2013-07-22

    ... regenerative medicine products have generated a great deal of interest. These efforts include standards... is done to coordinate the various existing efforts. In the public workshop, FDA hopes to bring...

  7. Natural Products from Chinese Medicines with Potential Benefits to Bone Health

    Directory of Open Access Journals (Sweden)

    Chun-Tao Che

    2016-02-01

    Full Text Available Osteoporosis is a progressive, systemic bone disorder characterized by loss of bone mass and microstructure, leading to reduced bone strength and increased risk of fracture. It is often associated with reduced quality of life and other medical complications. The disease is common in the aging population, particularly among postmenopausal women and patients who receive long-term steroidal therapy. Given the rapid growth of the aging population, increasing life expectancy, the prevalence of bone loss, and financial burden to the healthcare system and individuals, demand for new therapeutic agents and nutritional supplements for the management and promotion of bone health is pressing. With the advent of global interest in complementary and alternative medicine and natural products, Chinese medicine serves as a viable source to offer benefits for the improvement and maintenance of bone health. This review summarizes the scientific information obtained from recent literatures on the chemical ingredients of Chinese medicinal plants that have been reported to possess osteoprotective and related properties in cell-based and/or animal models. Some of these natural products (or their derivatives may become promising leads for development into dietary supplements or therapeutic drugs.

  8. Selected non-timber forest products with medicinal applications from Jilin Province in China

    Science.gov (United States)

    Yao Ge Huang; Branka Barl; Gerald. Ivanochko

    2001-01-01

    This paper provides a brief account of the distribution, production, and use of some non-timber forest products such as medicinal plants, medicinal and nutraceutical mushrooms, pharmaceutical insects, and "wild" vegetables in Jilin Province, China. All materials featured in this paper are used in Traditional Chinese Medicine (TCM) inside and outside of China...

  9. Antibody phage display applications for nuclear medicine imaging and therapy

    International Nuclear Information System (INIS)

    Winthrop, M.D.; Denardo, G.L.; Denardo, S.J.

    2000-01-01

    Antibody-based constructs genetically engineered from genes of diverse origin provide a remarkable opportunity to develop functional molecular imaging techniques and specific molecular targeted radionuclide therapies. Phage display libraries of antibody fragment genes can be used to select antibody-based constructs that bind any chosen epitope. A large naive human antibody-based library was used to illustrate binding of antibody constructs to a variety of common and unique antigens. Antibody-based libraries from hybridoma cells, lymphocytes from immunized humans or from mice and human antibody repertoires produced in transgenic mice have also been described. Several orders of magnitude of affinity enhancement can be achieved by random or site specific mutations of the selected binding peptide domains of the scFv. Affinities (K d ) as high as 10 - 11 M (10 pM) for affinity-matured scFv have been documented. Such gene libraries thus offer an almost limitless variety of antibody-based molecular binding peptide modules that can be used in creative ways for the construction of new targeting agents for functional or molecular imaging and therapy

  10. Selection and Training of Personnel for the New Nuclear Medicine and Radiation Therapy Centre in Bariloche

    International Nuclear Information System (INIS)

    Lopez, M.P.

    2016-01-01

    Full text: A basic strategy for the development of a new organization is the selection of personnel, especially if it is an institute that offers a technological and professional innovation. This work aims to define specific profiles for the Centre for Nuclear Medicine and Radiation Therapy, Bariloche, and to design a plan for selecting and training professionals. (author

  11. [Corticosteroid therapy and therapeutic education: experience of an internal medicine department

    NARCIS (Netherlands)

    Simon, A.; Ane, A.M.; Afroun, A.

    2013-01-01

    In 2003, we sought to determine what were the needs of patients prescribed with long-term glucocorticoid therapy in our internal medicine department. Following this inventory, we decided to homogenize the medical practices regarding glucocorticoid prescriptions in our institution. We also set up a

  12. The production of radionuclides for nuclear medicine from a compact, low-energy accelerator system.

    Science.gov (United States)

    Webster, William D; Parks, Geoffrey T; Titov, Dmitry; Beasley, Paul

    2014-05-01

    The field of nuclear medicine is reliant on radionuclides for medical imaging procedures and radioimmunotherapy (RIT). The recent shut-downs of key radionuclide producers have highlighted the fragility of the current radionuclide supply network, however. To ensure that nuclear medicine can continue to grow, adding new diagnostic and therapy options to healthcare, novel and reliable production methods are required. Siemens are developing a low-energy, high-current - up to 10 MeV and 1 mA respectively - accelerator. The capability of this low-cost, compact system for radionuclide production, for use in nuclear medicine procedures, has been considered. The production of three medically important radionuclides - (89)Zr, (64)Cu, and (103)Pd - has been considered, via the (89)Y(p,n), (64)Ni(p,n) and (103)Rh(p,n) reactions, respectively. Theoretical cross-sections were generated using TALYS and compared to experimental data available from EXFOR. Stopping power values generated by SRIM have been used, with the TALYS-generated excitation functions, to calculate potential yields and isotopic purity in different irradiation regimes. The TALYS excitation functions were found to have a good agreement with the experimental data available from the EXFOR database. It was found that both (89)Zr and (64)Cu could be produced with high isotopic purity (over 99%), with activity yields suitable for medical diagnostics and therapy, at a proton energy of 10MeV. At 10MeV, the irradiation of (103)Rh produced appreciable quantities of (102)Pd, reducing the isotopic purity. A reduction in beam energy to 9.5MeV increased the radioisotopic purity to 99% with only a small reduction in activity yield. This work demonstrates that the low-energy, compact accelerator system under development by Siemens would be capable of providing sufficient quantities of (89)Zr, (64)Cu, and (103)Pd for use in medical diagnostics and therapy. It is suggested that the system could be used to produce many other

  13. Integrative therapies for low back pain that include complementary and alternative medicine care: a systematic review.

    Science.gov (United States)

    Kizhakkeveettil, Anupama; Rose, Kevin; Kadar, Gena E

    2014-09-01

    Systematic review of the literature. To evaluate whether an integrated approach that includes different Complementary and Alternative Medicine (CAM) therapies combined or CAM therapies combined with conventional medical care is more effective for the management of low back pain (LBP) than single modalities alone. LBP is one of the leading causes of disability worldwide, yet its optimal management is still unresolved. The PRISMA Statement guidelines were followed. The Cochrane Back Review Group scale was used to rate the quality of the studies found. Twenty-one studies were found that met the inclusion criteria. The CAM modalities used in the studies included spinal manipulative therapy, acupuncture, exercise therapy, physiotherapy, massage therapy, and a topical ointment. Twenty studies included acupuncture and/or spinal manipulative therapy. Nine high quality studies showed that integrative care was clinically effective for the management of LBP. Spinal manipulative therapy combined with exercise therapy and acupuncture combined with conventional medical care or with exercise therapy appears to be promising approaches to the management of chronic cases of LBP. There is support in the literature for integrated CAM and conventional medical therapy for the management of chronic LBP. Further research into the integrated management of LBP is clearly needed to provide better guidance for patients and clinicians.

  14. [Surgical intensive care medicine. Current therapy concepts for septic diseases].

    Science.gov (United States)

    Niederbichler, A D; Ipaktchi, K; Jokuszies, A; Hirsch, T; Altintas, M A; Handschin, A E; Busch, K H; Gellert, M; Steinau, H-U; Vogt, P M; Steinsträsser, L

    2009-10-01

    The clinical appearance of septic disorders is characterized by an enormous dynamic. The sepsis-induced dysbalance of the immune system necessitates immediate and aggressive therapeutic interventions to prevent further damage progression of the disease to septic shock and multiple organ failure. This includes supportive therapy to normalize and maintain organ and tissue perfusion as well as the identification of the infection focus. In cases where an infectious focus is identified, surgical source control frequently is a key element of the treatment strategy besides pharmacologic and supportive measures. The integrative approach of the management of septic patients requires rapid communication between the involved medical disciplines and the nursing personnel. Therefore, this article outlines current therapeutic concepts of septic diseases as well as central nursing aspects.

  15. Compensation and Production in Family Medicine by Practice Ownership

    Directory of Open Access Journals (Sweden)

    Alison C. Essary

    2016-02-01

    Full Text Available The increasing focus on high performance, patient-centered, team-based care calls for a strategy to evaluate cost-effective primary care. The trend toward physician practice consolidation further challenges the primary care health care system. Productivity measures establish provider value and help inform decision making regarding resource allocation in this evolving health care system. In this national survey of family medicine practices, physician assistant (PA productivity, as defined by mean annual patient encounters, exceeds that of both nurse practitioners (NPs and physicians in physician-owned practices and of NPs in hospital or integrated delivery system-owned practices. Total compensation, defined as salary, bonus, incentives, and honoraria for physicians, is significantly more compared to both PAs and NPs, regardless of practice ownership or productivity. Physician assistants and NPs earn equivalent compensation, regardless of practice ownership or productivity. Not only do these data support the value and role of PAs and NPs on the primary care team but also highlight differences in patient encounters between practice settings. Rural and underserved community practices, where physician-owned practices persist, also merit further consideration. Further research is needed to inform both organizational and policy decisions for the provision of high-quality, cost-effective, and accessible primary health care.

  16. Medicines

    Science.gov (United States)

    Medicines can treat diseases and improve your health. If you are like most people, you need to take medicine at some point in your life. You may need to take medicine every day, or you may only need to ...

  17. Perceptions of family members of palliative medicine and hospice patients who experienced music therapy.

    Science.gov (United States)

    Gallagher, Lisa M; Lagman, Ruth; Bates, Debbie; Edsall, Melissa; Eden, Patricia; Janaitis, Jessica; Rybicki, Lisa

    2017-06-01

    Evidence shows that music therapy aids in symptom management and improves quality of life for palliative medicine and hospice patients. The majority of previous studies have addressed patient needs, while only a few addressed the needs of family members. The primary purpose of this study was to understand family members' perceptions of music therapy experienced by a relative in palliative medicine or hospice. Patient self-reported scales and music therapist assessment of change were also investigated. Patients scored their symptoms (pain, anxiety, depression, shortness of breath, and mood) before and after music therapy sessions. One family member present during the session assessed perceived effect on the patient's pain, anxiety, depression, shortness of breath, stress level, restlessness, comfort level, mood, and quality of life. The effect on family member's stress level, quality of life, and mood and helpfulness of the music therapy session for the patient and self were studied. Recommendations about future patient participation in music therapy and qualitative comments were also solicited. Fifty family member/patient dyads participated in the study. Family member perceptions were positive, with 82% of responders indicating improvement for self and patient in stress, mood, and quality of life; 80% rating the session as extremely helpful; and 100% of 49 recommending further music therapy sessions for the patient. Patients reported statistically significant improvement in pain, depression, distress, and mood scores. Family members of patients in palliative medicine and hospice settings reported an immediate positive impact of music therapy on the patient and on themselves. More research needs to be conducted to better understand the benefits of music therapy for family members.

  18. The Combination of Light and Stem Cell Therapies: A Novel Approach in Regenerative Medicine

    International Nuclear Information System (INIS)

    Anders, Juanita; Moges, Helina; Wu, Xingjia; Ilev, Ilko; Waynant, Ronald; Longo, Leonardo

    2010-01-01

    Light therapy commonly referred to as low level laser therapy can alter cellular functions and clinical conditions. Some of the commonly reported in vitro and in vivo effects of light therapy include cellular proliferation, alterations in the inflammatory response to injury, and increases in mitochondrial respiration and adenosine triphosphate synthesis. Based on the known effects of light on cells and tissues in general and on reports in the last 5 years on the interaction of light with stem cells, evidence is mounting indicating that light therapy could greatly benefit stem cell regenerative medicine. Experiments on a variety of harvested adult stem cells demonstrate that light therapy enhances differentiation and proliferation of the cells and alters the expression of growth factors in a number of different types of adult stem cells and progenitors in vitro. It also has the potential to attenuate cytotoxic effects of drugs used to purge harvested autologous stem cells and to increase survival of transplanted cells.

  19. Complementary Therapies for Significant Dysfunction from Tinnitus: Treatment Review and Potential for Integrative Medicine

    Directory of Open Access Journals (Sweden)

    Ruth Q. Wolever

    2015-01-01

    Full Text Available Tinnitus is a prevalent and costly chronic condition; no universally effective treatment exists. Only 20% of patients who report tinnitus actually seek treatment, and when treated, most patients commonly receive sound-based and educational (SBE therapy. Additional treatment options are necessary, however, for nonauditory aspects of tinnitus (e.g., anxiety, depression, and significant interference with daily life and when SBE therapy is inefficacious or inappropriate. This paper provides a comprehensive review of (1 conventional tinnitus treatments and (2 promising complementary therapies that have demonstrated some benefit for severe dysfunction from tinnitus. While there has been no systematic study of the benefits of an Integrative Medicine approach for severe tinnitus, the current paper reviews emerging evidence suggesting that synergistic combinations of complementary therapies provided within a whole-person framework may augment SBE therapy and empower patients to exert control over their tinnitus symptoms without the use of medications, expensive devices, or extended programs.

  20. Medicinal folk recipes used as traditional phyto therapies in district Dera Ismail Khan, KPK, Pakistan

    International Nuclear Information System (INIS)

    Marwat, S.K.; Rehman, F.; Khan, M.A.; Ahmad, M.

    2011-01-01

    This paper is based on the results of an ethno medicinal research work conducted in Dera Ismail Khan (D.I. Khan) District, Khyber Pakhtun Khwa (KPK), Pakistan, during May 2006 to March 2007. The study was focused for documentation of traditional knowledge of local people about the use of medicinal folk recipes of native plants. During field survey, questionnaires were used to interview the local inhabitants, older people including men and women both, who were familiar with traditional uses of indigenous plants. In total 40 new medicinal folk recipes of 26 plant species, belonging to 19 families were recorded. These folk recipes are used as traditional phyto therapies in the area. Plant specimens were identified, preserved and vouchers were deposited in the Department of Botany, Quaid-i-University Islamabad for future references. Results were systematically arranged by alphabetic order of botanical names followed by medicinal folk recipes. English name, local name, family name and voucher no., were listed. (author)

  1. Medicinal Leech Therapy for Glans Penis Congestion After Primary Bladder Exstrophy-Epispadias Repair in an Infant: A Case Report.

    Science.gov (United States)

    Wagenheim, Gavin N; Au, Jason; Gargollo, Patricio C

    2016-01-01

    Many postoperative complications have been reported after repair of classic bladder exstrophy. We present a case of medicinal leech therapy for glans penis congestion following exstrophy repair in an infant. A 2-week-old male with classic bladder exstrophy underwent complete primary repair. On postoperative day 1, he developed rapidly worsening glans penis venous congestion. Medicinal leech therapy was instituted with antibiotics and blood transfusions to maintain a hematocrit >30%. After 24 hours, venous congestion improved and therapy was discontinued. The patient's remaining hospital course was uncomplicated. Medicinal leeches are an effective therapy to relieve glans penis venous congestion. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. Effects of combined therapy of traditional Chinese medicine and western medicine on platelets, coagulative functions and inflammatory cytokines with ulcerative colitis

    Directory of Open Access Journals (Sweden)

    Yun-Xia Lei

    2016-07-01

    Full Text Available Objective: To explore the effects of combined therapy of traditional Chinese medicine and western medicine on platelets, coagulative functions and inflammatory cytokines in patients with ulcerative colitis (UC. Methods: A total of 267 patients with UC were collected. 137 patients were treated with combined therapy of traditional Chinese medicine and western medicine as experimental group and 130 patients were treated with only western medicine as controls. Platelet count, coagulation function indexes and inflammatory cytokines were measured before and 15 d after the treatment. Results: No significantly differences were found in all indexes before treatment between two groups. After different treatments, platelet count (PLT, platelet distribution width (PDW were significantly decreased in both groups, but mean platelet volumn (MPV were significantly increased than before treatment. PLT and PDW were significantly lower and MPV were significantly higher in experimental group than control group. Fibrinogen (Fib and D-dimer (DD decreased significantly after treatment. Fib and DD in experimental group were significantly lower than controls. No significantly differences were found in activated partial thromboplastin time (APTT and prothrobin time (PT. Tumor necrosisi factor-α (TNF-α, interleukin-6 (IL-6 and interleukin-8 (IL-8 decreased significantly in both group after treatment. TNF-毩, IL-6 and IL-8 were significantly lower in experimental group than controls. Conclusion: Combined therapy of traditional Chinese medicine and western medicine can more effectively improve the cogulation, fibrinolysis and inflammation in patients with UC than only western medicine therapy.

  3. Natural products as starting points for future anti-malarial therapies: going back to our roots?

    Directory of Open Access Journals (Sweden)

    Wells Timothy NC

    2011-03-01

    Full Text Available Abstract Background The discovery and development of new anti-malarials are at a crossroads. Fixed dose artemisinin combination therapy is now being used to treat a hundred million children each year, with a cost as low as 30 cents per child, with cure rates of over 95%. However, as with all anti-infective strategies, this triumph brings with it the seeds of its own downfall, the emergence of resistance. It takes ten years to develop a new medicine. New classes of medicines to combat malaria, as a result of infection by Plasmodium falciparum and Plasmodium vivax are urgently needed. Results Natural product scaffolds have been the basis of the majority of current anti-malarial medicines. Molecules such as quinine, lapachol and artemisinin were originally isolated from herbal medicinal products. After improvement with medicinal chemistry and formulation technologies, and combination with other active ingredients, they now make up the current armamentarium of medicines. In recent years advances in screening technologies have allowed testing of millions of compounds from pharmaceutical diversity for anti-malarial activity in cellular assays. These initiatives have resulted in thousands of new sub-micromolar active compounds – starting points for new drug discovery programmes. Against this backdrop, the paucity of potent natural products identified has been disappointing. Now is a good time to reflect on the current approach to screening herbal medicinal products and suggest revisions. Nearly sixty years ago, the Chinese doctor Chen Guofu, suggested natural products should be approached by dao-xing-ni-shi or ‘acting in the reversed order’, starting with observational clinical studies. Natural products based on herbal remedies are in use in the community, and have the potential unique advantage that clinical observational data exist, or can be generated. The first step should be the confirmation and definition of the clinical activity of herbal

  4. Production of 111In for diagnosis in nuclear medicine

    International Nuclear Information System (INIS)

    Osso Junior, J.A.

    1982-01-01

    111 In (t sub(1/2 = 2.82d)) due to its favorable physical decay characteristics, can substitute sup(113m) In (t sub(1/2 = 1.66hr)), whose application is limited to rapid physiological studies, advantageously. A routine production method has been developed by 28 MeV alpha particle bombardment of natural silver at the CV-28 Cyclotron of the Instituto de Engenharia Nuclear. The target is dissolved in conc. nitric acid, and silver is precipitated with hydrochloric acid. Carrier-free 111 In which remains in solution is separated from 109 Cd, the decay product of 109 In, which is produced simultaneously during the irradiation, by an anion exchange resin. All the production and separation steps are made remotely, with the use of manipulators, tongs and electric and pneumatic systems. The thick target yield is 0.18 mCi/μAh and in each run 16 mCi of 111 In are produced, which can be used in nuclear medicine centers. Methods of labelling 111 In-EDTA and 111 In-DTPA have been developed. 111 In offers a favorable half-life for the study of rather slow biological processes, in which observation periods of 24-72 hrs after administration are required, e.g., cisternography, visualization of the lymphatic system, tumor localization and others. (Author) [pt

  5. Synthetic and bioengineered products in nuclear medicine and drug delivery

    International Nuclear Information System (INIS)

    Frier, M.

    1997-01-01

    Full text. The supply of radio pharmaceuticals based on pooled human blood products, for example human serum albumin (H S A) and fibrinogen, has previously met with some problems due to the possibility of donor infection A common feature of all biologicals of animal or human origin is the potential risk of viral contamination from the source material. Recombinant DNA technology provides an alternative source of biological materials that have applications throughout medicine. Micro capsules prepared from recombinant human serum albumin (r H S A) are currently under development as ultrasound contrast agents. Similar products would serve as an alternative source of material to serum albumin pooled from human donors and would offer great potential in the production of radio pharmaceuticals. There is a growing interest in the use of macromolecular carriers for therapeutic agents. When labelled with and appropriate gamma-emitter, their biodistribution can be be followed by scintigraphy. The biodistribution of a synthetic branched polypeptide, based on a poly-L-lysine backbone (average molecular mass 45 kDa) is described. The polymer was conjugated to diethylene triamine penta-acetic acid and labelled by chelation with Indium-111. Mice were injected i.v. with labelled material and imaged with a gamma camera with a pin hole collimator. Images showed the majority of tracer remaining in the blood poll, but about 35% appeared in the urinary bladder within 1.5 h

  6. Evidences of Herbal Medicine-Derived Natural Products Effects in Inflammatory Lung Diseases

    Directory of Open Access Journals (Sweden)

    Fernanda Paula R. Santana

    2016-01-01

    Full Text Available Pulmonary inflammation is a hallmark of many respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD, and acute respiratory syndrome distress (ARDS. Most of these diseases are treated with anti-inflammatory therapy in order to prevent or to reduce the pulmonary inflammation. Herbal medicine-derived natural products have been used in folk medicine and scientific studies to evaluate the value of these compounds have grown in recent years. Many substances derived from plants have the biological effects in vitro and in vivo, such as flavonoids, alkaloids, and terpenoids. Among the biological activities of natural products derived from plants can be pointed out the anti-inflammatory, antiviral, antiplatelet, antitumor anti-allergic activities, and antioxidant. Although many reports have evaluated the effects of these compounds in experimental models, studies evaluating clinical trials are scarce in the literature. This review aims to emphasize the effects of these different natural products in pulmonary diseases in experimental models and in humans and pointing out some possible mechanisms of action.

  7. The cultural production of Bioterapia: psychic healing and the natural medicine movement in Slovakia.

    Science.gov (United States)

    Rubens, D; Gyurkovics, D; Hornacek, K

    1995-11-01

    Despite powerful opposition, natural medicine (NM) has achieved a toe-hold in the state-run biomedical system in the Slovak Republic. The physician-leader of the NM movement hopes to leverage his ministerial post as NM 'supreme expert' and his interlocking NM clinical and research facilities to achieve a complex, unified health care system under control of medical doctors. This health care model simultaneously reinforces biomedical hegemony and decenters classical medicine by substituting a bioenergetical paradigm. NM includes, among other diagnostic and healing modalities, acupuncture, herbal therapies, bee therapy, reflexology, iridology. However, its paradigmatic form is bioterapia, the focus of this paper. Bioterapia is a form of psychic healing or therapeutic touch. According to its practitioners, it is based on bioenergetic and information-processing principles. Conceptually, bioterapia unifies psyche, soma and energy dimensions of the human body and situates the human organism in an extended transpersonal social, physical and cosmological environment. Bioterapia is a scientized and medicalized reconstruction of a folk healing tradition whose appropriation simultaneously secularized and re-sacralized this tradition by re-locating its practice from lay healers to medical doctors, from the religious domain to the venerated scientific domain, from deviant science to normal science. The reconfiguration into bioterapia as part of the creation of an academic secular parapsychology in the former Soviet Bloc in the late 1960s, illustrates the use of the privileged discourse of science for a cultural production that seems to have both supported and subverted the regime.

  8. Acupuncture and Traditional Herbal Medicine Therapy Prevent Deliriumin Patients with Cardiovascular Disease in Intensive Care Units.

    Science.gov (United States)

    Matsumoto-Miyazaki, Jun; Ushikoshi, Hiroaki; Miyata, Shusaku; Miyazaki, Nagisa; Nawa, Takahide; Okada, Hideshi; Ojio, Shinsuke; Ogura, Shinji; Minatoguchi, Shinya

    2017-01-01

    The aim of this study was to determine the effect of combination therapy consisting of acupuncture and traditional herbal medicine (Kampo medicine) for reducing the incidence rate of delirium in patients with cardiovascular (CV) disease in ICUs. Twenty-nine patients who had been urgently admitted to the ICU in the control period were treated with conventional intensive care. Thirty patients in the treatment period received conventional therapy plus a combination therapy consisting of acupuncture and herbal medicine. Acupuncture treatment was performed once a day, and the herbal formula was administered orally three times a day during the first week of the ICU stay. The standard acupuncture points were GV20, Ex-HN3, HT7, LI4, Liv3, and KI3, and the main herbal preparation was Kamikihito. The incident rates of delirium, assessed using the confusion assessment method for ICU, in the treatment and control period were compared. The incidence rate of delirium was significantly lower in the treatment group than in the control group (6.6% vs. 37.9%, [Formula: see text]). Moreover, sedative drugs and non-pharmacological approaches against aggressive behavior of patients who were delirious were used less in the treatment group than in the control group. No serious adverse events were observed in the treatment group. Combination therapy consisting of acupuncture and herbal medicine was found to be effective in lowering the incidence of delirium in patients with CV disease in ICUs. Further studies with a large sample size and parallel randomized controlled design would be required to establish the effects of this therapy.

  9. Nuclear medicine in Uzbekistan and current status of radionuclide therapy in the country

    International Nuclear Information System (INIS)

    Rasulova, N.; Khodjibekova, M.

    2005-01-01

    Full text: The population of Uzbekistan is 26 million and to cater to this population we have only two nuclear medicine departments; one at the Clinical Centre for Surgery and the other at the Institute of Endocrinology, both situated in Tashkent, the capital city of Uzbekistan. Over the years through its own initiatives and through the support provided by several International Organizations including the IAEA, Uzbekistan has been able to marginally improve its nuclear medicine services. SPECT imaging was introduced through generous support from IAEA in the year 2001. As a result of this, the country is now able to provide modern in vivo nuclear medicine service to the population in a limited scale. At the Clinical Centre for Surgery we are able to provide gamma camera and SPECT imaging services to patients suffering from various nephro-urological, cardiac, neuro and oncological disorders. The other nuclear medicine centre at the Institute of Endocrinology does not have any modern imaging system. However it has been engaged in providing radionuclide therapy service for thyroid diseases like thyroid cancer and hyperthyroidism. From the year 1983 to 1999 the country has reported a total number of 6374 cases of Thyroid Cancer. This number is growing each year, for example the incidence of thyroid cancer in 1989 was 1.95 per 100,000, which has grown to 2.39 per 100,000 in 1999. While the Institute of Endocrinology provides therapeutic service to thyroid diseases, the main role of the Nuclear Medicine Department of Republic Specialized Center of Surgery is in following-up of patients after therapy by performing large dose I-131 whole body imaging, screening for metastases and for assessment of results of radioactive iodine therapy. Besides treating thyroid diseases with I-131 limited services are also available for treatment of polycythemia vera rubra with P-32 and radionuclide therapy for metastatic bone pain. Radionuclide therapy is growing rapidly around the world

  10. Evaluation of the physicians‘ of n hospital opinion on clinical trials of medicinal products

    OpenAIRE

    Videikaitė, Lina

    2014-01-01

    Aim of the research. To evaluate the physicians‘ of N Hospital opinion on clinical trials of medicinal products. Objectives. To evaluate the factors affecting physicians' motivation to perform clinical trials of medicinal products as well as those that prevent the physicians getting involved in the trials. To assess physicians' attitude towards clinical trials of medicinal products. To compare the opinions of physicians who have and have’nt participated in clinical trials. Methods of...

  11. Research advances in traditional Chinese medicine combined with interventional therapy for hepatocellular carcinoma

    Directory of Open Access Journals (Sweden)

    LIU Yang

    2015-01-01

    Full Text Available Interventional therapy has become the first choice of non-surgical treatment for hepatocellular carcinoma (HCC due to its advantages such as little trauma and marked local effect. However, the clinical efficiency is less than expected. One of the possibilities is the resistance of cancer cells to anti-cancer drugs. Increasing attention has been paid to the combination of traditional Chinese medicine (TCM and interventional therapy in HCC treatment. This paper reviews the progress in TCM combined with interventional therapy for HCC at animal experiment and clinical study levels in recent ten years. It is pointed out that the combination therapy with TCM and intervention for HCC has a unique advantage.

  12. Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use.

    Science.gov (United States)

    Cilia, Mark; Ruiz, Sol; Richardson, Peter; Salmonson, Tomas; Serracino-Inglott, Anthony; Wirth, Francesca; Borg, John Joseph

    2018-02-01

    The aim of this study was to identify trends in deficiencies raised during the EU evaluation of the quality part of dossiers for marketing authorisation applications of biosimilar medicinal products. All adopted day 120 list of questions on the quality module of 22 marketing authorisation applications for biosimilars submitted to the European Medicines Agency and concluded by the end of October 2015 was analysed. Frequencies of common deficiencies identified were calculated and summarised descriptions included. Frequencies and trends on quality deficiencies were recorded and presented for 22 biosimilar applications. Thirty-two 'major objections' for 9 products were identified from 14 marketing authorisation applications with 15 raised for drug substance and 17 for drug product. In addition, 547 'other concerns' for drug substance and 495 for drug product were also adopted. The frequencies and trends of the identified deficiencies together with their impact were discussed from a regulatory perspective and how these impact key manufacturing processes and key materials used in the production of biosimilars. This study provides an insight to the regulatory challenges prospective companies need to consider when developing biosimilars; it also helps elucidate common pitfalls in the development and production of biosimilars and in the submission of dossiers for their marketing authorisations. The results are expected to be of interest to pharmaceutical companies but also to regulators to obtain consistent information on medicinal products based on transparent rules safeguarding the necessary pharmaceutical quality of medicinal products.

  13. Usage of Intramammary Antimicrobial Veterinary Medicinal Products in The Republic of Serbia from 2011 to 2014

    Directory of Open Access Journals (Sweden)

    Andjelkovic Jelena

    2017-03-01

    Full Text Available Prudent use of antimicrobial medicine is an imperative in both human and veterinary medicine today. Antibiotic usage in humans and animals has increased over the years, consequently giving rise to antimicrobial resistance in pathogenic microorganisms. Mastitis is one of the most common conditions in bovine species, and intramammary antibacterial medicinal products are used in animal husbandry for mastitis treatment and prophylaxis.

  14. Clinical holistic medicine: avoiding the Freudian trap of sexual transference and countertransference in psychodynamic therapy.

    Science.gov (United States)

    Ventegodt, Søren; Kandel, Isack; Merrick, Joav

    2008-04-14

    Sexual transference and countertransference can make therapy slow and inefficient when libidinous gratification becomes more important for both the patient and the therapist than real therapeutic progress. Sexual transference is normal when working with a patient's repressed sexuality, but the therapeutic rule of not touching often hinders the integration of sexual traumas, as this needs physical holding. So the patient is often left with sexual, Oedipal energies projected onto the therapist as an "idealized father" figure. The strong and lasting sexual desire for the therapist without any healing taking place can prolong therapy for many years, as it often does in psychodynamic psychotherapy and psychoanalysis. We call this problem "Freud's Trap". Freud used intimate bodywork, such as massage, in the beginning of his career, but stopped, presumably for moral and political reasons. In the tradition of psychoanalysis, touch is therefore not allowed. Recent research in clinical holistic medicine (CHM), salutogenesis, and sexual healing has shown that touch and bodywork (an integral part of medicine since Hippocrates) are as important for healing as conversational therapy. CHM allows the patient to regress spontaneously to early sexual and emotional traumas, and to heal the deep wounds on body, soul, and sexual character from arrested psychosexual development. CHM treats sexuality in therapy more as the patient's internal affair (i.e., energy work) and less as a thing going on between the patient and the therapist (i.e., transference). This accelerates healing, and reduces sexual transference and the need for mourning at the end of therapy.

  15. New thoughts on the treatment of common complications of advanced liver cancer by external therapy of traditional Chinese medicine

    Directory of Open Access Journals (Sweden)

    PAN Shasha

    2017-12-01

    Full Text Available Cancerous pain, hepatic ascites and intractable hiccups are common complications in patients with advanced liver cancer, but clinical symptomatic treatment cannot achieve satisfactory results. This article reviews the application of external therapy of traditional Chinese medicine in the treatment of common complications in patients with advanced liver cancer and analyzes the clinical effect and feasibility of common therapeutic methods used in treatment, such as plaster sticking therapy, tumor thermotherapy, interventional therapy combined with traditional Chinese medicine, and sonophoresis of traditional Chinese medicine.

  16. Prospective regenerative medicine therapies for obstetric trauma-induced fecal incontinence.

    Science.gov (United States)

    Parmar, Nina; Kumar, Lalit; Emmanuel, Anton; Day, Richard M

    2014-01-01

    Fecal incontinence is a major public health issue that has yet to be adequately addressed. Obstetric trauma and injury to the anal sphincter muscles are the most common cause of fecal incontinence. New therapies are emerging aimed at repair or regeneration of sphincter muscle and restoration of continence. While regenerative medicine offers an attractive option for fecal incontinence there are currently no validated techniques using this approach. Although many challenges are yet to be resolved, the advent of regenerative medicine is likely to offer disruptive technologies to treat and possibly prevent the onset of this devastating condition. This article provides a review on regenerative medicine approaches for treating fecal incontinence and a critique of the current landscape in this area.

  17. Integrating motivational interviewing and narrative therapy to teach behavior change to family medicine resident physicians.

    Science.gov (United States)

    Oshman, Lauren D; Combs, Gene N

    2016-05-01

    Motivational interviewing is a useful skill to address the common problem of patient ambivalence regarding behavior change by uncovering and strengthening a person's own motivation and commitment to change. The Family Medicine Milestones underline the need for clear teaching and monitoring of skills in communication and behavior change in Family Medicine postgraduate training settings. This article reports the integration of a motivational interviewing curriculum into an existing longitudinal narrative therapy-based curriculum on patient-centered communication. Observed structured clinical examination for six participants indicate that intern physicians are able to demonstrate moderate motivational interviewing skill after a brief 2-h workshop. Participant self-evaluations for 16 participants suggest a brief 2-h curriculum was helpful at increasing importance of learning motivational interviewing by participants, and that participants desire further training opportunities. A brief motivational interviewing curriculum can be integrated into existing communication training in a Family Medicine residency training program. © The Author(s) 2016.

  18. General practitioners, complementary therapies and evidence-based medicine: the defence of clinical autonomy.

    Science.gov (United States)

    Adams, J

    2000-12-01

    Amidst the substantial change currently gripping primary health care are two developments central to contemporary debate regarding the very nature, territory and identity of general practice - the integration of complementary and alternative medicine (CAM) and the rise of evidence-based medicine (EBM). This paper reports findings from a study based upon 25 in-depth interviews with general practitioners (GPs) personally practising complementary therapies alongside more conventional medicine to treat their NHS patients. The paper outlines the GPs' perceptions of EBM, its relationship to their personal development of CAM, and their notions of good clinical practice more generally. Analysis of the GPs' accounts demonstrates how CAM can be seen as a useful resource with which some GPs defend their clinical autonomy from what they perceive to be the threat of EBM. Copyright 2000 Harcourt Publishers Ltd.

  19. The legal framework governing the quality of (traditional) herbal medicinal products in the European Union.

    Science.gov (United States)

    Kroes, Burt H

    2014-12-02

    In the European Union a complex regulatory framework is in place for the regulation of (traditional) herbal medicinal products. It is based on the principle that a marketing authorisation granted by the competent authorities is required for placing medicinal products on the market. The requirements and procedures for acquiring such a marketing authorisation are laid down in regulations, directives and scientific guidelines. This paper gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation. Pharmaceutical quality of medicinal product is the basis for ensuring safe and effective medicines. The basic principles governing the assurance of the quality of medicinal products in the European Union are primarily defined in the amended Directive 2001/83/EC and Directive 2003/63/EC. Quality requirements of herbal medicinal products are also laid down in scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in regulations and directives. Detailed quality requirements for herbal medicinal products on the European market are contained in European Union (EU) pharmaceutical legislation. They include a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community. The European regulatory framework encompasses specific requirements for herbal medicinal products. These requirements are independent from the legal status. Thus, the same quality standards equally apply

  20. [Interpretation of the concept of 'medicinal product' in relation to herb- and cannabinoid-based products].

    Science.gov (United States)

    Zsigmond, Ferge

    2014-11-30

    On 10th of July 2014 the European Court of Justice made in his decisions in relation to the cases D. (C-358/13) and G. (C-181/14) an interpretation, that the concept of 'medicinal product' according to the law of the European Union does not include the materials, which are - as not covering substances, such as those at issue in the main proceedings, which produce effects that merely modify physiological functions but which are not such as to have any beneficial effects, either immediately or in the long term, on human health, are consumed solely to induce a state of intoxication and are, as such, harmful to human health. The Court made his interpretation after the request for preliminary ruling from the Bundesgerichtshof (the High Court of Justice in Germany). The Court had to decide in two criminal procedures, whether for the retail of mixtures including syntetic canabinoids, such as complements of marihuana, due the fact that they are "unsafe medicinal products", a criminal proceeding can be initiated or not. The Ordinary Courts had two persons (D. and G.) for selling the unsafe medicinal products sentenced to one year and nine months imprisonment, and suspension (D.), and sentenced (G.) to four years and six months imprisonment and fined with a charge of two hundred thousand Euro. The retail of herb mixtures containing, inter alia, synthetic cannabinoids, did not fall under the German law on narcotic drugs at the material time, resulting that the German Authorities could not initiate a criminal procedure.

  1. Medicinal Plants of the Family Lamiaceae in Pain Therapy: A Review

    Directory of Open Access Journals (Sweden)

    Cristina M. Uritu

    2018-01-01

    Full Text Available Recently, numerous side effects of synthetic drugs have lead to using medicinal plants as a reliable source of new therapy. Pain is a global public health problem with a high impact on life quality and a huge economic implication, becoming one of the most important enemies in modern medicine. The medicinal use of plants as analgesic or antinociceptive drugs in traditional therapy is estimated to be about 80% of the world population. The Lamiaceae family, one of the most important herbal families, incorporates a wide variety of plants with biological and medical applications. In this study, the analgesic activity, possible active compounds of Lamiaceae genus, and also the possible mechanism of actions of these plants are presented. The data highlighted in this review paper provide valuable scientific information for the specific implications of Lamiaceae plants in pain modulation that might be used for isolation of potentially active compounds from some of these medicinal plants in future and formulation of commercial therapeutic agents.

  2. Efficacy and Safety of Medicinal Plants or Related Natural Products for Fibromyalgia: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Simone de Souza Nascimento

    2013-01-01

    Full Text Available To assess the effects of medicinal plants (MPs or related natural products (RNPs on fibromyalgia (FM patients, we evaluate the possible benefits and advantages of MP or RNP for the treatment of FM based on eight randomized placebo-controlled trials (RCTs involving 475 patients. The methodological quality of all studies included was determined according to JADAD and “Risk of Bias” with the criteria in the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0. Evidence suggests significant benefits of MP or RNP in sleep disruption, pain, depression, joint stiffness, anxiety, physical function, and quality of life. Our results demonstrated that MP or RNP had significant effects on improving the symptoms of FM compared to conventional drug or placebo; longer tests are required to determine the duration of the treatment and characterize the long-term safety of using MP, thus suggesting effective alternative therapies in the treatment of pain with minimized side effects.

  3. RIs used in diagnosis and therapy in nuclear medicine and new manufacturing process of RIs

    International Nuclear Information System (INIS)

    Nagai, Yasuki; Hashimoto, Kazuyuki

    2014-01-01

    Although various types of RIs are utilized in the field of nuclear medicine, their stable supply in the future poses anxiety worldwide. Taking up Tc-99m, which is most widely used in diagnosis in nuclear medicine, as an example, this paper introduces the condition to make RIs available in nuclear medicine as well as the worldwide challenge to their stable supply. In the following step, this paper introduces the innovative manufacturing process of RIs that is under development in Japan, in which undermentioned various types of RIs are manufactured in an identical facility (accelerator), although both nuclear reactor and accelerator have been used for manufacturing/supplying various types of RIs up to now: (1) Mo-99 as the parent nuclide of Tc-99m, (2) Cu-67, whose manufacturing process is urgently desired as the RI to enable simultaneous diagnosis and therapy, and (3) Y-90, Cu-64, and Sc-47, which are expected for use in new nuclear medicine based on the creation of new medicines. It also describes the future challenge in Japan to the construction of a prototype accelerator. (A.O.)

  4. Palliative medicine consultation for preparedness planning in patients receiving left ventricular assist devices as destination therapy.

    Science.gov (United States)

    Swetz, Keith M; Freeman, Monica R; AbouEzzeddine, Omar F; Carter, Kari A; Boilson, Barry A; Ottenberg, Abigale L; Park, Soon J; Mueller, Paul S

    2011-06-01

    To assess the benefit of proactive palliative medicine consultation for delineation of goals of care and quality-of-life preferences before implantation of left ventricular assist devices as destination therapy (DT). We retrospectively reviewed the cases of patients who received DT between January 15, 2009, and January 1, 2010. Of 19 patients identified, 13 (68%) received proactive palliative medicine consultation. Median time of palliative medicine consultation was 1 day before DT implantation (range, 5 days before to 16 days after). Thirteen patients (68%) completed advance directives. The DT implantation team and families reported that preimplantation discussions and goals of care planning made postoperative care more clear and that adverse events were handled more effectively. Currently, palliative medicine involvement in patients receiving DT is viewed as routine by cardiac care specialists. Proactive palliative medicine consultation for patients being considered for or being treated with DT improves advance care planning and thus contributes to better overall care of these patients. Our experience highlights focused advance care planning, thorough exploration of goals of care, and expert symptom management and end-of-life care when appropriate.

  5. Initiative for Molecular Profiling and Advanced Cancer Therapy and challenges in the implementation of precision medicine.

    Science.gov (United States)

    Tsimberidou, Apostolia-Maria

    In the last decade, breakthroughs in technology have improved our understanding of genomic, transcriptional, proteomic, epigenetic aberrations and immune mechanisms in carcinogenesis. Genomics and model systems have enabled the validation of novel therapeutic strategies. Based on these developments, in 2007, we initiated the IMPACT (Initiative for Molecular Profiling and Advanced Cancer Therapy) study, the first personalized medicine program for patients with advanced cancer at The University of Texas MD Anderson Cancer Center. We demonstrated that in patients referred for Phase I clinical trials, the use of tumor molecular profiling and treatment with matched targeted therapy was associated with encouraging rates of response, progression-free survival and overall survival compared to non-matched therapy. We are currently conducting IMPACT2, a randomized study evaluating molecular profiling and targeted agents in patients with metastatic cancer. Optimization of innovative biomarker-driven clinical trials that include targeted therapy and/or immunotherapeutic approaches for carefully selected patients will accelerate the development of novel drugs and the implementation of precision medicine. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Conformity of package inserts information to regulatory requirements among selected branded and generic medicinal products circulating on the East African market.

    Science.gov (United States)

    Sillo, Hiiti B; Masota, Nelson E; Kisoma, Sunday; Rago, Lembit; Mgoyela, Veronica; Kaale, Eliangiringa A

    2018-01-01

    Availability of correct and adequate information about medicines is an important aspect in ensuring rational use of medicines and hence facilitating safety and expected efficacy of medicines during therapy. Package inserts have proven to be a good source of information to the prescribers and patients whereby they have been useful in highlighting important information pertaining proper use and handling of the medicines. The present study was aimed at establishing the extent to which package inserts of medicines circulating on the markets of the East African Community (EAC) Partner States conform to medicines information requirements as established in the harmonized guidelines as well as national guidelines. A total of 99 package inserts from six (6) types of medicines namely Albendazole, Artemether/Lumefantrine (ALu), Ciprofloxacin, Paracetamol, Amoxicillin and Metronidazole were purposefully collected from three EAC Partner States: Kenya, Tanzania and Uganda. The medicines were selected based on their indications as first line treatments, high rates of utilization within the medicines supply system and their positions in treatment of diseases of public importance across EAC Partner States. The inserts were evaluated on the availability of information regarding fifteen (15) parameters as extracted from the EAC harmonized guidelines for registration of medicines. Moreover, comparisons were made between the percentage conformity of the branded versus generic products, markets from which the samples were collected, origin of the manufacturer and type of medicine. Majority (93.9-100%) of the medicines' package inserts highly conformed to the inclusion of the information regarding the description and composition of the medications, indications, dosage and methods of administration, warnings and precautions, contraindications and storage conditions. However, the information on handling and disposal, container package description, excipients used, clinical pharmacology of

  7. Case Study of Oriental Medicine Treatment with Acupotomy Therapy of the Peroneal Nerve Palsy through Ultrasound Case Report

    Directory of Open Access Journals (Sweden)

    Kim Sungha

    2011-03-01

    Full Text Available Purpose: In order to estimate clinical effects of Oriental Medicine Treatment with acupotomy therapy of Peroneal nerve Palsy. Methods: From 10th June, 2010 to 19th June, 2010, 1 female patient diagnosed as Peroneal nerve Palsy(clinical diagnosed was treated with general oriental medicine therapy (acupuncture, pharmacopuncture,moxibustion, cupping, physical therapy, herbal medication and acupotomy. Results: The patient's left foot drop was remarkably improved. Conclusions: This study demonstrates that oriental medical treatment with acuputomy therapy has notable effect in improving symptoms of peroneal nerve palsy. as though we had not wide experience in this treatment, more research is needed.

  8. Medicinal and aromatic crops: Production, Phytochemistry, and Utilization

    Science.gov (United States)

    In the later part of the 20th century the United States experienced a remarkable surge in public interest towards medicinal and aromatic crops and this trend continues. This consumer interest helped create a significant demand for plants with culinary and medicinal applications as the public discove...

  9. Use of herbal medicinal products among children and adolescents in Germany

    Science.gov (United States)

    2014-01-01

    Background Germany is a country with a high use of herbal medicinal products. Population-based data on the use of herbal medicinal products among children are lacking. The aim of this study is to investigate the prevalence, patterns and determinants of herbal medicine use among children and adolescents in Germany. Methods As data base served the German Health Interview and Examination Survey for Children and Adolescents (KiGGS), a representative population based survey conducted 2003–2006 by the Robert Koch Institute. 17,450 boys and girls aged 0–17 years provided information on drug use in the preceding seven days. Herbal medicinal products were defined according to the European and German drug laws. SPSS Complex Sample method was used to estimate prevalence rates and factors associated with herbal medicine use. Results The prevalence rate of herbal medicinal product use amounts to 5.8% (95% confidence interval 5.3-6.3%). Use of herbal medicine declines along with increasing age and shows no difference between boys and girls in younger age groups. Teenage girls are more likely to use herbal medicines than teenage boys. Two thirds of herbal medicines are used for the treatment of coughs and colds; nearly half of herbal medicines are prescribed by medical doctors. Determinants of herbal medicinal product use are younger age, residing in South Germany, having a poor health status, having no immigration background and coming from a higher social class family. Children’s and parents-related health behavior is not found to be associated with herbal medicine use after adjusting for social class. Conclusions Use of herbal medicinal products among children and adolescents between the ages of 0 and 17 years in Germany is widely spread and shows relatively higher rates compared to international data. This study provides a reference on the use of herbal medicinal products for policy-makers, health professionals and parents. Further studies are needed to investigate the

  10. A roadmap for cost-of-goods planning to guide economic production of cell therapy products.

    Science.gov (United States)

    Lipsitz, Yonatan Y; Milligan, William D; Fitzpatrick, Ian; Stalmeijer, Evelien; Farid, Suzanne S; Tan, Kah Yong; Smith, David; Perry, Robert; Carmen, Jessica; Chen, Allen; Mooney, Charles; Fink, John

    2017-12-01

    Cell therapy products are frequently developed and produced without incorporating cost considerations into process development, contributing to prohibitively costly products. Herein we contextualize individual process development decisions within a broad framework for cost-efficient therapeutic manufacturing. This roadmap guides the analysis of cost of goods (COG) arising from tissue procurement, material acquisition, facility operation, production, and storage. We present the specific COG considerations related to each of these elements as identified through a 2013 International Society for Cellular Therapy COG survey, highlighting the differences between autologous and allogeneic products. Planning and accounting for COG at each step in the production process could reduce costs, allowing for more affordable market pricing to improve the long-term viability of the cell therapy product and facilitate broader patient access to novel and transformative cell therapies. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  11. [Analysis of difficult problems on European Union laws and regulations of traditional herbal medicinal products].

    Science.gov (United States)

    Qu, Li-Ping; Zhang, Xiao-Qun; Xiong, Yan; Wang, Yi-Tao; Zou, Wen-Jun

    2017-10-01

    Registration of Chinese patent medicine in European Union (EU) is of great significance to the internationalization of traditional Chinese medicine as EU market acts as an important position in the global botanical market. In retrospect, the domestic studies on EU regulations of traditional herbal medicinal products have been conducted for more than 10 years, but there is still some cognitive bias and lack of research. In this paper, a review of the relevant research progress and the main misunderstanding problems about Directive 2004/24/EC, like the centralized and decentralized supervision system of traditional herbal medicinal products in the EU, marketing authorization procedures for traditional herbal medicinal products, Community Herbal Monograph and List Entries, would be systematically analyzed, so as to provide reference for the registration of Chinese patent medicine in EU. Copyright© by the Chinese Pharmaceutical Association.

  12. Emerging Glycolysis Targeting and Drug Discovery from Chinese Medicine in Cancer Therapy

    Directory of Open Access Journals (Sweden)

    Zhiyu Wang

    2012-01-01

    Full Text Available Molecular-targeted therapy has been developed for cancer chemoprevention and treatment. Cancer cells have different metabolic properties from normal cells. Normal cells mostly rely upon the process of mitochondrial oxidative phosphorylation to produce energy whereas cancer cells have developed an altered metabolism that allows them to sustain higher proliferation rates. Cancer cells could predominantly produce energy by glycolysis even in the presence of oxygen. This alternative metabolic characteristic is known as the “Warburg Effect.” Although the exact mechanisms underlying the Warburg effect are unclear, recent progress indicates that glycolytic pathway of cancer cells could be a critical target for drug discovery. With a long history in cancer treatment, traditional Chinese medicine (TCM is recognized as a valuable source for seeking bioactive anticancer compounds. A great progress has been made to identify active compounds from herbal medicine targeting on glycolysis for cancer treatment. Herein, we provide an overall picture of the current understanding of the molecular targets in the cancer glycolytic pathway and reviewed active compounds from Chinese herbal medicine with the potentials to inhibit the metabolic targets for cancer treatment. Combination of TCM with conventional therapies will provide an attractive strategy for improving clinical outcome in cancer treatment.

  13. Regulatory Oversight of Cell and Gene Therapy Products in Canada.

    Science.gov (United States)

    Ridgway, Anthony; Agbanyo, Francisca; Wang, Jian; Rosu-Myles, Michael

    2015-01-01

    Health Canada regulates gene therapy products and many cell therapy products as biological drugs under the Canadian Food and Drugs Act and its attendant regulations. Cellular products that meet certain criteria, including minimal manipulation and homologous use, may be subjected to a standards-based approach under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations. The manufacture and clinical testing of cell and gene therapy products (CGTPs) presents many challenges beyond those for protein biologics. Cells cannot be subjected to pathogen removal or inactivation procedures and must frequently be administered shortly after final formulation. Viral vector design and manufacturing control are critically important to overall product quality and linked to safety and efficacy in patients through concerns such as replication competence, vector integration, and vector shedding. In addition, for many CGTPs, the value of nonclinical studies is largely limited to providing proof of concept, and the first meaningful data relating to appropriate dosing, safety parameters, and validity of surrogate or true determinants of efficacy must come from carefully designed clinical trials in patients. Addressing these numerous challenges requires application of various risk mitigation strategies and meeting regulatory expectations specifically adapted to the product types. Regulatory cooperation and harmonisation at an international level are essential for progress in the development and commercialisation of these products. However, particularly in the area of cell therapy, new regulatory paradigms may be needed to harness the benefits of clinical progress in situations where the resources and motivation to pursue a typical drug product approval pathway may be lacking.

  14. Combatting Falsification and Counterfeiting Of Medicinal Products in the European Union

    DEFF Research Database (Denmark)

    Kohli, Vishv Priya

    and falsification of medicinal products meets the social objectives of public health (Articles 9 and 168) and consumer protection (Articles 12 and 169), as envisaged by the Treaty on the Function of the European Union. The thesis establishes that the problem of counterfeiting and falsification of medicinal products...... lies at the intersection of three spheres of law - IP law, Medicine law, and Criminal law. This insight provides the foundation for the understanding of the weaknesses in the legal regime that contains tools for combatting counterfeiting and falsification of medicines in the EU....

  15. Clinical Holistic Medicine: Avoiding the Freudian Trap of Sexual Transference and Countertransference in Psychodynamic Therapy

    Directory of Open Access Journals (Sweden)

    Søren Ventegodt

    2008-01-01

    Full Text Available Sexual transference and countertransference can make therapy slow and inefficient when libidinous gratification becomes more important for both the patient and the therapist than real therapeutic progress. Sexual transference is normal when working with a patient's repressed sexuality, but the therapeutic rule of not touching often hinders the integration of sexual traumas, as this needs physical holding. So the patient is often left with sexual, Oedipal energies projected onto the therapist as an “idealized father” figure. The strong and lasting sexual desire for the therapist without any healing taking place can prolong therapy for many years, as it often does in psychodynamic psychotherapy and psychoanalysis. We call this problem “Freud's Trap”. Freud used intimate bodywork, such as massage, in the beginning of his career, but stopped, presumably for moral and political reasons. In the tradition of psychoanalysis, touch is therefore not allowed. Recent research in clinical holistic medicine (CHM, salutogenesis, and sexual healing has shown that touch and bodywork (an integral part of medicine since Hippocrates are as important for healing as conversational therapy. CHM allows the patient to regress spontaneously to early sexual and emotional traumas, and to heal the deep wounds on body, soul, and sexual character from arrested psychosexual development. CHM treats sexuality in therapy more as the patient’s internal affair (i.e., energy work and less as a thing going on between the patient and the therapist (i.e., transference. This accelerates healing, and reduces sexual transference and the need for mourning at the end of therapy.

  16. Clinical Holistic Medicine: Avoiding the Freudian Trap of Sexual Transference and Countertransference in Psychodynamic Therapy

    Science.gov (United States)

    Ventegodt, Søren; Kandel, Isack; Merrick, Joav

    2008-01-01

    Sexual transference and countertransference can make therapy slow and inefficient when libidinous gratification becomes more important for both the patient and the therapist than real therapeutic progress. Sexual transference is normal when working with a patient's repressed sexuality, but the therapeutic rule of not touching often hinders the integration of sexual traumas, as this needs physical holding. So the patient is often left with sexual, Oedipal energies projected onto the therapist as an “idealized father” figure. The strong and lasting sexual desire for the therapist without any healing taking place can prolong therapy for many years, as it often does in psychodynamic psychotherapy and psychoanalysis. We call this problem “Freud's Trap”. Freud used intimate bodywork, such as massage, in the beginning of his career, but stopped, presumably for moral and political reasons. In the tradition of psychoanalysis, touch is therefore not allowed. Recent research in clinical holistic medicine (CHM), salutogenesis, and sexual healing has shown that touch and bodywork (an integral part of medicine since Hippocrates) are as important for healing as conversational therapy. CHM allows the patient to regress spontaneously to early sexual and emotional traumas, and to heal the deep wounds on body, soul, and sexual character from arrested psychosexual development. CHM treats sexuality in therapy more as the patient’s internal affair (i.e., energy work) and less as a thing going on between the patient and the therapist (i.e., transference). This accelerates healing, and reduces sexual transference and the need for mourning at the end of therapy. PMID:18454245

  17. Concurrent Complementary and Alternative Medicine CAM and Conventional Rehabilitation Therapy in the Management of Children with Developmental Disorders

    Directory of Open Access Journals (Sweden)

    Soo Yeon Kim

    2013-01-01

    Full Text Available Background. We investigated the concurrent use of conventional rehabilitations and complementary and alternative medicine (CAM therapies for the long-term management of children with developmental disorders (DDs. Methods. The parents or caregivers of 533 children with DDs (age range, 1–19 years who visited the rehabilitation centers were surveyed using in depth face-to-face interviews. Results. Of the 533 patients enrolled, 520 completed the questionnaire (97% response rate. A total of 292 (56% children were receiving multiple therapies, more than two conventional rehabilitations and CAM, at the time of the interview. A total of 249 (48% children reported lifetime CAM use, 23% used CAM at the time of the interview, and 62% of the patients planned to use CAM therapy in the future. Conventional rehabilitation therapies used at the time of the interview included physical therapy (30%, speech therapy (28%, and occupational therapy (19%, and the CAM therapies included herbal medicine (5% and acupuncture or moxibustion (3%. The respondents indicated that in the future they planned to use acupuncture or moxibustion (57%, occupational therapy (18%, cognitive behavioral therapy (16%, speech therapy (10%, and physical therapy (8%. Conclusion. Concurrent management as conventional rehabilitations and CAM therapies is widely used by children with DDs.

  18. Radiation therapy using the wildlife medicine: a reasoned obtained study in cases of literature

    International Nuclear Information System (INIS)

    Vettorato, Michel de Campos; Fernandes, Marco Antonio Rodrigues; Vulcano, Luis Carlos; Universidade Estadual Paulista Julio de Mesquita Filho

    2016-01-01

    The cancer is the kind of tumor that affects both humans and animals and is responsible for more deaths worldwide. In wildlife, cancer is a problem found most often in zoo animals. Thus veterinary oncologists have researched and developed therapeutic approaches to many types of cancer over the years in both curative and palliative therapies including therein the application of radiation. The basic principle of radiotherapy is the effect of ionizing radiation on the tumor cells, causing them to death. However, its application in veterinary medicine for wildlife is not much reported in the literature, especially in Brazil. This study aims to describe and compare some of radiotherapy applications in different species of wildlife looking to improve her knowledge in veterinary medicine through a brief literature review. After the descriptions and comparisons, it is concluded that despite the number of cases taken for this study, all the cases mentioned had satisfactory results using radiation therapy and all the presented cases provided relevant information that can guide future researchers in this area, thus improving knowledge of this therapy and improve the quality of life of animals. (author)

  19. Applying Precision Medicine and Immunotherapy Advances from Oncology to Host-Directed Therapies for Infectious Diseases.

    Science.gov (United States)

    Mahon, Robert N; Hafner, Richard

    2017-01-01

    To meet the challenges of increasing antimicrobial resistance, the infectious disease community needs innovative therapeutics. Precision medicine and immunotherapies are transforming cancer therapeutics by targeting the regulatory signaling pathways that are involved not only in malignancies but also in the metabolic and immunologic function of the tumor microenvironment. Infectious diseases target many of the same regulatory pathways as they modulate host metabolic functions for their own nutritional requirements and to impede host immunity. These similarities and the advances made in precision medicine and immuno-oncology that are relevant for the current development of host-directed therapies (HDTs) to treat infectious diseases are discussed. To harness this potential, improvements in drug screening methods and development of assays that utilize the research tools including high throughput multiplexes already developed by oncology are essential. A multidisciplinary approach that brings together immunologists, infectious disease specialists, and oncologists will be necessary to fully develop the potential of HDTs.

  20. Homeopathic medicinal products for preventing and treating acute respiratory tract infections in children.

    Science.gov (United States)

    Hawke, Kate; van Driel, Mieke L; Buffington, Benjamin J; McGuire, Treasure M; King, David

    2018-04-09

    Acute respiratory tract infections (ARTIs) are common and may lead to complications. Most children experience between three and six ARTIs each year. Although these infections are self limiting, the symptoms can be distressing. Many treatments are used to control symptoms and shorten the duration of illness. They often have minimal benefit and may lead to adverse effects. Oral homeopathic medicinal products could play a role in the treatment of ARTIs for children if evidence for effectiveness is established. To assess the effectiveness and safety of oral homeopathic medicinal products compared with placebo or conventional therapy to prevent and treat acute respiratory tract infections in children. We searched CENTRAL (2017, Issue 11), which contains the Cochrane Acute Respiratory Infections Specialised Register, MEDLINE (1946 to 27 November 2017), Embase (2010 to 27 November 2017), CINAHL (1981 to 27 November 2017), AMED (1985 to December 2014), CAMbase (searched 29 March 2018), British Homeopathic Library (searched 26 June 2013 - no longer operating). We also searched the WHO ICTRP and ClinicalTrials.gov trials registers (29 March 2018), checked references, and contacted study authors to identify additional studies. Double-blind, randomised controlled trials (RCTs) or double-blind cluster-RCTs comparing oral homeopathy medicinal products with identical placebo or self selected conventional treatments to prevent or treat ARTIs in children aged 0 to 16 years. We used standard methodological procedures expected by Cochrane. We included eight RCTs of 1562 children receiving oral homeopathic medicinal products or a control treatment (placebo or conventional treatment) for upper respiratory tract infections (URTIs). Four treatment studies examined the effect on recovery from URTIs, and four studies investigated the effect on preventing URTIs after one to three months of treatment and followed up for the remainder of the year. Two treatment and two prevention studies

  1. Production of alpha emitters for therapy

    International Nuclear Information System (INIS)

    Vucina, J.; Orlic, M.; Lukic, D.

    2006-01-01

    The basis for the introduction of alpha emitters into nuclear medical practice are their radiobiological properties. High LET values and short ranges in biological tissues are advantageous in comparison with nowadays most often used beta emitters, primarily 90 Y and 131 I. Given are the most important criteria for the introduction of a given radionuclide in the routine use. Shown are the procedures for the production of the most important alpha emitters 211 At, 212 Bi and 213 Bi. (author)

  2. Comparative Evaluation of the Complementary and Alternative Medicine Therapy and Conventional Therapy Use for Musculoskeletal Disorders Management and Its Association with Job Satisfaction among Dentists of West India.

    Science.gov (United States)

    Gupta, Devanand; Batra, Renu; Mahajan, Shveta; Bhaskar, Dara John; Jain, Ankita; Shiju, Mohammed; Yadav, Ankit; Chaturvedi, Mudita; Gill, Shruti; Verma, Renuka; Dalai, Deepak Ranjan; Gupta, Rajendra Kumar

    2014-10-01

    Musculoskeletal problems have become a significant issue in the profession of dentistry. There are currently no recommended effective disease-preventing and modifying remedies. High prevalence rates for musculoskeletal disorders (MSDs) among dentists have been reported in the literature. Complementary and alternative medicine can be helpful in managing and preventing the MSDs. The purpose of this study was to determine if dentists in the western part of India are using complementary and alternative medicine therapies for MSDs, and also to find if those who use complementary and alternative medicine therapies have greater job/career satisfaction compared to conventional therapy (CT) users. Dentists of western India registered under the Dental Council of India (N = 2166) were recruited for the study. Data were analyzed using univariate and bivariate analyses and logistic regression. A response rate of 73% (n = 1581) was obtained, of which 79% (n = 1249) was suffering from MSDs. The use of complementary and alternative medicine or CT was reported by 90% (n = 1124) of dentists with MSDs. Dentists using complementary and alternative medicine reported greater health (P alternative medicine therapies may improve the quality of life and enhance job satisfaction for a dentist who suffers from MSDs.

  3. The future of replacement and restorative therapies: from organ transplantation to regenerative medicine.

    Science.gov (United States)

    Daar, A S

    2013-01-01

    As we continue to have severe shortages of organs for transplantation, we need to consider alternatives for the future. The most likely to make a real difference in the long term is regenerative medicine (RM), a field that has emerged from the conjunction of stem cell biology and cell therapies; gene therapy; biomaterials and tissue engineering; and organ transplantation. Transplantation and RM share the same essential goal: to replace or restore organ function. Herein I briefly review some major breakthroughs of RM that are relevant to the future of organ transplantation, with a focus on the needs of people in the developing world. A definition of RM is provided and the ethical, legal, and social issues are briefly highlighted. In conclusion, I provide a projection of what the future may be for RM. Copyright © 2013 Elsevier Inc. All rights reserved.

  4. Radioiodine therapy in veterinary medicine: treatment of hyperthyroidism in a cat

    International Nuclear Information System (INIS)

    Reinartz, P.; Sabri, O.; Zimny, M.; Buell, U.

    1999-01-01

    A nine-year-old cat with symptoms of a distinct hyperthyroidism was presented at the University Hospital of the RWTH Aachen. The clinical symptoms as well as the diagnostic procedures performed at the hospital confirmed the diagnosis. After five weeks of thyreostatic medication a regular metabolism of the thyroid gland was established, followed by a radioiodine therapy with 70.3 MBq 131-iodine. Subsequently, the cat was hospitalized for two days before it could be released in good condition. Six weeks after treatment the former drastically reduced weight of the cat recovered to near normal. Even though the chemical analysis detected a discrete hyperthyroidism, clinical symptoms were no longer prominent. Three months after treatment, the final examination showed a regular metabolism of the thyroid gland without a specific thyroidal medication. The presented case illustrates that radioiodine therapy is a safe and efficient treatment of thyroidal dysfunctions in veterinary medicine. (orig.) [de

  5. Innovative Strategy in Treating Angina Pectoris with Chinese Patent Medicines by Promoting Blood Circulation and Removing Blood Stasis: Experience from Combination Therapy in Chinese Medicine.

    Science.gov (United States)

    Xiong, Xing-Jiang; Wang, Zhong; Wang, Jie

    2015-01-01

    Coronary heart disease (CHD) is one of the leading causes of death worldwide. Moreover, angina pectoris is one of the most important types of CHD. Therefore, prevention and effective treatment of angina pectoris is of utmost importance in both China and western countries. However, undesirable effects of antianginal therapy do influence treatment adherence to a certain extent. Therefore, it's not surprising that, complementary and alternative medicine (CAM), including Chinese medicine (CM), are widely welcomed among patients with CHD, hoping that it might complement western medicine. In our previous studies, blood stasis syndrome (BSS) (Xueyu Zheng) was the main syndrome (Zheng-hou) of angina pectoris. Currently, China Food and Drug Administration authoritatively recommended more than 200 Chinese patent medicines (CPMs) as complementary or adjunctive therapies for symptom management and enhancing quality of life along with mainstream care on angina pectoris management in mainland China. This paper reviewed 4 kinds of most frequently-used CPMs by promoting blood circulation and removing blood stasis in the treatment of angina pectoris. It aims to evaluate the current evidence of CPMs in combination therapy for angina pectoris. This review indicated that CPMs as adjunctive treatment to routine antianginal therapy play an active role in reducing the incidence of primary endpoint events, decreasing anginal attack rate, and improving electrocardiogram. Additionally, CPMs have been proven relatively safe. Further rigorously designed clinical trials should be conducted to confirm the results.

  6. The Quest for Evidence for Proton Therapy: Model-Based Approach and Precision Medicine

    Energy Technology Data Exchange (ETDEWEB)

    Widder, Joachim, E-mail: j.widder@umcg.nl [Department of Radiation Oncology, University of Groningen, University Medical Center Groningen, Groningen (Netherlands); Schaaf, Arjen van der [Department of Radiation Oncology, University of Groningen, University Medical Center Groningen, Groningen (Netherlands); Lambin, Philippe [Department of Radiation Oncology, School for Oncology and Developmental Biology (GROW), Maastricht University Medical Center, Maastricht (Netherlands); Marijnen, Corrie A.M. [Department of Radiation Oncology, Leiden University Medical Center, Leiden (Netherlands); Pignol, Jean-Philippe [Department of Radiation Oncology, Erasmus Medical Center Cancer Institute, Rotterdam (Netherlands); Rasch, Coen R. [Department of Radiation Oncology, Academic Medical Center, Amsterdam (Netherlands); Slotman, Ben J. [Department of Radiation Oncology, VU Medical Center, Amsterdam (Netherlands); Verheij, Marcel [Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam (Netherlands); Langendijk, Johannes A. [Department of Radiation Oncology, University of Groningen, University Medical Center Groningen, Groningen (Netherlands)

    2016-05-01

    Purpose: Reducing dose to normal tissues is the advantage of protons versus photons. We aimed to describe a method for translating this reduction into a clinically relevant benefit. Methods and Materials: Dutch scientific and health care governance bodies have recently issued landmark reports regarding generation of relevant evidence for new technologies in health care including proton therapy. An approach based on normal tissue complication probability (NTCP) models has been adopted to select patients who are most likely to experience fewer (serious) adverse events achievable by state-of-the-art proton treatment. Results: By analogy with biologically targeted therapies, the technology needs to be tested in enriched cohorts of patients exhibiting the decisive predictive marker: difference in normal tissue dosimetric signatures between proton and photon treatment plans. Expected clinical benefit is then estimated by virtue of multifactorial NTCP models. In this sense, high-tech radiation therapy falls under precision medicine. As a consequence, randomizing nonenriched populations between photons and protons is predictably inefficient and likely to produce confusing results. Conclusions: Validating NTCP models in appropriately composed cohorts treated with protons should be the primary research agenda leading to urgently needed evidence for proton therapy.

  7. Clinical evidence for orphan medicinal products-a cause for concern?

    NARCIS (Netherlands)

    Picavet, Eline; Cassiman, David; Hollak, Carla E.; Maertens, Johan A.; Simoens, Steven

    2013-01-01

    The difficulties associated with organising clinical studies for orphan medicinal products (OMPs) are plentiful. Recent debate on the long-term effectiveness of some OMPs, led us to question whether the initial standards for clinical evidence for OMPs, set by the European Medicines Agency (EMA) at

  8. Training needs for chemists in nuclear medicine research and production

    International Nuclear Information System (INIS)

    Welch, M.J.

    1993-01-01

    The field Nuclear Medicine has expanded rapidly over the last two decades. Individuals with training in radiochemistry are needed in industry, medical centers and hospitals. Although basic training in organic chemistry, inorganic chemistry, biochemistry or pharmacy are required, radiochemistry knowledge is essential for all these individuals. Opportunities and training requirements in these areas will be discussed. (author) 7 refs.; 5 tabs

  9. Knowledge, Attitudes, and Personal Use of Complementary and Alternative Medicine among Occupational Therapy Educators in the United States.

    Science.gov (United States)

    Bradshaw, Michelle L

    2016-01-01

    The purpose of this study was to establish a baseline description of American occupational therapy educators' knowledge, attitudes, and personal use of complementary and alternative medicine (CAM) as a first step in exploring the larger issue of future occupational therapy practitioners' preparedness for meeting clients' occupational needs in today's evolving healthcare environment. Results of this cross-sectional survey highlighted limitations of occupational therapy educators' knowledge of common CAM concepts and therapies across all demographic variables, varying attitudes towards CAM in general and its inclusion in occupational therapy education, and personal use of common CAM therapies. Without increased occupational therapy educator knowledge about CAM and engagement in the current healthcare practices, occupational therapy practitioners are at risk for having a limited role in integrative healthcare.

  10. Nuclear medicine - factors influencing the choice and use of radionuclides in diagnosis and therapy

    International Nuclear Information System (INIS)

    Anon.

    1983-01-01

    This report addresses the many factors which influence the choice of the proper radiopharmaceutical drug product for the diagnosis or treatment of a specific disease or condition in a human subject. The Report examines the historical factors that influence the choice of radionuclides, the factors that influence the localization of radionuclides in tissues, the factors that influence the choice of instruments, and include an evaluation of the nuclear medicine procedures that could be selected and their clinical usefulness. In examining these factors the desirable characteristics of the radiopharmaceutical drug products of the measurement systems are identified. The methods of dose determination and the assumptions used in determination of dose are developed. There is also a section on radiation effects. A chapter on guidelines for procedures in nuclear medicine and some general and specific recommendations for protection of patients conclude the body of the text

  11. C-Peptides for diagnostics and therapy: a veterinary medicine point of view

    Directory of Open Access Journals (Sweden)

    Derek A. Rosenfield

    Full Text Available ABSTRACT: Empirical studies proved that C-peptides are performing numerous intrinsic biological roles, and serve as a marker for pancreatic performance analysis. Since the last decade, C-peptide assays for differential diagnosis in veterinary diabetic patients are becoming more available, but still only for a very limited number of species. Studies on C-peptide as a diagnostic tool, therapy for associated complications, or as replacement therapies for C-peptide deficiency still showed not to be a common practice in veterinary medicine. This review was conducted to determine the potential importance of C-peptide in Veterinary Medicine, relevant in the diagnosis of diabetes and for other metabolic processes, as well as its proposed therapeutic benefits. Numerous articles were identified that reported positive results in their experimental studies, whether C-peptide as a biomarker for pancreatic performance in dogs, cats, and horses, as a non-invasive method to monitor nutritional status in primates, or to investigate its potential therapeutic benefits for diabetes-related illnesses.

  12. An Investigation of the Use of Traditional Chinese Medicine and Complementary and Alternative Medicine in Stroke Patients.

    Science.gov (United States)

    Yeh, Mei-Ling; Chiu, Wei-Ling; Wang, Yu-Jen; Lo, Chyi

    This study aimed to investigate the use of traditional Chinese medicine and complementary and alternative medicine in stroke patients in Taiwan. Chinese herbal medicine, massage, acupuncture, natural products, and exercise were widely used among stroke patients. Integrating safe and effective traditional Chinese medicine and complementary and alternative medicine into conventional therapies is suggested.

  13. Scientific Production about the Adherence to Antiretroviral Therapy

    Directory of Open Access Journals (Sweden)

    Regina Célia De Oliveira

    2017-09-01

    Full Text Available Objective: To identify the elite of authors about the subject adherence to antiretroviral therapy; to identify the journals turned to publishing articles about adherence to antiretroviral therapy; and to identify and analyze the most commonly used words in abstracts of articles about adherence to antiretroviral therapy. Method: A bibliometric study conducted through the Scopus base. We used articles published between 1996 and 2014, after application of the eligibility criteria, there were composed the sample with 24 articles. The data were analyzed descriptively. Were used the laws of bibliometric (Lotka, Bradford and Zipf and the conceptual cloud map of words, through the program Cmap tools. Results: Lotka's Law identified the 5 authors more productive (46% of the total published. Bradford is impaired in this study. Concerning Zipf, 3 zones were determined, 31.47% of the words with in the first zone, 26.46% in the second and 42.06% in the third. In the conceptual map, the words/factors that positively and negatively influence adherence were emphasized, among them the need for more research in the health services. Conclusion: There are few publications about the accession to antiretroviral therapy, and the scientific production is in the process of maturation. One can infer that the theme researched is not yet an obsolete topic. It should be noted that the Bibliometric was a relevant statistic tool to generate information about the publications about the antiretroviral therapy. Descriptors: Antiretroviral Therapy, Highly Active; Medication Adherence; Bibliometric; HIV; Acquired Immunodeficiency Syndrome

  14. The availability of reliable information about medicines in Serbia for health professionals summary of product characteristics

    Directory of Open Access Journals (Sweden)

    Đukić Ljiljana C.

    2015-01-01

    Full Text Available Introduction Today, there are many drugs for the treatment of a large number of indicator areas. Significant financial resources are invested in research with the aim of introducing reliable therapeutics to therapy. Therefore, it is necessary to provide health care professionals exact information about new therapies. The overall process of scientific data, ideas and information exchange is possible through numerous communications of modern IT tools. Methodology According to the Law, key information on registered drug is included in the Summary of Product Characteristics (SPC for health professionals, which is harmonized with EU directives and regulations (SmPC.Protocol content and structure of the information provided in SPC is determined in the guidelines of the EU, therefore, a unique set of data is established for all the drugs registered in Serbia. Topic This paper presents the key segments of SPC, with special reference to the description of the regulations that are required for data related to indications, mechanism of action, dosage, contraindications, side effects, interactions and other important information regarding the profile of the drug, which are standardized and harmonized with the structure of identical documents which operate at the EU level, or EMEA. Conclusions SPC is the regulatory determined technical document on medicinal products in the RS in which there are listed scientifically proven, clinical and pharmacological data and information on the profile of the drug, which are essential for health professionals - doctors and pharmacists in the implementation of pharmacotherapy in our society. This document is the starting point for the development of applied Pharmacoinformatics and it includes a range of activities important for the development of appropriate manuals and makes available data and information for monitoring indicators of the national policy on drugs and modern effective drugs treatment.

  15. Production and radioiodination of monoclonal antibodies and its applications in nuclear medicine

    International Nuclear Information System (INIS)

    Toledo e Souza, I.T. de; Okada, H.

    1988-12-01

    The basis of the monoclonal antibody production methodology, some immunological concepts which are important for the understanding of what is a Monoclonal Antibody, its radioiodination and acceptance as receptor-specific radiopharmaceuticals in nuclear medicine are reviewed. (author) [pt

  16. Sustainable Utilization of Traditional Chinese Medicine Resources: Systematic Evaluation on Different Production Modes

    Directory of Open Access Journals (Sweden)

    Xiwen Li

    2015-01-01

    Full Text Available The usage amount of medicinal plant rapidly increased along with the development of traditional Chinese medicine industry. The higher market demand and the shortage of wild herbal resources enforce us to carry out large-scale introduction and cultivation. Herbal cultivation can ease current contradiction between medicinal resources supply and demand while they bring new problems such as pesticide residues and plant disease and pests. Researchers have recently placed high hopes on the application of natural fostering, a new method incorporated herbal production and diversity protecting practically, which can solve the problems brought by artificial cultivation. However no modes can solve all problems existing in current herbal production. This study evaluated different production modes including cultivation, natural fostering, and wild collection to guide the traditional Chinese medicine production for sustainable utilization of herbal resources.

  17. Safety concerns of herbal products and traditional Chinese herbal medicines: Dehydropyrrolizidine alkaloids and aristolochic acid

    Science.gov (United States)

    In many countries, including the United States, herbal supplements, tisanes and vegetable products, including traditional Chinese medicines, are largely unregulated and their content is not registered, monitored or verified. Consequently, potent plant toxins including dehydropyrrolizidine alkaloids ...

  18. Safety concerns of herbal products and traditional Chinese herbal medicines: Dehydopyrrolizidine alkaloids and aristolochic acid

    Science.gov (United States)

    In many countries, including the United States, herbal supplements, tisanes and vegetable products including traditional Chinese medicines are largely unregulated and their content is not registered, monitored or verified. Consequently potent plant toxins including dehydopyrrolizidine alkaloids and...

  19. Approach and potentiality of low level laser therapy in veterinary medicine

    Science.gov (United States)

    Paterniani, Valentina; Grolli, Stefano

    2018-04-01

    The Low Level Laser Therapy (LLLT) is an innovative and increasing therapeutic technique in Veterinary Medicine. As in Human Medicine, the low power red/near-infrared laser light could be used to reduce inflammatory conditions, induce analgesia and promote damaged tissues repair, both in conventional animals like horses, dogs and cats and in unconventional ones, including reptiles, birds and exotic mammals. Since A.Eistein (1917) and E.Mester (1968) built its physical and biochemical fundamentals, a growing number of researches, over the years, have expanded the knowledge of the molecular process considered today at the basis of the macroscopic therapeutic effects. Producing a photochemical tissue interaction, laser light is absorbed by the mitochondrial respiratory chain stimulating the generation of ATP, ROS and NO; this determines a modulation in gene expression of proteins playing key roles in cellular processes as tissue repair, inflammatory response and pain control. Different animal pathological conditions could significantly benefit from this therapy, such as acute/chronic muscle-skeletal disorders, dental afflictions, dermatitis, otitis, stomatitis and different kind of skin lesions, as traumatic or post-operative ones. Furthermore, other significant applications are developing scientifically: the treatment of internal organ diseases, the regenerative effects on nervous tissue and the possibility of a beneficial cell-specific cytotoxicity, relevant for oncological cases, are some of these. A high-quality research is therefore crucial for this quickly expanding field of Veterinary Medicine, in order to find the most effective protocols and the ideal doses for each pathological conditions, aiming to always ensure the best and up-todate animal care.

  20. Concise Review: Bone Marrow Mononuclear Cells for the Treatment of Ischemic Syndromes: Medicinal Product or Cell Transplantation?

    Science.gov (United States)

    Rico, Laura; Herrera, Concha

    2012-01-01

    In November of 2011, the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) published two scientific recommendations regarding the classification of autologous bone marrow-derived mononuclear cells (BM-MNCs) and autologous bone marrow-derived CD133+ cells as advanced therapy medicinal products (ATMPs), specifically tissue-engineered products, when intended for regeneration in ischemic heart tissue on the basis that they are not used for the same essential function (hematological restoration) that they fulfill in the donor. In vitro and in vivo evidence demonstrates that bone marrow cells are physiologically involved in adult neovascularization and tissue repair, making their therapeutic use for these purposes a simple exploitation of their own essential functions. Therefore, from a scientific/legal point of view, nonsubstantially manipulated BM-MNCs and CD133+ cells are not an ATMP, because they have a physiological role in the processes of postnatal neovascularization and, when used therapeutically for vascular restoration in ischemic tissues, they are carrying out one of their essential physiological functions (the legal definition recognizes that cells can have several essential functions). The consequences of classifying BM-MNCs and CD133+ cells as medicinal products instead of cellular transplantation, like bone marrow transplantation, in terms of costs and time for these products to be introduced into clinical practice, make this an issue of crucial importance. Therefore, the recommendations of EMA/CAT could be reviewed in collaboration with scientific societies, in light of organizational and economic consequences as well as scientific knowledge recently acquired about the mechanisms of postnatal neovascularization and the function of bone marrow in the regeneration of remote tissues. PMID:23197819

  1. General sale of non-prescription medicinal products

    DEFF Research Database (Denmark)

    Lind, Johanna Lena Maria; Schafheutle, Ellen; Hägg, Annika Nordén

    2016-01-01

    BACKGROUND: The number of non-prescription medicines (NPMs) available for self-medication is increasing within the European Union (EU). This can enhance the autonomy of individuals but is also connected with risks. Under an existing EU Directive, Sweden has only recently deregulated and made NPMs...... market. There is a difference in the balance between confidence and control, as well as availability and safety when it comes to NPMs in non-pharmacy settings that needs to be further discussed....

  2. Medicinal and dietary supplements: specialty forest products with a long tradition

    Science.gov (United States)

    James L. Chamberlain; A.L. Hammett

    1999-01-01

    Over the last five years forest products other than timber-based products have received a great deal of attention. The markets for medicinal plants that are collected from the forests are growing rapidly. Some reports suggest this segment of the non-timber forest products industry is expanding faster than the timber-based industry. Plants used for their therapeutic...

  3. 21st century natural product research and drug development and traditional medicines.

    Science.gov (United States)

    Ngo, Linh T; Okogun, Joseph I; Folk, William R

    2013-04-01

    Natural products and related structures are essential sources of new pharmaceuticals, because of the immense variety of functionally relevant secondary metabolites of microbial and plant species. Furthermore, the development of powerful analytical tools based upon genomics, proteomics, metabolomics, bioinformatics and other 21st century technologies are greatly expediting identification and characterization of these natural products. Here we discuss the synergistic and reciprocal benefits of linking these 'omics technologies with robust ethnobotanical and ethnomedical studies of traditional medicines, to provide critically needed improved medicines and treatments that are inexpensive, accessible, safe and reliable. However, careless application of modern technologies can challenge traditional knowledge and biodiversity that are the foundation of traditional medicines. To address such challenges while fulfilling the need for improved (and new) medicines, we encourage the development of Regional Centres of 'omics Technologies functionally linked with Regional Centres of Genetic Resources, especially in regions of the world where use of traditional medicines is prevalent and essential for health.

  4. Nuclear medicine in the monitoring of organ function and the detection of injury related to cancer therapy

    International Nuclear Information System (INIS)

    Valdes Olmos, R.A.; Hoefnagel, C.A.; Schoot, J.B. van der

    1993-01-01

    This article emphasizes the role of nuclear medicine in the monitoring of function to prevent or limit injury in organs in which toxicity related to cancer therapy may have implications for the survival and/or the quality of life of the patient. After a brief discussion of the advantages of nuclear medicine techniques in detecting organ injury, the effect of radiation therapy and chemotherapy on normal tissue is discussed, underlining the need to characterize adverse effects of cancer therapy in long-term survivors. The use of radionuclides to document organ injury and effects from cancer therapy in heart, digestive tract, kidneys, lungs major salivary glands skeleton and brain is then reviewed. In a short section the potential applicability of positron emission tomography in documenting organ toxicity during cancer therapy is discussed. Thanks to the various available radiopharmaceuticals, the ability of the tracers to document specific functional aspects, the improved methods for visualization and quantitation of organ injury and the possibilities of physiological or pharmacological intervention, nuclear medicine gives the clinician potent tools for the monitoring of organ function at risk during cancer therapy. The trend to intensify cancer treatment by combining various treatment modalities and the increasing chances of prolonged survival in a large number of patients call for effective integration of nuclear medicine methods into the recommended guidelines for grading organ injury in clinical oncology. (orig.)

  5. In situ biomolecule production by bacteria; a synthetic biology approach to medicine.

    Science.gov (United States)

    Flores Bueso, Yensi; Lehouritis, Panos; Tangney, Mark

    2018-04-10

    The ability to modify existing microbiota at different sites presents enormous potential for local or indirect management of various diseases. Because bacteria can be maintained for lengthy periods in various regions of the body, they represent a platform with enormous potential for targeted production of biomolecules, which offer tremendous promise for therapeutic and diagnostic approaches for various diseases. While biological medicines are currently limited in the clinic to patient administration of exogenously produced biomolecules from engineered cells, in situ production of biomolecules presents enormous scope in medicine and beyond. The slow pace and high expense of traditional research approaches has particularly hampered the development of biological medicines. It may be argued that bacterial-based medicine has been "waiting" for the advent of enabling technology. We propose that this technology is Synthetic Biology, and that the wait is over. Synthetic Biology facilitates a systematic approach to programming living entities and/or their products, using an approach to Research and Development (R&D) that facilitates rapid, cheap, accessible, yet sophisticated product development. Full engagement with the Synthetic Biology approach to R&D can unlock the potential for bacteria as medicines for cancer and other indications. In this review, we describe how by employing Synthetic Biology, designer bugs can be used as drugs, drug-production factories or diagnostic devices, using oncology as an exemplar for the concept of in situ biomolecule production in medicine. Copyright © 2018 Elsevier B.V. All rights reserved.

  6. Expert Opinion on Three Phage Therapy Related Topics: Bacterial Phage Resistance, Phage Training and Prophages in Bacterial Production Strains

    Directory of Open Access Journals (Sweden)

    Christine Rohde

    2018-04-01

    Full Text Available Phage therapy is increasingly put forward as a “new” potential tool in the fight against antibiotic resistant infections. During the “Centennial Celebration of Bacteriophage Research” conference in Tbilisi, Georgia on 26–29 June 2017, an international group of phage researchers committed to elaborate an expert opinion on three contentious phage therapy related issues that are hampering clinical progress in the field of phage therapy. This paper explores and discusses bacterial phage resistance, phage training and the presence of prophages in bacterial production strains while reviewing relevant research findings and experiences. Our purpose is to inform phage therapy stakeholders such as policy makers, officials of the competent authorities for medicines, phage researchers and phage producers, and members of the pharmaceutical industry. This brief also points out potential avenues for future phage therapy research and development as it specifically addresses those overarching questions that currently call for attention whenever phages go into purification processes for application.

  7. Quantification of tomography images for dose calculation for diagnosis and therapy in nuclear medicine

    International Nuclear Information System (INIS)

    Massicano, Felipe

    2010-01-01

    The nuclear medicine area has an increasing slope in the therapy of diseases, particularly in the treatment of radiosensitive tumors. Due to the high dose levels in radionuclide therapy, it is very important the accurate quantify of the dose distribution to avoid deleterious effects on healthy tissues. In Brazil, the internal dosimetry system used is the MIRD (Medical Internal Radiation Dose) based on a reference model that does not have adequate patient data to obtain a dose accurate assessment in therapy. However, in recent years, internal radionuclide dosimetry evaluates the spatial dose distribution base ad on information obtained from CT and SPECT or PET images together with the using of Monte Carlo codes. Those systems are called patient-specific dosimetry systems. In the Nuclear Engineering Center at IPEN, this methodology is in development. When the CT images are inserted into the Monte Carlo code MCNP5 through of use of a interface software called SCMS the dosimetry can be accomplished using patient-specific data, resulting in a more accurate energy deposition in organs of interest. This work aim to contribute with the development of part of that patient-specific dosimetry for therapy. To achieve this goal we have proposed three specific objectives: (1) Development of a software to convert images from Computed Tomography (CT) in the tissue parameters (ρ, ω(ι)); (2) Development of a software to perform attenuation correction in nuclear medicine tomographic images (SPECT or PET) and to provide the map of relative activity and (3) Provide data to the SCMS code by these two software. The software developed for the rst specific objective was the Image Converter Computed Tomography (ICCT), which obtained a good accuracy to determine the density and the tissue composition; the elements that had high variation were carbon and oxygen. Fortunately, this variation for the energy range used in radionuclide therapy is not detrimental to the dose distribution. A

  8. Self-reported use of complementary and alternative medicine therapies in a reflexology randomized clinical trial.

    Science.gov (United States)

    Wyatt, Gwen; Sikorskii, Alla; You, Mei

    2013-01-01

    According to the National Center for Complementary and Alternative Medicine (NCCAM), about one-third of American cancer patients have used complementary and alternative medicine (CAM). The objective of this secondary analysis was an assessment of the use of other CAM by women with advanced breast cancer who were undergoing chemotherapy and who participated in a randomized clinical trial (RCT) studying the safety and efficacy of reflexology. For this secondary analysis, the research team hypothesized an increased CAM use due to exposure to the reflexology trial. For this secondary analysis, the team conducted telephone interviews at baseline, wk 5, and wk 11 to assess the use of 23 common CAM therapies. The study took place at 14 medical oncology clinics across the Midwestern United States. Participants included women with advanced breast cancer who were undergoing chemotherapy and/or hormonal therapy. In the study related to this secondary analysis, the research team randomly assigned the women to one of three primary groups: (1) reflexology; (2) lay foot manipulation (LFM); and (3) control. In addition, the research team used two test groups to establish the study's protocol: (1) test reflexology and (2) test LFM. For this secondary analysis, the research team considered the two reflexology groups (test and intervention) and the two LFM groups (test and intervention) to be the active groups, comparing their use of CAM to the control group's use at the selected time points. The research team used a linear, mixed-effects model to analyze the number of therapies used at the three time points. The team performed t tests to compare therapy use at baseline for those women who completed the study vs those who dropped out. The team used the CAM-use instrument. In total, 385 women participated. The research team found no differences in CAM use for the active groups vs the control group over time or in those women who stayed in the study vs those who dropped out. The team

  9. Genome medicine: gene therapy for the millennium, 30 September-3 October 2001, Rome, Italy.

    Science.gov (United States)

    Gruenert, D C; Novelli, G; Dallapiccola, B; Colosimo, A

    2002-06-01

    The recent surge of DNA sequence information resulting from the efforts of agencies interested in deciphering the human genetic code has facilitated technological developments that have been critical in the identification of genes associated with numerous disease pathologies. In addition, these efforts have opened the door to the opportunity to develop novel genetic therapies to treat a broad range of inherited disorders. Through a joint effort by the University of Vermont, the University of Rome, Tor Vergata, University of Rome, La Sapienza, and the CSS Mendel Institute, Rome, an international meeting, 'Genome Medicine: Gene Therapy for the Millennium' was organized. This meeting provided a forum for the discussion of scientific and clinical advances stimulated by the explosion of sequence information generated by the Human Genome Project and the implications these advances have for gene therapy. The meeting had six sessions that focused on the functional evaluation of specific genes via biochemical analysis and through animal models, the development of novel therapeutic strategies involving gene targeting, artificial chromsomes, DNA delivery systems and non-embryonic stem cells, and on the ethical and social implications of these advances.

  10. [Advantages of combined therapies in cosmetic medicine for the treatment of face aging: botulinum toxin, fillers and mesotherapy].

    Science.gov (United States)

    Braccini, F; Dohan Ehrenfest, D M

    2010-01-01

    Non surgical cosmetic medicine procedures for the face are developing considerably, as they deliver good results using simple, non invasive, atraumatic and reproducible techniques. Aesthetic mesotherapy, also known as anti-aging mesotherapy, uses intra-dermal injections of a nutritive and moisturizing solution to improve brightness, skin hydration and tonus, and also smooth out superficial wrinkles. Subcutaneous filler injections enable to fill wrinkles and folds; by using high density products it is also able to provide genuine facial volumetric reconstruction. Finally, botulinum toxin acts by reducing certain muscle contractions to smooth out expression lines and folds induced by facial dynamics. In this article, we explore the concept of combined therapy and describe our experience associating anti-aging mesotherapy (NCTF-135HA, Filorga, Paris, France), hyaluronic acid based fillers (X-HA3 and X-HA-Volume, Filorga, Paris, France) and botulinum toxin (Vistabel, Allergan, Irvine CA, USA). A therapy combining anti-aging mesotherapy, botulinum toxin and filler injections, offers full treatment of the 3 biological levels of the covering tissues. This non-invasive therapeutic strategy brings patient satisfaction through a global approach to facial aging.

  11. Human resource development contributes to the creation of outstanding regenerative medicine products

    Directory of Open Access Journals (Sweden)

    Fusako Nishigaki

    2017-12-01

    Full Text Available Regenerative medicine is currently the focus of global attention. Countries all around the world are actively working to create new regenerative treatment modalities through pioneering research and novel technologies. This is wonderful news for patients who could not be treated with existing medical options. New venture businesses and companies are being established in regenerative medicine and their rapid industrialization is anticipated. However, to ensure high-quality products, human resources qualified in research and development and the manufacturing of these products are essential. The Forum for Innovative Regenerative Medicine (FIRM conducted a questionnaire of its industry members to examine the training and hiring of people in research and development, product creation, manufacturing, and more. Regenerative medicine is a brand new field; thus, many different businesses will need to cooperate together. People with a broad range of technical skills, abilities, and knowledge will be in demand, with various levels of expertise, from basic to advanced.

  12. Environmental risk assessment for veterinary medicinal products. Part 1. Other than GMO-containing and immunological products. First update

    NARCIS (Netherlands)

    Montforts MHMM; CSR

    1999-01-01

    The EC has issued directives (1981, 1992) requesting for registration of veterinary medicinal product information to enable an assessment of the product's safety for the environment. As a whole, the risk assessment is structured around the hazard quotient approach used in USES (1994). Predicted

  13. Bar-HRM for Authentication of Plant-Based Medicines: Evaluation of Three Medicinal Products Derived from Acanthaceae Species.

    Science.gov (United States)

    Osathanunkul, Maslin; Madesis, Panagiotis; de Boer, Hugo

    2015-01-01

    Medicinal plants are used as a popular alternative to synthetic drugs, both in developed and developing countries. The economic importance of the herbal and natural supplement industry is increasing every year. As the herbal industry grows, consumer safety is one issue that cannot be overlooked. Herbal products in Thai local markets are commonly sold without packaging or labels. Plant powders are stored in large bags or boxes, and therefore buying local herbal products poses a high risk of acquiring counterfeited, substituted and/or adulterated products. Due to these issues, a reliable method to authenticate products is needed. Here DNA barcoding was used in combination with High Resolution Melting analysis (Bar-HRM) to authenticate three medicinal Acanthaceae species (Acanthus ebracteatus, Andrographis paniculata and Rhinacanthus nasutus) commonly used in Thailand. The rbcL barcode was selected for use in primers design for HRM analysis to produce standard melting profiles of the selected species. Melting data from the HRM assay using the designed rbcL primers showed that the three chosen species could be distinguished from each other. HRM curves of all fifteen test samples indicated that three of tested products did not contain the indicated species. Two closely related species (A. paniculata and R. nasutus), which have a high level of morphological similarity, were interchanged with one another in three tested products. Incorrect information on packaging and labels of the tested herbal products was the cause of the results shown here. Morphological similarity among the species of interest also hindered the collection process. The Bar-HRM method developed here proved useful in aiding in the identification and authentication of herbal species in processed samples. In the future, species authentication through Bar-HRM could be used to promote consumer trust, as well as raising the quality of herbal products.

  14. Use of medicinal plants as the additional therapy of viral hepatitis

    Directory of Open Access Journals (Sweden)

    I.B. Ershova

    2017-04-01

    Full Text Available Dear colleagues, continuing the rubric of the journal about the treatment of infectious diseases by medicinal plants, we want to present the methods of using medicinal plants as an additional therapy for treatment of viral hepatitis in addition to the main treatment according to the generally clinical standards of antiviral therapy. Viral hepatitis compiles a large group of human infectious diseases characterized by a predominant liver damage. “Currently, viral hepatitis is recognized as a major public health problem requiring urgent action”, said Dr Margaret Chan, WHO Director-General (WHO Global hepatitis report, 2017. Treatment of viral hepatitis is a complex task and involves the use of generally clinical recommendations or standards. There are criteria for determining the need for pharmacotherapy and the most rational scheme for antiviral treatment in every case of viral hepatitis. The purpose of antiviral therapy is to achieve a stable virologic response, to prevent the progression of the disease, the development of cirrhosis and hepatocellular carcinoma. However, at the present stage a stable virologic response in the general population of patients can be achieved in approximately 60 % of cases. In addition, standard antiviral drugs have side effects, are of high cost and are contraindicated in a number of clinical situations, for example, with a decrease in the number of blood elements (thrombocytopenia, leukopenia, anemia, at the stage of decompensated liver cirrhosis. Probably, all this induces to use alternative methods of therapy, which remain popular both among general practitioners and patients with this infection. The question of the treatment of viral hepatitis with medicinal herbs has been studied for a long time. According to some authors, there is no scientific evidence that hepatitis C can be cured by herbs. The only scientifically proven method of fighting the virus is antiviral therapy. However, there are other points

  15. Brain tumour stem cells: implications for cancer therapy and regenerative medicine.

    Science.gov (United States)

    Sanchez-Martin, Manuel

    2008-09-01

    The cancer relapse and mortality rate suggest that current therapies do not eradicate all malignant cells. Currently, it is accepted that tumorigenesis and organogenesis are similar in many respects, as for example, homeostasis is governed by a distinct sub-population of stem cells in both situations. There is increasing evidence that many types of cancer contain their own stem cells: cancer stem cells (CSC), which are characterized by their self-renewing capacity and differentiation ability. The investigation of solid tumour stem cells has gained momentum particularly in the area of brain tumours. Gliomas are the most common type of primary brain tumours. Nearly two-thirds of gliomas are highly malignant lesions with fast progression and unfortunate prognosis. Despite recent advances, two-year survival for glioblastoma (GBM) with optimal therapy is less than 30%. Even among patients with low-grade gliomas that confer a relatively good prognosis, treatment is almost never curative. Recent studies have demonstrated the existence of a small fraction of glioma cells endowed with features of primitive neural progenitor cells and a tumour-initiating function. In general, this fraction is characterized for forming neurospheres, being endowed with drug resistance properties and often, we can isolate some of them using sorting methods with specific antibodies. The molecular characterization of these stem populations will be critical to developing an effective therapy for these tumours with very dismal prognosis. To achieve this aim, the development of a mouse model which recapitulates the nature of these tumours is essential. This review will focus on glioma stem cell knowledge and discuss future implications in brain cancer therapy and regenerative medicine.

  16. Statin dose reduction with complementary diet therapy: A pilot study of personalized medicine

    Directory of Open Access Journals (Sweden)

    Bianca Scolaro

    2018-05-01

    Full Text Available Objective: Statin intolerance, whether real or perceived, is a growing issue in clinical practice. Our aim was to evaluate the effects of reduced-dose statin therapy complemented with nutraceuticals. Methods: First phase: Initially, 53 type 2 diabetic statin-treated patients received a supplementation with fish oil (1.7 g EPA + DHA/day, chocolate containing plant sterols (2.2 g/day, and green tea (two sachets/day for 6 weeks. Second phase: “Good responders” to supplementation were identified after multivariate analysis (n = 10, and recruited for a pilot protocol of statin dose reduction. “Good responders” were then provided with supplementation for 12 weeks: standard statin therapy was kept during the first 6 weeks and reduced by 50% from weeks 6–12. Results: First phase: After 6 weeks of supplementation, plasma LDL-C (−13.7% ± 3.7, P = .002 and C-reactive protein (−35.5% ± 5.9, P = .03 were reduced. Analysis of lathosterol and campesterol in plasma suggested that intensity of LDL-C reduction was influenced by cholesterol absorption rate rather than its synthesis. Second phase: no difference was observed for plasma lipids, inflammation, cholesterol efflux capacity, or HDL particles after statin dose reduction when compared to standard therapy. Conclusions: Although limited by the small sample size, our study demonstrates the potential for a new therapeutic approach combining lower statin dose and specific dietary compounds. Further studies should elucidate “good responders” profile as a tool for personalized medicine. This may be particularly helpful in the many patients with or at risk for CVD who cannot tolerate high dose statin therapy. Trial registration: ClinicalTrials.gov, NCT02732223. Keywords: Atherosclerosis, Omega-3 fatty acids, Plant sterols, Polyphenols, Responders

  17. Study of Scientific Production of Community Medicines' Department Indexed in ISI Citation Databases.

    Science.gov (United States)

    Khademloo, Mohammad; Khaseh, Ali Akbar; Siamian, Hasan; Aligolbandi, Kobra; Latifi, Mahsoomeh; Yaminfirooz, Mousa

    2016-10-01

    In the scientometric, the main criterion in determining the scientific position and ranking of the scientific centers, particularly the universities, is the rate of scientific production and innovation, and in all participations in the global scientific development. One of the subjects more involved in repeatedly dealt with science and technology and effective on the improvement of health is medical science fields. In this research using scientometric and citation analysis, we studied the rate of scientific productions in the field of community medicine, which is the numbers of articles published and indexed in ISI database from 2000 to 2010. This study is scientometric using the survey and analytical citation. The study samples included all of the articles in the ISI database from 2000 to 2010. For the data collection, the advance method of searching was used at the ISI database. The ISI analyses software and descriptive statistics were used for data analysis. Results showed that among the five top universities in producing documents, Tehran University of Medical Sciences with 88 (22.22%) documents are allocated to the first rank of scientific products. M. Askarian with 36 (90/9%) published documents; most of the scientific outputs in Community medicine, in the international arena is the most active author in this field. In collaboration with other writers, Iranian departments of Community Medicine with 27 published articles have the greatest participation with scholars of English authors. In the process of scientific outputs, the results showed that the scientific process was in its lowest in the years 2000 to 2004, and while the department of Community medicine in 2009 allocated most of the production process to itself. Iranian Journal of Public Health and Saudi Medical Journal each of them had 16 articles which had most participation rate in the publishing of community medicine's department. On the type of carrier, community medicine's department by

  18. A Pilot Feasibility Study of Whole-systems Ayurvedic Medicine and Yoga Therapy for Weight Loss.

    Science.gov (United States)

    Rioux, Jennifer; Thomson, Cynthia; Howerter, Amy

    2014-01-01

    To develop and test the feasibility of a whole-systems lifestyle intervention for obesity treatment based on the practices of Ayurvedic medicine/ Yoga therapy. A pre-post weight loss intervention pilot study using conventional and Ayurvedic diagnosis inclusion criteria, tailored treatment within a standardized treatment algorithm, and standardized data collection instruments for collecting Ayurvedic outcomes. A convenience sample of overweight/obese adult community members from Tucson, Arizona interested in a "holistic weight loss program" and meeting predetermined inclusion/exclusion criteria. A comprehensive diet, activity, and lifestyle modification program based on principles of Ayurvedic medicine/yoga therapy with significant self-monitoring of lifestyle behaviors. The 3-month program was designed to change eating and activity patterns and to improve self-efficacy, quality of life, well-being, vitality, and self-awareness around food choices, stress management, and barriers to weight loss. Changes in body weight, body mass index; body fat percentage, fat/lean mass, waist/hip circumference and ratio, and blood pressure. Diet and exercise self-efficacy scales; perceived stress scale; visual analog scales (VAS) of energy, appetite, stress, quality of life, well-being, and program satisfaction at all time points. Twenty-two adults attended an in-person Ayurvedic screening; 17 initiated the intervention, and 12 completed the 3-month intervention. Twelve completed follow-up at 6 months and 11 completed follow-up at 9 months. Mean weight loss at 3 months was 3.54 kg (SD 4.76); 6 months: 4.63 kg, (SD 6.23) and 9 months: 5.9 kg (SD 8.52). Self-report of program satisfaction was more than 90% at all time points. An Ayurveda-/yoga-based lifestyle modification program is an acceptable and feasible approach to weight management. Data collection, including self-monitoring and conventional and Ayurvedic outcomes, did not unduly burden participants, with attrition similar to

  19. Natural Fostering in Fritillaria cirrhosa: Integrating herbal medicine production with biodiversity conservation

    Directory of Open Access Journals (Sweden)

    Xiwen Li

    2012-02-01

    Full Text Available Protected areas are generally regarded as a power tool to conserve biodiversity. Nonetheless, few protected areas could address three crucial problems simultaneously, namely funding, public participation and rural living. Here, we introduced a new protective approach, Natural Fostering, which integrated herbal medicine production with community conservation. The principles of Natural Fostering adopted species–species interaction at community level. Most effective chemical components of herbal medicine are derived from such interaction. Fritillaria cirrhosa was selected as an economic botany, one of herbal medicines, to carry out Natural Fostering. Community habitats, herbal medicine production, funding and income of local family were investigated to verify the feasibility of Natural Fostering for biodiversity. We found the density of plant populations and the annual average personal income of rural people increased. F. cirrhosa production could provide sufficient funds for sustainable conservation. Local people gradually changed their life style of wild collection and overgrazing, instead of herbal medicine production. The fostering area set up a good sustainable economic cycle. Natural Fostering can be presented as an effective and pragmatic way to conserve biological diversity and sustainable utilization of traditional medicinal resources.

  20. The remote supervisory and controlling experiment system of traditional Chinese medicine production based on Fieldbus

    Science.gov (United States)

    Zhan, Jinliang; Lu, Pei

    2006-11-01

    Since the quality of traditional Chinese medicine products are affected by raw material, machining and many other factors, it is difficult for traditional Chinese medicine production process especially the extracting process to ensure the steady and homogeneous quality. At the same time, there exist some quality control blind spots due to lacking on-line quality detection means. But if infrared spectrum analysis technology was used in traditional Chinese medicine production process on the basis of off-line analysis to real-time detect the quality of semi-manufactured goods and to be assisted by advanced automatic control technique, the steady and homogeneous quality can be obtained. It can be seen that the on-line detection of extracting process plays an important role in the development of Chinese patent medicines industry. In this paper, the design and implement of a traditional Chinese medicine extracting process monitoring experiment system which is based on PROFIBUS-DP field bus, OPC, and Internet technology is introduced. The system integrates intelligence node which gathering data, superior sub-system which achieving figure configuration and remote supervisory, during the process of traditional Chinese medicine production, monitors the temperature parameter, pressure parameter, quality parameter etc. And it can be controlled by the remote nodes in the VPN (Visual Private Network). Experiment and application do have proved that the system can reach the anticipation effect fully, and with the merits of operational stability, real-time, reliable, convenient and simple manipulation and so on.

  1. Recent Advances in Developing Insect Natural Products as Potential Modern Day Medicines

    Directory of Open Access Journals (Sweden)

    Norman Ratcliffe

    2014-01-01

    Full Text Available Except for honey as food, and silk for clothing and pollination of plants, people give little thought to the benefits of insects in their lives. This overview briefly describes significant recent advances in developing insect natural products as potential new medicinal drugs. This is an exciting and rapidly expanding new field since insects are hugely variable and have utilised an enormous range of natural products to survive environmental perturbations for 100s of millions of years. There is thus a treasure chest of untapped resources waiting to be discovered. Insects products, such as silk and honey, have already been utilised for thousands of years, and extracts of insects have been produced for use in Folk Medicine around the world, but only with the development of modern molecular and biochemical techniques has it become feasible to manipulate and bioengineer insect natural products into modern medicines. Utilising knowledge gleaned from Insect Folk Medicines, this review describes modern research into bioengineering honey and venom from bees, silk, cantharidin, antimicrobial peptides, and maggot secretions and anticoagulants from blood-sucking insects into medicines. Problems and solutions encountered in these endeavours are described and indicate that the future is bright for new insect derived pharmaceuticals treatments and medicines.

  2. New thoughts on the treatment of common complications of advanced liver cancer by external therapy of traditional Chinese medicine

    OpenAIRE

    PAN Shasha

    2017-01-01

    Cancerous pain, hepatic ascites and intractable hiccups are common complications in patients with advanced liver cancer, but clinical symptomatic treatment cannot achieve satisfactory results. This article reviews the application of external therapy of traditional Chinese medicine in the treatment of common complications in patients with advanced liver cancer and analyzes the clinical effect and feasibility of common therapeutic methods used in treatment, such as plaster sticking therapy, tum...

  3. Honey: an effective regenerative medicine product in wound management.

    Science.gov (United States)

    Martinotti, Simona; Bucekova, Marcela; Majtan, Juraj; Ranzato, Elia

    2018-05-10

    Honey has successfully been used in treatment of a broad spectrum of injuries including burns and non-healing wounds. It acts as antibacterial and anti-biofilm agent with anti/pro-inflammatory properties. However, besides these traditional properties, recent evidence suggests that honey is also an immunomodulator in wound healing and contains several bee and plant-derived components that may speed up the wound healing and tissue regeneration process. Identifying their exact mechanism of action allows better understanding of honey healing properties and promotes its wider translation into clinical practice. This review will discuss the physiological basis for the use of honey in wound management, its current clinical uses, as well as the potential role of honey bioactive compounds in dermal regenerative medicine and tissue re-modelling. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  4. Back to the Roots: Prediction of Biologically Active Natural Products from Ayurveda Traditional Medicine

    DEFF Research Database (Denmark)

    Polur, Honey; Joshi, Tejal; Workman, Christopher

    2011-01-01

    Ayurveda, the traditional Indian medicine is one of the most ancient, yet living medicinal traditions. In the present work, we developed an in silico library of natural products from Ayurveda medicine, coupled with structural information, plant origin and traditional therapeutic use. Following this....... We hereby present a number of examples where the traditional medicinal use of the plant matches with the medicinal use of the drug that is structurally similar to a plant component. With this approach, we have brought to light a number of obscure compounds of natural origin (e.g. kanugin......, we compared their structures with those of drugs from DrugBank and we constructed a structural similarity network. Information on the traditional therapeutic use of the plants was integrated in the network in order to provide further evidence for the predicted biologically active natural compounds...

  5. Discovery Monday - Physics for medicine: the use of accelerators in therapy

    CERN Multimedia

    2004-01-01

    What does research at CERN have to do with medicine? Perhaps very little at first glance. And yet particle beams are proving to be efficient weapons in the fight against certain diseases. Doctors and physicists will explain how and why at the next Discovery Monday, to be held at Microcosm on 3 May. Various technologies and instruments will be presented during the evening. You will learn, for example, how scientists use radioisotopes to destroy tumours without damaging the surrounding tissues. You will also find out about LIBO, a small linear accelerator used for treating deep-seated tumours. Before therapy can begin, it is vital to make the right diagnosis. On this subject, radiologists will be showing how to interpret a number of X-rays, as well as teaching the youngest visitors about their anatomy and explaining how useful particle physics can be in medicine. The event will take place at Microcosm on 3rd May, from 7.30 p.m. to 9.00 p.m. Entrance free. For further information see: http://www.ce...

  6. Integrative medical therapy: examination of meditation's therapeutic and global medicinal outcomes via nitric oxide (review).

    Science.gov (United States)

    Stefano, George B; Esch, Tobias

    2005-10-01

    Relaxation techniques are part of the integrative medicine movement that is of growing importance for mainstream medicine. Complementary medical therapies have the potential to affect many physiological systems. Repeatedly studies show the benefits of the placebo response and relaxation techniques in the treatment of hypertension, cardiac arrhythmias, chronic pain, insomnia, anxiety and mild and moderate depression, premenstrual syndrome, and infertility. In itself, relaxation is characterized by a decreased metabolism, heart rate, blood pressure, and rate of breathing as well as an increase in skin temperature. Relaxation approaches, such as progressive muscle relaxation, autogenic training, meditation and biofeedback, are effective in lowering systolic and diastolic blood pressure in hypertensive patients by a significant margin. Given this association with changes in vascular tone, we have hypothesized that nitric oxide, a demonstrated vasodilator substance, contribute to physiological activity of relaxation approaches. We examined the scientific literature concerning the disorders noted earlier for their nitric oxide involvement in an attempt to provide a molecular rationale for the positive effects of relaxation approaches, which are physiological and cognitive process. We conclude that constitutive nitric oxide may crucially contribute to potentially beneficial outcomes and effects in diverse pathologies, exerting a global healing effect.

  7. Personalized Regenerative Medicine

    Directory of Open Access Journals (Sweden)

    Babak Arjmand

    2017-03-01

    Full Text Available Personalized medicine as a novel field of medicine refers to the prescription of specific therapeutics procedure for an individual. This approach has established based on pharmacogenetic and pharmacogenomic information and data. The terms precision and personalized medicines are sometimes applied interchangeably. However, there has been a shift from “personalized medicine” towards “precision medicine”. Although personalized medicine emerged from pharmacogenetics, nowadays it covers many fields of healthcare. Accordingly, regenerative medicine and cellular therapy as the new fields of medicine use cell-based products in order to develop personalized treatments. Different sources of stem cells including mesenchymal stem cells, embryonic stem cells and induced pluripotent stem cells (iPSCs have been considered in targeted therapies which could give many advantages. iPSCs as the novel and individual pluripotent stem cells have been introduced as the appropriate candidates for personalized cell therapies. Cellular therapies can provide a personalized approach. Because of person-to-person and population differences in the result of stem cell therapy, individualized cellular therapy must be adjusted according to the patient specific profile, in order to achieve best therapeutic results and outcomes. Several factors should be considered to achieve personalized stem cells therapy such as, recipient factors, donor factors, and the overall body environment in which the stem cells could be active and functional. In addition to these factors, the source of stem cells must be carefully chosen based on functional and physical criteria that lead to optimal outcomes.

  8. Effect of Physical Therapy Students' Clinical Experiences on Clinician Productivity.

    Science.gov (United States)

    Pivko, Susan E; Abbruzzese, Laurel D; Duttaroy, Pragati; Hansen, Ruth L; Ryans, Kathryn

    2016-01-01

    Physical therapy clinical education experiences (CEEs) are difficult to secure, particularly first-level CEEs. Our purpose was to determine 1) what impact student full-time CEEs have on PT clinician productivity and 2) whether there is a productivity difference between first vs final CEEs. Productivity logs, including possible factors impacting productivity, were distributed to clinician-student pairings on first and final CEEs. Two-week baseline data (without a student) were compared to weeks 1 and 6 (with a student) for 31 logs using a 2x4 repeated-measures ANOVA. In a subset of 17 logs for CEEs 8 weeks or longer, a 2x5 repeated-measures ANOVA was performed. There was a significant increase in the number of patients seen and CPT units billed by both levels of CEEs comparing weeks 1 and 6. In the subset of CEEs, 8 weeks or longer, there was a significant increase in the number of patients treated per hour at week 6 and a trend toward a change at week 8 when compared to baseline week A. The factors selected as impacting productivity were census (59%) and staffing (32%). Physical therapy clinician-student pairings showed an overall increase in productivity during both full-time first and final level CEEs.

  9. Toyota production system quality improvement initiative improves perioperative antibiotic therapy.

    Science.gov (United States)

    Burkitt, Kelly H; Mor, Maria K; Jain, Rajiv; Kruszewski, Matthew S; McCray, Ellesha E; Moreland, Michael E; Muder, Robert R; Obrosky, David Scott; Sevick, Mary Ann; Wilson, Mark A; Fine, Michael J

    2009-09-01

    To assess the role of a Toyota production system (TPS) quality improvement (QI) intervention on appropriateness of perioperative antibiotic therapy and in length of hospital stay (LOS) among surgical patients. Pre-post quasi-experimental study using local and national retrospective cohorts. We used TPS methods to implement a multifaceted intervention to reduce nosocomial methicillin-resistant Staphylococcus aureus infections on a Veterans Affairs surgical unit, which led to a QI intervention targeting appropriate perioperative antibiotic prophylaxis. Appropriate perioperative antibiotic therapy was defined as selection of the recommended antibiotic agents for a duration not exceeding 24 hours from the time of the operation. The local computerized medical record system was used to identify patients undergoing the 25 most common surgical procedures and to examine changes in appropriate antibiotic therapy and LOS over time. Overall, 2550 surgical admissions were identified from the local computerized medical records. The proportion of surgical admissions receiving appropriate perioperative antibiotics was significantly higher (P <.01) in 2004 after initiation of the TPS intervention (44.0%) compared with the previous 4 years (range, 23.4%-29.8%) primarily because of improvements in compliance with antibiotic therapy duration rather than appropriate antibiotic selection. There was no statistically significant decrease in LOS over time. The use of TPS methods resulted in a QI intervention that was associated with an increase in appropriate perioperative antibiotic therapy among surgical patients, without affecting LOS.

  10. The Brazilian market of herbal medicinal products and the impacts of the new legislation on traditional medicines.

    Science.gov (United States)

    Carvalho, Ana Cecília Bezerra; Lana, Túlio Nader; Perfeito, João Paulo Silvério; Silveira, Dâmaris

    2018-02-15

    the herbal medicinal products (HMP) market is expanding in the world, an expansion that has not occurred in Brazil when considering the number of licensed products. Despite being a megadiverse country, the number of HMP licensed in Brazil is small, and the number of HMP obtained from native species is even smaller. A new legislation for herbal products licensing, which divides the products into two categories, Herbal Medicine (HM) and Traditional Herbal Product (THP) was launched in Brazil focusing on traditional use, as well as a law regulating the use of biodiversity and traditional knowledge. to evaluate the situation of HMP licensed in Brazil and to make a comparison with the data obtained in 2008 and 2011, discussing the evolution of the licensed products and the possible impacts of the new legislation. a survey was carried out in the Brazilian Health Regulatory Agency (Anvisa) database to verify the HMP licensed in Brazil in September 2016. The data obtained were compared with two surveys previously published. There are 332 single, and 27 combined HM, totaling 359 HM licensed in Brazil. There is no THP notified in Anvisa's system yet. There are 214 HM classified as nonprescription (OTC), while 145 are sold under prescription, one of them with prescription retention. There are 101 plant species licensed as active in HM in Brazil, 39 of which are native, adapted or cultivated. The most licensed plant species is Mikania glomerata Spreng., with 25 HM licensed. The article includes tables with plant species that have derivatives licensed as simple and combined HM, their therapeutic classification, the native plant species indication and the distribution of the companies by Brazilian regions. There are few licensed HM in Brazil, and this number has been decreasing in recent years. It is expected that the data obtained, together with the changes promoted in sanitary and environmental rules, will help to develop and regulate HMP chain in Brazil. Copyright © 2017

  11. Cell Therapy and Tissue Engineering Products for Chondral Knee Injuries

    Directory of Open Access Journals (Sweden)

    Adriana Flórez Cabrera

    2017-07-01

    Full Text Available The articular cartilage is prone to suffer lesions of different etiology, being the articular cartilage lesions of the knee the most common. Although most conventional treatments reduce symptoms they lead to the production of fibrocartilage, which has different characteristics than the hyaline cartilage of the joint. There are few therapeutic approaches that promote the replacement of damaged tissue by functional hyaline cartilage. Among them are the so-called advanced therapies, which use cells and tissue engineering products to promote cartilage regeneration. Most of them are based on scaffolds made of different biomaterials, which seeded or not with endogenous or exogenous cells, can be used as cartilage artificial replacement to improve joint function. This paper reviews some therapeutic approaches focused on the regeneration of articular cartilage of the knee and the biomaterials used to develop scaffolds for cell therapy and tissue engineering of cartilage.

  12. Communication in production animal medicine: modelling a complex interaction with the example of dairy herd health medicine

    Directory of Open Access Journals (Sweden)

    Kleen Joachim L

    2011-07-01

    Full Text Available Abstract Background The importance of communication skills in veterinary medicine is increasingly recognised. Appropriate communication skills towards the client are of utmost importance in both companion animal practice and production animal field and consultancy work. The need for building a relationship with the client, alongside developing a structure for the consultation is widely recognised and applies to both types of veterinary practice. Results Veterinary advisory practice in production animal medicine is, however, characterised by a more complex communication on different levels. While the person-orientated communication is a permanent process between veterinarian and client with a rather personal perspective and defines the roles of interaction, the problem-orientated communication deals with emerging difficulties; the objective is to solve an acute health problem. The solution - orientated communication is a form of communication in which both veterinarian and client address longstanding situations or problems with the objective to improve herd health and subsequently productivity performance. All three forms of communication overlap. Conclusions Based on this model, it appears useful for a veterinary practice to offer both a curative and an advisory service, but to keep these two separated when deemed appropriate. In veterinary education, the strategies and techniques necessary for solution orientated communication should be included in the teaching of communication skills.

  13. Communication in production animal medicine: modelling a complex interaction with the example of dairy herd health medicine.

    Science.gov (United States)

    Kleen, Joachim L; Atkinson, Owen; Noordhuizen, Jos Ptm

    2011-07-20

    The importance of communication skills in veterinary medicine is increasingly recognised. Appropriate communication skills towards the client are of utmost importance in both companion animal practice and production animal field and consultancy work. The need for building a relationship with the client, alongside developing a structure for the consultation is widely recognised and applies to both types of veterinary practice. Veterinary advisory practice in production animal medicine is, however, characterised by a more complex communication on different levels. While the person-orientated communication is a permanent process between veterinarian and client with a rather personal perspective and defines the roles of interaction, the problem-orientated communication deals with emerging difficulties; the objective is to solve an acute health problem. The solution - orientated communication is a form of communication in which both veterinarian and client address longstanding situations or problems with the objective to improve herd health and subsequently productivity performance. All three forms of communication overlap. Based on this model, it appears useful for a veterinary practice to offer both a curative and an advisory service, but to keep these two separated when deemed appropriate. In veterinary education, the strategies and techniques necessary for solution orientated communication should be included in the teaching of communication skills.

  14. ECM and ECM-like materials - Biomaterials for applications in regenerative medicine and cancer therapy.

    Science.gov (United States)

    Hinderer, Svenja; Layland, Shannon Lee; Schenke-Layland, Katja

    2016-02-01

    Regenerative strategies such as stem cell-based therapies and tissue engineering applications are being developed with the aim to replace, remodel, regenerate or support damaged tissues and organs. In addition to careful cell type selection, the design of appropriate three-dimensional (3D) scaffolds is essential for the generation of bio-inspired replacement tissues. Such scaffolds are usually made of degradable or non-degradable biomaterials and can serve as cell or drug carriers. The development of more effective and efficient drug carrier systems is also highly relevant for novel cancer treatment strategies. In this review, we provide a summary of current approaches that employ ECM and ECM-like materials, or ECM-synthetic polymer hybrids, as biomaterials in the field of regenerative medicine. We further discuss the utilization of such materials for cell and drug delivery, and highlight strategies for their use as vehicles for cancer therapy. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

  15. Innovation, productivity, and pricing: Capturing value from precision medicine technology in Canada.

    Science.gov (United States)

    Emery, J C Herbert; Zwicker, Jennifer D

    2017-07-01

    For new technology and innovation such as precision medicine to become part of the solution for the fiscal sustainability of Canadian Medicare, decision-makers need to change how services are priced rather than trying to restrain emerging technologies like precision medicine for short-term cost savings. If provincial public payers shift their thinking to be public purchasers, value considerations would direct reform of the reimbursement system to have prices that adjust with technologically driven productivity gains. This strategic shift in thinking is necessary if Canadians are to benefit from the promised benefits of innovations like precision medicine.

  16. Efficacy and Safety of Pomegranate Medicinal Products for Cancer

    Science.gov (United States)

    Vlachojannis, Christian

    2015-01-01

    Preclinical in vitro and in vivo studies demonstrate potent effects of pomegranate preparations in cancer cell lines and animal models with chemically induced cancers. We have carried out one systematic review of the effectiveness of pomegranate products in the treatment of cancer and another on their safety. The PubMed search provided 162 references for pomegranate and cancer and 122 references for pomegranate and safety/toxicity. We identified 4 clinical studies investigating 3 pomegranate products, of which one was inappropriate because of the low polyphenol content. The evidence of clinical effectiveness was poor because the quality of the studies was poor. Although there is no concern over safety with the doses used in the clinical studies, pomegranate preparations may be harmful by inducing synthetic drug metabolism through activation of liver enzymes. We have analysed various pomegranate products for their content of anthocyanins, punicalagin, and ellagic acid in order to compare them with the benchmark doses from published data. If the amount of coactive constituents is not declared, patients risk not benefiting from the putative pomegranate effects. Moreover, pomegranate end products are affected by many determinants. Their declaration should be incorporated into the regulatory guidance and controlled before pomegranate products enter the market. PMID:25815026

  17. [Investigation on production process quality control of traditional Chinese medicine--Banlangen granule as an example].

    Science.gov (United States)

    Tan, Manrong; Yan, Dan; Qiu, Lingling; Chen, Longhu; Yan, Yan; Jin, Cheng; Li, Hanbing; Xiao, Xiaohe

    2012-04-01

    For the quality management system of herbal medicines, intermediate and finished products it exists the " short board" effect of methodologies. Based on the concept of process control, new strategies and new methods of the production process quality control had been established with the consideration of the actual production of traditional Chinese medicine an the characteristics of Chinese medicine. Taking Banlangen granule as a practice example, which was effective and widespread application, character identification, determination of index components, chemical fingerprint and biometrics technology were sequentially used respectively to assess the quality of Banlangen herbal medicines, intermediate (water extraction and alcohol precipitation) and finished product. With the transfer rate of chemical information and biological potency as indicators, the effectiveness and transmission of the above different assessments and control methods had been researched. And ultimately, the process quality control methods of Banlangen granule, which were based on chemical composition analysis-biometric analysis, had been set up. It can not only validly solute the current status that there were many manufacturers varying quality of Banlangen granule, but also ensure and enhance its clinical efficacy. Furthermore it provided a foundation for the construction of the quality control of traditional Chinese medicine production process.

  18. Risk assessment on the use of herbal medicinal products containing pyrrolizidine alkaloids.

    Science.gov (United States)

    Allgaier, Clemens; Franz, Stephanie

    2015-11-01

    Pyrrolizidine alkaloids (PA) are common plantal toxins directed against insect herbivores. Unsaturated PAs are known to be hepatotoxic. Many of the PAs are in addition mutagenic and some may possibly be carcinogenic for humans. The risk of an exposure to PAs associated with their occurrence in herbal medicinal products and in foodstuff is under current discussion. The present risk assessment for herbal medicinal products containing PAs is based on a margin of safety derivation for foodstuff indicating that a life-long exposure to maximally 0.007 μg/kg bw/day is not expected to be associated with safety concerns. This approach offers a possibility to estimate the potential risk of PA-containing herbal medicinal products irrespective of the route of administration. It assumes PA levels in the final herbal medicinal product below 0.01 ppm and considers for dermal administration a 100% skin penetration of the PAs reflecting a worst-case scenario. As a result, the calculated margins of safety show a potential exposure using herbal medicinal products 70-, 45.5-, and 19.3-fold lower on a one-day base and 608-, 396-, and 168- fold lower on a one-year base for adults, children aged 12 years, and children aged 4 years, respectively, than the thresholds considered acceptable for foodstuff. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. Mapping {sup 15}O Production Rate for Proton Therapy Verification

    Energy Technology Data Exchange (ETDEWEB)

    Grogg, Kira; Alpert, Nathaniel M.; Zhu, Xuping [Center for Advanced Radiological Sciences, Nuclear Medicine and Molecular Imaging, Radiology Department, Massachusetts General Hospital, Boston, Massachusetts (United States); Min, Chul Hee [Department of Radiological Science, College of Health Science, Yonsei University, Wonju, Kangwon (Korea, Republic of); Testa, Mauro; Winey, Brian [Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (United States); Normandin, Marc D. [Center for Advanced Radiological Sciences, Nuclear Medicine and Molecular Imaging, Radiology Department, Massachusetts General Hospital, Boston, Massachusetts (United States); Shih, Helen A.; Paganetti, Harald; Bortfeld, Thomas [Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (United States); El Fakhri, Georges, E-mail: elfakhri@pet.mgh.harvard.edu [Center for Advanced Radiological Sciences, Nuclear Medicine and Molecular Imaging, Radiology Department, Massachusetts General Hospital, Boston, Massachusetts (United States)

    2015-06-01

    Purpose: This work was a proof-of-principle study for the evaluation of oxygen-15 ({sup 15}O) production as an imaging target through the use of positron emission tomography (PET), to improve verification of proton treatment plans and to study the effects of perfusion. Methods and Materials: Dynamic PET measurements of irradiation-produced isotopes were made for a phantom and rabbit thigh muscles. The rabbit muscle was irradiated and imaged under both live and dead conditions. A differential equation was fitted to phantom and in vivo data, yielding estimates of {sup 15}O production and clearance rates, which were compared to live versus dead rates for the rabbit and to Monte Carlo predictions. Results: PET clearance rates agreed with decay constants of the dominant radionuclide species in 3 different phantom materials. In 2 oxygen-rich materials, the ratio of {sup 15}O production rates agreed with the expected ratio. In the dead rabbit thighs, the dynamic PET concentration histories were accurately described using {sup 15}O decay constant, whereas the live thigh activity decayed faster. Most importantly, the {sup 15}O production rates agreed within 2% (P>.5) between conditions. Conclusions: We developed a new method for quantitative measurement of {sup 15}O production and clearance rates in the period immediately following proton therapy. Measurements in the phantom and rabbits were well described in terms of {sup 15}O production and clearance rates, plus a correction for other isotopes. These proof-of-principle results support the feasibility of detailed verification of proton therapy treatment delivery. In addition, {sup 15}O clearance rates may be useful in monitoring permeability changes due to therapy.

  20. Callus production and regeneration of the medicinal plant Papaver ...

    African Journals Online (AJOL)

    Administrator

    2011-09-19

    Sep 19, 2011 ... and morphinan alkaloids production in two species of opium poppy. Biomed. Biotechnol. 1(2): 70-78. Murashige T, Skoog F (1962). A revised medium for rapid growth and bioassays with tobacco tissue cultures. Physiol. Plant, 15: 473-497. Rao AQ, Hussain SS, Shahzad MS, Bokhari SYA, Raza MH, Rakha ...

  1. Modeling belowground biomass of black cohosh, a medicinal forest product.

    Science.gov (United States)

    James Chamberlain; Gabrielle Ness; Christine Small; Simon Bonner; Elizabeth Hiebert

    2014-01-01

    Tens of thousands of kilograms of rhizomes and roots of Actaea racemosa L., a native Appalachian forest perennial, are harvested every year and used for the treatment of menopausal conditions. Sustainable management of this and other wild-harvested non-timber forest products requires the ability to effectively and reliably inventory marketable plant...

  2. Alternative Blood Products and Clinical Needs in Transfusion Medicine

    OpenAIRE

    Whitsett, Carolyn; Vaglio, Stefania; Grazzini, Giuliano

    2012-01-01

    The primary focus of national blood programs is the provision of a safe and adequate blood supply. This goal is dependent on regular voluntary donations and a regulatory infrastructure that establishes and enforces standards for blood safety. Progress in ex vivo expansion of blood cells from cell sources including peripheral blood, cord blood, induced pluripotent stem cells, and human embryonic stem cell lines will likely make alternative transfusion products available for clinical use in the...

  3. Medicinal herbs as possible sources of anti-inflammatory products

    Directory of Open Access Journals (Sweden)

    Andreia Corciovă

    2017-12-01

    Full Text Available Plants constitute an inexhaustible source of bioactive compounds that can be valuable for research in the chemistry field of anti-inflammatory compounds. This review describes several plants from international and national flora that have been shown to have anti-inflammatory activity in various clinical trials. The paper includes: general aspects regarding the vegetal source, compounds responsible for anti-inflammatory activity, mechanism of action and clinical trials carried out with extracts or products containing standardized extracts.

  4. Efficacy and Safety of Pomegranate Medicinal Products for Cancer

    OpenAIRE

    Vlachojannis, Christian; Zimmermann, Benno F.; Chrubasik-Hausmann, Sigrun

    2015-01-01

    Preclinical in vitro and in vivo studies demonstrate potent effects of pomegranate preparations in cancer cell lines and animal models with chemically induced cancers. We have carried out one systematic review of the effectiveness of pomegranate products in the treatment of cancer and another on their safety. The PubMed search provided 162 references for pomegranate and cancer and 122 references for pomegranate and safety/toxicity. We identified 4 clinical studies investigating 3 pomegranate ...

  5. SEMIOTICS, DIAGNOSTICS AND THERAPY TACTICS OF DEPRESSIVE DISORDERS IN CLINICAL MEDICINE

    Directory of Open Access Journals (Sweden)

    N. A. Kornetov

    2014-01-01

    Full Text Available Study objectives are dedicated to brief synthesized establishment of diagnostics general standard, management and therapy of major depressive disorders (MDD in clinical medicine to provide education in medical practice.Study methods are based on short-term, medium-term and long-term educational programs in 24 Russian and Ukraine cities, which were based on original educational programs under the direction of World Psychiatric Association (WPA and International Committee For Prevention and Treatment of Depression (PTD. There, about 1450 doctors of different occupations were acquainted with the detection, management and treatment of MDD. The Russian version of WPA/PTD programs was created. The program of education included 4 modules. The Core module included an overview of the epidemiology, impact, concepts and classification, and etiology of depressive disorders as well as their recognition, diagnosis, and management in the primary care setting. The second module focused on depressive disorders in physical illness and covered those major illnesses for which is reasonable evidence for an association with depressive disorders. The third module included the development of the depressive disorders in older persons. The forth module included training physicians in mental health skills. 39 theme improvements for 858 primary care setting physicians within the framework of faculty training program of physicians’ development were the part of other programs of physicians’ occupations.Results. A number of highlights were included in the general algorithm of the educational programs. The creation of optimum «physician-depressive patient» contact demands a number of new skills to establish effective communication. These skills involve training of meeting of depressive patient and physician, the ability to follow a certain communication style; identify emotional, cognitive, psychomotor and nonverbal patterns of behavior. Besides that, the education

  6. Recent progress of research on medicinal mushrooms, foods, and other herbal products used in traditional Chinese medicine

    Directory of Open Access Journals (Sweden)

    Kuo-Hsiung Lee

    2012-04-01

    Full Text Available This article will review selected herbal products used in traditional Chinese medicine, including medicinal mushrooms (巴西蘑菇 bā xī mó gū; Agaricus blazei, 雲芝 yún zhī; Coriolus versicolor, 靈芝 líng zhī; Ganoderma lucidum, 香蕈 xiāng xùn; shiitake, Lentinus edodes, 牛樟芝 niú zhāng zhī; Taiwanofungus camphoratus, Cordyceps (冬蟲夏草 dōng chóng xià cǎo, pomegranate (石榴 shí liú; Granati Fructus, green tea (綠茶 lǜ chá; Theae Folium Non Fermentatum, garlic (大蒜 dà suàn; Allii Sativi Bulbus, turmeric (薑黃 jiāng huáng; Curcumae Longae Rhizoma, and Artemisiae Annuae Herba (青蒿 qīng hāo; sweet wormwood. Many of the discussed herbal products have gained popularity in their uses as dietary supplements for health benefits. The review will focus on the active constituents of the herbs and their bioactivities, with emphasis on the most recent progress in research for the period of 2003 to 2011.

  7. Quality transitivity and traceability system of herbal medicine products based on quality markers.

    Science.gov (United States)

    Liu, Changxiao; Guo, De-An; Liu, Liang

    2018-05-15

    Due to a variety of factors to affect the herb quality, the existing quality management model is unable to evaluate the process control. The development of the concept of "quality marker" (Q-marker) lays basis for establishing an independent process quality control system for herbal products. To ensure the highest degree of safety, effectiveness and quality process control of herbal products, it is aimed to establish a quality transitivity and traceability system of quality and process control from raw materials to finished herbal products. Based on the key issues and challenges of quality assessment, the current status of quality and process controls from raw materials to herbal medicinal products listed in Pharmacopoeia were analyzed and the research models including discovery and identification of Q-markers, analysis and quality management of risk evaluation were designed. Authors introduced a few new technologies and methodologies, such as DNA barcoding, chromatographic technologies, fingerprint analysis, chemical markers, bio-responses, risk management and solution for quality process control. The quality and process control models for herbal medicinal products were proposed and the transitivity and traceability system from raw materials to the finished products was constructed to improve the herbal quality from the entire supply and production chain. The transitivity and traceability system has been established based on quality markers, especially on how to control the production process under Good Engineering Practices, as well as to implement the risk management for quality and process control in herbal medicine production. Copyright © 2018 Elsevier GmbH. All rights reserved.

  8. Nuclear Medicine in Diagnosis and Therapy of Bone and Joint Diseases

    International Nuclear Information System (INIS)

    Riccabona, G.

    1999-01-01

    Concerning bone and joint diseases therapy of rheumatic synovitis (radiosynoviorthesis) was introduced in 1952 before clinically relevant diagnostic procedures were developed. Radionuclides of Sr and later on 99mTc phosphonates then started the wide use of bone scintigraphy since > 30 years. The diagnostic methods have an excellent sensitivity for detection of local abnormalities of bone metabolism, the specificity of such studies, however, is low. Modifications of the technique (3-phase-bone-scintigraphy, pinhole collimators, ROI-technique), increasing knowledge of pathological scan patterns and introduction of other radionuclide studies (67Ga, 201Tl, inflammation scans with 99mTc-leukocytes or 99mTc-HIG) as well as 18FDG-PET have increased the specificity significantly in recent years and improvements of imaging systems (SPECT) also increased the accuracy of diagnostic methods in diseases of bone and joints. Therapy of such diseases has made considerable progress: inflamed, swollen joints can effectively be treated with 90Y-, 186Re, 169Er-colloids or with 165Dy-particles by radiosynoviorthesis. Severe pain due to disseminated bone metastases of cancer or polyarthritis can be controlled by radionuclide therapy with 89Sr, 153Sm-EDTMP, 186Re- or 188Re-HEDP and possibly 117mSn-DTPA with an acceptable risk of myelodepression. Possibilities, technical details and limitations of radionuclide applications for diagnostic and therapeutic purposes must be considered if optimal benefit for individual patients should be achieved. Overall Nuclear Medicine can become an essential element in management of bone and joint diseases. The relationship of Nuclear Medicine to bone and joint pathology is peculiar: In 1952 treatment of rheumatic synovitis by radiosynoviorthesis with 198Au Colloid was started by Fellinger and Schmid before diagnostic approaches to bone pathology existed. Bone scintigraphy was introduced only in 1961 using 85Sr but obviously the unfavourable radiation

  9. Cyclotron Production of Radionuclides for Nuclear Medicine at Academic Centers

    Science.gov (United States)

    Lapi, Suzanne

    2016-09-01

    The increase in use of radioisotopes for medical imaging has led to the development of new accelerator targetry and separation techniques for isotope production. For example, the development of longer-lived position emitting radionuclides has been explored to allow for nuclear imaging agents based on peptides, antibodies and nanoparticles. These isotopes (64Cu, 89Zr, 86Y) are typically produced via irradiation of solid targets on smaller cyclotrons (10-25 MeV) at academic or hospital based facilities. Recent research has further expanded the toolbox of PET tracers to include additional isotopes such as 52Mn, 55Co, 76Br and others. The smaller scale of these types of facilities can enable the straightforward involvement of students, thus adding to the next generation of nuclear science leaders. Research pertaining to development of robust and larger scale production technologies including solid target systems and remote systems for transport and purification of these isotopes has enabled both preclinical and clinical imaging research for many diseases. In particular, our group has focused on the use of radiolabeled antibodies for imaging of receptor expression in preclinical models and in a clinical trial of metastatic breast cancer patients.

  10. Adjunct therapy of Ayurvedic medicine with anti tubercular drugs on the therapeutic management of pulmonary tuberculosis.

    Science.gov (United States)

    Debnath, P K; Chattopadhyay, Jaydeb; Mitra, Achintya; Adhikari, Anjan; Alam, Mirza Samsur; Bandopadhyay, S K; Hazra, Jayram

    2012-07-01

    Pulmonary tuberculosis (PTB) is an age old disease described in Vedic Medicine as 'Yakshma'. Later on, in Ayurveda it earned a prefix and found way into mythology as 'Rajayakshma'. After the discovery of streptomycin, the therapeutic management of PTB received a major breakthrough. The treatment module changed remarkably with the formulation of newer anti-tubercular drugs (ATD) with appreciable success. Recent resurgence of PTB in developed countries like United States posed a threat to the medical community due to resistant strains. Consequently, WHO looked toward traditional medicine. Literature reveals that Ayurvedic treatment of PTB was in vogue in India before the introduction of ATD with limited success. Records show that 2766 patients of PTB were treated with Ayurvedic drugs in a tertiary care hospital in Kolkata in the year 1933-1947. To evaluate the toxicity reduction and early restoration by adjunct therapy of Ayurvedic drugs by increasing the bio-availability of ATDs. In the present study, treatment response of 99 patients treated with ATD as an adjunct with Aswagandha (Withania somnifera) and a multi-herbal formulation described in Chikitsa-sthana of Charaka samhita i.e. Chyawanprash were investigated. Hematological profile, sputum bacterial load count, immunoglobulin IgA and IgM, blood sugar, liver function test, serum creatinine were the assessed parameters besides blood isoniazid and pyrazinamide, repeated after 28 days of treatment. The symptoms abated, body weight showed improvement, ESR values were normal, there was appreciable change in IgA and IgM patterns and significantly increased bioavailability of isoniazid and pyrazinamide were recorded. This innovative clinical study coupled with empowered research may turn out to be promising in finding a solution for the treatment of PTB.

  11. Studies on saponin production in tropical medicinal plants Maesa argentea and Maesa lanceolata

    Science.gov (United States)

    Faizal, Ahmad; Geelen, Danny

    2015-09-01

    The continuous need for new compounds with important medicinal activities has lead to the identification and characterization of various plant-derived natural products. As a part of this program, we studied the saponin production from two tropical medicinal plants Maesa argentea and M. lanceolata and evaluated several treatments to enhance their saponin production. In this experiment, we present the analyses of saponin production from greenhouse grown plants by means of TLC and HPLC-MS. We observed that the content of saponin from these plants varied depending on organ and physiological age of the plants. In addition, the impact of elicitors on saponin accumulation on in vitro grown plants was analyzed using TLC. The production of saponin was very stable and not affected by treatment with methyl jasmonate, and salicylic acid. In conclusion, Maesa saponins are constitutively produced in plants and the level of these compounds in plants is mainly affected by the developmental or physiological stage.

  12. Could the products of Indian medicinal plants be the next alternative for the treatment of infections?

    Directory of Open Access Journals (Sweden)

    B Nandagopal

    2011-01-01

    Full Text Available Indian medicinal plants are now recognized to have great potential for preparing clinically useful drugs that could even be used by allopathic physicians. Traditionally, practitioners of Indian medicine have used plant products in powder, syrup or lotion forms, without identification, quantification and dose regulation, unlike their allopathic counterparts. The present review explores the immense potential of the demonstrated effect of Indian medicinal plants on microbes, viruses and parasites. In the present context, with the available talent in the country like pharmaceutical chemists, microbiologists, biotechnologists and interested allopathic physicians, significant national effort towards identification of an "active principle" of Indian medicinal plants to treat human and animal infections should be a priority.

  13. [Focal hyperhidrosis.Quality of life, socioeconomic importance and use of internal medicinal therapy].

    Science.gov (United States)

    Rzany, B; Müller, C; Hund, M

    2012-06-01

    Focal hyperhidrosis can have a substantial influence on the professional, physical, emotional and social life of those affected. This becomes clear when the results of quality of life studies and Health Service Research studies are reviewed, e.g. affected patients were prepared to contribute additional money for treatment of hyperhidrosis. The systemic therapy of focal hyperhidrosis with oral anticholinergic agents is a quite economical treatment strategy. These products can be administered continuously or sporadically. However, only good clinical date for the continous treatment exists. Focal hyperhidrosis is a disease which requires our full attention. It should be discussed whether e.g. QoL questionnaires should be used routinelly.

  14. 76 FR 9028 - Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability

    Science.gov (United States)

    2011-02-16

    ...] Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability AGENCY: Food and... Therapy Products'' dated January 2011. The guidance document provides manufacturers of cellular and gene... for Industry: Potency Tests for Cellular and Gene Therapy Products'' dated January 2011. The guidance...

  15. Successful in vivo hyperthermal therapy toward breast cancer by Chinese medicine shikonin-loaded thermosensitive micelle

    Directory of Open Access Journals (Sweden)

    Su Y

    2017-05-01

    Full Text Available Yonghua Su,1,* Nian Huang,1,* Di Chen,2,* Li Zhang,2,* Xia Dong,2 Yun Sun,2 Xiandi Zhu,2 Fulei Zhang,2 Jie Gao,2 Ying Wang,2 Kexing Fan,2 Puichi Lo,3 Wei Li,2 Changquan Ling1 1Department of Integrative Oncology, Changhai Hospital of Traditional Chinese Medicine, 2International Joint Cancer Institute, The Second Military Medical University, Shanghai, 3Department of Biomedical Sciences, City University of Hong Kong, Kowloon Tong, Hong Kong, China *These authors contributed equally to this work Abstract: The Chinese traditional medicine Shikonin is an ideal drug due to its multiple targets to tumor cells. But in clinics, improving its aqueous solubility and tumor accumulation is still a challenge. Herein, a copolymer with tunable poly(N-isopropylacrymaide and polylactic acid block lengths is designed, synthesized, and characterized in nuclear magnetic resonance. The corresponding thermosensitive nanomicelle (TN with well-defined core-shell structure is then assembled in an aqueous solution. For promoting the therapeutic index, the physical-chemistry properties of TNs including narrow size, low critical micellar concentration, high serum stability, tunable volume phase transition temperature (VPTT, high drug-loading capacity, and temperature-controlled drug release are systematically investigated and regulated through the fine self-assembly. The shikonin is then entrapped in a degradable inner core resulting in a shikonin-loaded thermosensitive nanomicelle (STN with a VPTT of ~40°C. Compared with small-molecular shikonin, the in vitro cellular internalization and cytotoxicity of STN against breast cancer cells (Michigan Cancer Foundation-7 are obviously enhanced. In addition, the therapeutic effect is further enhanced by the programmed cell death (PCD specifically evoked by shikonin. Interestingly, both the proliferation inhibition and PCD are synergistically promoted as T > VPTT, namely the temperature-regulated passive targeting. Consequently, as

  16. POLICY ON HERBAL TRADITIONAL MEDICINES THERAPY IN THREE PROVINCES IN INDONESIA

    Directory of Open Access Journals (Sweden)

    Max Joseph Herman

    2013-08-01

    Full Text Available Abstract A descriptive qualitative study on the implementation of MOH Decrees related to local herbal Traditional Medicine Therapy in Bali, West Java and Central Java, had been conducted cross-sectionally in 2011. Objectives of this study were to identify local licensing policy, perception of professional organization, and supports and obstacles of their implementation. Data were collected through in-depth interviews with one herbal CAM provider, purposively taken from each district, and Head of Health Resources Department of Provincial and District Health Office, whilst RTD participants were professional organizations like Indonesian Association of Herbal Medical Doctor, Indonesian Association of Traditional Therapist, Indonesian Pharmacist Association, Indonesian Association of Midwives and Indonesian National Nurse Union. Results of the study showed that in Bali no Surat Bukti Registrasi-Tenaga Pengobat Komplementer Altenatif had been issued. In West Java it had been given to trained doctor and in Central Java given only to doctors in Puskesmas following Jamu Scientification program. MOH Decree no. 1109 of 2007 which controls CAM providers in health facilities were differently perceived by Provincial Health Offices and as a result, implementation and also local policy differed amongst provinces. There were doctors providing herbal medicine services based on MOH Regulation no. 1076 of 2003. Nonetheless, few doctors had implemented Decree on Use of CAM, because there were no provincial collegiums of herbal medicine yet and no standard of competencies had been developed. The requirements to obtain licence for doctor were more complicated than for traditional provider. Keywords: complementary alternative medicine, herbal traditional medicine, licence, policy Abstrak Telah dilakukan suatu studi kualitatif implementasi peraturan-peraturan tentang pengobatan tradisional herbal secara potong lintang di Bali, Jawa Barat dan Jawa Tengah, pada tahun

  17. Assessment of herbal medicinal products: Challenges, and opportunities to increase the knowledge base for safety assessment

    International Nuclear Information System (INIS)

    Jordan, Scott A.; Cunningham, David G.; Marles, Robin J.

    2010-01-01

    Although herbal medicinal products (HMP) have been perceived by the public as relatively low risk, there has been more recognition of the potential risks associated with this type of product as the use of HMPs increases. Potential harm can occur via inherent toxicity of herbs, as well as from contamination, adulteration, plant misidentification, and interactions with other herbal products or pharmaceutical drugs. Regulatory safety assessment for HMPs relies on both the assessment of cases of adverse reactions and the review of published toxicity information. However, the conduct of such an integrated investigation has many challenges in terms of the quantity and quality of information. Adverse reactions are under-reported, product quality may be less than ideal, herbs have a complex composition and there is lack of information on the toxicity of medicinal herbs or their constituents. Nevertheless, opportunities exist to capitalise on newer information to increase the current body of scientific evidence. Novel sources of information are reviewed, such as the use of poison control data to augment adverse reaction information from national pharmacovigilance databases, and the use of more recent toxicological assessment techniques such as predictive toxicology and omics. The integration of all available information can reduce the uncertainty in decision making with respect to herbal medicinal products. The example of Aristolochia and aristolochic acids is used to highlight the challenges related to safety assessment, and the opportunities that exist to more accurately elucidate the toxicity of herbal medicines.

  18. Herbal medicinal products in the treatment of pain as a symptom of osteoarthritis

    Directory of Open Access Journals (Sweden)

    Maksimović Zoran

    2016-01-01

    Full Text Available Herbal medicinal products which are used perorally in the treatment of minor articular pain include those obtained from willow bark, Salicis cortex, devil's claw root, Harpagophyti radix, nettle leaf and herb, Urticae folium/herba, meadowsweet flower and herb, Filipendulae ulmariae flos/herba, ash leaf, Fraxini folium, and blackcurrant leaf, Ribis nigri folium. They can be in the form of a herbal tea or solid and liquid dosage forms. Anti-inflammatory and/or analgetic action form/s basis for their therapeutic usage. Among mentioned herbal drugs, only willow bark, Salicis cortex, is employed for producing herbal medicinal products with well-established use (dry standardised hydroethanolic extract in the solid dosage form intended for oral application. Furthermore, traditional herbal medicines prepared from arnica flower, Arnicae flos, which are intended for dermal application (liquid and semi-solid dosage forms are used for symptomatic relief of rheumatic complaints, also because of their anti-inflammatory and analgetic effects. Owing to rubefacient activity, herbal medicinal products with well-established use based on the soft extracts of capsicum, Capsici frustus, (medicated plasters and semi-solid dosage forms for cutaneous use, as well as traditional herbal medicines based on rosemary leaf and oil, Rosmarini folium/aetheroleum, juniper oil, Juniperi aetheroleum, and eucalyptus oil, Eucalypti aetheroleum (bath additives and/or liquid and semi-solid dosage forms for dermal application, are used to decrease pain.

  19. Traditional Chinese medicine therapy decreases the pneumonia risk in patients with dementia

    Science.gov (United States)

    Lin, Shun-Ku; Tsai, Yueh-Ting; Lo, Pei-Chia; Lai, Jung-Nien

    2016-01-01

    Abstract Pneumonia is a frequent complication in dementia patients and is associated with high mortality rates. The aim of this retrospective cohort study was to determine whether traditional Chinese medicine (TCM) therapy can decrease pneumonia risk in dementia patients. The cohort dataset was obtained from the Longitudinal Health Insurance Database 2005, a sublibrary of the National Health Insurance Research Database, containing all medical data of 1 million beneficiaries, randomly selected from the all Insurers in year 2005. Newly diagnosed dementia patients (n = 9712) without pneumonia were analyzed from January 1997 to December 2003. After matching by sex, age, urban level, Charlson comorbidity index, insured amount, and comorbidities, 1376 pairs (1:1) of TCM and non-TCM users were acquired. Every dementia patient was individually recorded from 1997 to 2012 to identify pneumonia incidence (onset after 3 months of dementia diagnosis). Demographic characteristics, Charlson comorbidity index, comorbidities, behavioral and psychological symptoms of dementia, and psychotropic drugs were also investigated. Cox proportional regression was used to compute hazard ratios and 95% confidence intervals (CIs) after adjustment for the above-mentioned variables. There were 419 (30.5%) and 762 (55.4%) pneumonia cases in the TCM and non-TCM cohorts during a mean follow-up period of 7.6 years. The adjusted hazard ratios (95% CI) for pneumonia admission was 0.62 (0.55–0.70) for the TCM group. Patients who received TCM therapy at higher cumulative doses or for longer periods experienced increased protection from pneumonia admission. Ma-Xing-Gan-Shi-Tang, Yin-Qiao-San, and Xiao-Qing-Long-Tang might represent possible formulae reducing the incidence of pneumonia. TCM might be associated with a lower risk of pneumonia in dementia patients. PMID:27631269

  20. Interactions of black cohosh, a traditional herbal medicine, with therapy for breast cancer

    International Nuclear Information System (INIS)

    Rockwell, S.; Liu, Y.; Higgins, S.A.

    2003-01-01

    Herbal medicines based on extracts of Cimicifuga racemosa (black cohosh) are widely used by breast cancer patients, but the effects of these extracts have not been rigorously studied. We examined the effects of standardized commercial extracts of black cohosh on the cytotoxicity of radiation, Adriamycin, Taxotere, and Cisplatin to breast cancer cells in vitro. Exponentially growing cultures of EMT6 mouse mammary tumor cells were exposed to black cohosh extracts continuously for 24 h, beginning 4 hours before irradiation or the 2 h drug treatment. Full dose-response curves were determined for radiation and for each drug under three conditions: alone, in combination with black cohosh extract, and in combination with the vehicle used to prepare the extract. Cell survival was assayed using a colony formation assay. The herbal extracts alone had no significant effect on the growth or viability of these breast cancer cells. The effects of the extracts on the outcome of treatment varied with the treatment agent. Black cohosh protected cells slightly from Cisplatin, had no effect on the dose-response curve for radiation, and sensitized cells to Adriamycin and Taxotere. The vehicle had no discernable effect. These findings show that black cohosh extracts are not simply 'harmless herbs' that can be ignored by physicians treating cancer patients, but instead contain active agents which can modulate the effects of therapy with conventional therapeutic agents. Further cell culture studies are needed to determine the mechanism underlying this effect. Studies with tumors and normal tissues in mice are needed to assess whether black cohosh extracts alter the effectiveness of radiation and drugs in treating breast cancer or alter the toxicities of these therapies

  1. Precision Medicine for Advanced Pancreas Cancer: The Individualized Molecular Pancreatic Cancer Therapy (IMPaCT) Trial.

    Science.gov (United States)

    Chantrill, Lorraine A; Nagrial, Adnan M; Watson, Clare; Johns, Amber L; Martyn-Smith, Mona; Simpson, Skye; Mead, Scott; Jones, Marc D; Samra, Jaswinder S; Gill, Anthony J; Watson, Nicole; Chin, Venessa T; Humphris, Jeremy L; Chou, Angela; Brown, Belinda; Morey, Adrienne; Pajic, Marina; Grimmond, Sean M; Chang, David K; Thomas, David; Sebastian, Lucille; Sjoquist, Katrin; Yip, Sonia; Pavlakis, Nick; Asghari, Ray; Harvey, Sandra; Grimison, Peter; Simes, John; Biankin, Andrew V

    2015-05-01

    Personalized medicine strategies using genomic profiling are particularly pertinent for pancreas cancer. The Individualized Molecular Pancreatic Cancer Therapy (IMPaCT) trial was initially designed to exploit results from genome sequencing of pancreatic cancer under the auspices of the International Cancer Genome Consortium (ICGC) in Australia. Sequencing revealed small subsets of patients with aberrations in their tumor genome that could be targeted with currently available therapies. The pilot stage of the IMPaCT trial assessed the feasibility of acquiring suitable tumor specimens for molecular analysis and returning high-quality actionable genomic data within a clinically acceptable timeframe. We screened for three molecular targets: HER2 amplification; KRAS wild-type; and mutations in DNA damage repair pathways (BRCA1, BRCA2, PALB2, ATM). Tumor biopsy and archived tumor samples were collected from 93 patients and 76 were screened. To date 22 candidate cases have been identified: 14 KRAS wild-type, 5 cases of HER2 amplification, 2 mutations in BRCA2, and 1 ATM mutation. Median time from consent to the return of validated results was 21.5 days. An inability to obtain a biopsy or insufficient tumor content in the available specimen were common reasons for patient exclusion from molecular analysis while deteriorating performance status prohibited a number of patients from proceeding in the study. Documenting the feasibility of acquiring and screening biospecimens for actionable molecular targets in real time will aid other groups embarking on similar trials. Key elements include the need to better prescreen patients, screen more patients, and offer more attractive clinical trial options. ©2015 American Association for Cancer Research.

  2. Production of 177Lu for targeted radionuclide therapy: Available options

    International Nuclear Information System (INIS)

    Dah, Ashutosh; Pillai, Maroor Raghavan Ambikalmajan; Knapp, Furn F. Jr.

    2015-01-01

    This review provides a comprehensive summary of the production of 177 Lu to meet expected future research and clinical demands. Availability of options represents the cornerstone for sustainable growth for the routine production of adequate activity levels of 177 Lu having the required quality for preparation of a variety of 177 Lu-labeled radiopharmaceuticals. The tremendous prospects associated with production of 177 Lu for use in targeted radionuclide therapy (TRT) dictate that a holistic consideration should evaluate all governing factors that determine its success. While both “direct” and “indirect” reactor production routes offer the possibility for sustainable 177 Lu availability, there are several issues and challenges that must be considered to realize the full potential of these production strategies. This article presents a mini review on the latest developments, current status, key challenges and possibilities for the near future. A broad understanding and discussion of the issues associated with 177 Lu production and processing approaches would not only ensure sustained growth and future expansion for the availability and use of 177 Lu-labeled radiopharmaceuticals, but also help future developments

  3. A framework for promoting scholarship productivity in occupational therapy curricula.

    Science.gov (United States)

    Scott, P J; Justiss, M J; Schmid, A A; Fisher, T F

    2013-01-01

    This paper describes a curricular model to support the production of quality research and development of occupational therapy professional students, prepared to become leaders in the production and utilization of evidence for practice. This model is designed for programs with faculty challenged by the dual mandate of program excellence and expectations for scholarly productivity needed for tenure and promotion: typically programs at research universities. The essence of the model is the paralleling of research and competencies for clinical practice where faculty and students participate as a community of scholars. It is based on the literature that addresses the tensions between achieving excellence in research and scholarly productivity, and excellence in teaching. The experience of one university with this model over a five-year period of time is shared with the student-faculty productivity outcomes. These outcomes include dissemination of 55 collaborative peer reviewed products and faculty has generated support for 25 paid graduate assistantships. The combination of student outcomes and faculty support for their research has strengthened the ability of the faculty to excel in meeting the University mandate of scholarship while providing a high quality professional educational program.

  4. Research and development for botanical products in medicinals and food supplements market.

    Science.gov (United States)

    Miroddi, Marco; Mannucci, Carmen; Mancari, Ferdinando; Navarra, Michele; Calapai, Gioacchino

    2013-01-01

    Botanical products sold in the health area are generally intended as drugs, medicinal products, food supplements or substances for therapeutic use. Use of botanicals for improving or to care human health has evolved independently in different countries worldwide. Regulatory issues regarding botanical products designed for the food supplements or medicinal market and their influence on research and development are discussed. European Union (EU) and United States (US) policies regulating these products are focused with comments on the legislations delivered during the last ten years and differences existing in rules between these countries are emphasized. Research and development on botanical products nowdays strongly influenced by the product destination in the market. Addressed and differentiated research for either food supplements or medicinal markets is necessary to purchase data really useful for assessment of safe and effective use for both the categories. The main objective is to catalyze interest of academic and companies' researchers on crucial aspects to be taken into account in the research for the development of botanical products.

  5. Research and Development for Botanical Products in Medicinals and Food Supplements Market

    Directory of Open Access Journals (Sweden)

    Marco Miroddi

    2013-01-01

    Full Text Available Botanical products sold in the health area are generally intended as drugs, medicinal products, food supplements or substances for therapeutic use. Use of botanicals for improving or to care human health has evolved independently in different countries worldwide. Regulatory issues regarding botanical products designed for the food supplements or medicinal market and their influence on research and development are discussed. European Union (EU and United States (US policies regulating these products are focused with comments on the legislations delivered during the last ten years and differences existing in rules between these countries are emphasized. Research and development on botanical products nowdays strongly influenced by the product destination in the market. Addressed and differentiated research for either food supplements or medicinal markets is necessary to purchase data really useful for assessment of safe and effective use for both the categories. The main objective is to catalyze interest of academic and companies' researchers on crucial aspects to be taken into account in the research for the development of botanical products.

  6. [Assessing research productivity in Department of Internal Medicine, University of Zagreb, School of Medicine and University Hospital Centre Zagreb].

    Science.gov (United States)

    Petrak, Jelka; Sember, Marijan; Granić, Davorka

    2012-01-01

    Bibliometric analysis may give an objective information about publishing activity, citation rate and collaboration patterns of individuals, groups and institutions. The publication productivity of the present medical staff (79 with specialist degree and 22 residents) in Department of Internal Medicine, University of Zagreb School of Medicine in University Hospital Centre Zagreb was measured by the number of papers indexed by Medline, their impact was measured by the number of times these papers had subsequently been cited in the medical literature, while the collaboration pattern was estimated by the authors' addresses listed in the papers. PubMed database was a source for verifying the bibliographic data, and the citation data were searched via Thomson Web of Scence (WoS) platform. There were a total of 1182 papers, published from 1974 to date. The number of papers per author ranged from 0 to 252. Sixty of papers were published in English, and 39% in Croatian language. The roughly equal share was published in local and foreign journals. The RCT studies and practice guidelines were among the most cited papers and were at the same time published by the highly ranked journals. The collaboration analysis confirmed the extensive involment in the international multicentric clinical trials as well as in the development of international/local practice guidelines.

  7. The Hippo Pathway as Drug Targets in Cancer Therapy and Regenerative Medicine.

    Science.gov (United States)

    Nagashima, Shunta; Bao, Yijun; Hata, Yutaka

    2017-01-01

    Yes-associated protein 1 (YAP1) and transcriptional co-activator with PDZ-binding motif (TAZ) co-operate with numerous transcription factors to regulate gene transcriptions. YAP1 and TAZ are negatively regulated by the tumor suppressive Hippo pathway. In human cancers, the Hippo pathway is frequently deregulated and YAP1 and TAZ escape the inhibition by the Hippo pathway. The upregulation of YAP1 and TAZ induces epithelial-mesenchymal transition and increases drug resistance in cancer cells. TAZ is implicated in cancer stemness. In consequence cancers with hyperactive YAP1 and TAZ are associated with poor clinical prognosis. Inhibitors of YAP1 and TAZ are reasoned to be beneficial in cancer therapy. On the other hand, since YAP1 and TAZ play important roles in the regulation of various tissue stem cells and in tissue repair, activators of YAP1 and TAZ are useful in the regenerative medicine. We discuss the potential application of inhibitors and activators of YAP1 and TAZ in human diseases and review the progress of drug screenings to search for them. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  8. Finding Inhibitors of Mutant Superoxide Dismutase-1 for Amyotrophic Lateral Sclerosis Therapy from Traditional Chinese Medicine

    Directory of Open Access Journals (Sweden)

    Hung-Jin Huang

    2014-01-01

    Full Text Available Superoxide dismutase type 1 (SOD1 mutations cause protein aggregation and decrease protein stability, which are linked to amyotrophic lateral sclerosis (ALS disease. This research utilizes the world’s largest traditional Chinese medicine (TCM database to search novel inhibitors of mutant SOD1, and molecular dynamics (MD simulations were used to analyze the stability of protein that interacted with docked ligands. Docking results show that hesperidin and 2,3,5,4′-tetrahydroxystilbene-2-O-β-D-glucoside (THSG have high affinity to mutant SOD1 and then dopamine. For MD simulation analysis, hesperidin and THSG displayed similar value of RMSD with dopamine, and the migration analysis reveals stable fluctuation at the end of MD simulation time. Interestingly, distance between the protein and ligand has distinct difference, and hesperidin changes the position from initial binding site to the other place. In flexibility of residues analysis, the secondary structure among all complexes does not change, indicating that the structure are not affect ligand binding. The binding poses of hesperidin and THSG are similar to dopamine after molecular simulation. Our result indicated that hesperidin and THSG might be potential lead compound to design inhibitors of mutant SOD1 for ALS therapy.

  9. Radioiodine 131 therapy in hyperthyroidism evaluation of French nuclear medicine practices

    International Nuclear Information System (INIS)

    Bernard, D.; Boin, C.; Desruet, M.; Roux, J.; Wolf, M.; Fagret, D.; Allenet, B.; Foroni, L.

    2015-01-01

    Full text of publication follows. Aim Radioiodine 131 I (RAI) is currently used routinely in the treatment of hyperthyroidism including Graves disease (GD), toxic multi-nodular goitre (TMNG) and toxic solitary nodule (TSN). It has proved to be safe, efficient and relatively inexpensive therapy. But after more than 60 years, many protocols are coexisting and no consensus exists on the most appropriate way to prescribe RAI dose: fixed dose regime or calculated doses based on gland size or turnover of RAI. This is the first nationwide French survey assessing the current practices about radioiodine treatment in thyrotoxicosis. Methods: we sent a questionnaire to French nuclear medicine hospital units and cancer treatment centres (n=69) about their practices in 2012. Questions were asked about RAI treatment: objectives, way to prescribe the therapeutic dose and its factors, radioisotope use to explore thyroid function and method of gland size measurement. Results: we received 40 responses. Euthyroidism was a successful treatment outcome for 33% of French respondents whereas hypothyroidism was the aim for 26%. Antithyroid drugs were stopped 7 days on average (range 3-21 days) before therapy. 68% of physicians used ultrasound for thyroid volume measurement. Calculated doses were used by 40% of clinicians (Marinelli's formula: 80%). Factors influencing prescription were thyroid uptake (100%) based on radiotracer iodine-131 (33%) or iodine-123 (67%), thyroid volume (93%) and disease (80%). Fixed activities represented 60% of the prescribed doses (72,5% for TMNG and TSN). The administered dose was chosen between 1 to 3 levels of standard doses, according to the patient characteristics. Factors influencing this choice were disease, with respectively a median of 370 MBq (range:185-740), 555 MBq (185-740), 555 MBq (296-925) for GD, TSN and TMNG, thyroid volume (59%) and thyroid uptake (52%) with the radiotracer iodine-123 (30%) or technetium-99m (70%). Even physicians

  10. Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.

    Science.gov (United States)

    Sullivan, Jane O'; Blake, Kevin; Berntgen, Michael; Salmonson, Tomas; Welink, Jan

    2017-12-05

    The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided. © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  11. Application of Feedback System Control Optimization Technique in Combined Use of Dual Antiplatelet Therapy and Herbal Medicines

    Directory of Open Access Journals (Sweden)

    Wang Liu

    2018-05-01

    Full Text Available Aim: Combined use of herbal medicines in patients underwent dual antiplatelet therapy (DAPT might cause bleeding or thrombosis because herbal medicines with anti-platelet activities may exhibit interactions with DAPT. In this study, we tried to use a feedback system control (FSC optimization technique to optimize dose strategy and clarify possible interactions in combined use of DAPT and herbal medicines.Methods: Herbal medicines with reported anti-platelet activities were selected by searching related references in Pubmed. Experimental anti-platelet activities of representative compounds originated from these herbal medicines were investigated using in vitro assay, namely ADP-induced aggregation of rat platelet-rich-plasma. FSC scheme hybridized artificial intelligence calculation and bench experiments to iteratively optimize 4-drug combination and 2-drug combination from these drug candidates.Results: Totally 68 herbal medicines were reported to have anti-platelet activities. In the present study, 7 representative compounds from these herbal medicines were selected to study combinatorial drug optimization together with DAPT, i.e., aspirin and ticagrelor. FSC technique first down-selected 9 drug candidates to the most significant 5 drugs. Then, FSC further secured 4 drugs in the optimal combination, including aspirin, ticagrelor, ferulic acid from DangGui, and forskolin from MaoHouQiaoRuiHua. Finally, FSC quantitatively estimated the possible interactions between aspirin:ticagrelor, aspirin:ferulic acid, ticagrelor:forskolin, and ferulic acid:forskolin. The estimation was further verified by experimentally determined Combination Index (CI values.Conclusion: Results of the present study suggested that FSC optimization technique could be used in optimization of anti-platelet drug combinations and might be helpful in designing personal anti-platelet therapy strategy. Furthermore, FSC analysis could also identify interactions between different

  12. Material science as basis for nuclear medicine: Holmium irradiation for radioisotopes production

    Science.gov (United States)

    Usman, Ahmed Rufai; Khandaker, Mayeen Uddin; Haba, Hiromitsu; Otuka, Naohiko

    2018-05-01

    Material Science, being an interdisciplinary field, plays important roles in nuclear science. These applications are seen in weaponry, armoured vehicles, accelerator structure and development, semiconductor detectors, nuclear medicine and many more. Present study presents the applications of some metals in nuclear medicine (radioisotope production). The charged-particle-induced nuclear reactions by using cyclotrons or accelerators have become a very vital feature of the modern nuclear medicine. Realising the importance of excitation functions for the efficient production of medical radionuclides, some very high purity holmium metals are generally prepared or purchased for bombardment in nuclear accelerators. In the present work, various methods to obtain pure holmium for radioisotope production have been discussed while also presenting details of our present studies. From the experimental work of the present studies, some very high purity holmium foils have been used in the work for a comprehensive study of residual radionuclides production cross-sections. The study was performed using a stacked-foil activation technique combined with γ-ray spectrometry. The stack was bombarded with 50.4 MeV alpha particle beam from AVF cyclotron of RI Beam Factory, Nishina Centre for Accelerator-Based Science, RIKEN, Japan. The work produced thulium radionuclides useful in nuclear medicine.

  13. PRICING, REIMBURSEMENT, AND HEALTH TECHNOLOGY ASSESSMENT OF MEDICINAL PRODUCTS IN BULGARIA.

    Science.gov (United States)

    Benisheva-Dimitrova, Tatyana; Sidjimova, Dobriana; Cherneva, Daniela; Kralimarkov, Nikolay

    2017-01-01

    The aim of this study was to investigate the analysis, discussion, and challenges of the price and reimbursement process of medicinal products in Bulgaria in the period 2000-15 and health technology assessment (HTA) role in these processes. The dynamics of the reform, with respect to the healthcare and pharmaceutical sectors, are tracked by documentary review of regulations, articles, and reports in the European Union (EU), as well as analytical and historical analysis. Pricing and reimbursement processes have passed through a variety of committees between 2003 and 2012. Separate units for pricing and reimbursement of medicinal products were established in Bulgaria for the first time, in 2013, when an independent body, the National Council at Prices and Reimbursement of Medicinal Products, was set up to approve medicinal products with new international nonproprietary names (INN) for reimbursement in Bulgaria. Over the course of 2 years (2013-14), thirty-three new INNs were approved for reimbursement. In December 2015, a new HTA body was introduced, and assigned to the National Centre for Public Health and Analyses. Although Bulgaria has current legislation on pricing and reimbursement which is in accordance with the EU rules, there is no mechanism for reporting and monitoring these processes or the financial resources annually, so as to provide an overall objective assessment and analysis by year. Therefore, this financial assessment should become a national policy objective for the future.

  14. 75 FR 50771 - Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products...

    Science.gov (United States)

    2010-08-17

    ...] (formerly Docket No. 1999D-4071) Draft Revised Guidance for Industry on Residual Solvents in New Veterinary...) entitled ``Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients... 2001 final guidance), has been developed for veterinary use by the International Cooperation on...

  15. Non-viral gene delivery strategies for cancer therapy, tissue engineering and regenerative medicine

    Science.gov (United States)

    Bhise, Nupura S.

    Gene therapy involves the delivery of deoxyribonucleic acid (DNA) into cells to override or replace a malfunctioning gene for treating debilitating genetic diseases, including cancer and neurodegenerative diseases. In addition to its use as a therapeutic, it can also serve as a technology to enable regenerative medicine strategies. The central challenge of the gene therapy research arena is developing a safe and effective delivery agent. Since viral vectors have critical immunogenic and tumorogenic safety issues that limit their clinical use, recent efforts have focused on developing non-viral biomaterial based delivery vectors. Cationic polymers are an attractive class of gene delivery vectors due to their structural versatility, ease of synthesis, biodegradability, ability to self-complex into nanoparticles with negatively charged DNA, capacity to carry large cargo, cellular uptake and endosomal escape capacity. In this thesis, we hypothesized that developing a biomaterial library of poly(betaamino esters) (PBAE), a newer class of cationic polymers consisting of biodegradable ester groups, would allow investigating vector design parameters and formulating effective non-viral gene delivery strategies for cancer drug delivery, tissue engineering and stem cell engineering. Consequently, a high-throughput transfection assay was developed to screen the PBAE-based nanoparticles in hard to transfect fibroblast cell lines. To gain mechanistic insights into the nanoparticle formulation process, biophysical properties of the vectors were characterized in terms of molecular weight (MW), nanoparticle size, zeta potential and plasmid per particle count. We report a novel assay developed for quantifying the plasmid per nanoparticle count and studying its implications for co-delivery of multiple genes. The MW of the polymers ranged from 10 kDa to 100 kDa, nanoparticle size was about 150 run, zeta potential was about 30 mV in sodium acetate buffer (25 mM, pH 5) and 30 to 100

  16. The Current Status and Future Directions of Heavy Charged Particle Therapy in Medicine

    Science.gov (United States)

    Levy, Richard P.; Blakely, Eleanor A.; Chu, William T.; Coutrakon, George B.; Hug, Eugen B.; Kraft, Gerhard; Tsujii, Hirohiko

    2009-03-01

    will require: (1) sophisticated target delineation that integrates CT, MRI and PET imaging; (2) reliable RBE modeling algorithms; (3) efficient beam-scanning technology that compensates for organ movements; (4) online beam control proximal to and within the patient; and (5) better understanding of dose-fractionation parameters. The current status and the anticipated future directions of the role of particle therapy in medicine is a complex subject that involves a very intimate interplay of radiobiology, accelerator physics and radiation oncology. The intention of this relatively brief manuscript is to describe the underlying principles, present the historical developments, highlight the clinical results, focus on the technical advances, and suggest likely future directions. We have also attempted to present a balanced, consensus view of the past achievements and current strategies in particle therapy, in a manner of interest both to long-term experts and to educated newcomers to this field.

  17. Worldwide withdrawal of medicinal products because of adverse drug reactions: a systematic review and analysis.

    Science.gov (United States)

    Onakpoya, Igho J; Heneghan, Carl J; Aronson, Jeffrey K

    2016-07-01

    We have systematically identified medicinal products withdrawn worldwide because of adverse drug reactions, assessed the level of evidence used for making the withdrawal decisions, and explored the patterns of withdrawals over time. We searched PubMed, the WHO database of withdrawn products, and selected texts. We included products that were withdrawn after launch from 1950 onwards, excluding non-human and over-the-counter medicines. We assessed the levels of evidence on which withdrawals were based using the Oxford Center for Evidence Based Medicine Levels of Evidence. Of 353 medicinal products withdrawn from any country, only 40 were withdrawn worldwide. Anecdotal reports were cited as evidence for withdrawal in 30 (75%) and deaths occurred in 27 (68%). Hepatic, cardiac, and nervous system toxicity accounted for over 60% of withdrawals. In 28 cases, the first withdrawal was initiated by the manufacturer. The median interval between the first report of an adverse drug reaction that led to withdrawal and the first withdrawal was 1 year (range 0-43 years). Worldwide withdrawals occurred within 1 year after the first withdrawal in any country. In conclusion, the time it takes for drugs to be withdrawn worldwide after reports of adverse drug reactions has shortened over time. However, there are inconsistencies in current withdrawal procedures when adverse drug reactions are suspected. A uniform method for establishing worldwide withdrawal of approved medicinal products when adverse drug reactions are suspected should be developed, to facilitate global withdrawals. Rapid synthesis of the evidence on harms should be a priority when serious adverse reactions are suspected.

  18. Developing a patient-centered outcome measure for complementary and alternative medicine therapies I: defining content and format

    Directory of Open Access Journals (Sweden)

    Ritenbaugh Cheryl

    2011-12-01

    Full Text Available Abstract Background Patients receiving complementary and alternative medicine (CAM therapies often report shifts in well-being that go beyond resolution of the original presenting symptoms. We undertook a research program to develop and evaluate a patient-centered outcome measure to assess the multidimensional impacts of CAM therapies, utilizing a novel mixed methods approach that relied upon techniques from the fields of anthropology and psychometrics. This tool would have broad applicability, both for CAM practitioners to measure shifts in patients' states following treatments, and conventional clinical trial researchers needing validated outcome measures. The US Food and Drug Administration has highlighted the importance of valid and reliable measurement of patient-reported outcomes in the evaluation of conventional medical products. Here we describe Phase I of our research program, the iterative process of content identification, item development and refinement, and response format selection. Cognitive interviews and psychometric evaluation are reported separately. Methods From a database of patient interviews (n = 177 from six diverse CAM studies, 150 interviews were identified for secondary analysis in which individuals spontaneously discussed unexpected changes associated with CAM. Using ATLAS.ti, we identified common themes and language to inform questionnaire item content and wording. Respondents' language was often richly textured, but item development required a stripping down of language to extract essential meaning and minimize potential comprehension barriers across populations. Through an evocative card sort interview process, we identified those items most widely applicable and covering standard psychometric domains. We developed, pilot-tested, and refined the format, yielding a questionnaire for cognitive interviews and psychometric evaluation. Results The resulting questionnaire contained 18 items, in visual analog scale format

  19. Impact of nanotechnology on the delivery of natural products for cancer prevention and therapy.

    Science.gov (United States)

    Siddiqui, Imtiaz A; Sanna, Vanna

    2016-06-01

    Chemoprevention of human cancer by dietary products is a practical approach of cancer control, especially when chemoprevention is involved during the early stages of the carcinogenesis process. Research over the last few decades has clearly demonstrated the efficacy of dietary products for chemoprevention in cell culture and preclinical animal model systems. However, these in vitro and in vivo effects have not been able to be translated to bedside for clinical use. Among many reasons, inefficient systemic delivery and bioavailability of promising chemopreventive agents are considered to significantly contribute to such a disconnection. Since its advent in the field of cancer, nanotechnology has provided researchers with expertise to explore new avenues for diagnosis, prevention, and therapy of the disease. In a similar trait, we introduced a novel concept in which nanotechnology was utilized for enhancing the outcome of chemoprevention (Cancer Res. 2009; 69:1712-1716). This idea, which we termed as 'nanochemoprevention', was exploited by several laboratories and has now become an advancing field in chemoprevention research. This review summarizes some of these applications of nanotechnology in medicine, particularly focused on controlled and sustained release of bioactive compounds with emphasis on current and future utilization of nanochemoprevention for prevention and therapy of cancer. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  20. Two approaches to incorporate clinical data uncertainty into multiple criteria decision analysis for benefit-risk assessment of medicinal products.

    Science.gov (United States)

    Wen, Shihua; Zhang, Lanju; Yang, Bo

    2014-07-01

    The Problem formulation, Objectives, Alternatives, Consequences, Trade-offs, Uncertainties, Risk attitude, and Linked decisions (PrOACT-URL) framework and multiple criteria decision analysis (MCDA) have been recommended by the European Medicines Agency for structured benefit-risk assessment of medicinal products undergoing regulatory review. The objective of this article was to provide solutions to incorporate the uncertainty from clinical data into the MCDA model when evaluating the overall benefit-risk profiles among different treatment options. Two statistical approaches, the δ-method approach and the Monte-Carlo approach, were proposed to construct the confidence interval of the overall benefit-risk score from the MCDA model as well as other probabilistic measures for comparing the benefit-risk profiles between treatment options. Both approaches can incorporate the correlation structure between clinical parameters (criteria) in the MCDA model and are straightforward to implement. The two proposed approaches were applied to a case study to evaluate the benefit-risk profile of an add-on therapy for rheumatoid arthritis (drug X) relative to placebo. It demonstrated a straightforward way to quantify the impact of the uncertainty from clinical data to the benefit-risk assessment and enabled statistical inference on evaluating the overall benefit-risk profiles among different treatment options. The δ-method approach provides a closed form to quantify the variability of the overall benefit-risk score in the MCDA model, whereas the Monte-Carlo approach is more computationally intensive but can yield its true sampling distribution for statistical inference. The obtained confidence intervals and other probabilistic measures from the two approaches enhance the benefit-risk decision making of medicinal products. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  1. The clinical effectiveness of cognitive behavior therapy and an alternative medicine approach in reducing symptoms of depression in adolescents.

    Science.gov (United States)

    Charkhandeh, Mansoureh; Talib, Mansor Abu; Hunt, Caroline Jane

    2016-05-30

    The main aim of the study was to investigate the effectiveness of two psychotherapeutic approaches, cognitive behavioral therapy (CBT) and a complementary medicine method Reiki, in reducing depression scores in adolescents. We recruited 188 adolescent patients who were 12-17 years old. Participants were randomly assigned to CBT, Reiki or wait-list. Depression scores were assessed before and after the 12 week interventions or wait-list. CBT showed a significantly greater decrease in Child Depression Inventory (CDI) scores across treatment than both Reiki (peffect for Reiki than did female participants. Both CBT and Reiki were effective in reducing the symptoms of depression over the treatment period, with effect for CBT greater than Reiki. These findings highlight the importance of early intervention for treatment of depression using both cognitive and complementary medicine approaches. However, research that tests complementary therapies over a follow-up period and against a placebo treatment is required. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  2. An individually tailored behavioral medicine treatment in physical therapy for tension-type headache - two experimental case studies.

    Science.gov (United States)

    Söderlund, Anne; Lagerlöf, Helena

    2016-01-01

    The aim of this study was to describe and evaluate the effect of an individually tailored behavioral medicine treatment in physical therapy, based on a functional behavioral analysis (FBA), for tension-type headache (TTH). Two case studies with A1-A2-B-A3 design of two patients with TTH was conducted. Outcome variables were headache frequency, headache index (mean intensity), consumption of analgesics, self-efficacy in headache management (Headache Management Self-efficacy Scale [HMSE]), disability, and perceived loss of happiness for activities with family and friends. The results showed that headache frequency and headache index decreased for one of the patients. Self-efficacy in headache management increased markedly for both patients. A behavioral medicine treatment in physical therapy based on an FBA can be a way for physical therapists to handle patients with TTH. Future investigations should focus on large group studies with longer observation periods.

  3. Diet Therapy for Cancer Prevention and Treatment Based on Traditional Persian Medicine.

    Science.gov (United States)

    Javadi, Behjat

    2018-04-01

    Cancer is the second leading cause of death with profound socio-economic consequences worldwide. Growing evidence suggests the crucial role of diet on cancer prevention and treatment. In Traditional Persian Medicine (TPM) there is a major focus on contribution of special diet and foods to cancer management. In the present article, the cytotoxic and antitumor activities of several food items including plants and animal products recommended by TPM as anticancer agents are discussed. Strong evidence supports the anticancer effects of beetroot (Beta vulgris) and its major compound betanin, cinnamon and cinnamaldehyde, barley (H. vulgare) and its products, extra-virgin olive oil, black pepper (P. nigrum) and its piperine, grapes (V. vinifera) and its compound resveratrol, ginger and its compound 6-gingerol, whey protein, fish, and honey. However, additional pharmacological studies and clinical trials are needed to elucidate their molecular and cellular mechanisms of actions, frequency, and amount of consumption, possible adverse effects, and optimum preparation methods. Moreover, studying mechanisms of actions of the bioactive compounds present in the discussed food items can be helpful in identifying and development of new anticancer agents.

  4. Underestimating the Toxicological Challenges Associated with the Use of Herbal Medicinal Products in Developing Countries

    Directory of Open Access Journals (Sweden)

    Vidushi S. Neergheen-Bhujun

    2013-01-01

    Full Text Available Various reports suggest a high contemporaneous prevalence of herb-drug use in both developed and developing countries. The World Health Organisation indicates that 80% of the Asian and African populations rely on traditional medicine as the primary method for their health care needs. Since time immemorial and despite the beneficial and traditional roles of herbs in different communities, the toxicity and herb-drug interactions that emanate from this practice have led to severe adverse effects and fatalities. As a result of the perception that herbal medicinal products have low risk, consumers usually disregard any association between their use and any adverse reactions hence leading to underreporting of adverse reactions. This is particularly common in developing countries and has led to a paucity of scientific data regarding the toxicity and interactions of locally used traditional herbal medicine. Other factors like general lack of compositional and toxicological information of herbs and poor quality of adverse reaction case reports present hurdles which are highly underestimated by the population in the developing world. This review paper addresses these toxicological challenges and calls for natural health product regulations as well as for protocols and guidance documents on safety and toxicity testing of herbal medicinal products.

  5. Underestimating the toxicological challenges associated with the use of herbal medicinal products in developing countries.

    Science.gov (United States)

    Neergheen-Bhujun, Vidushi S

    2013-01-01

    Various reports suggest a high contemporaneous prevalence of herb-drug use in both developed and developing countries. The World Health Organisation indicates that 80% of the Asian and African populations rely on traditional medicine as the primary method for their health care needs. Since time immemorial and despite the beneficial and traditional roles of herbs in different communities, the toxicity and herb-drug interactions that emanate from this practice have led to severe adverse effects and fatalities. As a result of the perception that herbal medicinal products have low risk, consumers usually disregard any association between their use and any adverse reactions hence leading to underreporting of adverse reactions. This is particularly common in developing countries and has led to a paucity of scientific data regarding the toxicity and interactions of locally used traditional herbal medicine. Other factors like general lack of compositional and toxicological information of herbs and poor quality of adverse reaction case reports present hurdles which are highly underestimated by the population in the developing world. This review paper addresses these toxicological challenges and calls for natural health product regulations as well as for protocols and guidance documents on safety and toxicity testing of herbal medicinal products.

  6. Application of plant cell and tissue culture for the production of phytochemicals in medicinal plants.

    Science.gov (United States)

    Pant, Bijaya

    2014-01-01

    Approximately 80% of the world inhabitants depend on the medicinal plants in the form of traditional formulations for their primary health care system well as in the treatment of a number of diseases since the ancient time. Many commercially used drugs have come from the information of indigenous knowledge of plants and their folk uses. Linking of the indigenous knowledge of medicinal plants to modern research activities provides a new reliable approach, for the discovery of novel drugs much more effectively than with random collection. Increase in population and increasing demand of plant products along with illegal trade are causing depletion of medicinal plants and many are threatened in natural habitat. Plant tissue culture technique has proved potential alternative for the production of desirable bioactive components from plants, to produce the enough amounts of plant material that is needed and for the conservation of threatened species. Different plant tissue culture systems have been extensively studied to improve and enhance the production of plant chemicals in various medicinal plants.

  7. Stakeholders' perspectives on the regulation and integration of complementary and alternative medicine products in Lebanon: a qualitative study

    Science.gov (United States)

    2011-01-01

    Background The regulation of the markets for Complementary and Alternative Medicine (CAM) products presents a global challenge. There is a dearth of studies that have examined or evaluated the regulatory policies of CAM products in the Eastern Mediterranean Region (EMR). We investigate the regulatory frameworks and the barriers for the proper regulation and integration of CAM products in Lebanon, as an example of an EMR country with a weak public infrastructure. Methods We utilized a qualitative study design involving a series of semi-structured interviews with stakeholders of the CAM market in Lebanon. Snowball sampling was used to identify interviewees; interviews continued until the "saturation" point was reached. A total of 16 interviews were carried out with decision makers, representatives of professional associations, academic researchers, CAM product importers, policy makers and a media representative. Interviews were transcribed and thematic analysis of scripts was carried out. Results There was a consensus among all stakeholders that the regulation of the market for CAM products in Lebanon needs to be strengthened. Thematic analysis identified a number of impediments jeopardizing the safety of public consumption and hindering the integration of CAM therapies into mainstream medicine; including: weak infrastructure, poor regulation, ineffective policies and politics, weak CAM awareness and sub-optimal coordination and cooperation among stakeholders. With respect to policy instruments, voluntary instruments (self regulation) were deemed ineffective by stakeholders due to poor awareness of both users and providers on safe use of CAM products. Stakeholders' rather recommended the adoption of a combination of mixed (enhancing public awareness and integration of CAM into medical and nursing curricula) and compulsory (stricter governmental regulation) policy instruments for the regulation of the market for CAM products. Conclusions The current status quo with

  8. Precision medicine and personalising therapy in pulmonary hypertension: seeing the light from the dawn of a new era.

    Science.gov (United States)

    Savale, Laurent; Guignabert, Christophe; Weatherald, Jason; Humbert, Marc

    2018-06-30

    Pulmonary hypertension (PH) and pulmonary arterial hypertension (PAH) include different cardiopulmonary disorders in which the interaction of multiple genes with environmental and behavioural factors modulates the onset and the progression of these severe conditions. Although the development of therapeutic agents that modulate abnormalities in three major pathobiological pathways for PAH has revolutionised our approach to the treatment of PAH, the long-term survival rate remains unsatisfactory. Accumulating evidence has underlined that clinical outcomes and responses to therapy in PAH are modified by multiple factors, including genetic variations, which will be different for each individual. Since precision medicine, also known as stratified medicine or personalised medicine, aims to better target intervention to the individual while maximising benefit and minimising harm, it has significant potential advantages. This article aims to assemble and discuss the different initiatives that are currently underway in the PH/PAH fields together with the opportunities and prospects for their use in the near future. Copyright ©ERS 2018.

  9. Evolution of European Union legislation of herbal medicinal products and its transposition to national legislation in 1965-2007: case Finland.

    Science.gov (United States)

    Koski, Sari M; Laitinen-Parkkonen, Pirjo; Airaksinen, Marja

    2015-01-01

    The study aim was to explore the progress of legislation relating to herbal medicinal products in the European Union and compare it with the corresponding progress of the legislation in Finland in 1965-2007. The study was carried out using content analysis. Data were searched from publicly available European Union directives and national acts. All definitions and safety-related requirements for herbal medicinal products were identified. The transposition of safety-related requirements into the national legislation was studied. Medicinal products from plant origins have been part of the European Union legislation since 1965. Most plant-based products have not initially been regarded as medicinal products but rather as some kind of medicine-like products. The official definition of herbal medicinal products was introduced in Directive 2004/24/EC and implemented into the Finnish legislation with the terminology to recognise herbal medicinal products as part of medicinal products. The current safety-related requirements of medicinal products concern analogously herbal medicinal products. Herbal medicinal products have had different definitions in pharmaceutical legislation over the study period in the European Union and Finland. The current definition places herbal medicinal products more clearly under the medicinal products' legislation. Safety-related requirements are now practically identical for all medicinal products. Transposition of the European Union legislation into the national legislation in Finland is apparent. Copyright © 2013 John Wiley & Sons, Ltd.

  10. Medicinal plants and natural products in amelioration of arsenic toxicity: a short review.

    Science.gov (United States)

    Bhattacharya, Sanjib

    2017-12-01

    Chronic arsenic toxicity (arsenicosis) is considered a serious public health menace worldwide, as there is no specific, safe, and efficacious therapeutic management of arsenicosis. To collate the studies on medicinal plants and natural products with arsenic toxicity ameliorative effect, active pre-clinically and/or clinically. Literature survey was carried out by using Google, Scholar Google and Pub-Med. Only the scientific journal articles found on the internet for last two decades were considered. Minerals and semi-synthetic or synthetic analogs of natural products were excluded. Literature study revealed that 34 medicinal plants and 14 natural products exhibited significant protection from arsenic toxicity, mostly in preclinical trials and a few in clinical studies. This research could lead to development of a potentially useful agent in clinical management of arsenicosis in humans.

  11. A single European pharmaceutical market: Does maximum harmonization enhance medicinal product innovation?

    DEFF Research Database (Denmark)

    Faeh, Andrea Beata

    2013-01-01

    the orphan medicinal products scheme. The latter is subject to uniform Union rules specifically introduced to stimulate research and development and has led to the development of a number of new products. The article shows that the most radical positive integration depends to a large extent on the prospect...... – Innovation Union’ – market fragmentation to be one of the major causes of the lack of innovation. In order to establish if maximum harmonization benefits innovation, two distinct legal regimes in the pharmaceutical sector will be compared. The general rules for medicinal products are weighed against...... of it yielding revenue for the innovator. Hence, fuller harmonization can benefit innovation, but it is just as important, if not more important, to address other factors such as pricing, reimbursement and patent protection....

  12. Restrictions on the reimbursement policy with regard to retail marketing of medicinal products in Poland.

    Science.gov (United States)

    Zimmermann, Agnieszka

    2013-01-01

    On January 1, 2012, the law of 12 May 2011 on the reimbursement of medicines, food products of special nutritional purpose and medicinal products, intended to tighten up the reimbursement system, came into force in Poland. The new legislative act has significantly altered the previous principles of retail marketing of products subject to publicly financed reimbursement. First of all, the prices of reimbursed products have been unified through the introduction of fixed margins and prices and a ban--completely unknown until now--on using free market sales practices. These regulations are intended to lead to the abolition of price competition and its replacement with competition as to the quality of services provided by pharmacies. At the same time, entities engaged in retail marketing of medicinal products have been imposed a number of new obligations and highly repressive penalties for failure to fulfill them. The paper analyzes the legislative changes and points out the consequences, both those which can already be seen and the predictable ones. The assumed priority and criterion of evaluation of the reimbursement policy in question is its impact on the functioning of pharmacies which, according to the premises of Polish pharmaceutical law, should play the role of public health protection institutions.

  13. The univocal identification and safe dispensation of medicinal products across Europe – challenges and solution proposal

    Directory of Open Access Journals (Sweden)

    Stroetmann, Karl A.

    2017-12-01

    Full Text Available Problem: The Smart Open Services for European Patients (epSOS the exchange of electronic Patient Summaries and ePrescriptions between selected member states of the European Union (EU. This project basically solved the ‘communication’ or message transfer problem. However, it encountered a serious ‘delivery’ problem: the safe dispensation of a medicinal product noted in a prescription from a given country by a retail pharmacist in another country. The reason for this was that the specified medicine could in many instances not univocally be identified – the same name may identify a product with a different active ingredient, or the product with identical composition may carry a different name in the other country. If the prescribed medicine had not been authorised for marketing in the other country, information on its attributes may not be available. This rendered dispensation by the pharmacist impossible, even where substitution would, in principle, be allowed and possible.Objectives: This paper reports on the goal, activities and achievements of the openMedicine project towards development of a digital solution and its implementation to meet this identification and the resulting delivery challenge. European-wide and cross-Atlantic endeavours to enhance pharmacovigilance by being able to match adverse event reports filed under different drug names which provide, however, for the same active ingredient(s were developed upon. And the need for and benefits of being able to trace for clinical purposes, e.g. the longer-term treatment with the same active ingredient, even when the name of the prescribed medicine changed several times, were explored.Methodological approach: The openMedicine project was funded by the European Commission (EC on behalf of member states to analyse this European-wide problem. Work benefitted from the epSOS project and work by the European Medicines Agency (EMA, the USA Federal Drug Agency (FDA, and standard

  14. A Case Report of Metastatic Breast Cancer Treated with Korean Medicine Therapy as a Substitute for Chemotherapy

    Directory of Open Access Journals (Sweden)

    Dong-hyun Lee

    2017-01-01

    Full Text Available The purpose of this case report is to show the potential benefit of Korean medicine therapy for treating multiple metastatic breast cancer. A 45-year-old Korean woman was diagnosed with right breast invasive ductal carcinoma in August 2012 but did not receive any treatment until October 2015 when she was diagnosed with stage 4 right breast cancer with multiple liver, bone, mesentery, retroperitoneum, and axillary lymph node metastases. After chemo-port insertion, she was treated with palliative chemotherapy and the first line of trastuzumab and paclitaxel, and the port was removed due to port infection. To treat sepsis, vancomycin and tazoperan were administered, before the third line of trastuzumab and paclitaxel was carried out. However, the patient gave up chemotherapy due to vancomycin-resistant enterococci and general weakness. Later, she received Korean medicine therapy with wild ginseng pharmacopuncture, distilled Soramdan S, Hae, and Jeobgoldan for 8 months, which led to a significant decrease of the multiple metastases. The patient was able to start walking again with the help of a walking stick. However, a new metastatic lesion was found on the right adrenal gland. This case suggests that the combination of chemotherapy and Korean medicine therapy may be valuable. Further research is indicated.

  15. Effects of oriental medicine music therapy in an ovarian cancer patient with So-Eum-type constitution: a case report

    Directory of Open Access Journals (Sweden)

    Seung-Hyun Lee

    2015-03-01

    Full Text Available The cancer incidence in Korea has been increasing, although there is a serious lack of supportive care for the treatment and management of the rapidly increasing number of cancer patients, and there is an immense need for therapeutic interventions to support cancer patients. A 47-year-old So-Eum-type Korean female patient, who was diagnosed with ovarian cancer, had been receiving chemotherapies. She was experiencing pain due to swelling of her hands and feet, and under extreme stress due to hardships of life. During the patient's fourth chemotherapy treatment, she received oriental medicine music therapy twice per week for 2 weeks, for 1 hour each time (4 sessions in total. A self-administered questionnaire and the visual analog scale were used to assess and determine the level of negative and positive feelings. After receiving the oriental medicine music therapy, her negative and positive feelings as well as the visual analog scale score that reflects subjective health conditions have improved and stabilized. This case report suggests the potential of oriental medicine music therapy as a complementary and alternative medical treatment method to promote and enhance quality of life and health conditions of cancer patients in postsurgical care and chemotherapy treatment.

  16. Effects of oriental medicine music therapy in an ovarian cancer patient with So-Eum-type constitution: a case report.

    Science.gov (United States)

    Lee, Seung-Hyun; Song, Eunhye; Kim, Seul-Ki

    2015-03-01

    The cancer incidence in Korea has been increasing, although there is a serious lack of supportive care for the treatment and management of the rapidly increasing number of cancer patients, and there is an immense need for therapeutic interventions to support cancer patients. A 47-year-old So-Eum -type Korean female patient, who was diagnosed with ovarian cancer, had been receiving chemotherapies. She was experiencing pain due to swelling of her hands and feet, and under extreme stress due to hardships of life. During the patient's fourth chemotherapy treatment, she received oriental medicine music therapy twice per week for 2 weeks, for 1 hour each time (4 sessions in total). A self-administered questionnaire and the visual analog scale were used to assess and determine the level of negative and positive feelings. After receiving the oriental medicine music therapy, her negative and positive feelings as well as the visual analog scale score that reflects subjective health conditions have improved and stabilized. This case report suggests the potential of oriental medicine music therapy as a complementary and alternative medical treatment method to promote and enhance quality of life and health conditions of cancer patients in postsurgical care and chemotherapy treatment.

  17. Radiation exposure to nuclear medicine technologists from administering I-131 therapy dosages

    International Nuclear Information System (INIS)

    Chaudakshetrin, P.; Pusuwan, P.; Sritongkul, N.; Tuntawiroon, M.

    2007-01-01

    Full text: Therapeutic doses of I-131 for treatment of thyroid cancer are administered orally in liquid or capsule form. During the last few years, a total number of patients loaded in our isolation ward increased from 4 to 10 patients per week. When considering radiation safety precautions for attending technologists, it is preferable to use the dose in capsules. The purpose of this study is to compare radiation exposure to nuclear medicine technologists from administering I-131 therapy dosages in capsules and in liquid form in a closed system. Materials and Methods: Three year radiation exposure to technologists during I-131 administration was analyzed. From January 2004 to June 2005 dose administration was in liquid form (n=263) and from July 2005 to February 2007 in capsules (n=541). Radiation dose assessment was performed with an electronic personal dosimeter (PDM 112). The dose rate in μSv and time spent per patient were recorded. Results: Dose received per patient when I-131 was given in a liquid was 3.50 ± 1.67 μSv and 1.17 ± 0.66 μSv when given in capsules. Compared with the use of a liquid, capsules significantly reduced radiation dose to technologists by 66% (P < 0.001). These doses received depended not only on the administered activity but also on the time, distance and shielding. Time spent per patient, including a brief visit before the time of dosing to explain the procedure and answer questions was reduced slightly from 4.4 ± 2.2 to 3.7 ± 1.8 minutes (P < 0.01). These correspond to a reduction in a yearly dose to 1 technologist by 40%, from 0.63 mSv to 0.38 mSv from dosing to 175 and 325 patients respectively. Conclusions: The measured doses clearly showed that handling of I-131 therapy dosages either in a liquid form or capsules are not the major contributors to the technologist's radiation exposure in routine clinical practice. However, one has to be cautious and follow good work practice to avoid risk of radiation exposure and radioiodine

  18. Application of plant metabonomics in quality assessment for large-scale production of traditional Chinese medicine.

    Science.gov (United States)

    Ning, Zhangchi; Lu, Cheng; Zhang, Yuxin; Zhao, Siyu; Liu, Baoqin; Xu, Xuegong; Liu, Yuanyan

    2013-07-01

    The curative effects of traditional Chinese medicines are principally based on the synergic effect of their multi-targeting, multi-ingredient preparations, in contrast to modern pharmacology and drug development that often focus on a single chemical entity. Therefore, the method employing a few markers or pharmacologically active constituents to assess the quality and authenticity of the complex preparations has a number of severe challenges. Metabonomics can provide an effective platform for complex sample analysis. It is also reported to be applied to the quality analysis of the traditional Chinese medicine. Metabonomics enables comprehensive assessment of complex traditional Chinese medicines or herbal remedies and sample classification of diverse biological statuses, origins, or qualities in samples, by means of chemometrics. Identification, processing, and pharmaceutical preparation are the main procedures in the large-scale production of Chinese medicinal preparations. Through complete scans, plants metabonomics addresses some of the shortfalls of single analyses and presents a considerable potential to become a sharp tool for traditional Chinese medicine quality assessment. Georg Thieme Verlag KG Stuttgart · New York.

  19. Application of Metabolomics to Quality Control of Natural Product Derived Medicines.

    Science.gov (United States)

    Lee, Kyung-Min; Jeon, Jun-Yeong; Lee, Byeong-Ju; Lee, Hwanhui; Choi, Hyung-Kyoon

    2017-11-01

    Metabolomics has been used as a powerful tool for the analysis and quality assessment of the natural product (NP)-derived medicines. It is increasingly being used in the quality control and standardization of NP-derived medicines because they are composed of hundreds of natural compounds. The most common techniques that are used in metabolomics consist of NMR, GC-MS, and LC-MS in combination with multivariate statistical analyses including principal components analysis (PCA) and partial least squares-discriminant analysis (PLS-DA). Currently, the quality control of the NP-derived medicines is usually conducted using HPLC and is specified by one or two indicators. To create a superior quality control framework and avoid adulterated drugs, it is necessary to be able to determine and establish standards based on multiple ingredients using metabolic profiling and fingerprinting. Therefore, the application of various analytical tools in the quality control of NP-derived medicines forms the major part of this review. Veregen ® (Medigene AG, Planegg/Martinsried, Germany), which is the first botanical prescription drug approved by US Food and Drug Administration, is reviewed as an example that will hopefully provide future directions and perspectives on metabolomics technologies available for the quality control of NP-derived medicines.

  20. Natural products as potential cancer therapy enhancers: A preclinical update

    Directory of Open Access Journals (Sweden)

    Abed Agbarya

    2014-09-01

    Full Text Available Cancer is a multifactorial disease that arises as a consequence of alterations in many physiological processes. Recently, hallmarks of cancer were suggested that include sustaining proliferative signaling, evading growth suppressors, resisting cell death, enabling replicative immortality, inducing angiogenesis, and activating invasion and metastasis, along with two emerging hallmarks including reprogramming energy metabolism and escaping immune destruction. Treating multifactorial diseases, such as cancer with agents targeting a single target, might provide partial treatment and, in many cases, disappointing cure rates. Epidemiological studies have consistently shown that the regular consumption of fruits and vegetables is strongly associated with a reduced risk of developing chronic diseases, such as cardiovascular diseases and cancer. Since ancient times, plants, herbs, and other natural products have been used as healing agents. Moreover, the majority of the medicinal substances available today have their origin in natural compounds. Traditionally, pharmaceuticals are used to cure diseases, and nutrition and herbs are used to prevent disease and to provide an optimal balance of macro- and micro-nutrients needed for good health. We explored the combination of natural products, dietary nutrition, and cancer chemotherapeutics for improving the efficacy of cancer chemotherapeutics and negating side effects.

  1. Translational research on advanced therapies

    Directory of Open Access Journals (Sweden)

    Filippo Belardelli

    2011-01-01

    Full Text Available Fostering translational research of advanced therapies has become a major priority of both scientific community and national governments. Advanced therapy medicinal products (ATMP are a new medicinal product category comprising gene therapy and cell-based medicinal products as well as tissue engineered medicinal products. ATMP development opens novel avenues for therapeutic approaches in numerous diseases, including cancer and neurodegenerative and cardiovascular diseases. However, there are important bottlenecks for their development due to the complexity of the regulatory framework, the high costs and the needs for good manufacturing practice (GMP facilities and new end-points for clinical experimentation. Thus, a strategic cooperation between different stakeholders (academia, industry and experts in regulatory issues is strongly needed. Recently, a great importance has been given to research infrastructures dedicated to foster translational medicine of advanced therapies. Some ongoing European initiatives in this field are presented and their potential impact is discussed.

  2. Translational research on advanced therapies.

    Science.gov (United States)

    Belardelli, Filippo; Rizza, Paola; Moretti, Franca; Carella, Cintia; Galli, Maria Cristina; Migliaccio, Giovanni

    2011-01-01

    Fostering translational research of advanced therapies has become a major priority of both scientific community and national governments. Advanced therapy medicinal products (ATMP) are a new medicinal product category comprising gene therapy and cell-based medicinal products as well as tissue engineered medicinal products. ATMP development opens novel avenues for therapeutic approaches in numerous diseases, including cancer and neurodegenerative and cardiovascular diseases. However, there are important bottlenecks for their development due to the complexity of the regulatory framework, the high costs and the needs for good manufacturing practice (GMP) facilities and new end-points for clinical experimentation. Thus, a strategic cooperation between different stakeholders (academia, industry and experts in regulatory issues) is strongly needed. Recently, a great importance has been given to research infrastructures dedicated to foster translational medicine of advanced therapies. Some ongoing European initiatives in this field are presented and their potential impact is discussed.

  3. Exploring the role of multiple chronic conditions in traditional Chinese medicine use and three types of traditional Chinese medicine therapy among adults in Taiwan.

    Science.gov (United States)

    Cheng, Ting-Yi; Chou, Yiing-Jenq; Huang, Nicole; Pu, Christy; Chou, Yu-Ju; Chou, Pesus

    2015-06-01

    Numerous people with chronic conditions like to use traditional Chinese medicine (TCM) treatment, or integrated treatment of TCM and Western medicine (WM). Our study explored the associations between multiple chronic conditions (MCC) and TCM use and the use of specific types of TCM therapy among adults in Taiwan. In addition, we explored the TCM use of adults with seven common types of chronic conditions. In our study, a national representative sample in 2005 was used. The Chronic Condition Indicator and the Clinical Classifications System created by the U.S. Agency for Healthcare Research and Quality were used to define the number of chronic conditions of adults. Logistic regressions adjusted for demographic characteristics were used to analyze the associations. The frequency of TCM use among adults with different numbers of chronic conditions was quantified. TCM use for adults with ≥5 chronic conditions (odds ratio [OR] 1.86) was higher than TCM use for adults with 2-4 chronic conditions (OR 1.51) and TCM use for adults with one chronic condition (OR 1.48). The increase in the OR of the use of Chinese herbs and traumatology manipulative therapy according to the number of chronic conditions was not as substantial as that of acupuncture-moxibustion. The frequency of TCM use exhibited an increasing trend with the increase in the number of chronic conditions (pherbs use, traumatology manipulative therapy use, and, particularly, acupuncture-moxibustion use increased as the number of chronic conditions increased. We suggest that government policy makers emphasize administering integrated TCM and WM care to people with chronic conditions or MCC.

  4. Traditional drug therapies from various medicinal plants of central Karakoram National Park, Gilgit-Baltistan, Pakistan

    International Nuclear Information System (INIS)

    Hussain, I.; Ullah, F.

    2011-01-01

    Traditional medicines derived from indigenous plants play an important role in treating infectious diseases. This study examined traditional medicinal uses of indigenous plants and documented different traditional recipes used by local communities to treat different diseases in Baltistan Region. Forty-seven medicinal plants belonging to 22 families were collected. Twenty-one families were angiosperms, one was a pteridophyte (Equisetaceae), and one a gymnosperm (Ephedraceae). Crude extracts of these medicinal plants were used by the local people for treating diseases in a traditional system of medicine. Ranunculaceae, Asteraceae, Polygonaceae and Rosaceae were the most important families, each having five species with medicinal value. The species were found across a wide range of altitudes, from 2000 m to over 4000 m. (author)

  5. Restrictions on the conduct of advertising of medicinal products in Poland and their violations.

    Science.gov (United States)

    Czerw, Aleksandra; Marek, Ewelina Maria

    2013-01-01

    Similarly to other European countries, the Polish pharmaceutical market is in the phase of maturity characterized by limited speed of increase in sales. In connection with escalation of the competitive struggle, being the result of globalization and development of enterprises producing generic medications, the most important aim for pharmaceutical companies has been to maintain profitability on the right level. To perform this task, companies producing medications have to carry out proper marketing actions. The marketing elements include, apart from the product, the price and the distribution, also promotion which is inextricably linked with advertising. It is a special type of information message that aims at evoking a specific consumer's attitude and belief. Advertising of medicinal products is subject to detailed legislative and non-legislative regulations. The aim of the article is to present legal regulations within the scope of advertising of medicinal products and violations of these regulations based on example decisions of the Main Pharmaceutical Inspector issued in the years 2008-2010. Abundant rulings of the Main Pharmaceutical Inspector prove that both advertisements addressed to public attention and those addressed to specialists often diverge from the criteria determined by the Pharmaceutical Law. In the face of still increasing violations of the provisions of the Pharmaceutical Law act, it seems that introducing a ban on advertising or any possible financial sanctions is not a sufficient punishment for advertisers. Thus, an introduction of other, more rigorous legal regulations as a deterrent for those involved in illegal advertising of medicinal products ought to be considered.

  6. Case Reports of Idiopathic Thrombocytopenia Unresponsive to First-Line Therapies Treated With Traditional Herbal Medicines Based on Syndrome Differentiation.

    Science.gov (United States)

    Yang, Juno; Lee, Beom-Joon; Lee, Jun-Hwan

    The objective of our study is to present two cases showing the effects of traditional Korean herbal medicines based on traditional Korean medicine (TKM) for the treatment of immune thrombocytopenic purpura (ITP). One patient showed no response to treatment with steroids and an immunosuppressive agent. Moreover, liver toxicity and side effects of steroids were evident. However, after he ceased conventional treatment and started to take an herbal medicine, his liver function normalized and the steroid side effects resolved. Ultimately, he achieved complete remission. Another patient with ITP had sustained remission after steroid therapy in childhood, but extensive uterine bleeding and thrombocytopenia recurred when she was 16 years old. She was managed with steroids again for 2 years, but severe side effects occurred, and eventually she ceased taking steroids. She refused a splenectomy, and was then treated with a herbal medicine for 7 months, ultimately leading to sustained remission again. Many patients with resistance to first-line treatments tend to be reluctant to undergo a splenectomy, considered a standard second-line treatment. In conclusion, herbal medicines, based on TKM, may offer alternative treatments for persistent or chronic ITP that is resistant to existing first-line treatments. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  7. Chinese Herbal Medicines as an Adjunctive Therapy for Unresectable Pancreatic Cancer: A Systematic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Bin Li

    2015-01-01

    Full Text Available Pancreatic cancer is a common malignancy with a high mortality. Most patients present clinically with advanced pancreatic cancer. Moreover, the effect of radiotherapy or chemotherapy is limited. Complementary and alternative medicines represent exciting adjunctive therapies. In this study, we ascertained the beneficial and adverse effects of Chinese herbal medicine (CHM in combination with conventional therapy for inoperable pancreatic cancer by using meta-analysis methods for controlled clinical trials. We extracted data for studies searched from six electronic databases that were searched and also assessed the methodological quality of the included studies. We evaluated the following outcome measures: 6-month and 1-year survival rate, objective response rate, disease control rate, quality of life, and adverse effects. The final analysis showed CHM is a promising strategy as an adjunctive therapy to treat advanced or inoperable pancreatic cancer and that CHM in combination with conventional therapy is a promising strategy for resistant disease. However, convincing evidence must be obtained and confirmed by high-quality trials in future studies.

  8. Medical-legal aspects of the fungal infection drug therapy in neonatology: evidence-based medicine and off-label prescribing

    Directory of Open Access Journals (Sweden)

    Marta Ciuffi

    2014-06-01

    Full Text Available The aim of this paper is to focus on the well-known issue of the clinical use of off-label drug therapy in neonatology with respect to evidence-based medicine, with particular reference to antifungal products, in comparison with the wider use in pediatric and adult population. Then we considered the new regulatory approaches carried out in the past decade by the FDA (Food and Drug Administration and the EMA (European Medicine Agency, aimed to improve newborn and children population inclusion into scientific trials and to promote drug labeling with respect to pediatric indications, and the goals nowadays achieved through the American Pediatric Research Equity Act / Best Pharmaceuticals for Children Act and the European Pediatric Investigation Plans. Finally we pointed out, on the basis of the Italian regulatory framework, the Italian medical-legal liability profiles related to the use of off-label therapies in neonatology. Further efforts are required in the international context to carry forward the process started while in the particular Italian scenario it is to be hoped that a general change of mind towards the off-label drug use in neonatology clinical practice may take place.

  9. Neuroscience of drug craving for addiction medicine: From circuits to therapies.

    Science.gov (United States)

    Ekhtiari, Hamed; Nasseri, Padideh; Yavari, Fatemeh; Mokri, Azarkhsh; Monterosso, John

    2016-01-01

    Drug craving is a dynamic neurocognitive emotional-motivational response to a wide range of cues, from internal to external environments and from drug-related to stressful or affective events. The subjective feeling of craving, as an appetitive or compulsive state, could be considered a part of this multidimensional process, with modules in different levels of consciousness and embodiment. The neural correspondence of this dynamic and complex phenomenon may be productively investigated in relation to regional, small-scale networks, large-scale networks, and brain states. Within cognitive neuroscience, this approach has provided a long list of neural and cognitive targets for craving modulations with different cognitive, electrical, or pharmacological interventions. There are new opportunities to integrate different approaches for carving management from environmental, behavioral, psychosocial, cognitive, and neural perspectives. By using cognitive neuroscience models that treat drug craving as a dynamic and multidimensional process, these approaches may yield more effective interventions for addiction medicine. © 2016 Elsevier B.V. All rights reserved.

  10. For the development of therapy with ionising radiation in tooth, mouth and jaw medicine. An historical summary

    International Nuclear Information System (INIS)

    Halbleib, T.

    1983-01-01

    Based on the corresponding literature study, the development of therapy with ionising radiation, especially in the areas of tooth, mouth and jaw medicine, is reported from the discovery of X-rays up till the present. First from 1915 on did the X-ray antiphlogistic irradiation with in importance, from 1925 to about 1940 it played a domineering role, after the war was hardly still in use and since 1970 is considered in the stomatological sector obsolete. In comparison, already in 1905 there were individual successes in tumor therapy using X radiation. After many failures and competition with the method of radium therapy in the following years, a new upswing in X-radiation came starting in around 1930 with the introduction of the Chaoul contact therapy. The high point of this development is the introduction of supervolt therapy starting around 1965. It is the result of comprehensive research in the area of radiation physics. As a result of further developed techniques there were soon combined and competing procedures available, whose results, however, have not been adequately compared and documented. From 1970 on electronic data processing has primarily taken over individual irradiation planning (cobalt 60 and electron irradiation), predictions about clinically relevant therapy successes are not present at this time. (TRV) [de

  11. Accelerating cancer therapy development: the importance of combination strategies and collaboration. Summary of an Institute of Medicine workshop.

    Science.gov (United States)

    LoRusso, Patricia M; Canetta, Renzo; Wagner, John A; Balogh, Erin P; Nass, Sharyl J; Boerner, Scott A; Hohneker, John

    2012-11-15

    Cancer cells contain multiple genetic changes in cell signaling pathways that drive abnormal cell survival, proliferation, invasion, and metastasis. Unfortunately, patients treated with single agents inhibiting only one of these pathways--even if showing an initial response--often develop resistance with subsequent relapse or progression of their cancer, typically via the activation of an alternative uninhibited pathway. Combination therapies offer the potential for inhibiting multiple targets and pathways simultaneously to more effectively kill cancer cells and prevent or delay the emergence of drug resistance. However, there are many unique challenges to developing combination therapies, including devising and applying appropriate preclinical tests and clinical trial designs, prioritizing which combination therapies to test, avoiding overlapping toxicity of multiple agents, and overcoming legal, cultural, and regulatory barriers that impede collaboration among multiple companies, organizations, and/or institutions. More effective strategies to efficiently develop combination cancer therapies are urgently needed. Thus, the Institute of Medicine's National Cancer Policy Forum recently convened a workshop with the goal of identifying barriers that may be impeding the development of combination investigational cancer therapies, as well as potential solutions to overcome those barriers, improve collaboration, and ultimately accelerate the development of promising combinations of investigational cancer therapies. ©2012 AACR.

  12. Gaps in Radiation Therapy Awareness: Results From an Educational Multi-institutional Survey of US Internal Medicine Residents.

    Science.gov (United States)

    Shaverdian, Narek; Yoo, Sun Mi; Cook, Ryan; Chang, Eric M; Jiang, Naomi; Yuan, Ye; Sandler, Kiri; Steinberg, Michael; Lee, Percy

    2017-08-01

    Internists and primary care providers play a growing role in cancer care. We therefore evaluated the awareness of radiation therapy in general and specifically the clinical utility of stereotactic body radiation therapy (SBRT) for early-stage non-small cell lung cancer (NSCLC) among current US internal medicine residents. A web-based institutional review board-approved multi-institutional survey was distributed to US internal medicine residency programs. The survey evaluated trainee demographic characteristics, baseline radiation oncology awareness, knowledge of the role of SBRT for early-stage NSCLC, and whether the survey successfully improved awareness. Thirty US internal medicine programs participated, with an overall participant response rate of 46% (1177 of 2551). Of the trainees, 93% (n=1076) reported no radiation oncology education in their residency, 39% (n=452) reported confidence in knowing when to consult radiation oncology in an oncologic emergency, and 26% (n=293) reported confidence in knowing when to consult radiation oncology in the setting of a newly diagnosed cancer. Of the participants, 76% (n=850) correctly identified that surgical resection is the standard treatment in operable early-stage NSCLC, but only 50% (n=559) of participants would recommend SBRT to a medically inoperable patient, followed by 31% of participants (n=347) who were unsure of the most appropriate treatment, and 10% (n=117) who recommended waiting to offer palliative therapy. Ninety percent of participants (n=1029) agreed that they would benefit from further training on when to consult radiation oncology. Overall, 96% (n=1072) indicated that the survey increased their knowledge and awareness of the role of SBRT. The majority of participating trainees received no education in radiation oncology in their residency, reported a lack of confidence regarding when to consult radiation oncology, and overwhelmingly agreed that they would benefit from further training. These findings

  13. [Establishment of design space for production process of traditional Chinese medicine preparation].

    Science.gov (United States)

    Xu, Bing; Shi, Xin-Yuan; Qiao, Yan-Jiang; Wu, Zhi-Sheng; Lin, Zhao-Zhou

    2013-03-01

    The philosophy of quality by design (QbD) is now leading the changes in the drug manufacturing mode from the conventional test-based approach to the science and risk based approach focusing on the detailed research and understanding of the production process. Along with the constant deepening of the understanding of the manufacturing process, the design space will be determined, and the emphasis of quality control will be shifted from the quality standards to the design space. Therefore, the establishment of the design space is core step in the implementation of QbD, and it is of great importance to study the methods for building the design space. This essay proposes the concept of design space for the production process of traditional Chinese medicine (TCM) preparations, gives a systematic introduction of the concept of the design space, analyzes the feasibility and significance to build the design space in the production process of traditional Chinese medicine preparations, and proposes study approaches on the basis of examples that comply with the characteristics of traditional Chinese medicine preparations, as well as future study orientations.

  14. Translating cell-based regenerative medicines from research to successful products: challenges and solutions.

    Science.gov (United States)

    Bayon, Yves; Vertès, Alain A; Ronfard, Vincent; Egloff, Matthieu; Snykers, Sarah; Salinas, Gabriella Franco; Thomas, Robert; Girling, Alan; Lilford, Richard; Clermont, Gaelle; Kemp, Paul

    2014-08-01

    The Tissue Engineering & Regenerative Medicine International Society-Europe (TERMIS-EU) Industry Committee as well as its TERMIS-Americas (AM) counterpart intend to address the specific challenges and needs facing the industry in translating academic research into commercial products. Over the last 3 years, the TERMIS-EU Industry Committee has worked with commercial bodies to deliver programs that encourage academics to liaise with industry in proactive collaborations. The TERMIS-EU 2013 Industry Symposium aimed to build on this commercial agenda by focusing on two topics: Operations Management (How to move a process into the good manufacturing practice [GMP] environment) and Clinical Translation (Moving a GMP process into robust trials). These topics were introduced by providing the synergistic business perspective of partnering between the multiple regenerative medicine stakeholders, throughout the life cycle of product development. Seven industry leaders were invited to share their experience, expertise, and strategies. Due to the complex nature of regenerative medicine products, partnering for their successful commercial development seems inevitable to overcome all obstacles by sharing experiences and expertise of all stakeholders. When ideally implemented, the "innovation quotient" of a virtual team resulting from the combination of internal and external project teams can be maximized through maximizing the three main dimensions: core competences, technology portfolio, and alliance management.

  15. The Opportunities Map at Cornell University: finding direction in dairy production medicine.

    Science.gov (United States)

    Mitchell, Hilda M; Nydam, Daryl V; Reyher, Kristen; Gilbert, Robert O

    2004-01-01

    Discussion between faculty and interested students revealed the existence of a multitude of opportunities in dairy production medicine at the College of Veterinary Medicine at Cornell University. Many of these were not well known to students, or even to some of the faculty, and the means of accessing specific learning experiences were sometimes obscure. Together, an informal group of faculty, students, and alumni set about cataloging available educational opportunities, resulting in a 31-page publication referred to as the "Opportunities Map." Essentially a student handbook for production medicine students, the Opportunities Map at Cornell helps guide the travel of food animal-interested students through the curriculum without missing the important highlights along the way. The map was originally developed to chronicle the opportunities and resources available to students, but it has also been used to foster face-to-face communications between students and faculty, to welcome incoming students with production animal interests, and to provide a baseline description for further discussion about the curriculum.

  16. The production and recovery of 77Br at Los Alamos for nuclear medicine studies

    International Nuclear Information System (INIS)

    Grant, P.M.; Whipple, R.E.; Barnes, J.W.; Bentley, G.E.; Wanek, P.M.; O'Brien, H.A. Jr.

    1981-01-01

    A procedure for the synthesis and isolation of 77 Br for nuclear medicine research has been developed at LASL. Metallic Mo targets are irradiated at LAMPF with medium-energy protons at high beam current. Following dissolution, volatilization, precipitation, and ion exchange techniques, 77 Br is recovered with a (91 +- 7)% chemical yield and is completely free of all other radioactive species with the exception of small levels of 76 Br and 82 Br. Ci-quantity production capabilities have been demonstrated, and the product is proving successful for the labelling of diverse radiopharmaceuticals. Future improvements in the process are also discussed. (author)

  17. Safety concerns of herbal products and traditional Chinese herbal medicines: dehydropyrrolizidine alkaloids and aristolochic acid.

    Science.gov (United States)

    Stegelmeier, Bryan L; Brown, Ammon W; Welch, Kevin D

    2015-12-01

    In many countries, including the United States, herbal supplements, tisanes and vegetable products, including traditional Chinese medicines, are largely unregulated and their content is not registered, monitored or verified. Consequently, potent plant toxins including dehydropyrrolizidine alkaloids and other potential carcinogens can contaminate these products. As herbal and food supplement producers are left to their own means to determine the safety and purity of their products prior to marketing, disturbingly often good marketing practices currently in place are ignored and content is largely undocumented. Historical examples of poisoning and health issues relating to plant material containing dehydopyrrolizidine alkaloids and aristolochic acids were used as examples to demonstrate the risk and potential toxicity of herbal products, food supplements, or traditional medicines. More work is needed to educate consumers of the potential risk and require the industry to be more responsible to verify the content and insure the safety of their products. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

  18. Development of departmental standard for traceability of measured activity for 131I therapy capsules used in nuclear medicine

    International Nuclear Information System (INIS)

    Ravichandran, Ramamoorthy; Binukumar, J.P.

    2011-01-01

    International Basic Safety Standards (International Atomic Energy Agency, IAEA) provide guidance levels for diagnostic procedures in nuclear medicine indicating the maximum usual activity for various diagnostic tests in terms of activities of injected radioactive formulations. An accuracy of ± 10% in the activities of administered radio-pharmaceuticals is being recommended, for expected outcome in diagnostic and therapeutic nuclear medicine procedures. It is recommended that the long-term stability of isotope calibrators used in nuclear medicine is to be checked periodically for their performance using a long-lived check source, such as 137 Cs, of suitable activity. In view of the un-availability of such a radioactive source, we tried to develop methods to maintain traceability of these instruments, for certifying measured activities for human use. Two re-entrant chambers ((HDR 1000 and Selectron Source Dosimetry System (SSDS)) with 125 I and 192 Ir calibration factors in the Department of Radiotherapy were used to measure Iodine-131 ( 131 I) therapy capsules to establish traceability to Mark V isotope calibrator of the Department of Nuclear Medicine. Special nylon jigs were fabricated to keep 131 I capsule holder in position. Measured activities in all the chambers showed good agreement. The accuracy of SSDS chamber in measuring 192 Ir activities in the last 5 years was within 0.5%, validating its role as departmental standard for measuring activity. The above method is adopted because mean energies of 131 I and 192 Ir are comparable. (author)

  19. Clinical nuclear medicine in radiation therapy - state and perspectives; Klinische Nuklearmedizin in der Strahlentherapie - Stand und Perspektiven

    Energy Technology Data Exchange (ETDEWEB)

    Schultze, J. [Kiel Univ. (Germany). Klinik fuer Strahlentherapie (Radioonkologie)

    1995-08-01

    Clinical nuclear medicine has severely changed due to the technical and pharmacological developments within the last 15 years. An evaluation of the importance of nuclear medicine for treatment planning purposes in radiation therapy revealed in 20.6% of the cases relevant new information due to the scans. That nevertheless the demand for nuclearmedical examinations is decreasing might be a result of an increasing alienation between nuclear medicine and referring physicians of other specialities. Therefore a reapproach of nuclear medicine with her main clinical partners is desireable which could be achieved e.g. by exchange of rotating house officers, participation in tumor conferences and consiliary statements to scan indications. (orig.) [Deutsch] Die klinische Nuklearmedizin hat sich durch die technischen und pharmakologischen Entwicklungen der letzten 15 Jahre erheblich veraendert. Eine Evaluation der Bedeutung nuklearmedizinischer Verfahren fuer die Bestrahlungsplanung in der Strahlentherapie hat in 20,6% der Faelle eine untersuchungsbedingte, planungsrelevante Information erbracht, auf die nicht verzichtet werden konnte. Dass die Nachfrage nach nuklearmedizinischen Untersuchungen in diesem Bereich trotzdem ruecklaeufig ist, duerfte Ergebnis einer zunehmenden Entfremdung der Zuweiser aus den verwandten Faechern von der Nuklearmedizin sein. Es ist deshalb eine Wiederannaeherung der Nuklearmedizin an ihre klinischen Hauptpartner wuenschenswert, die durch Austausch von Rotationsassistenten, die Beteiligung an Tumorkonferenzen und die konsiliarische Stellungnahme zu Untersuchungsindikationen erreicht werden koennte. (orig.)

  20. Clinical Report of Oriental Medicine Treatment with Bee Venom Therapy of Progressive muscle atrophy 1 Patient

    Directory of Open Access Journals (Sweden)

    Kim Young-Ho

    2000-07-01

    Full Text Available The authors reports in order to study the effect of Bee Venom therapy of progressive muscle atrophy. The authors investigated 1 patient who is treated at Woosuk University Oriental Medical Hospital. The patient diagnosed by MRI EMG Hematology Muscle biopsy as progressive muscle atrophy is administered by Bee Venom therapy for 4 months. Bee Venom therapy is operated by 2 times per a week(every 3 days, 0.1cc per one operation, 0.05cc per one acupuncture point. The authors checked changes of this patient's chief symptoms by comparing before and after Bee Venom therapy is operated at 30 times. After Bee Venom therapy, the patient increased motor power & ROM, decreased general cooling sense & swallowing disorder. As above, the authors conclude that better results can be obtained Oriental Medical Treatment with Bee Venom therapy in progressive muscle atrophy

  1. 76 FR 44015 - Thirteenth International Paul-Ehrlich-Seminar: Allergen Products for Diagnosis and Therapy...

    Science.gov (United States)

    2011-07-22

    ... fees apply to all attendees. Registration will be accepted by mail, fax, or online. Register online at... Postgraduate Institute for Medicine (PIM) and the DIA. PIM is accredited by the ACCME to provide continuing... trials and the marketing authorization of particular groups of medicinal products. Since its foundation...

  2. DNA barcoding: a tool for standardization of herbal medicinal products (HMPS) of lamiaceae from pakistan

    International Nuclear Information System (INIS)

    Zahra, N.B.; Shinwari, Z.K.

    2016-01-01

    There has been a considerable interest worldwide in traditional and alternative medicine, particularly herbal products over the past few decades but the adulteration or contamination of herbal medicinal products (HMPs) is a potential threat to consumer safety. The fact highlights the importance of an effective and accurate science integrated method for taxonomic identification of the medicinal plants and their HMPs. DNA barcoding is a molecular technique which has made it possible to identify the herbs and to find the adulterants in HMPs. The current study was designed on DNA barcoding of medicinal plants of family Lamiaceae for their correct identification and to fix the problem of adulteration for protecting consumers from health risks associated with product substitution and contamination. Many Lamiaceae species are used as traditional medicines, as culinary herbs, spices and as source of essential oils. HMPs representing 32 Lamiaceae plant samples were purchased/collected from three herbal stores (Pansar stores) in Islamabad and a herbal pharmaceutical industry. We selected three plastid loci rbcL, matK and psbA-trnH to barcode these HMPs. MEGABLAST sequence comparison was performed to verify the taxonomic identity of the samples. We found four mislabeled samples and two product substitutions. The overall amplification success for rbcL and matK was 87% and 81% while psbA-trnH showed 69%. matK and psbA-trnH were able to distinguish the species relatively better with 40% success rate than rbcL (16%). On the whole we generated a total of 22 genus-level barcodes (78%) and 12 species-level barcodes (44%). The species-level identification was considerably low due to insufficient reference data and selection of plastid markers. Therefore, it is recommended to develop herbal barcode library for adequate availability of reference sequence data and addition of nuclear markers. DNA barcoding can help the regulatory authorities to devise a mechanism for quality control and

  3. Molecular Imaging and Precision Medicine: PET/Computed Tomography and Therapy Response Assessment in Oncology.

    Science.gov (United States)

    Sheikhbahaei, Sara; Mena, Esther; Pattanayak, Puskar; Taghipour, Mehdi; Solnes, Lilja B; Subramaniam, Rathan M

    2017-01-01

    A variety of methods have been developed to assess tumor response to therapy. Standardized qualitative criteria based on 18F-fluoro-deoxyglucose PET/computed tomography have been proposed to evaluate the treatment effectiveness in specific cancers and these allow more accurate therapy response assessment and survival prognostication. Multiple studies have addressed the utility of the volumetric PET biomarkers as prognostic indicators but there is no consensus about the preferred segmentation methodology for these metrics. Heterogeneous intratumoral uptake was proposed as a novel PET metric for therapy response assessment. PET imaging techniques will be used to study the biological behavior of cancers during therapy. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. An Evidence-Based Medicine Approach to Antihyperglycemic Therapy in Diabetes Mellitus to Overcome Overtreatment.

    Science.gov (United States)

    Makam, Anil N; Nguyen, Oanh K

    2017-01-10

    Overtreatment is pervasive in medicine and leads to potential patient harms and excessive costs in health care. Although evidence-based medicine is often derided as practice by rote algorithmic medicine, the appropriate application of key evidence-based medicine principles in clinical decision making is fundamental to preventing overtreatment and promoting high-value, individualized patient-centered care. Specifically, this article discusses the importance of (1) using absolute rather than relative estimates of benefits to inform treatment decisions; (2) considering the time horizon to benefit of treatments; (3) balancing potential harms and benefits; and (4) using shared decision making by physicians to incorporate the patient's values and preferences into treatment decisions. Here, we illustrate the application of these principles to considering the decision of whether or not to recommend intensive glycemic control to patients to minimize microvascular and cardiovascular complications in type 2 diabetes mellitus. Through this lens, this example will illustrate how an evidence-based medicine approach can be used to individualize glycemic goals and prevent overtreatment, and can serve as a template for applying evidence-based medicine to inform treatment decisions for other conditions to optimize health and individualize patient care. © 2017 American Heart Association, Inc.

  5. Evaluation of phytochemicals from medicinal plants of Myrtaceae family on virulence factor production by Pseudomonas aeruginosa.

    Science.gov (United States)

    Musthafa, Khadar Syed; Sianglum, Wipawadee; Saising, Jongkon; Lethongkam, Sakkarin; Voravuthikunchai, Supayang Piyawan

    2017-05-01

    Virulence factors regulated by quorum sensing (QS) play a critical role in the pathogenesis of an opportunistic human pathogen, Pseudomonas aeruginosa in causing infections to the host. Hence, in the present work, the anti-virulence potential of the medicinal plant extracts and their derived phytochemicals from Myrtaceae family was evaluated against P. aeruginosa. In the preliminary screening of the tested medicinal plant extracts, Syzygium jambos and Syzygium antisepticum demonstrated a maximum inhibition in QS-dependent violacein pigment production by Chromobacterium violaceum DMST 21761. These extracts demonstrated an inhibitory activity over a virulence factor, pyoverdin, production by P. aeruginosa ATCC 27853. Gas chromatography-mass spectrometric (GC-MS) analysis revealed the presence of 23 and 12 phytochemicals from the extracts of S. jambos and S. antisepticum respectively. Three top-ranking phytochemicals, including phytol, ethyl linoleate and methyl linolenate, selected on the basis of docking score in molecular docking studies lowered virulence factors such as pyoverdin production, protease and haemolytic activities of P. aeruginosa to a significant level. In addition, the phytochemicals reduced rhamnolipid production by the organism. The work demonstrated an importance of plant-derived compounds as anti-virulence drugs to conquer P. aeruginosa virulence towards the host. © 2017 APMIS. Published by John Wiley & Sons Ltd.

  6. Condensed tannins in extracts from European medicinal plants and herbal products.

    Science.gov (United States)

    Ropiak, Honorata M; Ramsay, Aina; Mueller-Harvey, Irene

    2016-03-20

    Medicinal plant materials are not usually analysed for condensed tannins (CT). Thirty commercially available European medicinal plants and herbal products were screened for CT and fourteen CT samples were analysed in detail. This is also the first comprehensive CT analysis of pine buds, walnut leaves, heather flowers and great water dock roots. Acetone/water extracts contained between 3.2 and 25.9 g CT/100g of extract, had CT with mean degrees of polymerisation of 2.9 to 13.3, procyanidin/prodelphinidin ratios of 1.6/98.4 to 100/0 and cis/trans flavan-3-ol ratios of 17.7/82.3 to 97.3/2.7. The majority of samples contained procyanidins, four contained A-type linkages (blackthorn flowers, heather flowers, bilberry leaves and cowberry leaves) and one sample also had galloylated procyanidins (great water dock roots). Copyright © 2015 Elsevier B.V. All rights reserved.

  7. [Strategic considerations on the design and choice of animal models for non-clinical investigations of cell-based medicinal products].

    Science.gov (United States)

    Lehmann, Jörg; Schulz, Ronny M; Sanzenbacher, Ralf

    2015-11-01

    For the development of medicinal products animal models are still indispensable to demonstrate efficacy and safety prior to first use in humans. Advanced therapy medicinal products (ATMP), which include cell-based medicinal products (CBMP), differ in their pharmacology and toxicology compared to conventional pharmaceuticals, and thus, require an adapted regime for non-clinical development. Developers are, therefore, challenged to develop particular individual concepts and to reconcile these with regulatory agencies. Guidelines issued by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and other sources can provide direction.The published approaches for non-clinical testing of efficacy document that homologous animal models where the therapeutic effect is investigated in a disease-relevant animal model utilizing cells derived from the same species are commonly used. The challenge is that the selected model should reflect the human disease in all critical features and that the cells should be comparable to the investigated human medicinal product in terms of quality and biological activity. This is not achievable in all cases. In these cases, alternative methods may provide supplemental information. To demonstrate the scientific proof-of-concept (PoC), small animal models such as mice or rats are preferred. During the subsequent product development phase, large animal models (i.e. sheep, minipigs, dogs) must be considered, as they may better reflect the anatomical or physiological situation in humans. In addition to efficacy, those models may also be suitable to prove some safety aspects of ATMP (e.g. regarding dose finding, local tolerance, or undesired interactions and effects of the administered cells in the target tissue). In contrast, for evaluation of the two prominent endpoints for characterizing the safety of ATMP (i.e. biodistribution, tumorigenicity) heterologous small animal models, especially immunodeficient mouse strains

  8. Spontaneously Reported Adverse Reactions for Herbal Medicinal Products and Natural Remedies in Sweden 2007-15: Report from the Medical Products Agency.

    Science.gov (United States)

    Svedlund, Erika; Larsson, Maria; Hägerkvist, Robert

    2017-06-01

    In relation to the extensive use of herbal medicinal products in self-care, the safety information is limited and there is a need for improvement. This study describes spontaneously reported adverse reactions related to herbal medicinal products and natural remedies in Sweden. To evaluate the characteristics and frequency of adverse events recorded by the Swedish Medical Products Agency, where herbal medicinal products and natural remedies were suspected as causative agents. Adverse drug reactions reported to the Swedish Medical Product Agency during 2007-15 related to approved herbal medicinal products or natural remedies were included and analysed in the retrospective study. Reports had been assessed for causality when they were lodged and only reports that had been assessed as at least possible were included in the study. In total, 116 reports (concerning 259 adverse reactions) related to herbal medicinal products or natural remedies were found in the Swedish national pharmacovigilance database. The active ingredients most frequently suspected during the study period were black cohosh rhizome (15 reports), purple coneflower herb (14 reports) and a combination of extracts of pollen (13 reports). Adverse reactions related to skin and subcutaneous tissue were the most commonly reported reactions. No previously unknown safety problems have been discovered in the present study. This finding could be explained by a thorough pre-approval assessment of medicinal products and the fact that most herbal preparations in medicinal products have been in clinical use for many years (for traditional herbal medicinal products, the requirements are ≥30 years), i.e. adverse reactions are acknowledged and assessed before approval.

  9. Individualised medicine from the perspectives of patients using complementary therapies: a meta-ethnography approach.

    Science.gov (United States)

    Franzel, Brigitte; Schwiegershausen, Martina; Heusser, Peter; Berger, Bettina

    2013-06-03

    Personalised (or individualised) medicine in the days of genetic research refers to molecular biologic specifications in individuals and not to a response to individual patient needs in the sense of person-centred medicine. Studies suggest that patients often wish for authentically person-centred care and personal physician-patient interactions, and that they therefore choose Complementary and Alternative medicine (CAM) as a possibility to complement standard care and ensure a patient-centred approach. Therefore, to build on the findings documented in these qualitative studies, we investigated the various concepts of individualised medicine inherent in patients' reasons for using CAM. We used the technique of meta-ethnography, following a three-stage approach: (1) A comprehensive systematic literature search of 67 electronic databases and appraisal of eligible qualitative studies related to patients' reasons for seeking CAM was carried out. Eligibility for inclusion was determined using defined criteria. (2) A meta-ethnographic study was conducted according to Noblit and Hare's method for translating key themes in patients' reasons for using CAM. (3) A line-of-argument approach was used to synthesize and interpret key concepts associated with patients' reasoning regarding individualized medicine. (1) Of a total of 9,578 citations screened, 38 studies were appraised with a quality assessment checklist and a total of 30 publications were included in the study. (2) Reasons for CAM use evolved following a reciprocal translation. (3) The line-of-argument interpretations of patients' concepts of individualised medicine that emerged based on the findings of our multidisciplinary research team were "personal growth", "holism", "alliance", "integrative care", "self-activation" and "wellbeing". The results of this meta-ethnographic study demonstrate that patients' notions of individualised medicine differ from the current idea of personalised genetic medicine. Our study

  10. Individualised medicine from the perspectives of patients using complementary therapies: a meta-ethnography approach

    Science.gov (United States)

    2013-01-01

    Background Personalised (or individualised) medicine in the days of genetic research refers to molecular biologic specifications in individuals and not to a response to individual patient needs in the sense of person-centred medicine. Studies suggest that patients often wish for authentically person-centred care and personal physician-patient interactions, and that they therefore choose Complementary and Alternative medicine (CAM) as a possibility to complement standard care and ensure a patient-centred approach. Therefore, to build on the findings documented in these qualitative studies, we investigated the various concepts of individualised medicine inherent in patients’ reasons for using CAM. Methods We used the technique of meta-ethnography, following a three-stage approach: (1) A comprehensive systematic literature search of 67 electronic databases and appraisal of eligible qualitative studies related to patients’ reasons for seeking CAM was carried out. Eligibility for inclusion was determined using defined criteria. (2) A meta-ethnographic study was conducted according to Noblit and Hare's method for translating key themes in patients’ reasons for using CAM. (3) A line-of-argument approach was used to synthesize and interpret key concepts associated with patients’ reasoning regarding individualized medicine. Results (1) Of a total of 9,578 citations screened, 38 studies were appraised with a quality assessment checklist and a total of 30 publications were included in the study. (2) Reasons for CAM use evolved following a reciprocal translation. (3) The line-of-argument interpretations of patients’ concepts of individualised medicine that emerged based on the findings of our multidisciplinary research team were “personal growth”, “holism”, “alliance”, “integrative care”, “self-activation” and “wellbeing”. Conclusions The results of this meta-ethnographic study demonstrate that patients’ notions of individualised medicine

  11. Does the development of new medicinal products in the European Union address global and regional health concerns?

    Directory of Open Access Journals (Sweden)

    Álvarez-Martín Elena

    2010-12-01

    Full Text Available Abstract Background Since 1995, approval for many new medicinal products has been obtained through a centralized procedure in the European Union. In recent years, the use of summary measures of population health has become widespread. We investigated whether efforts to develop innovative medicines are focusing on the most relevant conditions from a global public health perspective. Methods We reviewed the information on new medicinal products approved by centralized procedure from 1995 to 2009, information that is available to the public in the European Commission Register of medicinal products and the European Public Assessment Reports from the European Medicines Agency. Morbidity and mortality data were included for each disease group, according to the Global Burden of Disease project. We evaluated the association between authorized medicinal products and burden of disease measures based on disability-adjusted life years (DALYs in the European Union and worldwide. Results We considered 520 marketing authorizations for medicinal products and 338 active ingredients. New authorizations were seen to increase over the period analyzed. There was a positive, high correlation between DALYs and new medicinal product development (ρ = 0.619, p = 0.005 in the European Union, and a moderate correlation for middle-low-income countries (ρ = 0.497, p = 0.030 and worldwide (ρ = 0.490, p = 0.033. The most neglected conditions at the European level (based on their attributable health losses were neuropsychiatric diseases, cardiovascular diseases, respiratory diseases, sense organ conditions, and digestive diseases, while globally, they were perinatal conditions, respiratory infections, sense organ conditions, respiratory diseases, and digestive diseases. Conclusions We find that the development of new medicinal products is higher for some diseases than others. Pharmaceutical industry leaders and policymakers are invited to consider the implications of this

  12. Not Missing the Future: A Call to Action for Investigating the Role of Regenerative Medicine Therapies in Pediatric/Adolescent Sports Injuries.

    Science.gov (United States)

    Best, Thomas M; Caplan, Arnold; Coleman, Michael; Goodrich, Laurie; Hurd, Jason; Kaplan, Lee D; Noonan, Ben; Schoettle, Philip; Scott, Christopher; Stiene, Henry; Huard, Johnny

    In August 2016, a group including sport medicine clinicians, researchers, and a bioethicist met in Vail, Colorado to discuss regenerative medicine and its potential role in youth sports injuries. There was consensus that a call to action is urgently needed to understand the current evidence base, the risks and rewards, and future directions of research and clinical practice for regenerative medicine therapies in youth sports. We present here a summary of our meeting, which was supported by the National Youth Sports Health and Safety Institute (NYSHSI), a partnership between the American College of Sports Medicine (ACSM) and Sanford Health. The group's goal is to educate practitioners and the public, and to pioneer a means of accumulating meaningful clinical data on regenerative medicine therapies in pediatric and adolescent athletes.

  13. [Molecular-Genetic Diagnosis and Molecular-Targeted Therapy in Cancer: Challenges in the Era of Precision Medicine].

    Science.gov (United States)

    Miyachi, Hayato

    2015-10-01

    Elucidation of the molecular pathogenesis of neoplasms and application of emerging technologies for testing and therapy have resulted in a series of paradigm shifts in patient care, from conventional to personalized medicine. This has been promoted by companion diagnostics and molecular targeted therapy, tailoring the treatment to the individual characteristics of each patient. Precision oncology has been accelerated by integrating the enhanced resolution of molecular analysis, mechanism clarity, and therapeutic relevance through genomic knowledge. In its clinical implementation, there are laboratory challenges concerning accurate measurement using stored samples, differentiation between driver and passenger mutations as well as between germline and somatic mutations, bioinformatics availability, practical decision-making algorithms, and ethical issues regarding incidental findings. The medical laboratory has a new role in providing not only testing services but also an instructive approach to users to ensure the sample quality and privacy protection of personal genome information, supporting the quality of patient practice based on laboratory diagnosis.

  14. Medium selection for exopolysaccharide and biomass production in submerged cultures of culinary-medicinal mushrooms from Turkey

    NARCIS (Netherlands)

    Kizilcik, M.; Yamaç, M.; Griensven, van L.J.L.D.

    2010-01-01

    The present study investigates the exopolysaccharide (EPS) and biomass production of 18 strains of 15 species of culinary-medicinal higher Basidiomycetes in submerged culture under four different media. Gloeophyllum abietinum and Schizophyllum commune produced the highest EPS and biomass

  15. [The use of medicinal products "off-label use" in the pediatric population--the border risk, or reasonable diligence?].

    Science.gov (United States)

    Zajdel, Justyna

    2011-01-01

    Any medicinal product marketed in the country has its registration, under which are strictly defined indications and the extent to which a product can be used. It is of significance that the use of the product which is registered in the given range produces an effect similar to or identical to that effect, which is obtained after applying the product having a registration in a given indication. Relied on to justify the use of a medicinal product or medical product "off-label use" in Poland, there is also the fact that the same product has a registration in a particular indication in another EU member state or outside the Community. It is worth noting that the medicinal product may be used in therapeutic management of omitting or reducing the principles resulting from the SPC. However, this applies only to cases where the use of the medicinal product "off-label use" dictated by the necessity of saving life or health of the patient, and the previous ways and methods of treatment with the use of registered medicines have proved ineffective or insufficient to achieve the desired therapeutic effect.

  16. Prediction of iodine-131 biokinetics and radiation doses from therapy on the basis of tracer studies: an important question for therapy planning in nuclear medicine.

    Science.gov (United States)

    Willegaignon, José; Pelissoni, Rogério A; Lima, Beatriz C G D; Sapienza, Marcelo T; Coura-Filho, George B; Buchpiguel, Carlos A

    2016-05-01

    This study aimed to present a comparison of iodine-131 (I) biokinetics and radiation doses to red-marrow (rm) and whole-body (wb), following the administration of tracer and therapeutic activities, as a means of confirming whether I clearance and radiation doses for therapy procedures can be predicted by tracer activities. Eleven differentiated thyroid cancer patients were followed after receiving tracer and therapeutic I activity. Whole-body I clearance was estimated using radiation detectors and OLINDA/EXM software was used to calculate radiation doses to rm and wb. Tracer I activity of 86 (±14) MBq and therapeutic activity of 8.04 (±1.18) GBq were administered to patients, thereby producing an average wb I effective half-time and residence time of, respectively, 13.51 (±4.05) and 23.13 (±5.98) h for tracer activities and 13.32 (±3.38) and 19.63 (±4.77) h for therapy. Radiation doses to rm and wb were, respectively, 0.0467 (±0.0208) and 0.0589 (±0.0207) mGy/MBq in tracer studies and 0.0396 (±0.0169) and 0.0500 (±0.0163) mGy/MBq in therapy. Although the differences were not considered statistically significant between averages, those between the values of effective half-times (P=0.906), residence times (P=0.145), and radiation doses to rm (P=0.393) and to wb (P=0.272), from tracer and therapy procedures, large differences of up to 80% in wb I clearance, and up to 50% in radiation doses were observed when patients were analyzed individually, thus impacting on the total amount of I activity calculated to be safe for application in individual therapy. I biokinetics and radiation doses to rm and wb in therapy procedures are well predicted by diagnostic activities when average values of a group of patients are compared. Nonetheless, when patients are analyzed individually, significant differences may be encountered, thus implying that nuclear medicine therapy-planning requires due consideration of changes in individual patient-body status from

  17. Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

    DEFF Research Database (Denmark)

    Gluud, Christian; Kubiak, Christine; Whitfield, Kate

    2012-01-01

    In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.......In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe....

  18. Advances toward regenerative medicine in the central nervous system: challenges in making stem cell therapy a viable clinical strategy.

    Science.gov (United States)

    Stoll, Elizabeth A

    2014-01-01

    Over recent years, there has been a great deal of interest in the prospects of stem cell-based therapies for the treatment of nervous system disorders. The eagerness of scientists, clinicians, and spin-out companies to develop new therapies led to premature clinical trials in human patients, and now the initial excitement has largely turned to skepticism. Rather than embracing a defeatist attitude or pressing blindly ahead, I argue it is time to evaluate the challenges encountered by regenerative medicine in the central nervous system and the progress that is being made to solve these problems. In the twenty years since the adult brain was discovered to have an endogenous regenerative capacity, much basic research has been done to elucidate mechanisms controlling proliferation and cellular identity; how stem cells may be directed into neuronal lineages; genetic, pharmacological, and behavioral interventions that modulate neurogenic activity; and the exact nature of limitations to regeneration in the adult, aged, diseased and injured CNS. These findings should prove valuable in designing realistic clinical strategies to improve the prospects of stem cell-based therapies. In this review, I discuss how basic research continues to play a critical role in identifying both barriers and potential routes to regenerative therapy in the CNS.

  19. Thermal tomography imaging in photonic traditional Chinese medicine information therapy with holistic effect for health whole nursing.

    Science.gov (United States)

    Ye, Binggang; Guo, Zhouyi; Huang, Hanchuan; Yang, Xicheng

    2015-01-01

    A photonic traditional Chinese medicine (TCM) information therapy was developed that has applications in whole health nursing including the prevention and treatment of ischemic cardiovascular and cerebrovascular diseases as well as the conditioning of the subhealth state. This therapy utilizes the beam of a 630 nm LED light to irradiate the oropharynx, while simultaneously employing two beams of 650 nm LED light to irradiate corresponding acupuncture points resulting in a synergistic outcome. This method was named "1 + 2 phototherapy." The principle mechanism of the therapy is a series of photon induced biological effects that are triggered by stimulating the photosensitive tissues of the oropharynx. This tissue includes the oral mucosa, capillaries, lymph nodes, saliva glands, nerves, and Jingluo and is stimulated by light beams of certain photon energy and imitative acupuncture information. Thermal tomography imaging shows that the average temperature of the upper-body was improved significantly after oropharyngeal irradiation under irradiation of "Futu point": the heat radiation of the spine, as well as chest, shoulders, arms, and clavicle, increased under irradiation of "Hoku," whereas the overall average temperature was below the temperature before irradiation. The experiment indicates that this therapy can promote blood circulation, regulate varied physiological parameters, and have holistic effects in whole health nursing.

  20. Principles governing heart failure therapy re-examined relative to standard evidence-based medicine-driven guidelines.

    Science.gov (United States)

    Tan, Lip-Bun; Chinnappa, Shanmugakumar; Tan, David K H; Hall, Alistair S

    2011-09-01

    Although all aspects of clinical work nowadays are modified by the pervading influence of evidence-based medicine (EBM) and multiplicative guidelines, not many clinicians realize that the underlying premise of EBM-driven guidelines is a particular strain of consequentialist ideology. Subservience to this ideology has transformed modern medical practice, but there is a real risk of distorting good medical practice, of belittling clinical judgement, of disempowering clinicians, and subjecting patients to skewed medical reality and treatment options. With so many heart failure (HF) guidelines issued by various august bodies, it is therefore timely to reappraise principles governing modern HF therapy with a fresh examination of the hierarchy of medical imperatives, the role of alternatives to consequentialism including deontological principles in HF therapy. In addition, other ideology worth re-examining, aside from EBM, are the principle of appropriate definition of HF underlying therapeutic goals and the principle of prioritizing objectives of HF therapy. Even within standard EBM, there are many questions to reconsider: about what types of evidence are admissible, different interpretations of available evidence, emphasizing patient-centered outcome measures instead of randomized controlled trials quantifiable therapeutic outcomes, how to prescribe drugs for prognostic versus symptomatic benefits, and how to deliver HF therapy based on pathophysiological features through mechanistic considerations and not just confined to randomized controlled trials or meta-analytical statistical imperatives. Through re-examination of these fundamental principles of HF therapy, it is hoped that clinicians will be empowered to manage HF patients more holistically and better deliver HF therapies in the best interest of each individual patient.

  1. Effectiveness of traditional Chinese medicine as an adjunct therapy for Parkinson's disease: a systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Guoxin Zhang

    Full Text Available Idiopathic Parkinson disease (PD is a common neurodegenerative disease that seriously hinders limb activities and affects patients' lives. We performed a meta-analysis aiming to systematically review and quantitatively synthesize the efficacy and safety of traditional Chinese medicine (TCM as an adjunct therapy for clinical PD patients.An electronic search was conducted in PubMed, Cochrane Controlled Trials Register, China National Knowledge Infrastructure, Chinese Scientific Journals Database and Wanfang data to identify randomized trials evaluating TCM adjuvant therapy versus conventional treatment. The change from baseline of the Unified Parkinson's Disease Rating Scale score (UPDRS was used to estimate the effectiveness of the therapies.Twenty-seven articles involving 2314 patients from 1999 to 2013 were included. Potentially marked improvements were shown in UPDRS I (SMD 0.68, 95%CI 0.38, 0.98, II (WMD 2.41, 95%CI 1.66, 2.62, III (WMD 2.45, 95%CI 2.03, 2.86, IV (WMD 0.32, 95%CI 0.15, 049 and I-IV total scores (WMD 6.18, 95%CI 5.06, 7.31 in patients with TCM plus dopamine replacement therapy (DRT compared to DRT alone. Acupuncture add-on therapy was markedly beneficial for improving the UPDRS I-IV total score of PD patients (WMD 10.96, 95%CI 5.85, 16.07. However, TCM monotherapy did not improve the score. The effectiveness seemed to be more obvious in PD patients with longer adjunct durations. TCM adjuvant therapy was generally safe and well tolerated.Although the data were limited by methodological flaws in many studies, the evidence indicates the potential superiority of TCM as an alternative therapeutic for PD treatment and justifies further high-quality studies.

  2. Studies On Sterilization Process For Some Traditional Products Of Herbal Medicine By Gamma Radiation

    International Nuclear Information System (INIS)

    Hoang Phuong Thao; Nguyen Van Binh; Tran Bang Diep; Hoang Dang Sang; Nguyen Thuy Huong Trang; Pham Duy Duong; Tran Minh Quynh

    2014-01-01

    Herbal eyebright products and their raw materials have been irradiated with 1, 2, 3 and 5 kGy by Co-60 gamma radiation source at Hanoi Irradiation Center (VINATOM) for sterilization. Initial bioburdens were under the limitation levels established for the traditional medicines according to the decree of 16/2011/TT-BYT issued by Vietnam Health Ministry. These values for both bacteria and fungus slightly increased during storage to three months, reach to about 10 3 and 10 2 CFU/g for bacteria and mold, respectively. However, there are no microbial colony could be observed in the samples irradiated with dose higher than 3 kGy, suggested that the radiation dose of 3 kGy was enough for sterilization of eyebright raw powders and products. At higher radiation dose of 5 kGy, the moisture and vitamin A content of the samples were insignificantly changed. These mean the radiation treatment with lower dose did not influenced on the quality of eyebright products, and radiation treatment can be applied to prolong the storage of not only eyebright, but also other traditional medicines. (author)

  3. Probiotics, fibre and herbal medicinal products for functional and inflammatory bowel disorders

    Science.gov (United States)

    Ianiro, Gianluca; Pecere, Silvia; Bibbò, Stefano; Cammarota, Giovanni

    2016-01-01

    Functional bowel disorders (FBD), mainly irritable bowel syndrome (IBS) and functional constipation (FC, also called chronic idiopathic constipation), are very common worldwide. Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, although less common, has a strong impact on patients' quality of life, as well as being highly expensive for our healthcare. A definite cure for those disorders is still yet to come. Over the years, several therapeutic approaches complementary or alternative to traditional pharmacological treatments, including probiotics, prebiotics, synbiotics, fibre and herbal medicinal products, have been investigated for the management of both groups of diseases. However, most available studies are biased by several drawbacks, including small samples and poor methodological quality. Probiotics, in particular Saccharomyces boulardii and Lactobacilli (among which Lactobacillus rhamnosus), synbiotics, psyllium, and some herbal medicinal products, primarily peppermint oil, seem to be effective in ameliorating IBS symptoms. Synbiotics and fibre seem to be beneficial in FC patients. The probiotic combination VSL#3 may be effective in inducing remission in patients with mild‐to‐moderate ulcerative colitis, in whom Escherichia coli Nissle 1917 seems to be as effective as mesalamine in maintaining remission. No definite conclusions can be drawn as to the efficacy of fibre and herbal medicinal products in IBD patients due to the low number of studies and the lack of randomized controlled trials that replicate the results obtained in the individual studies conducted so far. Thus, further, well‐designed studies are needed to address the real role of these therapeutic options in the management of both FBD and IBD. Linked Articles This article is part of a themed section on Principles of Pharmacological Research of Nutraceuticals. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph

  4. Reactor production and processing of radioisotopes for therapeutic applications in nuclear medicine

    International Nuclear Information System (INIS)

    Knapp, F.F. Jr.; Mirzadeh, S.; Beets, A.L.

    1995-01-01

    Nuclear reactors continue to play an important role in providing radioisotopes for nuclear medicine. Many reactor-produced radioisotopes are ''neutron rich'' and decay by beta-emission and are thus of interest for therapeutic applications. This talk discusses the production and processing of a variety of reactor-produced radioisotopes of current interest, including those produced by the single neutron capture process, double neutron capture and those available from beta-decay of reactorproduced radioisotopes. Generators prepared from reactorproduced radioisotopes are of particular interest since repeated elution inexpensively provides many patient doses. The development of the alumina-based W-188/Re-188 generator system is discussed in detail

  5. Refurbishing of a Freeze Drying Machine, used in Nuclear Medicine for Radiopharmaceuticals Production

    International Nuclear Information System (INIS)

    Gaytan-Gallardo, E.; Desales-Galeana, G.

    2006-01-01

    The refurbishing of a freeze drying machine used in the radiopharmaceuticals production, applied in nuclear medicine in the Radioactive Materials Department of the Nuclear Research National Institute in Mexico (ININ in Spanish), is presented. The freeze drying machine was acquired in the 80's decade and some components started having problems. Then it was necessary to refurbish this equipment by changing old cam-type temperature controllers and outdated recording devices, developing a sophisticated software system that substitutes those devices. The system is composed by a freeze drying machine by Hull, AC output modules for improved temperature control, a commercial data acquisition card, and the software system

  6. Hospital structure and technical efficiency in the production of nuclear medicine. Doctoral thesis

    International Nuclear Information System (INIS)

    Wilson, G.W.

    1976-01-01

    The relationship of hospital structure to production efficiency is explored. The hospital subindustry on which this research centers is nuclear medicine. The hypotheses generated were that technical efficiency is reduced by increased competitive intensity, by a lack of profit incentive, by a broader service range, and by in-house training of technical personnel. Most data employed in the study were gathered from the American College of Radiology and the Energy Research and Development Administration Census of Nuclear Medicine. More specific information came from questionnaires sent to 2,050 short-term general hospitals known to have a nuclear medicine facility. Of the responses 1,362 were usable for the study. A major study finding was that over half of the variations observed in technical efficiency were attributable to the structural elements being studied. The research indicated that competition for staff physicians has a role in reducing technical efficiency; that the output effect of in-house manpower training was relatively unimportant; and that profit incentives do have a significant impact. It is suggested that increased technical efficiency could be achieved through reduced competitive intensity, stronger profit orientation, and reduced service range. A bibliography is included

  7. [Development of a Novel Liposomal DDS by Manipulating Pharmacokinetics and Intracellular Trafficking for Drug Therapy and Nucleic Acid Medicine].

    Science.gov (United States)

    Hatakeyama, Hiroto

    2018-01-01

     Nucleic acid therapy is expected to be a next generation medicine. We recently developed a multifunctional envelope-type nano device (MEND) for use as a novel delivery system. The modification of polyethylene glycol (PEG), i.e., PEGylation, is useful for achieving the delivery of MENDs to tumors via an enhanced permeability and retention (EPR) effect. However, PEGylation strongly inhibits the cellular uptake and endosomal escape of MEND, which results in significant loss of action, and therefore lost effectiveness, of the cargo therapeutic. For successful nucleic acid delivery in cancer treatment, the crucial problem associated with the use of PEG, known as the "PEG dilemma", must be solved. In this review, we describe the development and application of MEND in overcoming the PEG dilemma based on manipulating both the pharmacokinetics and intracellular trafficking of cellular uptake and endosomal release using a cleavable PEG lipid, a pH-sensitive fusogenic peptide, and a pH-sensitive cationic lipid. We also developed dual-ligand liposomes with a controlled diameter of around 300 nm, then modified these with a specific ligand and a cell penetrating peptide designed to target the neovasculature of tumors. Dual-ligand liposomes could induce an anti-tumor effect in drug resistant tumors by delivering drugs to tumor blood vessels, rather than to the cancer cells themselves. Here, we review our recent efforts to develop a novel liposomal drug delivery system (DDS) by manipulating pharmacokinetics and intracellular trafficking for drug therapy and nucleic acid medicine.

  8. Patterns of care study and evidence based medicine for radiation therapy. Prostate cancer

    International Nuclear Information System (INIS)

    Nakamura, Katsumasa; Mitsuhashi, Norio

    2002-01-01

    In Japan, where the mortality rate of prostate cancer is lower than in Western countries, there is little evidence of radiation therapy for prostate cancer. Therefore, we have to refer to the evidence of radiation therapy from Western countries, but we should pay attention to the differences of cultural, racial, or social background between Japan and Western countries. The Patterns of Care Study (PCS) was conducted in Japan and extramural audits were performed for 50 randomly selected institutions. Detailed information of 311 prostate cancer patients without distant metastases and other cancers, who were treated with radiation therapy in 1996-1998, was collected. In this article, the results of PCS for primary prostate cancer were shown, with a review of literature for the appropriate choice of radiation therapy. This study was supported by the Grantin-Aid for Cancer Research from Ministry of Health, Labor and Welfare (10-17). (author)

  9. The History, Mechanism, and Clinical Application of Auricular Therapy in Traditional Chinese Medicine

    Directory of Open Access Journals (Sweden)

    Pu-Wei Hou

    2015-01-01

    Full Text Available Auricular therapy includes acupuncture, electroacupuncture, acupressure, lasering, cauterization, moxibustion, and bloodletting in the auricle. For 2500 years, people have employed auricular therapy for treating diseases, but the methods have been limited to bloodletting and cauterization. Only after 1957, the international scientific community became aware that the map of the ear resembles an inverted fetus, its introduction has led to auricular acupuncture (AA becoming a more systemic approach, and, following the identification and standardization of more precise points, AA has been employed in clinical applications. The mechanisms of AA are considered to have a close relationship with the autonomic nervous system, the neuroendocrine system, neuroimmunological factors, neuroinflammation, and neural reflex, as well as antioxidation. Auricular therapy has been applied, for example, for pain relief, for the treatment of epilepsy, anxiety, and obesity, and for improving sleep quality. However, the mechanisms and evidence for auricular therapy warrant further study.

  10. Medicinal cannabis (Bedrolite) substitution therapy in inpatients with a psychotic disorder and a comorbid cannabis use disorder: A case series.

    Science.gov (United States)

    Schipper, Regi; Dekker, Mathilde; de Haan, Lieuwe; van den Brink, Wim

    2018-03-01

    Cannabis use disorders are frequently comorbid in patients with a psychotic disorder and are associated with worse outcomes. To date there are no proven effective strategies to achieve cannabis abstinence in this population. An alternative for abstinence might be harm reduction, i.e. replacing the use of street cannabis with high tetrahydrocannabinol and low cannabidiol levels by medicinal cannabis variants with relatively low tetrahydrocannabinol and relatively high cannabidiol levels, thereby reducing the psychosis inducing effects of cannabis and enhancing the antipsychotic effects of cannabis. Here we present the data of a case series with seven inpatients diagnosed with a psychotic disorder and a treatment-resistant cannabis use disorder who received substitution therapy with a low tetrahydrocannabinol medicinal cannabis variant (Bedrolite). The results suggest that the low tetrahydrocannabinol medicinal cannabis variant Bedrolite is not effective in the treatment of inpatients with a psychotic disorder and comorbid cannabis use disorder. Bedrolite is thus not very likely to become an effective harm reduction strategy in these patients.

  11. Precision Medicine Approach to Anaplastic Thyroid Cancer: Advances in Targeted Drug Therapy Based on Specific Signaling Pathways.

    Science.gov (United States)

    Samimi, Hilda; Fallah, Parviz; Naderi Sohi, Alireza; Tavakoli, Rezvan; Naderi, Mahmood; Soleimani, Masoud; Larijani, Bagher; Haghpanah, Vahid

    2017-03-01

    Personalized medicine is a set of diagnostic, prognostic and therapeutic approaches in which medical interventions are carried out based on individual patient characteristics. As life expectancy increases in developed and developing countries, the incidence of diseases such as cancer goes up among people in the community. Cancer is a disease that the response to treatment varies from one person to another and also it is costly for individuals, families, and society. Among thyroid cancers, anaplastic thyroid carcinoma (ATC) is the most aggressive, lethal and unresponsive form of the disease. Unfortunately, current drugs are not targetable, and therefore they have restricted role in ATC treatment. Consequently, mortality of this cancer, despite advances in the field of diagnosis and treatment, is one of the most important challenges in medicine. Cellular, molecular and genetic evidences play an important role in finding more effective diagnostic and therapeutic approaches. Review of these evidences confirms the application of personalized medicine in cancer treatment including ATC. A growing body of evidence has elucidated that cellular and molecular mechanisms of cancer would pave the way for defining new biomarkers for targeted therapy, taking into account individual differences. It should be noted that this approach requires further progress in the fields of basic sciences, pharmacogenetics and drug design. An overview of the most important aspects in individualized anaplastic thyroid cancer treatment will be discussed in this review.

  12. Calculation of electron and isotopes dose point kernels with FLUKA Monte Carlo code for dosimetry in nuclear medicine therapy

    CERN Document Server

    Mairani, A; Valente, M; Battistoni, G; Botta, F; Pedroli, G; Ferrari, A; Cremonesi, M; Di Dia, A; Ferrari, M; Fasso, A

    2011-01-01

    Purpose: The calculation of patient-specific dose distribution can be achieved by Monte Carlo simulations or by analytical methods. In this study, FLUKA Monte Carlo code has been considered for use in nuclear medicine dosimetry. Up to now, FLUKA has mainly been dedicated to other fields, namely high energy physics, radiation protection, and hadrontherapy. When first employing a Monte Carlo code for nuclear medicine dosimetry, its results concerning electron transport at energies typical of nuclear medicine applications need to be verified. This is commonly achieved by means of calculation of a representative parameter and comparison with reference data. Dose point kernel (DPK), quantifying the energy deposition all around a point isotropic source, is often the one. Methods: FLUKA DPKS have been calculated in both water and compact bone for monoenergetic electrons (10-3 MeV) and for beta emitting isotopes commonly used for therapy ((89)Sr, (90)Y, (131)I, (153)Sm, (177)Lu, (186)Re, and (188)Re). Point isotropic...

  13. In vitro propagation and withaferin A production in Withania ashwagandha, a rare medicinal plant of India.

    Science.gov (United States)

    Mir, Bilal Ahmad; Mir, Shabir Ahmad; Koul, Sushma

    2014-07-01

    Withania ashwagandha, belonging to the family Solanaceae, is an important medicinal herb of India with restricted geographic distribution. It is a rich source of withaferin A (WA) and other bioactive withanolides. In the present study a rapid in vitro mass propagation protocol of W. ashwagandha was developed from nodal explants. Nodal explants were cultured on MS medium supplemented with various concentrations and combinations of plant growth regulators (PGRs). The highest number of regenerated shoots per ex-plant (33 ± 2.7) and highest WA (13.4 ± 1.15 mg/g of DW) production was obtained on MS medium supplemented with 5.0 μM 6-benzyladenine (BA) and 1.0 μM Kinetin (Kn). In vitro raised shoots were further rooted on half-strength MS medium containing 2.0 μM Indole-3-butyric acid (IBA) and analyzed for WA production. The rooted plantlets when transferred to poly bags in the greenhouse showed 90 % survival frequency. Levels of WA were higher in the in vitro and ex vitro derived shoot and root tissues as compared to field grown mother plants. In an attempt to further maximize WA production, shoot cultures were further grown in liquid MS medium supplemented with 5.0 μM 6-benzyladenine (BA) and 1.0 μM Kinetin (Kn). Root cultures were grown on half strength MS liquid medium fortified with 2.0 μM of IBA. WA production in the liquid cultures was significantly higher compared to the static composition of the same media. This protocol, first of its kind in this plant, can be successfully employed for conservation, proliferation and large-scale production of WA. The regenerated plants can also be used in traditional medicine as an alternative to naturally collected plants.

  14. Musculoskeletal colour/power Doppler in sports medicine: image parameters, artefacts, image interpretation and therapy

    DEFF Research Database (Denmark)

    Boesen, M I; Boesen, Mikael; Kønig, Merete Juhl

    2010-01-01

    This review article discusses the aspects of sports medicine where musculoskeletal Doppler ultrasound has valuable contribution in diagnosis and/or treatment of some of the typical musculoskeletal sports injuries. Also, conditions where the Doppler ultrasound has no value are discussed. Some...

  15. Musculoskeletal colour/power Doppler in sports medicine: image parameters, artefacts, image interpretation and therapy

    DEFF Research Database (Denmark)

    Boesen, M I; Boesen, Mikael; Kønig, Merete Juhl

    2011-01-01

    This review article discusses the aspects of sports medicine where musculoskeletal Doppler ultrasound has valuable contribution in diagnosis and/or treatment of some of the typical musculoskeletal sports injuries. Also, conditions where the Doppler ultrasound has no value are discussed. Some...

  16. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications.

    Science.gov (United States)

    Riboh, Jonathan C; Saltzman, Bryan M; Yanke, Adam B; Cole, Brian J

    2016-09-01

    Amniotic membrane (AM)-derived products have been successfully used in ophthalmology, plastic surgery, and wound care, but little is known about their potential applications in orthopaedic sports medicine. To provide an updated review of the basic science and preclinical and clinical data supporting the use of AM-derived products and to review their current applications in sports medicine. Systematic review. A systematic search of the literature was conducted using the Medline, EMBASE, and Cochrane databases. The search term amniotic membrane was used alone and in conjunction with stem cell, orthopaedic, tissue engineering, scaffold, and sports medicine. The search identified 6870 articles, 80 of which, after screening of the titles and abstracts, were considered relevant to this study. Fifty-five articles described the anatomy, basic science, and nonorthopaedic applications of AM-derived products. Twenty-five articles described preclinical and clinical trials of AM-derived products for orthopaedic sports medicine. Because the level of evidence obtained from this search was not adequate for systematic review or meta-analysis, a current concepts review on the anatomy, physiology, and clinical uses of AM-derived products is presented. Amniotic membranes have many promising applications in sports medicine. They are a source of pluripotent cells, highly organized collagen, antifibrotic and anti-inflammatory cytokines, immunomodulators, and matrix proteins. These properties may make it beneficial when applied as tissue engineering scaffolds, improving tissue organization in healing, and treatment of the arthritic joint. The current body of evidence in sports medicine is heavily biased toward in vitro and animal studies, with little to no human clinical data. Nonetheless, 14 companies or distributors offer commercial AM products. The preparation and formulation of these products alter their biological and mechanical properties, and a thorough understanding of these

  17. Development of a Database for Study Data in Registration Applications for Veterinary Medicinal Products

    Directory of Open Access Journals (Sweden)

    Anke Finnah

    2017-02-01

    Full Text Available Objective: In the present study, the feasibility of a systematic record of clinical study data from marketing authorisation applications for veterinary medicinal products (VMP and benefits of the selected approach were investigated.Background: Drug registration dossiers for veterinary medicinal products contain extensive data from drug studies, which are not easily accessible to assessors.Evidentiary value: Fast access to these data including specific search tools could facilitate a meaningful use of the data and allow assessors for comparison of test and studies from different dossiers.Methods: First, pivotal test parameters and their mutual relationships were identified. Second, a data model was developed and implemented in a relational database management system, including a data entry form and various reports for database searches. Compilation of study data in the database was demonstrated using all available clinical studies involving VMPs containing the anthelmintic drug Praziquantel. By means of descriptive data analysis possibilities of data evaluation including graphical presentation were shown. Suitability of the database to support the performance of meta-analyses was tentatively validated.Results: The data model was designed to cover the specific requirements arising from study data. A total of 308 clinical studies related to 95 VMPs containing Praziquantel (single agent and combination drugs was selected for prototype testing. The relevant data extracted from these studies were appropriately structured and shown to be basically suitable for descriptive data analyses as well as for meta-analyses.Conclusion: The database-supported collection of study data would provide users with easy access to the continuously increasing pool of scientific information held by competent authorities. It enables specific data analyses. Database design allows expanding the data model to all types of studies and classes of drugs registered in veterinary

  18. Modelling study on production cross sections of {sup 111}In radioisotopes used in nuclear medicine

    Energy Technology Data Exchange (ETDEWEB)

    Kara, Ayhan; Korkut, Turgay [Sinop Univ. (Turkey). Faculty of Engineering; Yigit, Mustafa [Aksaray Univ. (Turkey). Faculty of Science and Arts; Tel, Eyyup [Osmaniye Korkut Ata Univ. (Turkey). Faculty of Science and Arts

    2015-07-15

    Radiopharmaceuticals are radioactive drugs used for diagnosis or treatment in a tracer quantity with no pharmacological action. The production of radiopharmaceuticals is carried out in the special research centers generally using by the cyclotron systems. Indium-111 is one of the most useful radioisotopes used in nuclear medicine. In this paper, we calculated the production cross sections of {sup 111}In radioisotope via {sup 111-114}Cd(p,xn) nuclear reactions up to 60 MeV energy. In the model calculations, ALICE/ASH, TALYS 1.6 and EMPIRE 3.2 Malta nuclear reaction code systems were used. The model calculation results were compared to the experimental literature data and TENDL-2014 (TALYS-based) data.

  19. Medicinal mushroom Ganoderma lucidum in the production of special beer types

    Directory of Open Access Journals (Sweden)

    Leskošek-Čukalović Ida I.

    2009-01-01

    Full Text Available Mushrooms like Ganoderma lucidum have been used for thousands of years as a traditional medicine in the Far East. Ganoderma received wide popularity as an eating mushroom with high nutritive value, but even more as medical fungi. It has been used for the treatment of various diseases: hepatitis, hypertension, insomnia, and even cancer. Due to its extraordinary action, it is often called 'Elixir of life', 'Food of gods' and 'Mushroom of universe'. The intracellular and extracellular polysaccharides (b-glucane inhibit the growth of several types of cancer. Mushroom produces triterpenes of which especially ganoderic acid showed cytotoxicity on primary tumor liver cells, inhibition of histamine release, hepatoprotective effect, stimulation of the immune system functions, inhibition of the aggregation of blood plates, etc. On the other hand, beer as a purely natural beverage obtained in the process of fermentation, contains a number of ingredients which are important for human organism, and in moderate usage has favorable reaction on the general health condition of the body. As such, beer is a very good basis for the development of a number of new products with defined pharmacodynamics influence. In this work, we have investigated the possibilities of using extracts of mushroom Ganoderma lucidum in the production of special beer types. The composition of mushroom, properties of the most important active ingredients, extraction procedures, and sensory characteristics of the beers on the basis of such extracts were determined. The most important parameters of quality and possibility of adjustments using extracts of different medicinal herbs were investigated.

  20. Animals and their products utilized as medicines by the inhabitants surrounding the Ranthambhore National Park, India

    Directory of Open Access Journals (Sweden)

    Jaroli DP

    2006-11-01

    Full Text Available Abstract The present ethnozoological study describes the traditional knowledge related to the use of different animals and animal-derived products as medicines by the inhabitants of villages surrounding the Ranthambhore National Park of India (Bawaria, Mogya, Meena, which is well known for its very rich biodiversity. The field survey was conducted from May to July 2005 by performing interviews through structured questionnaires with 24 informants (16 men and 8 women, who provided information regarding therapeutic uses of animals. A total of 15 animals and animal products were recorded and they are used for different ethnomedical purposes, including tuberculosis, asthma, paralysis, jaundice, earache, constipation, weakness, snake poisoning. The zootherapeutic knowledge was mostly based on domestic animals, but some protected species like the collared dove (Streptopelia sp., hard shelled turtle (Kachuga tentoria, sambhar (Cervus unicolor were also mentioned as important medicinal resources. We would suggest that this kind of neglected traditional knowledge should be included into the strategies of conservation and management of faunistic resources in the investigated area.

  1. Hospital-based proton linear accelerator for particle therapy and radioisotope production

    Science.gov (United States)

    Lennox, Arlene J.

    1991-05-01

    Taking advantage of recent advances in linear accelerator technology, it is possible for a hospital to use a 70 MeV proton linac for fast neutron therapy, boron neutron capture therapy, proton therapy for ocular melanomas, and production of radiopharmaceuticals. The linac can also inject protons into a synchrotron for proton therapy of deep-seated tumors. With 180 μA average current, a single linac can support all these applications. This paper presents a conceptual design for a medical proton linac, switchyard, treatment rooms, and isotope production rooms. Special requirements for each application are outlined and a layout for sharing beam among the applications is suggested.

  2. Medicinal Plants Based Products Tested on Pathogens Isolated from Mastitis Milk

    Directory of Open Access Journals (Sweden)

    Claudia Pașca

    2017-09-01

    Full Text Available Bovine mastitis a major disease that is commonly associated with bacterial infection. The common treatment is with antibiotics administered intramammary into infected quarters of the udder. The excessive use of antibiotics leads to multidrug resistance and associated risks for human health. In this context, the search for alternative drugs based on plants has become a priority in livestock medicine. These products have a low manufacturing cost and no reports of antimicrobial resistance to these have been documented. In this context, the main objective of this study was to determine the antimicrobial effect of extracts and products of several indigenous, or acclimatized plants on pathogens isolated from bovine mastitis. A total of eleven plant alcoholic extracts and eight plant-derived products were tested against 32 microorganisms isolated from milk. The obtained results have shown an inhibition of bacterial growth for all tested plants, with better results for Evernia prunastri, Artemisia absinthium, and Lavandula angustifolia. Moreover, E. prunastri, Populus nigra, and L. angustifolia presented small averages of minimum inhibitory and bactericidal concentrations. Among the plant-derived products, three out of eight have shown a strong anti-microbial effect comparable with the effect of florfenicol and enrofloxacin, and better than individual plant extracts possibly due to synergism. These results suggest an important anti-microbial effect of these products on pathogens isolated from bovine mastitis with a possible applicability in this disease.

  3. Effect of oriental medicine music therapy on patients with Hwa-byung: a study protocol for a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background Hwa-byung, a Korean culture-bound syndrome with both psychological and somatic symptoms, is also known as ‘anger syndrome’. It includes various physical symptoms including anxiety, a feeling of overheating, a sensation of pressure on the chest, heart palpitations, respiratory stuffiness, insomnia, and anxiety. Methods/design The proposed study is a single-center, double-blind, randomized, controlled trial with two parallel arms: an oriental medicine music therapy (OMMT) group and a control music therapy (CMT) group. In total, 48 patients will be enrolled into the trial. The first visit will be the screening visit. At baseline (visit 2), all participants fulfilling both the inclusion and the exclusion criteria will be split and randomly divided into two equal groups: the OMMT and the CMT (n = 24 each). Each group will receive treatment sessions over the course of 4 weeks, twice per week, for eight sessions in total. The primary outcome is the State-Trait Anxiety Inventory (STAI), and the secondary outcomes are the Hwa-byung scale (H-scale), the Center for Epidemiologic Studies Depression Scale (CES-D), the Hwa-byung visual analogue scale (H-VAS) for primary symptoms, the World Health Organization Quality of Life scale, brief version (WHOQOL-BREF), and levels of salivary cortisol. Patients will be asked to complete questionnaires at the baseline visit (visit 2), after the last treatment session (visit 9), and at 4 weeks after the end of all trial sessions (visit 10). From the baseline (visit 2) through the follow-up (visit 10), the entire process will take a total of 53 days. Discussion This proposed study targets patients with Hwa-byung, especially those who have exhibited symptoms of anxiety. Therefore, the primary outcome is set to measure the level of anxiety. OMMT is music therapy combined with traditional Korean medicinal theories. Unlike previously reported music therapies, for which patients simply listen to music passively, in OMMT, patients

  4. Effect of oriental medicine music therapy on patients with Hwa-byung: a study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Park Jeong-Su

    2012-09-01

    Full Text Available Abstract Background Hwa-byung, a Korean culture-bound syndrome with both psychological and somatic symptoms, is also known as ‘anger syndrome’. It includes various physical symptoms including anxiety, a feeling of overheating, a sensation of pressure on the chest, heart palpitations, respiratory stuffiness, insomnia, and anxiety. Methods/design The proposed study is a single-center, double-blind, randomized, controlled trial with two parallel arms: an oriental medicine music therapy (OMMT group and a control music therapy (CMT group. In total, 48 patients will be enrolled into the trial. The first visit will be the screening visit. At baseline (visit 2, all participants fulfilling both the inclusion and the exclusion criteria will be split and randomly divided into two equal groups: the OMMT and the CMT (n = 24 each. Each group will receive treatment sessions over the course of 4 weeks, twice per week, for eight sessions in total. The primary outcome is the State-Trait Anxiety Inventory (STAI, and the secondary outcomes are the Hwa-byung scale (H-scale, the Center for Epidemiologic Studies Depression Scale (CES-D, the Hwa-byung visual analogue scale (H-VAS for primary symptoms, the World Health Organization Quality of Life scale, brief version (WHOQOL-BREF, and levels of salivary cortisol. Patients will be asked to complete questionnaires at the baseline visit (visit 2, after the last treatment session (visit 9, and at 4 weeks after the end of all trial sessions (visit 10. From the baseline (visit 2 through the follow-up (visit 10, the entire process will take a total of 53 days. Discussion This proposed study targets patients with Hwa-byung, especially those who have exhibited symptoms of anxiety. Therefore, the primary outcome is set to measure the level of anxiety. OMMT is music therapy combined with traditional Korean medicinal theories. Unlike previously reported music therapies, for which patients simply listen to music passively, in

  5. Bibliometric Analysis of Traditional Chinese Medicine Scientific Production between 1982 and 2016 Indexed in PubMed.

    Science.gov (United States)

    Consentino, Ricardo; Santos, Maria João; Matos, Luís Carlos; Machado, Jorge Pereira

    2018-05-03

    Background: Traditional Chinese medicine (TCM) may be understood as a system of sensations and findings designed to establish the functional vegetative state of the body. This state may be treated by several therapeutic methods such as acupuncture, Chinese pharmacotherapy, dietetics, Tuina , and Qigong . Nowadays, as a result of several evidence-based reported beneficial effects over specific pathological conditions, there is an increasing tendency to integrate some of these practices in Western medicine. The main goal of this study was to perform a bibliometric analysis of TCM scientific production between 1982 and 2016 indexed in PubMed, by analyzing several parameters including time and location distribution, publication quality, experimental design, and treatment methods. Methods: The methodology was based on the quantitative inventory of published scientific research indexed in PubMed medical subject headings (MeSH), sorted within the broad term “Traditional Chinese Medicine” and integrating the following criteria as limit filters: “Species: Humans”, “Article Type: Clinical Trial”. In addition, the articles’ triage was ruled by temporal limitations set between 1945 and 2016. Results: The overall analysis of data allowed observation of an average annual growth of approximately 33%, with a productive peak of 122 articles in 2007. The scientific production was distributed in 27 countries, led by China (76.1%), followed by the United States of America (3.0%) and South Korea (2.1%). A significant amount of references were published in Chinese journals: more than 50%; however, these journals had a low impact factor. The most cited treatments in the keywords section of the articles were phytotherapy (55%) and acupuncture (40%). Conclusion: The increasing demand for TCM seems to be due to factors such as lower side effects and greater efficacy in some patients not responding well to conventional therapy. As a result, a considerable amount of TCM science

  6. A systematic review and meta-analysis of traditional insect Chinese medicines combined chemotherapy for non-surgical hepatocellular carcinoma therapy.

    Science.gov (United States)

    Shi, Zhaofeng; Song, Tiebing; Wan, Yi; Xie, Juan; Yan, Yiquan; Shi, Kekai; Du, Yongping; Shang, Lei

    2017-06-28

    On the background of high morbidity and mortality of hepatocellular carcinoma (HCC) and rapid development of traditional Chinese medicine (TCM), we conducted a systematic review and meta-analysis of randomized clinical trials (RCTs) according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement to assess the clinical effectiveness and safety of traditional insect Chinese medicine and related preparation for non-surgical HCC. RCTs were searched based on standardized searching rules in mainstream medical databases from the inception up to May 2016. Ultimately, a total of 57 articles with 4,651 patients enrolled in this meta-analysis. We found that traditional insect Chinese medicine and related preparation combined chemotherapy show significantly effectiveness and safety in objective response rate (P traditional insect Chinese medicine and related preparations could be recommended as auxiliary therapy combined chemotherapy for HCC therapy.

  7. Principles of diet therapy in ancient Chinese medicine: 'Huang Di Nei Jing'.

    Science.gov (United States)

    Ho, Z C

    1993-06-01

    Huang Di Nei Jing, the first systematic Chinese medical book, was compiled from the observations of imperial herbal doctors in the Qin and Han periods (221 BC - 220 AD). From this classic traditional source may be derived the concept of a balanced and complete diet and probably the world's first dietary guidelines. Basic to the tradition are han, re, wen and bu foods, respectively 'cold', 'hot', 'neutral', 'strengthening'. Basic to Chinese cuisine are jan and tsai- 'cereal' (the rice staple and main meal) and 'dishes' to accompany the rice. Chinese traditional medicine, as in Huang Di Nei Jing, considers the nourishment of body and mind. It also emphasises that herbal medicine and food have the same origin. Diet was essential to the prevention of disease which a glossary of Chinese terms is given at the end of the paper in the Chinese tradition, was superior to treatment.

  8. Discovery Monday - Physics for medicine: the use of accelerators in therapy

    CERN Multimedia

    2004-01-01

    What does research at CERN have to do with medicine? Perhaps very little at first glance. And yet particle beams are proving to be efficient weapons in the fight against certain diseases. Doctors and physicists will explain how and why at the next Discovery Monday, to be held at Microcosm on 3 May. The event will take place at Microcosm on 3 May, from 7.30 p.m. to 9.00 p.m. Entrance free.

  9. Changing educational paradigms in transfusion medicine and cellular therapies: development of a profession.

    Science.gov (United States)

    Hathaway, Elaine Osier

    2005-10-01

    The transfusion medicine profession can be easily compared and contrasted with an early 1900 ironclad ship operating in the rough seas of the 21st century. Without modifying the old ship to today's standards, even the captain and crew will begin to expect the ship to meet its demise. The unfortunate passengers, on the other hand, do not expect that they are on an old obsolete ship and, instead, are innocent victims stuck on a doomed course. The old ironclad ship must change into a sleek cruiser and utilize the latest available technology so that its well-educated and competent captain and crew can safely navigate even the most challenging waters. The transfusion medicine profession must transform itself into a state-of-the-art ship so that it, like the refurbished ironclad ship, can be set on cruise control through the open seas. The question facing our industry is do we have the courage to utilize modern technology and to commit the funds necessary to develop, implement, and maintain our existence? It is difficult to plot a steady course into the future because of existing challenges that stand ready to sink our profession, including economic wrangling over regulation, technologic changes, generation conflict, and political differences that threaten our excellence. The primary purpose of this article is to focus on the educational needs that affect all personnel involved in transfusion medicine. In addition, this article will address potential adverse outcomes and investigate possible resolutions to avoid the "sinking ship." Within the next 5 to 7 years, without a corrective course of action, our profession will be at the bottom of the clinical ladder, remembered more for its demise and tragic ending than for its accomplishments. It is hoped, successful implementation of changes in educational paradigms in transfusion medicine may lead to a renaissance within our workforce-generations working together, each sharing and learning from one another.

  10. Toward An Ethics of Reciprocity: Ethnobotanical Knowledge and Medicinal Plants as Cancer Therapies

    Directory of Open Access Journals (Sweden)

    John Charles Ryan

    2014-10-01

    Full Text Available This article develops a reciprocity ethics of the environment through a discussion of ethnobotanical medicines used in the treatment of cancer. The moral virtue of reciprocity, defined as the returning of good when good is received or anticipated, is central to the posthumanist rethinking of human relationships to the plant world. As herbal medicines are used progressively more around the globe and as plant diversity decreases as a result of habitat loss and climate change, an ethics of reciprocity should be a concern for environmental philosophers and conservationists. Aldo Leopold’s land ethic and J. Baird Callicott’s distinction between deontological and prudential environmental ethics provide theoretical contexts for the development of a reciprocity ethics vis-à-vis ethnobotanical species. While this article does not necessarily specify modes or forms of reciprocity, it does outline some of the more prominent ethnobotanical species used in the treatment of cancer, including those from Native American, African, Chinese, and Indian traditions. In the form of a dialogue between the fields of ethnobotany, herbal medicine, and environmental philosophy, this article presents a position from which further articulations of reciprocity can be developed, particularly those involving the rights of indigenous cultures and plants.

  11. Artificial intelligence: A joint narrative on potential use in pediatric stem and immune cell therapies and regenerative medicine.

    Science.gov (United States)

    Sniecinski, Irena; Seghatchian, Jerard

    2018-05-09

    Artificial Intelligence (AI) reflects the intelligence exhibited by machines and software. It is a highly desirable academic field of many current fields of studies. Leading AI researchers describe the field as "the study and design of intelligent agents". McCarthy invented this term in 1955 and defined it as "the science and engineering of making intelligent machines". The central goals of AI research are reasoning, knowledge, planning, learning, natural language processing (communication), perception and the ability to move and manipulate objects. In fact the multidisplinary AI field is considered to be rather interdisciplinary covering numerous number of sciences and professions, including computer science, psychology, linguistics, philosophy and neurosciences. The field was founded on the claim that a central intellectual property of humans, intelligence-the sapience of Homo Sapiens "can be so precisely described that a machine can be made to simulate it". This raises philosophical issues about the nature of the mind and the ethics of creating artificial beings endowed with human-like intelligence. Artificial Intelligence has been the subject of tremendous optimism but has also suffered stunning setbacks. The goal of this narrative is to review the potential use of AI approaches and their integration into pediatric cellular therapies and regenerative medicine. Emphasis is placed on recognition and application of AI techniques in the development of predictive models for personalized treatments with engineered stem cells, immune cells and regenerated tissues in adults and children. These intelligent machines could dissect the whole genome and isolate the immune particularities of individual patient's disease in a matter of minutes and create the treatment that is customized to patient's genetic specificity and immune system capability. AI techniques could be used for optimization of clinical trials of innovative stem cell and gene therapies in pediatric patients

  12. Structure, control and regulation of the formal market for medicinal plants' products in Nigeria.

    Science.gov (United States)

    Oguntade, Adegboyega E; Oluwalana, Isaac B

    2011-01-01

    There are informal and formal markets for medicinal plants' products in Nigeria. The formal market is subject to the national regulatory framework for Food and Drug Administration and Control. It is relatively new and underdeveloped. This study was designed to appraise this market with special emphasis on the market participants, market structure, marketing functions performed, conduct of sellers in the market and; standards and regulations to which the market is subject. Information used for this study was collected through personal interviews and interactions with key participants in the market; especially the officials of regulatory agency. The market structure was analysed in terms of the share of market controlled by participants and product types. Concentration Ratios (CR2 and CR4) were used to assess the market share. Marketing functions being performed were described in terms of the exchange, physical and facilitating functions while the conduct was described in terms of pricing and promotional strategies. The regulatory framework under which the market operates was appraised. The market was highly concentrated with a CR2 and CR4 of 58.5% and 80.8 %; respectively. Imported products accounted for only 12.3% of the market. The predominant modes of presentation of the product were capsule (41.6%) and liquid (36.2%). About 20.77% of the products were classified as multivitamins, 13.85% were antibiotics while 10.77% addressed sexual dysfunctional problems. These products were regulated under the Food and Drug Administration and Control (NAFDAC) decrees, 1993-1999. Only 2.3% of the products have received full registration status while the others were only listed.

  13. Photodynamic Therapy of Skin using Porphyrin Precursors: Optical Monitoring, Vascular Effects and Personalized Medicine

    NARCIS (Netherlands)

    T.A. Middelburg (Tom)

    2014-01-01

    markdownabstract__Abstract__ Photodynamic therapy (PDT) is based on a photochemical reaction that involves three basic components: (1) a photosensitizer, which is a light-sensitive molecule that mediates transfer of light energy to molecular oxygen; (2) light of the appropriate wavelength that

  14. Challenges in implementing individualized medicine illustrated by antimetabolite therapy of childhood acute lymphoblastic leukemia

    DEFF Research Database (Denmark)

    Nersting, Jacob; Borst, Louise; Schmiegelow, Kjeld

    2011-01-01

    , but also multiplied the complex interaction of genetic and other laboratory parameters that can be used for therapy adjustments. Thus, with the advances in the laboratory techniques, post laboratory issues have become major obstacles for treatment individualization. Many of these challenges have been...

  15. Clinical relevance of nuclear medicine in diagnostics and therapy of the thyroid

    International Nuclear Information System (INIS)

    1982-01-01

    50 papers divided into 7 interrelated topics including the corresponding discussions are reported. The papers deal with diagnostics and therapy of thyroid diseases by means of radiopharmaceuticals. Carcinomas and functional disorders of the thyroid are discussed in the same way as problems of thyroiditis and thyroid immunology as well as morphological diagnostics of the thyroid and thyroid function related to other internal diseases

  16. Giving information on medicinal products to the general public--in search of a definition to safeguard the patient.

    Science.gov (United States)

    Faeh, Andrea

    2014-04-01

    Information on medicinal products is vital for enabling patients to give informed consent to the use of a specific product. Within the European Union (EU) the debate about how much information about prescription-only medicinal products should be made available to patients has gone on for the past five years with no definite conclusion yet. This contribution assesses the current legislation and the ongoing debate in order to identify the challenges and the prospect of new legislation, and consider its potential implications for the scope for advertising and for patient safety.

  17. Sustainability of a public system for plasma collection, contract fractionation and plasma-derived medicinal product manufacturing.

    Science.gov (United States)

    Grazzini, Giuliano; Ceccarelli, Anna; Calteri, Deanna; Catalano, Liviana; Calizzani, Gabriele; Cicchetti, Americo

    2013-09-01

    In Italy, the financial reimbursement for labile blood components exchanged between Regions is regulated by national tariffs defined in 1991 and updated in 1993-2003. Over the last five years, the need for establishing standard costs of healthcare services has arisen critically. In this perspective, the present study is aimed at defining both the costs of production of blood components and the related prices, as well as the prices of plasma-derived medicinal products obtained by national plasma, to be used for interregional financial reimbursement. In order to analyse the costs of production of blood components, 12 out 318 blood establishments were selected in 8 Italian Regions. For each step of the production process, driving costs were identified and production costs were. To define the costs of plasma-derived medicinal products obtained by national plasma, industrial costs currently sustained by National Health Service for contract fractionation were taken into account. The production costs of plasma-derived medicinal products obtained from national plasma showed a huge variability among blood establishments, which was much lower after standardization. The new suggested plasma tariffs were quite similar to those currently in force. Comparing the overall costs theoretically sustained by the National Health Service for plasma-derived medicinal products obtained from national plasma to current commercial costs, demonstrates that the national blood system could gain a 10% cost saving if it were able to produce plasma for fractionation within the standard costs defined in this study. Achieving national self-sufficiency through the production of plasma-derived medicinal products from national plasma, is a strategic goal of the National Health Service which must comply not only with quality, safety and availability requirements but also with the increasingly pressing need for economic sustainability.

  18. Application of stem cell/growth factor system, as a multimodal therapy approach in regenerative medicine to improve cell therapy yields.

    Science.gov (United States)

    Pourrajab, Fatemeh; Babaei Zarch, Mojtaba; Baghi Yazdi, Mohammad; Rahimi Zarchi, Abolfazl; Vakili Zarch, Abbas

    2014-04-15

    Stem cells hold a great promise for regenerative medicine, especially for replacing cells in infarcted organ that hardly have any intrinsic renewal capacity, including heart and brain. Signaling pathways that regulate pluripotency or lineage-specific gene and protein expression have been the major focus of stem cell research. Between them, there are some well known signaling pathways such as GF/GFR systems, SDF-1α/CXC4 ligand receptor interaction and PI3K/Akt signaling, and cytokines may regulate cell fate decisions, and can be utilized to positively influence cell therapy outcomes or accentuate synergistic compliance. For example, contributing factors in the progression of heart failure are both the loss of cardiomyocytes after myocardial infarction, and the absence of an adequate endogenous repair signaling. Combining cell engraftment with therapeutic signaling factor delivery is more exciting in terms of host progenitor/donor stem cell survival and proliferation. Thus stem cell-based therapy, besides triggering signaling pathways through GF/GFR systems can become a realistic option in regenerative processes for replacing lost cells and reconstituting the damaged organ, as before. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  19. Food effects in paediatric medicines development for products Co-administered with food.

    Science.gov (United States)

    Batchelor, Hannah; Kaukonen, Ann Marie; Klein, Sandra; Davit, Barbara; Ju, Rob; Ternik, Robert; Heimbach, Tycho; Lin, Wen; Wang, Jian; Storey, David

    2018-02-05

    A small amount of food is commonly used to aid administration of medicines to children to improve palatability and/or swallowability. However the impact of this co-administered food on the absorption and subsequent pharmacokinetic profile of the drug is unknown. Existing information on food effects is limited to standard protocols used to evaluate the impact of a high fat meal in an adult population using the adult medication. In the absence of a substantial body of data, there are no specific guidelines available during development of paediatric products relating to low volumes of potentially low calorie food. This paper brings together expertise to consider how the impact of co-administered food can be risk assessed during the development of a paediatric medicine. Two case studies were used to facilitate discussions and seek out commonalities in risk assessing paediatric products; these case studies used model drugs that differed in their solubility, a poorly soluble drug that demonstrated a positive food effect in adults and a highly soluble drug where a negative food effect was observed. For poorly soluble drugs risk assessments are centred upon understanding the impact of food on the in vivo solubility of the drug which requires knowledge of the composition of the food and the volumes present within the paediatric gastrointestinal tract. Further work is required to develop age appropriate in vitro and in silico models that are representative of paediatric populations. For soluble drugs it is more important to understand the mechanisms that may lead to a food effect, this may include interactions with transporters or the impact of the food composition on gastro-intestinal transit or even altered gastric motility. In silico models have the most promise for highly soluble drug products although it is essential that these models reflect the relevant mechanisms involved in potential food effects. The development of appropriate in vitro and in silico tools is

  20. Animal-derived natural products of Sowa Rigpa medicine: Their pharmacopoeial description, current utilization and zoological identification.

    Science.gov (United States)

    Yeshi, Karma; Morisco, Paolo; Wangchuk, Phurpa

    2017-07-31

    The Bhutanese Sowa Rigpa medicine (BSM) uses animal parts in the preparation of numerous polyingredient traditional remedies. Our study reports the taxonomical identification of medicinal animals and the description of traditional uses in English medical terminologies. To taxonomically identify the medicinal animals and their derived natural products used as a zootherapeutic agents in BSM. First, the traditional textbooks were reviewed to generate a list of animal products described as ingredients. Second, animal parts that are currently used in Bhutan were identified. Third, the ethnopharmacological uses of each animal ingredients were translated into English medical terminologies by consulting Traditional Physicians, clinical assistants, pharmacognosists, and pharmacists in Bhutan. Fourth, the animal parts were taxonomically identified and their Latin names were confirmed by crosschecking them with online animal databases and relevant scientific literature. The study found 73 natural products belonging to 29 categories derived from 45 medicinal animals (36 vertebrates and 9 invertebrates), comprising of 9 taxonomic categories and 30 zoological families. Out of 116 formulations currently produced, 87 of them contain one or more extracts and products obtained from 13 medicinal animals to treat more than 124 traditionally classified illnesses. Only five animal ingredients were found available in Bhutan and rest of the animal parts are being imported from India. Out of 73 natural products described in the traditional textbooks, only 13 of them (some omitted and few substituted by plants) are currently included in 87 formulations of BSM. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

  1. Proceedings of the signature series event of the international society for cellular therapy: "Advancements in cellular therapies and regenerative medicine in digestive diseases," London, United Kingdom, May 3, 2017.

    Science.gov (United States)

    Ciccocioppo, Rachele; Dos Santos, Claudia C; Baumgart, Daniel C; Cangemi, Giuseppina C; Cardinale, Vincenzo; Ciacci, Carolina; De Coppi, Paolo; Haldar, Debashis; Klersy, Catherine; Nostro, M Cristina; Ott, Michael; Piemonti, Lorenzo; Tomei, Alice A; Uygun, Basak; Vetrano, Stefania; Orlando, Giuseppe

    2018-03-01

    A summary of the First Signature Series Event, "Advancements in Cellular Therapies and Regenerative Medicine for Digestive Diseases," held on May 3, 2017, in London, United Kingdom, is presented. Twelve speakers from three continents covered major topics in the areas of cellular therapy and regenerative medicine applied to liver and gastrointestinal medicine as well as to diabetes mellitus. Highlights from their presentations, together with an overview of the global impact of digestive diseases and a proposal for a shared online collection and data-monitoring platform tool, are included in this proceedings. Although growing evidence demonstrate the feasibility and safety of exploiting cell-based technologies for the treatment of digestive diseases, regulatory and methodological obstacles will need to be overcome before the successful implementation in the clinic of these novel attractive therapeutic strategies. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  2. Non-timber forest products marketing systems and market players in southwest Virginia: crafts, medicinal and herbal, and specialty wood products

    Science.gov (United States)

    S.M. Greene; A.L. Hammett; S. Kant

    2000-01-01

    Non-timber forest products (NTFPs) are important in rural southwest Virginia as a source of household income. Marketing system of crafts, medicinal and herbal, and specialty wood products are studied using exploratory and qualitative research methods. Fifty market players at various levels in marketing chains are interviewed to get the information on elements of...

  3. Risks in production and utilisation of labelled compounds for nuclear medicine. 2. Benefits and risks of utilization of 99mTc generator in nuclear medicine

    International Nuclear Information System (INIS)

    Olteanu-Chiper, D.; Barna, C.; Gard, E.; Negoita, N.

    1999-01-01

    The growth of radioisotope applications in nuclear medicine, imposed the reduction of the radiation effects and so, the reduction of associated risk of these applications. The utilization of radioactive isotopes for investigations in nuclear medicine is conditioned by the chemical behaviour and the means of detection of the emitted radiation on one hand, and by the radiation doses received by the patient, on the other hand. In these conditions, the nuclear medicine uses only the radioisotopes which are short half-time and low radiation energy, but high enough to be detected from the exterior of human body, 99m Tc being the most favourable for utilization in diagnostic purpose. This advantage is increased by the multiple possibilities to obtain different chemical forms with 99m Tc included, which permit the production of a large variety of radiopharmaceutical products, having a specific localization in the human body (organ-targets), thus allowing the diagnosis of numerous diseases. In the work the benefits and risks of the 99m Tc-Generator utilization in the nuclear medicine are shown and the utilization technique in these applications is presented . The 99m Tc-Generator is a compact chromatographic system, with lead shielding, which permits the elution of a sterile, pyrogen-free, injectable sodium pertechnetate solution, from an aluminium chromatographic column which keeps the 99 Mo. The 99m Tc-Generator system ensures the operator protection. The radioactive solution with 99m Tc is obtained in a closed vial, within lead shielding, the irradiation or contamination risks being mostly reduced. The utilization of 99m Tc in scintigraphic exam for diagnostic medicine implies a labelling operation with 99m Tc chemically bounded in forms appropriate to the target-organ and than the intravenously injection in doses dependent on the specific scintigraphic investigation or examination. (authors)

  4. Effectiveness of active self-care complementary and integrative medicine therapies: options for the management of chronic pain symptoms.

    Science.gov (United States)

    Crawford, Cindy; Lee, Courtney; Freilich, Daniel

    2014-04-01

    Chronic pain management typically consists of prescription medications or provider-based, behavioral, or interventional procedures that are often ineffective, may be costly, and can be associated with undesirable side effects. Because chronic pain affects the whole person (body, mind, and spirit), patient-centered complementary and integrative medicine (CIM) therapies that acknowledge the patients' roles in their own healing processes have the potential to provide more efficient and comprehensive chronic pain management. Active self-care CIM (ACT-CIM) therapies allow for a more diverse, patient-centered treatment of complex symptoms, promote self-management, and are relatively safe and cost-effective. To date, there are no systematic reviews examining the full range of ACT-CIM used for chronic pain symptom management. A systematic review was conducted, using Samueli Institute's Rapid Evidence Assessment of the Literature methodology, to rigorously assess both the quality of the research on ACT-CIM modalities and the evidence for their efficacy and effectiveness in treating chronic pain symptoms. A working group of subject matter experts was also convened to evaluate the overall literature pool and develop recommendations for the use and implementation of these modalities. Following key database searches, 146 randomized controlled trials were included in the review, 18 of which directly compared ACT-CIM approaches with one another. This article summarizes the current evidence, quality, effectiveness, and safety of these modalities. Recommendations and next steps to move this field of research forward are also discussed. The entire scope of the review is detailed throughout the current Pain Medicine supplement. Wiley Periodicals, Inc.

  5. Herbal medicinal products versus botanical-food supplements in the European market: state of art and perspectives.

    Science.gov (United States)

    Bilia, Anna Rita

    2015-01-01

    Botanical products marketed in Europe are diverse, classified as herbal medicinal products, dietary supplements, cosmetics, foods and beverages depending on the relevant applicable legislation. Many factors are taken into account in the classification of a botanical product (e.g. intended use, labeling, preparations and dosages) according to how it is placed on the market. Herbal medicinal products (HMPs) can only be sold in pharmacies, under the supervision of a pharmacist, and are marketed after full or simplified registration procedures according to their classification, i.e. as over-the-counter drugs (OTC) available without special restrictions and prescription only medicine (POM), which must be prescribed by a licensed medical practitioner. The dietary supplement segment is also sold in the market in dose form (such as capsules, tablets, ampoules of liquids, drops etc) and represents 15-20% of the botanical market at the European level with high variability among each country (i.e. in Italy it reaches up to 80%). In many cases the distinction between medicinal products and food supplements has generated borderline botanical-sourced products, which generally produce confusion and mislead the consumers. As a consequence, there is an urgent need of consumer education and in addition to collect comprehensive data and make this database systematically available to herbalists, nutritionists and medical specialists for a proper classification and harmonization of the use of botanical ingredients, and, as consequence, a correct use of these products.

  6. Cellular Therapies in Trauma and Critical Care Medicine: Forging New Frontiers.

    Science.gov (United States)

    Pati, Shibani; Pilia, Marcello; Grimsley, Juanita M; Karanikas, Alexia T; Oyeniyi, Blessing; Holcomb, John B; Cap, Andrew P; Rasmussen, Todd E

    2015-12-01

    Trauma is a leading cause of death in both military and civilian populations worldwide. Although medical advances have improved the overall morbidity and mortality often associated with trauma, additional research and innovative advancements in therapeutic interventions are needed to optimize patient outcomes. Cell-based therapies present a novel opportunity to improve trauma and critical care at both the acute and chronic phases that often follow injury. Although this field is still in its infancy, animal and human studies suggest that stem cells may hold great promise for the treatment of brain and spinal cord injuries, organ injuries, and extremity injuries such as those caused by orthopedic trauma, burns, and critical limb ischemia. However, barriers in the translation of cell therapies that include regulatory obstacles, challenges in manufacturing and clinical trial design, and a lack of funding are critical areas in need of development. In 2015, the Department of Defense Combat Casualty Care Research Program held a joint military-civilian meeting as part of its effort to inform the research community about this field and allow for effective planning and programmatic decisions regarding research and development. The objective of this article is to provide a "state of the science" review regarding cellular therapies in trauma and critical care, and to provide a foundation from which the potential of this emerging field can be harnessed to mitigate outcomes in critically ill trauma patients.

  7. Towards precision medicine-based therapies for glioblastoma: interrogating human disease genomics and mouse phenotypes.

    Science.gov (United States)

    Chen, Yang; Gao, Zhen; Wang, Bingcheng; Xu, Rong

    2016-08-22

    Glioblastoma (GBM) is the most common and aggressive brain tumors. It has poor prognosis even with optimal radio- and chemo-therapies. Since GBM is highly heterogeneous, drugs that target on specific molecular profiles of individual tumors may achieve maximized efficacy. Currently, the Cancer Genome Atlas (TCGA) projects have identified hundreds of GBM-associated genes. We develop a drug repositioning approach combining disease genomics and mouse phenotype data towards predicting targeted therapies for GBM. We first identified disease specific mouse phenotypes using the most recently discovered GBM genes. Then we systematically searched all FDA-approved drugs for candidates that share similar mouse phenotype profiles with GBM. We evaluated the ranks for approved and novel GBM drugs, and compared with an existing approach, which also use the mouse phenotype data but not the disease genomics data. We achieved significantly higher ranks for the approved and novel GBM drugs than the earlier approach. For all positive examples of GBM drugs, we achieved a median rank of 9.2 45.6 of the top predictions have been demonstrated effective in inhibiting the growth of human GBM cells. We developed a computational drug repositioning approach based on both genomic and phenotypic data. Our approach prioritized existing GBM drugs and outperformed a recent approach. Overall, our approach shows potential in discovering new targeted therapies for GBM.

  8. [Efficacy on nervous tinnitus of kidney deficiency treated with Zhuang medicine at Qineihuan point and conventional acupuncture therapy].

    Science.gov (United States)

    Li, Xiujuan; Li, Jie; Han, Haitao; Huang, Jinming; Li, Meikang; Lu Xuanlin; Song, Ning; Lin, Hua-sheng; Li, Xuemei; Huang, Guihua

    2015-04-01

    To compare the difference of the clinical efficacy in treatment of nervous tinnitus of kidney deficiency between the combined therapy of Zhuang medicine at Qineihuan point combined with the conventional acupuncture and simple conventional acupancture. Sixty patients were randomized into an observation group and a control group, 30 cases in each one. In the control group, the conventional acupuncture was applied to Taixi (KI 3), Zhaohai (KI 6), Tinggong (SI 19) and Waiguan (TE 5), etc. and the needles were retained for 30 min. In the observation group, on the basic treatment as the control group, Zhuang medicine acupuncture at Qineihuan point was added. The treatment was given once every day, 10 treatments made one session and there were 2 days of interval between the sessions. In 3 sessions of treatment, the changes of tinnitus were observed and the clinical efficacy was evaluated. After treatment, tinnitus score and tinnitus grade were all improved as compared with those before treatment in the two groups (all Pacupuncture achieves the better efficacy on nervous tinnitus of kidney deficiency as compared with the simple conventional acupuncture.

  9. Regulation (EC No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations

    Directory of Open Access Journals (Sweden)

    Lehmann Birka

    2008-12-01

    Full Text Available Abstract Before any medicinal product is authorised for use in adults, it must undergo extensive pharmaceutical consistency and stability tests, toxicological tests and clinical trials to ensure that it is of high quality, safe and effective. The same approach may not always be applied to medicinal products used to treat children. Studies showed that over 50% of the medicinal products used in children may not have been tested for use in this age group. The absence of suitable authorised medicinal products to treat conditions in children results from the fact that pharmaceutical companies do not adapt medicinal products to the needs of the paediatric population. This leaves health care professionals with no alternative other than to use medicinal products "off-label" and to use unauthorised products with the associated risks of inefficacy and/or adverse reactions. The Regulation (EC No 1901/2006 sets up a system of requirements, rewards and incentives, together with horizontal measures, to ensure that medicinal products are researched, developed and authorised to meet the therapeutic needs of children. The Regulation is addressed to: 1. The pharmaceutical industry by setting out the legal framework for receiving rewards and incentives by conducting clinical trials in the paediatric population. 2. The Member States to set out to support research into, and the development and availability of, medicinal products for paediatric use. 3. The Community as funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate. The legal framework for conducting clinical trials, including children/minors, is set up in Directive 2001/20/EC, the Clinical Trials Directive (CTD, for the European Union (EU. The CTD establishes specific provisions regarding conduct of

  10. [Vigilance for veterinary medicinal products: declarations of adverse reactions in the year 2009].

    Science.gov (United States)

    Müntener, C R; Bruckner, L; Stürer, A; Althaus, F R; Caduff-Janosa, P

    2010-12-01

    During the year 2009, 134 reports of suspected adverse drug reactions (ADRs) to veterinary medicinal products (VMPs) were received (106 in the year 2008). The distribution according to species and drug classes remained in line with previous years. Companion animals were involved in most of the reports (46 % dogs, 19 % cats), followed by cattle or calves (22 %). Antiparasitic drugs made the biggest part with 30 % of the reports, followed by antiinfectives (19 %) and hormones (13 %). Some reactions following their use are specifically discussed. 95 additional enquiries about ADRs of VMPs were received by the Swiss Toxicological Information Centre in Zürich. Most of them concerned dogs or cats and antiparasitics or anti-inflammatory drugs. In the vaccinovigilance program, a total of 1020 reports were received, of which 1000 were related to the vaccination against blue tongue disease. The most frequently reported adverse reactions were aborts, mastitis or alterations of milk quality and they are specifically discussed.

  11. Revision of the ICH guideline on detection of toxicity to reproduction for medicinal products: SWOT analysis.

    Science.gov (United States)

    Barrow, Paul

    2016-09-01

    SWOT analysis was used to gain insights and perspectives into the revision of the ICH S5(R2) guideline on detection of toxicity to reproduction for medicinal products. The current ICH guideline was rapidly adopted worldwide and has an excellent safety record for more than 20 years. The revised guideline should aim to further improve reproductive and developmental (DART) safety testing for new drugs. Alternative methods to animal experiments should be used whenever possible. Modern technology should be used to obtain high quality data from fewer animals. Additions to the guideline should include considerations on the following: limit dose setting, maternal toxicity, biopharmaceuticals, vaccines, testing strategies by indication, developmental immunotoxicity, and male-mediated developmental toxicity. Emerging issues, such as epigenetics and the microbiome, will most likely pose challenges to DART testing in the future. It is hoped that the new guideline will be adopted even outside the ICH regions. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Do ultra-orphan medicinal products warrant ultra-high prices? A review

    Directory of Open Access Journals (Sweden)

    Picavet E

    2013-06-01

    Full Text Available Eline Picavet,1 David Cassiman,2 Steven Simoens1 1Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium; 2Department of Hepatology, University Hospital Leuven, Leuven, Belgium Abstract: Ultra-orphan medicinal products (ultra-OMPs are intended for the treatment, prevention, or diagnosis of ultra-rare diseases, ie, life-threatening or chronically debilitating diseases that affect less than one per 50,000 individuals. Recently, high prices for ultra-OMPs have given rise to debate on the sustainability and justification of these prices. The aim of this article is to review the international scientific literature on the pricing of ultra-OMPs and to provide an overview of the current knowledge on the drivers of ultra-OMP pricing. The pricing process of ultra-OMPs is a complex and nontransparent issue. Evidence in the literature seems to indicate that ultra-OMPs are priced according to rarity and what the manufacturer believes the market will bear. Additionally, there appears to be a trend between the price of an ultra-OMP and the number of available alternatives. Patients, third-party payers, and pharmaceutical companies could benefit from more transparent pricing strategies. With a view to containing health care costs, it is likely that cost-sharing strategies, such as performance-based risk sharing arrangements, will become increasingly more important. However, it is vital that any measures for price control are consistent with the intended goals of the incentives to promote the development of new OMPs. Ideally, a balance must be struck between attaining affordable prices for ultra-OMPs and securing a realistic return on investment for the pharmaceutical industry. Keywords: ultra-orphan medicinal product, ultra-rare disease, pricing

  13. USE OF FRESH PARTS OF MEDICINAL PLANTS FOR HEALTH AND PRODUCTION IN LIVESTOCK – A NEW CONCEPT OF FARMING

    Directory of Open Access Journals (Sweden)

    Shibabrata Pattanayak

    2013-06-01

    Full Text Available Farm animals are reared for production to meet up the demand for animal protein in human. Various modern medicines are extensively used for production as well as treatment and prevention of diseases of animals, which can ultimately reach us through food chain. Herbs are now considered as an important source of alternative medicines. The Ayurvedic medicines prepared by manufacturers contain processed plant parts and added with preservative and other chemicals in many cases. The present way of research on herbal medicine follows the path of identification of active principles from the extracts of preserved parts of medicinal plants after testing of their efficacy in laboratory. This concept of research have the limitation of loss of many aromatic and other phytochemicals present in the living plant, which may have very important role when used together. Animals maintained in modern farm may be given relief from modern medicines in minor and moderate ailments, cure of problems related with their production with the validated fresh plant medicine available from the plants cultivated adjacent to the farm area. Consulting the reports of ethno-botanical study, a preliminary list of medicinal plant is prepared which are having antipyretic, analgesic, wound healing, immunostimulant, hepato-protective, fertility enhancing, pregnancy assisting, lactation assisting, anthelmintic, astringent, expectorant, purgative and anti-flatulent, nutriceutical, antiseptic, anti-dermatitis, anti-dysenteric and anti-enteric, hematenic, stomachic, diuretic and kidney stone removing effects and insecticidal or insect repelling effects. This list may be enriched further and plants may be selected for a farm from these groups according to the agro-climatic condition of the area, disease prevalence, problems encountered during farming practice and other requirements of the farm. Validation of reported effects of the plants is to be performed in fresh condition, so that parts

  14. [European Union regulatory and quality requirements for botanical drugs and their implications for Chinese herbal medicinal products development].

    Science.gov (United States)

    Zhu, You-Ping

    2017-06-01

    This paper introduces regulatory pathways and characteristic quality requirements for marketing authorization of herbal medicinal products in the European Union(EU), and the legal status and applications of "European Union list of herbal substances, preparations and combinations" and "European Union herbal monographs". Also introduced are Chinese herbs that have been granted the EU list entry, those with EU herbal monographs, and registered EU traditional herbal medicinal products with Chinese herbs as active ingredients. Special attention is paid to the technical details of three authorized EU herbal medicinal products (Veregen, Sativex and Episalvan) in comparison with Andrographis paniculata extract HMPL-004 that failed the phase Ⅲ clinical trial for ulcerative colitis. The paper further emphasizes the importance of enriching active fractions of herbal extracts and taking regulatory and quality considerations into account in early stage of botanical drug development. Copyright© by the Chinese Pharmaceutical Association.

  15. [Nanotechnology future of medicine].

    Science.gov (United States)

    Terlega, Katarzyna; Latocha, Małgorzata

    2012-10-01

    Nanotechnology enables to produce products with new, exactly specified, unique properties. Those products are finding application in various branches of electronic, chemical, food and textile industry as well as in medicine, pharmacy, agriculture, architectural engineering, aviation and in defense. In this paper structures used in nanomedicine were characterized. Possibilities and first effort of application of nanotechnology in diagnostics and therapy were also described. Nanotechnology provides tools which allow to identifying changes and taking repair operations on cellular and molecular level and applying therapy oriented for specific structures in cell. Great hope are being associated with entering nanotechnology into the regenerative medicine. It requires astute recognition bases of tissue regeneration biology--initiating signals as well as the intricate control system of the progress of this process. However application of nanotechnology in tissue engineering allows to avoiding problems associated with loss properties of implants what is frequent cause of performing another surgical procedure at present.

  16. Scientific Production of Research Fellows at the Zagreb University School of Medicine, Croatia

    Science.gov (United States)

    Polašek, Ozren; Kolčić, Ivana; Buneta, Zoran; Čikeš, Nada; Pećina, Marko

    2006-01-01

    Aim To evaluate scientific production among research fellows employed at the Zagreb University School of Medicine and identify factors associated with their scientific output. Method We conducted a survey among research fellows and their mentors during June 2005. The main outcome measure was publication success, defined for each fellow as publishing at least 0.5 articles per employment year in journals indexed in the Current Contents bibliographic database. Bivariate methods and binary logistic regression were used in data analysis. Results A total of 117 fellows (response rate 95%) and 83 mentors (100%) were surveyed. The highest scientific production was recorded among research fellows employed in public health departments (median 3.0 articles, interquartile range 4.0), compared with those from pre-clinical (median 0.0, interquartile range 2.0) and clinical departments (median 1.0, interquartile range 2.0) (Kruskal-Wallis, P = 0.003). A total of 36 (29%) research fellows published at least 0.5 articles per employment year and were considered successful. Three variables were associated with fellows’ publication success: mentor’s scientific production (odds ratio [OR], 3.14; 95% confidence interval [CI], 1.31-7.53), positive mentor’s assessment (OR, 3.15; 95% CI, 1.10-9.05), and fellows’ undergraduate publication in journals indexed in the Current Contents bibliographic database (OR, 4.05; 95% CI, 1.07-15.34). Conclusion Undergraduate publication could be used as one of the main criteria in selecting research fellows. One of the crucial factors in a fellow’s scientific production and career advancement is mentor’s input, which is why research fellows would benefit most from working with scientifically productive mentors. PMID:17042070

  17. Clinical evidence for orphan medicinal products-a cause for concern?

    Science.gov (United States)

    Picavet, Eline; Cassiman, David; Hollak, Carla E; Maertens, Johan A; Simoens, Steven

    2013-10-16

    The difficulties associated with organising clinical studies for orphan medicinal products (OMPs) are plentiful. Recent debate on the long-term effectiveness of some OMPs, led us to question whether the initial standards for clinical evidence for OMPs, set by the European Medicines Agency (EMA) at the time of marketing authorization, are too low. Therefore, the aim of this study was to quantitatively evaluate the characteristics and quality of clinical evidence that is presented for OMPs to obtain marketing authorization in Europe, using the new and validated COMPASS tool. We quantitatively assessed the characteristics and quality of clinical evidence of the pivotal studies of 64 OMPs as described in the European Public Assessment Report and/or the Scientific Discussion document prepared by the Committee for Human Medicinal Products of the EMA. The 64 OMPs were altogether authorized for 78 orphan indications, for which 117 studies were identified as 'pivotal' or 'main' studies. In approximately two thirds of the studies, the allocation was randomized (64.8%) and a control arm was used (68.5%). Half of the studies applied some type of blinding. Only a minority (26.9%) of the studies included a Quality-of-Life (QoL) related endpoint, of which a third claim an improvement in QoL. Upon analyzing the quality of reporting, we found that some aspects (i.e. the endpoints, the sampling criteria, and the interventions) are well described, whereas other items (i.e. a description of the patients and of potential biases) are not reported for all studies. In conclusion, the pivotal studies that are the basis for marketing authorization of OMPs are a cause for concern, as they exhibit methodological flaws i.e. the lack of QoL-related endpoints as outcome, lack of blinding in the study design and the use of surrogate endpoints. Additionally, there are shortcomings in the reporting of those studies that complicate the interpretation. A more demanding regulatory process for OMPs is

  18. Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

    Science.gov (United States)

    Arguello, Blanca; Salgado, Teresa M; Fernandez-Llimos, Fernando

    2015-01-01

    Aims To assess the completeness and applicability of information for the use of medicines in pregnancy and lactation contained in European Summaries of Product Characteristics (SmPCs). Methods SmPCs available on the EMA website in April 2011 were retrieved, and information on the use of medicines during pregnancy and lactation was analyzed. A form was designed to extract information regarding drug concentrations crossing the placenta, excretion of the drug in milk, the existence of pre-clinical and clinical studies and clinical experience describing the use of the medicine in pregnancy and lactation, medicine effects on human fertility, medicines use in women of child-bearing potential and specific recommendations for use during pregnancy and breastfeeding. SmPCs were classified as containing ‘conclusive’ or ‘ambiguous’ information depending on whether (or not) they provided clear instructions regarding medicine use in pregnancy and lactation. Results Of the 534 SmPCs, 89.3% did not mention whether the drug crossed the placenta, 67.6% indicated that there was no clinical experience during pregnancy and in 61.4% it was unknown whether the medicine was excreted in human milk. Recommendations for medicine use during pregnancy and breastfeeding were ambiguous in 57.0% and 16.5% of the SmPCs, respectively, and medicine use was restricted in over 90% SmPCs for both pregnancy and breastfeeding, despite no information supporting these restrictions being reported. The time elapsed since a SmPCs first approval was not associated with an increase in information quality. Conclusions Important information deficits on the use of medicines during pregnancy and breastfeeding were found in European SmPCs. PMID:25224071

  19. Stem Cell Therapy: Repurposing Cell-Based Regenerative Medicine Beyond Cell Replacement.

    Science.gov (United States)

    Napoli, Eleonora; Lippert, Trenton; Borlongan, Cesar V

    2018-02-27

    Stem cells exhibit simple and naive cellular features, yet their exact purpose for regenerative medicine continues to elude even the most elegantly designed research paradigms from developmental biology to clinical therapeutics. Based on their capacity to divide indefinitely and their dynamic differentiation into any type of tissue, the advent of transplantable stem cells has offered a potential treatment for aging-related and injury-mediated diseases. Recent laboratory evidence has demonstrated that transplanted human neural stem cells facilitate endogenous reparative mechanisms by initiating multiple regenerative processes in the brain neurogenic areas. Within these highly proliferative niches reside a myriad of potent regenerative molecules, including anti-inflammatory cytokines, proteomes, and neurotrophic factors, altogether representing a biochemical cocktail vital for restoring brain function in the aging and diseased brain. Here, we advance the concept of therapeutically repurposing stem cells not towards cell replacement per se, but rather exploiting the cells' intrinsic properties to serve as the host brain regenerative catalysts.

  20. Genome network medicine: innovation to overcome huge challenges in cancer therapy.

    Science.gov (United States)

    Roukos, Dimitrios H

    2014-01-01

    The post-ENCODE era shapes now a new biomedical research direction for understanding transcriptional and signaling networks driving gene expression and core cellular processes such as cell fate, survival, and apoptosis. Over the past half century, the Francis Crick 'central dogma' of single n gene/protein-phenotype (trait/disease) has defined biology, human physiology, disease, diagnostics, and drugs discovery. However, the ENCODE project and several other genomic studies using high-throughput sequencing technologies, computational strategies, and imaging techniques to visualize regulatory networks, provide evidence that transcriptional process and gene expression are regulated by highly complex dynamic molecular and signaling networks. This Focus article describes the linear experimentation-based limitations of diagnostics and therapeutics to cure advanced cancer and the need to move on from reductionist to network-based approaches. With evident a wide genomic heterogeneity, the power and challenges of next-generation sequencing (NGS) technologies to identify a patient's personal mutational landscape for tailoring the best target drugs in the individual patient are discussed. However, the available drugs are not capable of targeting aberrant signaling networks and research on functional transcriptional heterogeneity and functional genome organization is poorly understood. Therefore, the future clinical genome network medicine aiming at overcoming multiple problems in the new fields of regulatory DNA mapping, noncoding RNA, enhancer RNAs, and dynamic complexity of transcriptional circuitry are also discussed expecting in new innovation technology and strong appreciation of clinical data and evidence-based medicine. The problematic and potential solutions in the discovery of next-generation, molecular, and signaling circuitry-based biomarkers and drugs are explored. © 2013 Wiley Periodicals, Inc.

  1. Production cost structure in US outpatient physical therapy health care.

    Science.gov (United States)

    Lubiani, Gregory G; Okunade, Albert A

    2013-02-01

    This paper investigates the technology cost structure in US physical therapy care. We exploit formal economic theories and a rich national data of providers to tease out implications for operational cost efficiencies. The 2008-2009 dataset comprising over 19 000 bi-weekly, site-specific physical therapy center observations across 28 US states and Occupational Employment Statistics data (Bureau of Labor Statistics) includes measures of output, three labor types (clinical, support, and administrative), and facilities (capital). We discuss findings from the iterative seemingly unrelated regression estimation system model. The generalized translog cost estimates indicate a well-behaved underlying technology structure. We also find the following: (i) factor demands are downwardly sloped; (ii) pair-wise factor relationships largely reflect substitutions; (iii) factor demand for physical therapists is more inelastic compared with that for administrative staff; and (iv) diminishing scale economies exist at the 25%, 50%, and 75% output (patient visits) levels. Our findings advance the timely economic understanding of operations in an increasingly important segment of the medical care sector that has, up-to-now (because of data paucity), been missing from healthcare efficiency analysis. Our work further provides baseline estimates for comparing operational efficiencies in physical therapy care after implementations of the 2010 US healthcare reforms. Copyright © 2012 John Wiley & Sons, Ltd.

  2. Computer aided design of medicinal products based on interactive chemical/herbal ingredients - An R&D approach

    Science.gov (United States)

    Siontorou, Christina G.

    2012-12-01

    Herbal products have gained increasing popularity in the last decades, and are now broadly used to treat illness and improve health. Notwithstanding the public opinion, both, safety and efficacy, are major sources of dispute among the scientific community, mainly due to lack of (or scarcity or scattered) conclusive data linking a herbal constituent to pharmacological action in vivo, in a way that benefit overrides risk. This paper presents a methodological framework for addressing natural medicine in a systematic and holistic way with a view to providing medicinal products based on interactive chemical/herbal ingredients.

  3. Complementary and alternative medicine use of women with breast cancer : Self-help CAM attracts other women than guided CAM therapies

    NARCIS (Netherlands)

    Lo-Fo-Wong, Deborah N. N.; Ranchor, Adelita V.; de Haes, Hanneke C. J. M.; Sprangers, Mirjam A. G.; Henselmans, Inge

    2012-01-01

    Objective: Examine stability of use of complementary and alternative medicine (CAM) of breast cancer patients, reasons for CAM use, and sociodemographic, clinical, and psychological predictors of CAM use. Methods: CAM use was assessed after adjuvant therapy and six months later. Following the CAM

  4. Complementary and alternative medicine use of women with breast cancer: Self-help CAM attracts other women than guided CAM therapies

    NARCIS (Netherlands)

    Lo-Fo-Wong, Deborah N. N.; Ranchor, Adelita V.; de Haes, Hanneke C. J. M.; Sprangers, Mirjam A. G.; Henselmans, Inge

    2012-01-01

    Objective: Examine stability of use of complementary and alternative medicine (CAM) of breast cancer patients, reasons for CAM use, and sociodemographic, clinical, and psychological predictors of CAM use. Methods: CAM use was assessed after adjuvant therapy and six months later. Following the CAM

  5. Development of a productive research culture in emergency medicine: Report of the outcomes of a research forum.

    Science.gov (United States)

    Taylor, David McD; Cohen, Donna R; Epstein, Joseph; Freeman, Peter; Gosbell, Andrew D; Judkins, Simon; Mowatt, Elizabeth J M; O'Reilly, Gerard M; Vinen, John

    2016-02-01

    In recent years, the Australasian College for Emergency Medicine (ACEM) has increasingly focused on the need for high-quality research in emergency medicine (EM). One important initiative was the establishment of the ACEM Foundation, which among other responsibilities, is required to support clinical research through the provision of research funding and other measures. In February 2015, the Foundation held a Research Forum that was attended by the leading EM researchers from Australasia. The Forum aimed to determine how a productive research culture could be developed within the ACEM. Nine key objectives were determined including that research should be a core business of the ACEM and a core activity of the EM workforce, and that EM research should be sustainable and adequately supported. This report describes the background and conduct of the Forum, its recommendations and the way in which they could be implemented. © 2015 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  6. Characteristics of an ideal practice educator: Perspectives from practice educators in diagnostic radiography, nuclear medicine, nutrition and dietetics, occupational therapy and physiotherapy and radiation therapy

    International Nuclear Information System (INIS)

    Francis, A.; Hills, C.; MacDonald-Wicks, L.; Johnston, C.; James, D.; Surjan, Y.; Warren-Forward, H.

    2016-01-01

    Background: Practice education is a compulsory component of health programs with practice educators playing a critical role in the education of students. Practice educator characteristics may positively or negatively affect student learning in practice settings. This study aimed to identify characteristics of the ideal practice educator that lead to successful practical experiences as perceived by current practice educators working in the Australian context of diagnostic radiography, nuclear medicine, nutrition and dietetics, occupational therapy, physiotherapy and radiation therapy. Methods: All practice educators (n = 1063) on the University of Newcastle Practice Educator Database were invited to participate in this prospective, cross-sectional, descriptive study via online link or paper format. Results: There was a 52% response rate. The five most valued characteristics were feedback skills, non-judgemental, professionalism, clarity and listening skills. The five least valued characteristics were scholarly activity, respect for students' autonomy, well-prepared, availability and being a role model. Comparisons between disciplines, genders, ages, years in practice and levels of supervisory experience indicated some statistically significant differences, though actual differences were small. Discussion: Overall there was a high degree of agreement within and between disciplines on the characteristics of the ideal practice educator. The top five skills could be classed as generic skills and not specific clinical and practice skills, thus formal training and certification schemes may enhance practice educator competence. - Highlights: • The most important characteristics were feedback skills and non-judgmental. • The least important characteristics were scholarly activity and respects student autonomy. • Female educators valued all characteristics except scholarly activities as being more important. • Older participants valued availability, and

  7. Targeted therapy and personalized medicine in hepatocellular carcinoma: drug resistance, mechanisms, and treatment strategies

    Directory of Open Access Journals (Sweden)

    Galun D

    2017-07-01

    Full Text Available Danijel Galun,1,2 Tatjana Srdic-Rajic,3 Aleksandar Bogdanovic,1 Zlatibor Loncar,2,4 Marinko Zuvela1,2 1Hepato-Pancreato-Biliary Unit, University Clinic for Digestive Surgery, Clinical Center of Serbia, 2Medical School, University of Belgrade, 3Institute for Oncology and Radiology of Serbia/Unit for Experimental Oncology, 4Emergency Center, Clinical Center of Serbia, Belgrade, Serbia Abstract: Hepatocellular carcinoma (HCC is characterized by a growing number of new cases diagnosed each year that is nearly equal to the number of deaths from this cancer. In a majority of the cases, HCC is associated with the underlying chronic liver disease, and it is diagnosed in advanced stage of disease when curative treatment options are not applicable. Sorafenib is a treatment of choice for patients with performance status 1 or 2 and/or macrovascular invasion or extrahepatic spread, and regorafenib is the only systemic treatment found to provide survival benefit in HCC patients progressing on sorafenib treatment. Other drugs tested in different trials failed to demonstrate any benefit. Disappointing results of numerous trials testing the efficacy of various drugs indicate that HCC has low sensitivity to chemotherapy that is in great part caused by multidrug resistance. Immunotherapy for HCC is a new challenging treatment option and involves immune checkpoint inhibitors/antibody-based therapy and peptide-based vaccines. Another challenging approach is microRNA-based therapy that involves two strategies. The first aims to inhibit oncogenic miRNAs by using miRNA antagonists and the second strategy is miRNA replacement, which involves the reintroduction of a tumor-suppressor miRNA mimetic to restore a loss of function. Keywords: hepatocellular carcinoma, drug resistance, multimodal treatment, chemotherapy 

  8. Place of the nuclear medicine in the clinical development of the gene therapy

    International Nuclear Information System (INIS)

    Crochet, T.; Vis, J. de; Vincent, D.; Zanca, M.

    2006-01-01

    Although gene therapy has been proposed first for genetic diseases, its concept has been extended to many acquired diseases, owing to a better understanding of pathology at a molecular level. Overall, very few trials have shown to be efficient, and safety concerns have emerged, as a result of several patients deaths. There is a need for new techniques able to improve both the knowledge of the therapeutic gene fate once administered and the early detection of events likely to lead to serious adverse events. In vivo imaging of a reporter gene associated with the therapeutic one is certainly the most promising technique for these goals. Among available imaging modalities, nuclear imaging is the most likely to be applied to patients. This review begins with a summary of current knowledge about the steps that a therapeutic gene has to cross from vector delivery to appropriate expression in target cells. We show how gene imaging could allow to investigate many pitfalls of trials by providing a better understanding of these steps in patients. The reporter genes available for nuclear imaging are presented in the second section, through animal studies. Then, relevant examples of clinical trials are presented. These include cancer (suicide gene therapy and adoptive immunotherapy), ischemic heart diseases and cystic fibrosis. The results are commented with emphasis on the role of nuclear imaging to address the questions raised by these studies, and imaging studies carried out on animals or patients for the corresponding diseases or organs are presented. The results obtained in animal studies warrant the introduction of gene imaging in clinical trials. (authors)

  9. ENERGY MEDICINE

    OpenAIRE

    Srinivasan, T. M.

    1987-01-01

    Energy medicine is the most comprehensive concept introduced in medical diagnostics and therapy to account for a whole range of phenomena and methods available to help an individual proceed from sickness to health. The modern medical theories do not account for, much less accept many traditional therapies due to deep suspicion that the older methods are not scientific. However, the Holistic Health groups around the world have now created an environment for therapies which work at subtle energ...

  10. COMPUTING THERAPY FOR PRECISION MEDICINE: COLLABORATIVE FILTERING INTEGRATES AND PREDICTS MULTI-ENTITY INTERACTIONS.

    Science.gov (United States)

    Regenbogen, Sam; Wilkins, Angela D; Lichtarge, Olivier

    2016-01-01

    Biomedicine produces copious information it cannot fully exploit. Specifically, there is considerable need to integrate knowledge from disparate studies to discover connections across domains. Here, we used a Collaborative Filtering approach, inspired by online recommendation algorithms, in which non-negative matrix factorization (NMF) predicts interactions among chemicals, genes, and diseases only from pairwise information about their interactions. Our approach, applied to matrices derived from the Comparative Toxicogenomics Database, successfully recovered Chemical-Disease, Chemical-Gene, and Disease-Gene networks in 10-fold cross-validation experiments. Additionally, we could predict each of these interaction matrices from the other two. Integrating all three CTD interaction matrices with NMF led to good predictions of STRING, an independent, external network of protein-protein interactions. Finally, this approach could integrate the CTD and STRING interaction data to improve Chemical-Gene cross-validation performance significantly, and, in a time-stamped study, it predicted information added to CTD after a given date, using only data prior to that date. We conclude that collaborative filtering can integrate information across multiple types of biological entities, and that as a first step towards precision medicine it can compute drug repurposing hypotheses.

  11. Optimization of ethanol production from garcinia cambogia residues and the effects of its medicinal component on production yield

    International Nuclear Information System (INIS)

    Ma, H.; Zhang, F.

    2017-01-01

    Garcinia cambogia, a Chinese herbal medicine, was popular due to its effect for weight loss. The main medical component inside was determined to be hydroxycitric acid (HCA). To realize the resource technology of garcinia cambogia residue, Optimum ethanol production from residues was investigated, and the effects of remaining HCA on the ethanol yield were investigated. A Plackett-Burman experimental design was used to screen the significance of several influencing factors, and cellulase, yeast extract, and KH2PO4 were observed to exert important effects. The optimum ethanol fermentation conditions were determined through an orthogonal design to include a cellulase concentration of 100 U/g, a yeast extract concentration of 15 g/L, and a KH2PO4 concentration of 1.0 g/L. The ethanol concentration obtained under optimal conditions was 4.0 g/L. The remained HCA in the residues showed minimal influences on ethanol fermentation and could even increase ethanol yield at low concentrations. (author)

  12. Analytical similarity assessment of rituximab biosimilar CT-P10 to reference medicinal product.

    Science.gov (United States)

    Lee, Kyoung Hoon; Lee, Jihun; Bae, Jin Soo; Kim, Yeon Jung; Kang, Hyun Ah; Kim, Sung Hwan; Lee, So Jung; Lim, Ki Jung; Lee, Jung Woo; Jung, Soon Kwan; Chang, Shin Jae

    2018-04-01

    CT-P10 (Truxima™) was recently approved as the world's first rituximab biosimilar product in the European Union (EU) and South Korea. To demonstrate biosimilarity of CT-P10 with the reference medicinal product (RMP), extensive 3-way similarity assessment has been conducted between CT-P10, EU-Rituximab and US-Rituximab, focusing on the physicochemical and biological quality attributes. A multitude of state-of-the-art analyses revealed that CT-P10 has identical primary and higher order structures compared to the original product. Purity/impurity profiles of CT-P10 measured by the levels of aggregates, fragments, non-glycosylated form and process-related impurities were also found to be comparable with those of RMPs. In terms of the post-translational modification, CT-P10 contains slightly less N-terminal pyro-glutamate variant, which has been known not to affect product efficacy or safety. Oligosaccharide profiling has revealed that, although CT-P10 contains the same conserved glycan species and relative proportion with the RMPs, the content of total afucosylated glycan in CT-P10 was slightly higher than in EU- or US-Rituximab. Nevertheless, the effect of the observed level of afucosylation in CT-P10 drug product on Fc receptor binding affinity or antibody-dependent cell-mediated cytotoxicity was found to be negligible based on the spiking study with highly afucosylated sample. Arrays of biological assays representative of known and putative mechanisms of action for rituximab have shown that biological activities of CT-P10 are within the quality range of RMPs. Recent results of clinical studies have further confirmed that the CT-P10 exhibits equivalent clinical efficacy and safety profiles compared to EU- and US-Rituximab. The current 3-way similarity assessment together with clinical study results confidently demonstrate that CT-P10 is highly similar with EU- and US-Rituximab in terms of physicochemical properties, biological activities, efficacy, and safety for

  13. Integration of Complementary and Alternative Medicine Therapies into Primary-Care Pain Management for Opiate Reduction in a Rural Setting.

    Science.gov (United States)

    Mehl-Madrona, Lewis; Mainguy, Barbara; Plummer, Julie

    2016-08-01

    Opiates are no longer considered the best strategy for the long-term management of chronic pain. Yet, physicians have made many patients dependent on them, and these patients still request treatment. Complementary and alternative medicine (CAM) therapies have been shown to be effective, but are not widely available and are not often covered by insurance or available to the medically underserved. Group medical visits (GMVs) provided education about non-pharmacological methods for pain management and taught mindfulness techniques, movement, guided imagery, relaxation training, yoga, qigong, and t'ai chi. Forty-two patients attending GMVs for at least six months were matched prospectively with patients receiving conventional care. No one increased their dose of opiates. Seventeen people reduced their dose, and seven people stopped opiates. On a 10-point scale of pain intensity, reductions in pain ratings achieved statistical significance (p = 0.001). The average reduction was 0.19 (95% confidence interval [CI] 0.12-0.60; p = 0.01). The primary symptom improved on average by -0.42 (95% CI -0.31 to -0.93; p = 0.02) on the My Medical Outcome Profile, 2nd version. Improvement in the quality-of-life rating was statistically significant (p = 0.007) with a change of -1.42 (95% CI = -0.59 to -1.62). In conventional care, no patients reduced their opiate use, and 48.5% increased their dose over the two years of the project. GMVs that incorporated CAM therapies helped patients reduce opiate use. While some patients found other physicians to give them the opiates they desired, those who persisted in an environment of respect and acceptance significantly reduced opiate consumption compared with patients in conventional care. While resistant to CAM therapies initially, the majority of patients came to accept and to appreciate their usefulness. GMVs were useful for incorporating non-reimbursed CAM therapies into primary medical care.

  14. Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture

    Directory of Open Access Journals (Sweden)

    Bate R

    2012-07-01

    Full Text Available Roger Bate,1 Lorraine Mooney,2 Kimberly Hess,3 Julissa Milligan,1 Amir Attaran41American Enterprise Institute, Washington DC, USA; 2Africa Fighting Malaria, London, UK; 3Africa Fighting Malaria, Washington DC, USA; 4Faculty of Law and Medicine, University of Ottawa, Ottawa, CanadaBackground: Some medicines for sale in developing countries are approved by a stringent regulatory authority (SRA or the World Health Organization (WHO prequalification program; many of these are global brands. This study ascertains whether medicines approved by SRAs or the WHO perform better in simple quality tests than those that have not been approved by either.Methods: Over the past 4 years, 2652 essential drugs (products to treat malaria, tuberculosis, and bacterial infections were procured by covert shoppers from eleven African cities and eight cities in a variety of mid-income nations. All samples were assessed using the Global Pharma Health Fund eV Minilab® protocol to identify whether they were substandard, degraded, or counterfeit.Results: The failure rate among SRA-approved products was 1.01%, among WHO-approved products was 6.80%, and 13.01% among products that were not approved by either. African cities had a greater proportion of SRA- or WHO-approved products (31.50% than Indian cities (26.57%, but they also experienced a higher failure rate (14.21% than Indian cities (7.83%. The remainder of cities tested had both the highest proportion of approved products at 34.46% and the lowest failure rate at 2.70%. Products made in Africa had the highest failure rate at 25.77%, followed by Chinese products at 15.74%, Indian products at 3.70%, and European/US products, which failed least often, at 1.70%. Most worrying is that 17.65% of Chinese products approved by the WHO failed.Conclusion: The results strongly indicate that approval by either an SRA or the WHO is correlated with higher medicine quality at a statistically significant level. The comparatively high

  15. Use of bodily sensations as a risk assessment tool: exploring people with Multiple Sclerosis' views on risks of negative interactions between herbal medicine and conventional drug therapies.

    Science.gov (United States)

    Skovgaard, Lasse; Pedersen, Inge Kryger; Verhoef, Marja

    2014-02-18

    Most users of complementary and alternative medicine (CAM) combine it with conventional medicine. Recent risk assessment studies have shown risks of negative interactions between CAM and conventional medicine, particularly when combining herbal medicine and conventional drug therapies (CDT). Little is known about the way users consider such risks. The present paper aims to gain knowledge about this issue by exploring views on risks of negative interactions when combining herbal medicine and CDT among people with multiple sclerosis (MS). This paper draws on a qualitative follow-up study on a survey among members of the Danish MS Society. Semi-structured, in-depth qualitative interviews were conducted with a strategic selection from the survey respondents. The study was inspired by a phenomenological approach and emerging themes were extracted from the data through meaning condensation. Four themes characterized the informants' views on risks of negative interactions when combining herbal medicine and CDT: 1) 'naturalness' in herbal medicine; 2) 'bodily sensations' as guidelines; 3) trust in the CAM practitioner; 4) lack of dialogue with medical doctor. Generally, the combination of herbal medicine and CDT was considered by the informants to be safe. In particular, they emphasized the 'non-chemical' nature of herbal medicine and of their own bodily sensations as warrants of safety. A trustful relation to the CAM practitioner furthermore made some of them feel safe in their use of herbal medicine and CDT in combination. The informants' use of bodily sensations as a non-discursive risk assessment may be a relevant element in understanding these issues.

  16. The use of terrestrial and aquatic microcosms and mesocosms for the ecological risk assessment of veterinary medicinal products

    NARCIS (Netherlands)

    Brink, van den P.J.; Tarzona, J.V.; Solomon, K.R.; Knacker, T.; Brink, van den N.W.; Brock, T.C.M.; Hoogland, J.P.

    2005-01-01

    In this paper, we investigate the applicability of experimental model ecosystems (microcosms and mesocosms) for the ecological risk assessment of veterinary medicinal products (VMPs). VMPs are used in large quantities, but the assessment of associated risks to the environment is limited, although

  17. Conservation and sustainable use of medicinal and aromatic products in North America: Are there really lessons to be learned?

    Science.gov (United States)

    A. L. Hammett; James L. Chamberlain

    2002-01-01

    This paper discusses the legacy of nontimber forest products (NTFPs) and, more specifically, medicinal plant use in North America. It also discusses briefly MAP markets both in North America and throughout the world, and describes the constraints to the sustainable use and development of MAP resources. Lastly, the paper relates some lessons that may be appropriate for...

  18. Optimization, validation and application of UV-Vis spectrophotometric-colorimetric methods for determination of trimethoprim in different medicinal products

    Directory of Open Access Journals (Sweden)

    Goran Stojković

    2016-03-01

    Full Text Available Two simple, sensitive, selective, precise, and accurate methods for determination of trimethoprim in different sulfonamide formulations intended for use in human and veterinary medicine were optimized and validated. The methods are based on the trimethoprim reaction with bromcresol green (BCG and 2,4-dinitro-1-fluorobenzene (DNFB. As extraction solvents we used 10 % N,N-dimethylacetamide in methanol and acetone for both methods, respectively. The colored products are quantified applying visible spectrophotometry at their corresponding absorption maxima. The methods were validated for linearity, sensitivity, accuracy, and precision. We tested the method applicability on four different medicinal products in tablet and powder forms containing sulfametrole and sulfamethoxazole in combination with trimethoprim. The results revealed that both methods are equally accurate with recoveries within the range 95-105 %. The obtained between-day precision for both methods, when applied on four different medicinal products, was within in the range 1.08-3.20 %. By applying the F-statistical test (P<0.05, it was concluded that for three medicinal products tested both methods are applicable with statistically insignificant difference in precision. The optimized and validated BCG and DNFB methods could find application in routine quality control of trimethoprim in various formulation forms, at different concentration levels, and in combination with different sulfonamides.

  19. [Analysis on influential factors in China's exports of primary and semi-finished products of traditional Chinese medicine to ASEAN].

    Science.gov (United States)

    Qian, Yun-Xu; Yang, Yue; Zhao, Wei; Bi, Kai-Shun

    2014-04-01

    Two regression models, based on panel data over the period of 2000-2011, are built and used to analyze what factors determine China's exports of primary and semi-finished products of traditional Chinese medicine to ASEAN. The results indicate that, China GDP, the ratio of ASEAN to China GDP per capita, average export price, the ratio of state-owned assets to total assets, have a significant positive influence on the export volumes of primary products of Chinese medicine. At the same time, RMB appreciation, the ratio of three kinds of foreign-invested assets to total assets, China-ASEAN Early Harvest Program, ASEAN-China Free Trade Area have a significant negative influence. In respect of the export volumes of semi-finished products of Chinese medicine, the significant influential factors are ASEAN GDP and the ratio of ASEAN to China GDP per capita. The former is positive and the latter is negative. In order to optimize the commodity composition of experts, it is needed to increase export volumes of both primary and semi-finished products of Chinese medicine. According to the analysis above, some proposals are put forward, such as, improving the performance of foreign capital, playing an exemplary and leading role in technological innovation by state-owned enterprises, taking advantage of bargaining power of suppliers, increasing outward foreign direct investment.

  20. Regulation of miRNAs by herbal medicine: An emerging field in cancer therapies.

    Science.gov (United States)

    Mohammadi, Ali; Mansoori, Behzad; Baradaran, Behzad

    2017-02-01

    MicroRNAs' expression profiles have recently gained major attention as far as cancer research is concerned. MicroRNAs are able to inhibit target gene expression via binding to the 3' UTR of target mRNA, resulting in target mRNA cleavage or translation inhibition. MicroRNAs play significant parts in a myriad of biological processes; studies have proven, on the other hand, that aberrant microRNA expression is, more often than not, associated with the growth and progression of cancers. MicroRNAs could act as oncogenes (oncomir) or tumor suppressors and can also be utilized as biomarkers for diagnosis, prognosis, and cancer therapy. Recent studies have shown that such herbal extracts as Shikonin, Sinomenium acutum, curcumin, Olea europaea, ginseng, and Coptidis Rhizoma could alter microRNA expression profiles through inhibiting cancer cell development, activating the apoptosis pathway, or increasing the efficacy of conventional cancer therapeutics. Such findings patently suggest that the novel specific targeting of microRNAs by herbal extracts could complete the restriction of tumors by killing the cancerous cells so as to recover survival results in patients diagnosed with malignancies. In this review, we summarized the current research about microRNA biogenesis, microRNAs in cancer, herbal compounds with anti-cancer effects and novel strategies for employing herbal extracts in order to target microRNAs for a better treatment of patients diagnosed with cancer. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  1. Optimal therapy and prospects for new medicines in eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome).

    Science.gov (United States)

    Pagnoux, Christian; Groh, Matthieu

    2016-10-01

    The prevalence of eosinophilic granulomatosis with polyangiitis (EGPA; previously known as Churg-Strauss syndrome) is lower than that of other antineutrophil cytoplasm antibody (ANCA)-associated vasculitides (AAV's), and only a few randomized controlled trials have been conducted for this rare disease. However, recent international efforts have helped delineate the best treatment approach. At present, EGPA conventional therapy is by default similar to that of other AAVs. Limited, non-severe EGPA can initially be treated with glucocorticoids (GCs) alone. Patients with life-threatening manifestations and/or major organ involvement must receive a combination of GCs and an immunosuppressant, mainly cyclophosphamide. Remission can be achieved in >85% of patients with these first-line treatments, but vasculitis relapses occur in more than one-third of patients, and about 85% cannot stop GC treatment because of GC-dependent asthma and/or ENT manifestations. A few biologic agents, including rituximab or mepolizumab, are now under investigation after interesting preliminary results. Expert commentary: Treatment for EGPA still has several unmet needs. Several biologic agents are now under investigation in randomized controlled trials, but a few others should be considered soon. Their benefit should be demonstrated for devising more EGPA-tailored therapeutic strategies (ideally GC-free).

  2. Use of medicines and other products for therapeutic purposes among children in Brazil.

    Science.gov (United States)

    Pizzol, Tatiane da Silva Dal; Tavares, Noemia Urruth Leão; Bertoldi, Andréa Dâmaso; Farias, Mareni Rocha; Arrais, Paulo Sergio Dourado; Ramos, Luiz Roberto; Oliveira, Maria Auxiliadora; Luiza, Vera Lucia; Mengue, Sotero Serrate

    2016-12-01

    To assess the prevalence of the use of medicines and other products for therapeutic purposes in the Brazilian pediatric population and test whether demographic, socioeconomic and health factors are associated with use. A cross-sectional population-based study (National Survey on Access, Use and Promotion of Rational Use of Medicines - PNAUM), including 7,528 children aged 12 or younger, living in urban areas in Brazil. Medicine use to treat chronic or acute diseases was reported by the primary caregiver present at the household interview. Associations between independent variables and medicine use were investigated by Poisson regression. The overall prevalence of medicine use was 30.7% (95%CI 28.3-33.1). The prevalence of medicine use for chronic diseases was 5.6% (95%CI 4.7-6.7) and for acute conditions, 27.1% (95%CI 24.8-29.4). The factors significantly associated with overall use were five years old or under, living in the Northeast region, having health insurance and using health services in the last 12 months (emergency visits and hospitalizations). The following were associated with drug use for chronic diseases: age ≥ 2 years, Southeast and South regions, and use of health services. For drug use in treating acute conditions, the following associated factors were identified: ≤ 5 years, North, Northeast or Midwest regions, health insurance, and one or more emergency visits. The most commonly used drugs among children under two years of age were paracetamol, ascorbic acid, and dipyrone; for children aged two years or over they were dipyrone, paracetamol, and amoxicillin. The use of medicine by children is considerable, especially in treating acute medical conditions. Children using drugs for chronic diseases have a different demographic profile from those using drugs for acute conditions in relation to gender, age, and geographic region. Estimar a prevalência de uso de medicamentos e outros produtos com finalidade terapêutica na população pedi

  3. Preliminary investigation of the possibility for implementation of modified pharmacopoeial HPLC methods for quality control of metronidazole and ciprofloxacin in medicinal products used in veterinary medicine

    Directory of Open Access Journals (Sweden)

    Marjan Piponski

    2015-03-01

    Full Text Available Quality control of veterinary medicine products containing two different frequently used antibiotics metronidazole and ciprofloxacin hydrochloride, was considered and performed, using modified pharmacopoeial HPLC methods. Three different HPLC systems were used: Varian ProStar, Perkin Elmer Series and UPLC Shimadzu Prominence XR. The chromatographic columns used were LiChropher RP Select B 75 mm x 4 mm with 5 μm particles and Discovery C18 100 mm x 4,6 mm with 5 μm particles. Chromatographic methods used for both analytes were compendial, with minor modifications made for experimental purposes. Minor modifications of the pharmacopoeia prescribed chromatographic conditions, in both cases, led to better chromatographic parameters, good resolution and shorter analysis times. Optimized methods can be used for: determination of metronidazole in gel formulation, for its simultaneous quantification with preservatives present in the formulation and even for identification and quantification of its specified impurity, 2-methyl-5-nitroimidazole; determination of ciprofloxacin hydrochloride in film coated tablets and eye drops and identification and quantification of its specified impurities. These slightly modified and optimized pharmacopoeial methods for quality control of metronidazole and ciprofloxacin dosage forms used in veterinary medicine can be successfully applied in laboratories for quality control of veterinary medicines.

  4. Using SSR-HRM to Identify Closely Related Species in Herbal Medicine Products: A Case Study on Licorice.

    Science.gov (United States)

    Li, Jingjian; Xiong, Chao; He, Xia; Lu, Zhaocen; Zhang, Xin; Chen, Xiaoyang; Sun, Wei

    2018-01-01

    Traditional herbal medicines have played important roles in the ways of life of people around the world since ancient times. Despite the advanced medical technology of the modern world, herbal medicines are still used as popular alternatives to synthetic drugs. Due to the increasing demand for herbal medicines, plant species identification has become an important tool to prevent substitution and adulteration. Here we propose a method for biological assessment of the quality of prescribed species in the Chinese Pharmacopoeia by use of high resolution melting (HRM) analysis of microsatellite loci. We tested this method on licorice, a traditional herbal medicine with a long history. Results showed that nine simple sequence repeat (SSR) markers produced distinct melting curve profiles for the five licorice species investigated using HRM analysis. These results were validated by capillary electrophoresis. We applied this protocol to commercially available licorice products, thus enabling the consistent identification of 11 labels with non-declared Glycyrrhiza species. This novel strategy may thus facilitate DNA barcoding as a method of identification of closely related species in herbal medicine products. Based on this study, a brief operating procedure for using the SSR-HRM protocol for herbal authentication is provided.

  5. The use of Chinese herbal medicine as an adjuvant therapy to reduce incidence of chronic hepatitis in colon cancer patients: A Taiwanese population-based cohort study.

    Science.gov (United States)

    Lin, Tsai-Hui; Yen, Hung-Rong; Chiang, Jen-Huai; Sun, Mao-Feng; Chang, Hen-Hong; Huang, Sheng-Teng

    2017-04-18

    There is a decided lack of in-depth studies to evaluate the effectiveness of Chinese Herbal Medicine (CHM) as an adjuvant therapy on the incidence of chronic hepatitis in patients with colon cancer. The aim of this study is to assess whether CHM treatment decreased the incidence of chronic hepatitis in colon cancer patients who received conventional Western medical treatment. A Taiwanese nationwide population-based study of colon cancer patients receiving Western medicine treatment in conjunction with CHM treatment, using data provided by the National Health Insurance (NHI) Research Database, was conducted. A total of 61676 patients were diagnosed with colon cancer in Taiwan within the defined study period, from 1997 to 2010. After randomly equal matching for age, sex, excluding patients younger than 18 years of age, chronic hepatitis before colon cancer diagnosis date, receiving acupuncture and/or moxibustion and taking CHM for less than 30 days, data from 155 patients were analyzed. Hazard ratios of incidence rate of chronic hepatitis were used to determine the influence of CHM and the therapeutic potential of herbal products in treating patients with colon cancer. CHM used for patients with colon cancer exhibited significantly decreased incidence rates of chronic hepatitis [hazard ratio (HR)=0.53; 95% confidence interval (CI):0.38-0.74], with multivariate adjustment, compared to those without CHM use. The protective effect of CHM treatment with statistical significance across the stratification of age, gender, co-morbidity and treatment modality was noted. The cumulative incidence of chronic hepatitis was also reduced in patients with colon cancer receiving CHM treatment during a five-year period. In this study, we provide the ten most used single herbs and herbal formulas that were prescribed for patients with colon cancer; moreover, we identify the eight single herbs and five formulas used in CHM treatment which significantly decreased incidence of chronic

  6. Traditional, complementary and alternative medicine use by HIV patients a decade after public sector antiretroviral therapy roll out in South Africa: a cross sectional study.

    Science.gov (United States)

    Nlooto, Manimbulu; Naidoo, Panjasaram

    2016-05-17

    The roll out of antiretroviral therapy in the South African public health sector in 2004 was preceded by the politicisation of HIV-infection which was used to promote traditional medicine for the management of HIV/AIDS. One decade has passed since; however, questions remain on the extent of the use of traditional, complementary and alternative medicine (TCAM) by HIV-infected patients. This study therefore aimed at investigating the prevalence of the use of African traditional medicine (ATM), complementary and alternative medicines (CAM) by adult patients in the eThekwini and UThukela Health Districts, South Africa. A cross- sectional study was carried out at 8 public health sector antiretroviral clinics using interviewer-administered semi-structured questionnaires. These were completed from April to October 2014 by adult patients who had been on antiretroviral therapy (ART) for at least three months. Use of TCAM by patients was analysed by descriptive statistics using frequency and percentages with standard error. Where the associated relative error was equal or greater to 0.50, the percentage was rejected as unstable. A p-value public health sector, the use of TCAM is still prevalent amongst a small percentage of HIV infected patients attending public healthcare sector antiretroviral clinics. Further research is needed to explore reasons for use and health benefits or risks experienced by the minority that uses both conventional antiretroviral therapy with TCAM.

  7. [Case-control study on Chinese medicine fumigation and massage therapy for the treatment of knee stability and func tional recovery after anterior cruciate ligament reconstruction operation].

    Science.gov (United States)

    Min, Zhong-han; Zhou, Ying; Jing, Lin; Zhang, Hong-mei; Wang, Sheng; Chen, Wei-heng; Chen, Ping-quan

    2016-05-01

    To study clinical outcomes of Chinese medidine fumigation and massage therapy for the treatment of knee stability and functional recovery after anterior cruciate ligament reconstruction operation,and to explore the effect on tendon-bone healing. Total 50 patients were divided into two groups: the control group (normal rehabilitation therapy group),the treatment group (Chinese medicin