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Sample records for medicinal product haemate

  1. A systematic overview of the first pasteurised VWF/FVIII medicinal product, Haemate P/ Humate -P: history and clinical performance

    DEFF Research Database (Denmark)

    Berntorp, E.; Archey, W.; Auerswald, G.

    2008-01-01

    , plasma-derived VWF/FVIII medicinal product, which was first licensed in Germany in 1981 for the treatment of HA-associated bleeding. It has since then come to be accepted as the gold standard for both the treatment and prophylaxis of bleeding in VWD, especially in cases where desmopressin [1-deamino-8-D......-arginine vasopressin (DDAVP)] has been ineffective. Haemate P was the first effectively virus-inactivated (pasteurisation: 60 degrees C for 10 h in aqueous solution) FVIII product, whereby the risk of potentially threatening infective complications of plasma-derived products was reduced. Haemate P was also shown...... including surgical interventions. By virtue of its plasma-derived combination of VWF and FVIII, in addition to its high VWF:FVIII content ratio (2.4:1), Haemate P is also associated with successful immune tolerance induction in those patients developing inhibitor antibodies. Although the theoretical risk...

  2. Haematic silicon in drowning.

    Science.gov (United States)

    Pierucci, Giovanni; Merlano, Federica; Chen, Yao; Sturini, Michela; Maraschi, Federica; Profumo, Antonella

    2016-04-01

    The aim of this paper was to evaluate silicon (Si) concentration in human whole ventricular blood as a further potential chemical marker in the diagnosis of drowning. We employed an acidic digestion for the extraction of soluble Si, and an alkaline digestion for the determination of total Si, including particulate matter, both arising from drowning medium. 29 suspected drowning situations, 24 in fresh water (Fw) and 5 in seawater (Sw), were examined. The difference in Si concentration between the left and right ventricular blood (Si ΔL-R) was measured and alkaline Si ΔL-R seems, indeed, a potentially significant complementary tool in the diagnosis of Fw drowning, because insoluble silicon fraction does not undergo hemo-dilution or hemo-concentration, and the ΔL-R is not affected by exogenous factors. In spite of the limited number of cases investigated, a good correlation was observed between the analytical results and the macro-microscopic autoptic findings. Copyright © 2016 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

  3. Publication productivity in nuclear medicine.

    Science.gov (United States)

    McKellar, Cheryl; Currie, Geoff

    2015-06-01

    Publications form the knowledge base of any profession. Patterns in professional publications provide insight into the profession's maturity and global status. To our knowledge, publication productivity in nuclear medicine technology has not been reported. A recent study on publication productivity in radiography and radiation therapy provided interesting insight; however, a sampling bias resulted in study flaws. The most productive medical radiation technologists were determined by collecting data from 7 key, international peer-reviewed journals for the medical radiation sciences over a 5-y period. A full list of the technologists' publications, for the 5-y period, was obtained using a PubMed and ResearchGate search, and the authors were analyzed. In total, 165 medical radiation technologists were identified who had published 3 or more articles between 2009 and 2013. Of these authors, 55.2% (91/165) were radiographers, 35.2% (58/165) were radiation therapists, and 9.6% (16/165) were nuclear medicine technologists. Overall, the majority of the most prolific authors were academics (104/165; 63.0%). After we applied a correction factor (the productivity per member of the registered workforce), radiography had the fewest authors publishing, compared with the relative workflow sizes. Nuclear medicine technologists demonstrated a high degree of productivity both absolutely and relatively. Consequently, nuclear medicine technologists have a productive research culture and command a large footprint within and outside the key medical radiation science journals. © 2015 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

  4. 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.

  5. 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.

  6. 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...

  7. Intestinal and haematic parasitism in the birds of the Almuñecar (Granada, Spain) ornithological garden.

    Science.gov (United States)

    Cordón, G Pérez; Prados, A Hitos; Romero, D; Moreno, M Sánchez; Pontes, A; Osuna, A; Rosales, M J

    2009-11-12

    Birds from the Almuñecar ornithological garden (Granada, Spain) were surveyed from June 2006 to May 2007 to establish programmes to prevent, control, and treat intestinal and haematic parasites. A total of 984 faecal samples and 41 samples of blood were collected from Psittacidae, Cacatuidae, Phasianidae, and Anatidae. One or more intestinal parasites were identified in 51.6% of the samples. Blood parasites were found in 26.8% of the birds examined. The most frequent pathogenic endoparasites were coccidians, such as Cyclospora sp. (4.5%), Eimeria sp. (4.1%) and Isospora sp. (2%) and helminths such as Capillaria sp. (10. 1%), Ascaridia sp. (4.9%) and Heterakis gallinarum (4.9%). All the parasites varied with season but the most were found year round. Multiple parasitic infections by intestinal parasites were common, with 196 of 984 faecal samples having 2-5 intestinal parasites. The most frequent cases of multiple parasitism were Blastocystis plus Entamoeba sp. and Blastocystis plus Cyclospora sp. The haematic protozoa detected were Haemoproteus sp. (17%) and Plasmodium sp. (7.3%). Multiple parasitism by Haemoproteus sp. and Plasmodium sp. was detected in 1 sample of Gallus gallus. After each sampling, some of the affected animals were treated according to our results, and the corresponding programmes of prevention and control were designed.

  8. Research Productivity of Sports Medicine Fellowship Faculty.

    Science.gov (United States)

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

    2016-12-01

    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. 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. Descriptive epidemiology study. Characteristics of orthopaedic sports medicine fellowship programs were obtained from the AOSSM and program websites. Metrics of academic productivity (Hirsch index [ h index], I-10 index, publications, citations, and number of publications in several journals) were obtained from Scopus. Statistical analyses were conducted to determine whether academic productivity differs with fellowship attributes and academic rank. A total of 90 AOSSM sports medicine fellowship programs with 610 associated faculty members were identified. Faculty were predominantly male (94%), at academic medical centers (74%), members of AOSSM (71%), and sports medicine-fellowship trained (84%). Faculty had a median of 18 (range, 0-684) publications overall, including a median of 3 (range, 0-161) publications since 2012. All measures of academic productivity were significantly higher among faculty employed at academic medical centers compared with those not employed at academic centers ( P Sports Medicine and Arthroscopy per faculty member ( P sports medicine fellowship faculty. Research productivity was higher among faculty employed at academic centers in the Northeast and Midwest regions and at programs with a larger number of fellows.

  9. 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.

  10. Research Productivity of Sports Medicine Fellowship Faculty

    Science.gov (United States)

    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: Descriptive epidemiology study. Methods: Characteristics of orthopaedic sports medicine fellowship programs were obtained from the AOSSM and program websites. Metrics of academic productivity (Hirsch index [h index], I-10 index, publications, citations, and number of publications in several journals) were obtained from Scopus. Statistical analyses were conducted to determine whether academic productivity differs with fellowship attributes and academic rank. Results: A total of 90 AOSSM sports medicine fellowship programs with 610 associated faculty members were identified. Faculty were predominantly male (94%), at academic medical centers (74%), members of AOSSM (71%), and sports medicine–fellowship trained (84%). Faculty had a median of 18 (range, 0-684) publications overall, including a median of 3 (range, 0-161) publications since 2012. All measures of academic productivity were significantly higher among faculty employed at academic medical centers compared with those not employed at academic centers (P Sports Medicine and Arthroscopy per faculty member (P sports medicine fellowship faculty. Research productivity was higher among faculty employed at academic centers in the Northeast and Midwest regions and at programs with a larger number of fellows. PMID:28210650

  11. 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

  12. Apitherapy Products for Medicinal Use.

    Science.gov (United States)

    Fratellone, Patrick M; Tsimis, Flora; Fratellone, Gregory

    2016-12-01

    For the past 10 years, beekeeping has increased due to a growing awareness of the disappearance of bees since Colony Collapse Disorder. Most of the disappearance of honey bees can be attributed to the use of pesticides. Apitherapy is the science and art of maintaining health with the use of products from the honeybee hive: honey, bee pollen, propolis, royal jelly, and bee venom. We have been beekeeping for the last 10 years. We use every product from the beehive for both personal and patient use.

  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. traditional medicinal uses of small mammal products

    African Journals Online (AJOL)

    Dr. Nelson Boniface

    particularly in Asian countries. The cultural use of animal products for medicinal purposes in many societies has led to the development of pharmaceuticals worldwide, although it has been largely responsible for extinction or near extinction of some animals, especially large ones (Cavaliere 2010). Tanzania is among African ...

  15. DNA Barcoding of Philippine Herbal Medicinal Products.

    Science.gov (United States)

    Pedales, Ronniel D; Damatac, Amor M; Limbo, Carlo A; Marquez, Cielo Mae D; Navarro, Anna Isabel B; Molina, Jeanmaire

    2016-11-01

    The Philippine government established the Traditional and Alternative Medicine Act in 1997 to promote traditionally used herbal products and to provide an effective yet affordable alternative to conventional medicines. However, government regulation of herbal medicinal products (HMPs) is not stringent, relying only on submitted quality data from the manufacturer. In this study we validated the taxonomic identity of 26 plant samples contained within 22 HMPs, each produced by different local manufacturers, through DNA barcoding of the nuclear internal transcribed spacer-2 (ITS2) region. We recovered 19 ITS2 barcodes from 26 samples. These were compared to sequences in GenBank using MEGABLAST, but ambiguous results (similar max scores for different species) were phylogenetically analyzed. Twelve of the 19 samples matched the indicated species on the product label, three were equivocal in specific identity but were placed in the expected genus, and four other samples from three manufacturers contained contamination and/or substitution. GenBank's reference database was at times problematic because some sequences were lacking or were misidentified, but the database was still useful. Overall, ITS2 barcoding was successful in authenticating the HMPs, and it is recommended during the premarket evaluation process so as to obtain a certificate of registration from the government. The government should also develop a comprehensive database of barcodes for Philippine plants, and should prioritize the development of the traditional pharmacopeia because many locally produced HMPs are not indigenous.

  16. Editorial for Special Issue on Herbal Medicines and Natural Products.

    Science.gov (United States)

    Zhou, Zhi-Wei; Zhou, Shu-Feng

    2015-11-16

    Herbal medicines and natural products have been the most productive source of drug development and there is a large line of evidence on the applications of herbal medicines and natural products for the management of body function and the treatment of aliments. The multiple bioactive components in herbal medicines and natural products can explain the multiple targets effect in their medical applications. The increasing usage of state-of-art computational, molecular biological, and analytical chemistry techniques will promote the exploration of the pharmacological effect of previously inaccessible sources of herbal medicines and natural products. Notably, with the increasing reports on the safety issues regarding the medical use of herbal medicines and natural products, the awareness of pharmacovigilance in herbal medicines and natural products needs to be strengthened. To prevent the adverse drug reactions related to herbal medicines and natural products, physicians need to be aware of potential risks and alert patients in the use of herbal medicines and natural products.

  17. Antiviral Natural Products and Herbal Medicines

    Directory of Open Access Journals (Sweden)

    Liang-Tzung Lin

    2014-01-01

    Full Text Available Viral infections play an important role in human diseases, and recent outbreaks in the advent of globalization and ease of travel have underscored their prevention as a critical issue in safeguarding public health. Despite the progress made in immunization and drug development, many viruses lack preventive vaccines and efficient antiviral therapies, which are often beset by the generation of viral escape mutants. Thus, identifying novel antiviral drugs is of critical importance and natural products are an excellent source for such discoveries. In this mini-review, we summarize the antiviral effects reported for several natural products and herbal medicines.

  18. 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.

  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. Traditional medicinal uses of small mammal products: a case study ...

    African Journals Online (AJOL)

    Traditional medicines, both plant and animal products, have been used to cure various diseases since time immemorial especially in rural areas worldwide. Many studies have focused on traditional plant products, but little research has been conducted on animal traditional medicines. This study investigated the use of ...

  1. Nigerian Journal of Natural Products and Medicine: Editorial Policies

    African Journals Online (AJOL)

    Focus and Scope. 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 ...

  2. An efficient system for the production of the medicinally important ...

    African Journals Online (AJOL)

    An efficient system for the production of the medicinally important plant: Asparagus cochinchinensis (Lour.) Merr. J Xiang-Hui, Z Gui-Ping, OL Jun, S Chao-Wen. Abstract. An in vitro cultivation protocol was developed for Asparagus cochinchinensis a species threatened by over collection due to its importance as a medicinal ...

  3. 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.

  4. Nigerian Journal of Natural Products and Medicine - Vol 13 (2009)

    African Journals Online (AJOL)

    Nigerian Journal of Natural Products and Medicine. ... Quality control of Harpagophytum procumbens products using High Pressure Liquid Chromatography-Diode Array Detection (HPLC-DAD) · EMAIL FULL TEXT EMAIL FULL ... Patenting for economic development: how aware are Nigerian pharmaceutical researchers?

  5. European regulatory tools for advanced therapy medicinal products.

    Science.gov (United States)

    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.

  6. Publication productivity of faculty of medicine, Mansoura University ...

    African Journals Online (AJOL)

    Conclusion: The publication productivity of Mansoura Faculty of Medicine showed fluctuating pattern from the end of the calendar year 2012 and earlier. Future prospects for increasing research productivity should be considered to increase the number and quality of publications and academic staff participating in ...

  7. 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.

  8. 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.

  9. Community pharmacist's responsibilities with regards to traditional medicine/complementary medicine products: A systematic literature review.

    Science.gov (United States)

    Ung, Carolina Oi Lam; Harnett, Joanna; Hu, Hao

    The use of Traditional Medicine/Complementary Medicine (TM/CM) products has gained popularity in many countries. There is a growing body of evidence to support that concomitant use of TM/CM products with certain pharmaceutical medicines may adversely affect treatment outcomes. There is a general consensus that pharmacists have a role to play in the safe and appropriate use of these products. However, the extent of their involvement and responsibilities are not yet defined. Clear guidelines that inform their duty of care are essential for pharmacists to establish their role in the management of TM/CM product use. The purpose of this study was to determine pharmacist's responsibilities with regards to TM/CM products that have been discussed in the literature since 2000. A literature search in 3 electronic databases (Web of Science, Science Direct and PubMed) was used to extract publications from 2000 to 2015 that related pharmacist to TM/CM products. Out of the 2859 publications extracted for abstract review, 171 documents were selected for full text assessment. 41 publications which reported findings from exploratory studies or discussed pharmacists' responsibilities towards TM/CM products were selected for inclusion in this study. Seven major responsibilities were frequently discussed in the literature: (1) to acknowledge the use; (2) to be knowledgeable about the TM/CM products; (3) to ensure safe use of TM/CM products; (4) to document the use of TM/CM products; (5) to report ADRs related to TM/CM products; (6) to educate about TM/CM products; and (7) to collaborate with other health care professionals. Various forms and levels of pharmacists' responsibilities with TM/CM products have been mentioned in the literature. Subsequent work towards a common consensus must take into account three influential factors strategically: the scope of TM/CM products, objectives of pharmacists' involvement and the perspectives of key stakeholders. Copyright © 2016 Elsevier Inc

  10. 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.

  11. 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

  12. 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

  13. Commercial production of radioisotopes for nuclear medicine, 1970-1980

    International Nuclear Information System (INIS)

    Lamb, J.F.

    1981-01-01

    The first small cyclotrons were installed for commercial production of radioisotopes at New England Nuclear Corporation, Billerica, Massachusetts, and at Medi-Physics, Emeryville, California. Both machines were Cyclotron Corporation Cs-22 multiple particle, fixed energy cyclotrons. In the ten years that followed, the total number of commercial radioisotope producing small accelerators has grown to ten, with four more projected for 1981. The beam energy requirement for the first accelerators was modest; 22 MeV protons, 12 MeV deuterons, 24 MeV He-4, and 31 MeV He-3; and commercial radioisotope production for nuclear medicine utilized all four particles. The first product available from cyclotron production was fluorine-18 from the 16 O( 3 He, p) 18 F reaction. Injected intravenously as no-carrier-added Na 18 F, the radionuclide quickly concentrated in bone, providing the nuclear medicine physician with diagnostic information on skeletal abnormalities including metastatic bone disease

  14. 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, ...

  15. 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...

  16. World integrated medicine forum on the regulation of homoeopathic medicinal products: National and global strategies

    Directory of Open Access Journals (Sweden)

    Harleen Kaur

    2017-01-01

    Full Text Available The first World Integrated Medicine Forum on the regulation of homoeopathic medicinal products included 50 delegates from 25 countries to discuss the current state of regulation of homoeopathic medicinal products (HMPs. The stakeholders in attendance included government officials, manufacturers, pharmacopoeia organisations, pharmacists, and healthcare providers worldwide. The Minister of Ayurveda, Yoga, Unani, Siddha and Homoeopathy from India, who is likely the only high ranking national official in the world specifically dedicated to oversight of traditional medicines including Homoeopathy, was the keynote speaker for the meeting. The core presentations delivered information on the country-to-country variance in regulatory requirements for homoeopathic medicine manufacture and marketing. Different speakers addressed the current pharmacopeia structures in various countries, variance in premarket approval process, regulatory frameworks for homoeopathic medicines, labelling requirements, safety requirements, marketing approaches and good manufacturing practices. Debates focused on quality control testing, stability of intermediate stocks, shelf life of finished products, pre-market approval process and labelling and they shed light on regional differences in regulation. A lengthy discussion was held on the potential value of harmonisation of pharmacopoeias, manufacturing standards, safety evaluation and labelling. The group consensus was to meet again to pursue specific topics. Daily summaries of take-away points are provided at the end of each day's talk summaries. Much acclaim was won by the organisers for materialising this unique forum which proved to be an apt platform for rigorous discussions on lesser discussed, but very vital points such as regulations of HMPs, harmonisation of pharmacopeias and linking industry and regulators' sectors for unified efforts for global development of Homoeopathy.

  17. Regulatory Consequences of "Brexit" for the Development of Medicinal Products.

    Science.gov (United States)

    Jackson, E L; Feldschreiber, P; Breckenridge, A

    2017-08-01

    The United Kingdom voted in a referendum in June 2016 to leave the European Union (EU) after 45 years of membership. Among the many political, social, and scientific consequences are those for the regulation of health care products. No longer will the efficacy, safety, and quality of medicines in the United Kingdom be subject to an EU regulatory framework. The European Medicines Agency (EMA), which is currently located in London, will move elsewhere in Europe. The pharmaceutical industry will reassess its commitment to the UK health scene. © 2017, ASCPT.

  18. 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

  19. 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...

  20. [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.

  1. 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

  2. Herbal medicinal products - Evidence and tradition from a historical perspective.

    Science.gov (United States)

    Jütte, Robert; Heinrich, Michael; Helmstädter, Axel; Langhorst, Jost; Meng, Günter; Niebling, Wilhelm; Pommerening, Tanja; Trampisch, Hans J

    2017-07-31

    Aside from the fully licensed herbal medicines there are products on the European pharmaceutical market which are registered by virtue of their longstanding traditional use. The normal registration procedure does not apply to them because presently they do not meet the legal requirements for a full license as set out in the relevant European Union Directive. One of these requirements, "proof of tradition", has so far been dealt with in different ways and fails to meet the criteria of good practice. This analysis is based on a selective literature search in PubMed and in databases of medical and pharmaceutical history, interviews with licensing experts, a consensus meeting attended by researchers with a background in general medicine, phytotherapy, medical and pharmaceutical history, biometry, ethnopharmacology, pharmacognosy and the pharmaceutical industry. The 2004 EU Directive, which governs the registration of Traditional Herbal Medicinal Products and demands proof of tradition, is a regulatory construct and, above all, the outcome of a political process that has ended in a pragmatic compromise. The concept of tradition applied in the Directive does not sufficiently reflect the semantic breadth of the term. The only condition defined is that a specific commercial preparation needs to have been on the market for 30 years (15 of them inside the EU). Such an approach does not make full scientific use of the evidence available because the information excerpted from historical sources, if adequately processed, may yield valuable insights. This applies to indications, modes of application, efficacy and product safety (innocuousness). Such criteria should enter in full into the benefit-risk-analysis of applied preparations, in the registration process as well as in the therapeutic practice. When registering Traditional Herbal Medicinal Products the criterion of evidence-based medicine will only be met if all the facts available are assessed and evaluated, over and

  3. 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.

  4. 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.

  5. 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.

  6. [Public production of medicines in Brazil: an overview].

    Science.gov (United States)

    de Oliveira, Egléubia Andrade; Labra, Maria Eliana; Bermudez, Jorge

    2006-11-01

    This paper analyzes the role of government production of medicines in Brazil, based on a review of the literature and public documents. It begins by examining the main characteristics of the national and international pharmaceutical industry and market dimensions, mainly in the public sector. The government view was examined through Ministry of Health documents. The article concludes with a diagnosis of the state-owned pharmaceutical industry in Brazil, showing a variety of difficulties faced by the laboratories due to political and institutional constraints, management deficiencies, shortage of qualified human resources, and low technological capability.

  7. 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...... basis of Ayurveda medicine and in drug repurposing....

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

    Science.gov (United States)

    Figueiredo, Tatiana Aragão; Schramm, Joyce Mendes de Andrade; Pepe, Vera Lúcia Edais

    2017-09-28

    : 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.

  9. 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.

  10. 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...

  11. 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.

  12. [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.

  13. [The use of nanotechnology in medicinal products in the light of European Union law].

    Science.gov (United States)

    Jurewicz, Margin

    2014-12-01

    The purpose of EU regulations in relation to nanotechnology, according to the European Commission's Communication "Regulatory aspects of nanomaterials", is to allow the public to use innovative applications of nanotechnology while ensuring a high level of safety, health care and environmental protection. This article characterizes and comments on EU legislation in respect of medicinal products containing nanomaterials. Medicinal products manufactured using nanotechnology are subject to the optional centralized authorization procedure by the European Commission authorizations for the placing on the market throughout the EU; advanced therapy medicinal products containing nanomaterials are covered by the mandatory centralized procedure. Evaluation of medicines in centralized authorization mode for the marketing of medicinal products, including those containing nanomaterials, is carried out by the Committee on Medicinal Products for Human Use (CHMP) subject to the European Medicines Agency (EMA).

  14. [What doctors need to know about biosimilar medicinal products?].

    Science.gov (United States)

    Kes, Petar; Mesar, Ines; Bašić-Jukić, Nikolina; Rački, Sanjin

    2014-04-01

    Biological drug is a drug containing one or more active substances produced or secreted from a biological source. Some of them may be previously present in the human body, and examples include proteins such as insulin, growth hormone or erythropoetin. Biosimilar drug is a medical product that is a copy of the original approved drug whose patent has expired. Strict rules apply to similar biological medicines: 1) it is unable to support extrapolation of data on safety and efficacy between individual indications, except in the case of appropriate, science-based evidence; 2) biosimilar drugs must meet the requirements associated with testing the immunogenicity and safety monitoring afterthe introduction of the drug in clinical practice, including the risk management program; 3) each biosimilar drug has to be labeled under its own name in order to allow clear traceability of all medications; and 4) the principle of automatic substitution cannot apply to biosimilar drugs because they are not interchangeable.

  15. Medicinal and cosmetics soap production from Jatropha oil.

    Science.gov (United States)

    Shahinuzzaman, M; Yaakob, Zahira; Moniruzzaman, M

    2016-06-01

    Soap is the most useful things which we use our everyday life in various cleansing and cosmetics purposes. Jatropha oil is nonedible oil which has more benefits to soap making. It has also cosmetics and medicinal properties. But the presence of toxic Phorbol esters in Jatropha oil is the main constrains to use it. So it is necessary to search a more suitable method for detoxifying the Jatropha oil before the use as the main ingredient of soap production. This review implies a more suitable method for removing phorbol esters from Jatropha oil. Several parameters such as the % yield of pure Jatropha oil soap, TFM value of soap, total alkali content, free caustic alkalinity content, pH, the antimicrobial activity, and CMC value of general soap should be taken into consideration for soap from detoxified Jatropha oil. © 2016 Wiley Periodicals, Inc.

  16. 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

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

    Science.gov (United States)

    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

  18. Contribution of the spanish agency for medicines and healthcare products to the European committee for the evaluation of medicinal products for human use.

    Science.gov (United States)

    Alonso-Gutiérrez, A; Díaz-Ramos, P; Sulleiro-Avendaño, E; de Miguel-Marañón, M; Padilla-Gallego, M E; Sancho-López, A; Ruiz-Antúnez, S; Prieto-Yerro, C

    2015-05-01

    The centralized procedure for registering medicinal products involves a joint assessment by all regulatory agencies of European Union member states, which are coordinated by the European Medicines Agency. Since its implementation in 1995, the Spanish Agency for Medicines and Healthcare Products (AEMPS) has actively contributed to the committee on medicinal products for human use. The therapeutic areas in which AEMPS has the greatest presence are cardiovascular, sensory organs (mainly ophthalmology) and genitourinary/sexual hormones. The technical staff of AEMPS contributes their expertise and extensive experience to this task, as do the practitioners of the Spanish healthcare system who act as external experts, providing their clinical vision and bringing the daily clinical practice to the evaluation of medicinal products. As with other European decision spaces, the joint participation of the member states is not homogeneous, with a minority of countries still heading the majority of assessments for the committee on medicinal products for human use, although all member countries take part in the final decision. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  19. [Outline study on production place of Chinese medicine in Han dynasty].

    Science.gov (United States)

    Zhang, Rui-xian; Wang, Jing; Zhang, Wei; Zhang, Mu-qun

    2008-07-01

    The administrative area of Han dynasty was basically divided into 13 states. There were very little records about the place of medicine production in literatures. This article tried to outline the basic feature of region of medicine production from the available books of , , and .

  20. 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

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

    Science.gov (United States)

    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

  2. [Application of risk-based approach for determination of critical factors in technology transfer of production of medicinal products].

    Science.gov (United States)

    Beregovykh, V V; Spitskiy, O R

    2014-01-01

    Risk-based approach is used for examination of impact of different factors on quality of medicinal products in technology transfer. A general diagram is offered for risk analysis execution in technology transfer from pharmaceutical development to production. When transferring technology to full- scale commercial production it is necessary to investigate and simulate production process application beforehand in new real conditions. The manufacturing process is the core factorfor risk analysis having the most impact on quality attributes of a medicinal product. Further importantfactors are linked to materials and products to be handled and manufacturing environmental conditions such as premises, equipment and personnel. Usage of risk-based approach in designing of multipurpose production facility of medicinal products is shown where quantitative risk analysis tool RAMM (Risk Analysis and Mitigation Matrix) was applied.

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

    DEFF Research Database (Denmark)

    Kohli, Vishv Priya

    The study of counterfeiting and falsification of medicinal products, from a legal perspective, is a relatively new area in the EU. Specific regulations that focus on falsification of medicines came as recently as 2011. Therefore, this discipline is also new for research. There are two primary obj...

  4. 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

  5. The biosynthetic products of chinese insect medicine, Aspongopus chinensis

    Science.gov (United States)

    Luo, Xiao-Hong; Wang, Xiao-Zheng; Jiang, Hai-Long; Yang, Jun-Li; Crews, Phillip; Valeriote, Frederick A.; Wu, Quan-Xiang

    2012-01-01

    A new oxazole (1) was obtained from chinese insect medicine Aspongopus chinensis, along with three known N-acetyldopamine derivatives (2–4). Their structures were determined on the basis of NMR and ESI-MS analyses. The possible biosynthetic pathways of the isolated compounds are discussed. Cytotoxicities of those compounds against 10 selected cancer cells were measured in vitro. PMID:22430116

  6. The relevance of pharmacognosy in pharmacological research on herbal medicinal products.

    Science.gov (United States)

    Pferschy-Wenzig, Eva-Maria; Bauer, Rudolf

    2015-11-01

    As all medicines, herbal medicinal products are expected to be safe, effective, and of appropriate quality. However, regulations on herbal medicinal products vary from country to country, and herbal preparations do occur not only in the form of medicinal products but also as less strictly regulated product groups like dietary supplements. Therefore, it is not always easy for the consumers to discriminate high-quality products from low-quality products. On the other hand, herbal medicines have many special features that distinguish them from conventional medicinal products. Plants are complex multicomponent mixtures; in addition, their phytochemical composition is not constant because of inherent variability and a plethora of external influences. Therefore, the production process of an herbal medicinal product needs to be strictly monitored. First of all, the starting materials need to be correctly authenticated and free of adulterants and contaminants. During plant growth, many factors like harvest season and time, developmental stage, temperature, and humidity have a strong impact on plant metabolite production. Also, postharvest processing steps like drying and storage can significantly alter the phytochemical composition of herbal material. As the production of many phytopharmaceuticals includes an extraction step, the extraction solvent and conditions need to be optimized in order to enrich the bioactive constituents in the extract. The quality of finished preparations needs to be determined either on the basis of marker constituents or on the basis of analytical fingerprints. Thus, all production stages should be accompanied by appropriate quality assessment measures. Depending on the particular task, different methods need to be applied, ranging from macroscopic, microscopic, and DNA-based authentication methods to spectroscopic methods like vibrational spectroscopy and chromatographic and hyphenated methods like HPLC, GC-MS and LC-MS. Also, when performing

  7. 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.

  8. 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

  9. 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.

  10. 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...

  11. 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 ...

  12. 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...... available in non-pharmacy outlets; The United Kingdom (UK) is a more established NPM market; both are guided by the same EU directives. OBJECTIVE: The aim of this study was to compare specific requirements under the legislation, rationales and outcomes regarding the sale of NPMs through non-pharmacy outlets...... between Sweden and the UK. METHOD: The main method was analysis of legislative text and policy documents, conducted in 2012. RESULTS: Both countries had specified medicines available to the public in non-pharmacy outlets, but with restrictions on different factors, e.g. placement and package size...

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

    Science.gov (United States)

    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.

  14. 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.

  15. 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.

  16. Proposal for new European pharmaceutical legislation to permit access to custom-made anti-sense oligonucleotide medicinal products.

    Science.gov (United States)

    Johnston, John D; Feldschreiber, Peter

    2014-06-01

    Current European pharmaceutical legislation is not adequate to meet advances in science and technologies that will lead to rapid development of custom-made medicines. Using existing legislation for custom-made medical devices as a template and anti-sense oligonucleotides as model medicinal products, we propose new European pharmaceutical legislation to permit timely access to custom-made anti-sense oligonucleotide medicinal products. The proposals may be more widely applicable to other medicinal products. © 2013 The British Pharmacological Society.

  17. 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.

  18. 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.

  19. Is Patent "Evergreening" Restricting Access to Medicine/Device Combination Products?

    Science.gov (United States)

    Beall, Reed F; Nickerson, Jason W; Kaplan, Warren A; Attaran, Amir

    2016-01-01

    Not all new drug products are truly new. Some are the result of marginal innovation and incremental patenting of existing products, but in such a way that confers no major therapeutic improvement. This phenomenon, pejoratively known as "evergreening", can allow manufacturers to preserve market exclusivity, but without significantly bettering the standard of care. Other studies speculate that evergreening is especially problematic for medicine/device combination products, because patents on the device component may outlast expired patents on the medicine component, and thereby keep competing, possibly less-expensive generic products off the market. We focused on four common conditions that are often treated by medicine/device product combinations: asthma and chronic obstructive pulmonary disease (COPD), diabetes, and severe allergic reactions. The patent data for a sample of such products (n = 49) for treating these conditions was extracted from the United States Food and Drug Administration's Orange Book. Additional patent-related data (abstracts, claims, etc) were retrieved using LexisNexis TotalPatent. Comparisons were then made between each product's device patents and medicine patents. Unexpired device patents exist for 90 percent of the 49 medicine/device product combinations studied, and were the only sort of unexpired patent for 14 products. Overall, 55 percent of the 235 patents found by our study were device patents. Comparing the last-to-expire device patent to that of the last-to-expire active ingredient patent, the median additional years of patent protection afforded by device patents was 4.7 years (range: 1.3-15.2 years). Incremental, patentable innovation in devices to extend the overall patent protection of medicine/device product combinations is very common. Whether this constitutes "evergreening" depends on whether these incremental innovations and the years of extra patent protection they confer are proportionately matched by therapeutic

  20. 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.

  1. [Risk-benefit evaluation of medicinal products. An element of Health Technology Assessment].

    Science.gov (United States)

    Hart, D

    2005-02-01

    This paper aims to further develop and specify the method and the process of risk-benefit evaluation for determining the safety of medicinal products in national and European pharmaceutical law. The term "safety" (Unbedenklichkeit=the relationship between efficacy and harmfulness) is one of the central categories of national and European pharmaceutical law. The guaranteeing of the safety of pharmaceuticals is not a static but a dynamic and process oriented objective. It aims to preserve what has been approved on the one hand, and to increase the standard of safety by innovation on the other. A medicinal product is only found to be safe if the result of the risk-benefit evaluation is a positive risk-benefit balance. Safety must be guaranteed permanently through the entire lifecycle of the medicinal product. One must differentiate between absolute safety, which is related to the individual product, and relative safety, which is related to already available medicinal products of the same indication. The process of risk-benefit evaluation is determined by the indication of the medicinal product. The different types of medicinal products or their different mechanisms of action require different risk-benefit evaluations. The established, estimated and evaluated benefit has to be compared with the established, estimated and evaluated risks of the medicinal product. The comparative risk-benefit evaluation requires a procedural optimisation of benefits as well as minimisation of risks and a reciprocal optimisation of both requirements. If the comparison of the benefits and risks of the product results in a negative risk-benefit balance, the product is rated absolutely unsafe. The product is relatively unsafe if its standard of safety is lower than that of already available pharmaceuticals of the same indication and the existing safety gap (increased benefit or lesser risks) is deemed considerable. Differences in benefit and/or differences in risk between the medicinal

  2. [Publish or perish: the scientific productivity of academics in the field of occupational medicine].

    Science.gov (United States)

    Franco, G

    2009-01-01

    A new Italian law aiming at improving and supporting research productivity establishes that evaluation of academic products is a requisite for accessing research funds,for acting as examiner for recruitments and for individual financial benefits. To analyse the scientific products of full professors of Occupational Medicine in Italian Universities in order to provide a framework for discussing a standard of productivity with objective metric parameters. Research products of the 40 full professors of Occupational Medicine indexed in the National Library of Medicine PubMed database were identified. By means of l0 different indicators, including the total number of papers, the papers published in journals included in the Journal Citation Reports (JCR), total Impact Factor (IF), the individual productivity of the last 5 years was measured. In the last 5 years 503 scientific products were published, 231 of which in JCR-indexed journals, with a mean individual IF = 16.741. The total number of papers indexed in PubMed, the number of papers included in JCR-indexed journals and the number of papers included in JCR-indexed journal of Public, Environmental & Occupational Health were associated with the overall number of authors (p total number of papers is inversely associated with age (p productivity authors have an elevated number of products both in JCR-indexed journals (targeted to a small number of specialists in the field) and in PubMed-indexed journal (addressed to the broad audience of occupational health professionals). The productivity standard of academics of Occupational Medicine should take into account the overall research products within the Public Health field. In addition, the standard should be shared with that of academics of Hygiene and of Forensic medicine in order to address the recruitment policy in the Public Health field

  3. 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

  4. 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

  5. Non-Prescription Medicinal Products Exclusively Dispensed in Pharmacies in Portugal

    Directory of Open Access Journals (Sweden)

    Elisabete Gonçalves

    2016-04-01

    Full Text Available Self-medication is a process through which the individual assumes a greater degree of responsibility for the management of a minor health problem, by acquiring a medicine that is accessible without the need to obtain a medical prescription. Access to health care is undergoing important changes in the European Union. In the presence of factors such as aging populations and economic constraints on health systems, greater emphasis to the efficient use of health resources has been given. Self-care, which comprises self-medication assumes, in this context, an important role by encouraging individuals to take greater responsibility for their own health and wellbeing, choose healthy life choices, consult the pharmacist when appropriate and to establish whether and when medical treatment should be sought. In order to promote the rational use of medicinal products, the subcategory of non-prescription medicinal products exclusively dispensed in pharmacies has gained expression in different European countries. As the name implies, this category includes medicines that, by their nature and given the framework of the condition for which they are intended, are considered safe for dispensing without the requirement of a prescription, possess some attribute that makes them elective for dispensing under the supervision of a health professional, in this case the pharmacist, in order to promote safety and efficiency in their use. The different Member States have advanced at different times with the implementation of this category of classification regarding the dispensing to the public of medicines. Portugal introduced in 2013 this category of medicines in its legal framework. If, on one hand, the big drivers for the classification of more medicines in categories non-prescription medicinal products and non-prescription medicinal products exclusively dispensed in pharmacies have been the greater empowerment of the patient regarding the management of his health and

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

    Science.gov (United States)

    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.

  7. 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.

  8. 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...

  9. 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 ...

  10. Nigerian Journal of Natural Products and Medicine: Contact

    African Journals Online (AJOL)

    Principal Contact. J. M.Agbedahunsi Ph.D. Editor in Chief Drug Research and Production Unit, Faculty of Pharmacy Faculty of Pharmacy, Obafemi Awolowo University, Ile-Ife, NIGERIA. Phone: +2348034093594. Fax: +234 36 231 733. Email: jagbedah@oauife.edu.ng ...

  11. Generation of mesenchymal stem cells as a medicinal product in organ transplantation.

    Science.gov (United States)

    Verbeek, Richard

    2013-02-01

    Mesenchymal stem cells (MSCs) are emerging as an alternative treatment in solid-organ transplantation. The use of MSCs as a therapeutic product requires the translation of basic research protocols into a production process under good manufacturing practice (GMP) to obtain a safe product of high quality. This requires a different mindset from the academic setting of changing protocols into a well defined, controlled and documented process. This review describes some of the challenges faced by culturing MSCs as a medicinal product. Clinical-grade MSCs are used in the clinical trials and proved to be safe as a medicinal product. Because of the differences in the type of MSCs and in the production process, clinical outcome is not always comparable. New standardized methods in the culture condition such as the use of alternatives for fetal bovine serum (FBS), standardized plating densities or the use of bioreactors may further standardize the production process. To generate MSCs as a medicinal product in organ transplantation, regulation requires that MSCs have to be generated under GMP. During the whole production process, all critical steps should be known and described. Further steps should be taken to optimize and standardize the production process.

  12. 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.

  13. 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 ...

  14. Impact of nanotechnology on public health : production of medicines

    OpenAIRE

    Dimer, Frantiescoli Anversa; Friedrich, Rossana Barcellos; Beck, Ruy Carlos Ruver; Guterres, Silvia Stanisçuaski; Pohlmann, Adriana Raffin

    2013-01-01

    Several studies have described the benefits of nanoscience and nanotechnology (N&N) in different sectors such as agriculture, energy, environmental preservation, and public health. The rapid evolution of N&N can be shown through a panoramic analysis of scientific papers and patents. In the area of public health, it is estimated that the global market for nanotechnology products will expand to 160 billion U.S. dollars in 2015. The Brazilian government has also strengthened its innovative poten...

  15. Micropropagation: a tool for the production of high quality plant-based medicines.

    Science.gov (United States)

    Debnath, Mousumi; Malik, C P; Bisen, P S

    2006-02-01

    Medicinal plants are the most important source of life saving drugs for the majority of the world's population. The biotechnological tools are important to select, multiply and conserve the critical genotypes of medicinal plants. Plant tissue culture techniques offer an integrated approach for the production of standardized quality phytopharmaceutical through mass-production of consistent plant material for physiological characterization and analysis of active ingredients. Micropropagation protocols for cloning of some medicinal plants such as Catharanthus roseus (Apocynaceae), Chlorophytum borivilianum (Liliaceae), Datura metel (Solanaceae), and Bacopa monnieri (Scrophulariaceae) have been developed. Regeneration occurred via organogenesis and embryogenesis in response to auxins and cytokinins. The integrated approaches of our culture systems will provide the basis for the future development of novel, safe, effective, and high-quality products for consumers.

  16. Exploring anti-TB leads from natural products library originated from marine microbes and medicinal plants.

    Science.gov (United States)

    Liu, Xueting; Chen, Caixia; He, Wenni; Huang, Pei; Liu, Miaomiao; Wang, Qian; Guo, Hui; Bolla, Krishna; Lu, Yan; Song, Fuhang; Dai, Huanqin; Liu, Mei; Zhang, Lixin

    2012-10-01

    Multidrug-resistant tuberculosis (MDR-TB) and TB-HIV co-infection have become a great threat to global health. However, the last truly novel drug that was approved for the treatment of TB was discovered 40 years ago. The search for new effective drugs against TB has never been more intensive. Natural products derived from microbes and medicinal plants have been an important source of TB therapeutics. Recent advances have been made to accelerate the discovery rate of novel TB drugs including diversifying strategies for environmental strains, high-throughput screening (HTS) assays, and chemical diversity. This review will discuss the challenges of finding novel natural products with anti-TB activity from marine microbes and plant medicines, including biodiversity- and taxonomy-guided microbial natural products library construction, target- and cell-based HTS, and bioassay-directed isolation of anti-TB substances from traditional medicines.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

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

    2018-03-06

    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.

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. Local production of pharmaceuticals in Africa and access to essential medicines: 'urban bias’ in access to imported medicines in Tanzania and its policy implications

    Science.gov (United States)

    2014-01-01

    Background International policy towards access to essential medicines in Africa has focused until recently on international procurement of large volumes of medicines, mainly from Indian manufacturers, and their import and distribution. This emphasis is now being challenged by renewed policy interest in the potential benefits of local pharmaceutical production and supply. However, there is a shortage of evidence on the role of locally produced medicines in African markets, and on potential benefits of local production for access to medicines. This article contributes to filling that gap. Methods This article uses WHO/HAI data from Tanzania for 2006 and 2009 on prices and sources of a set of tracer essential medicines. It employs innovative graphical methods of analysis alongside conventional statistical testing. Results Medicines produced in Tanzania were equally likely to be found in rural and in urban areas. Imported medicines, especially those imported from countries other than Kenya (mainly from India) displayed 'urban bias’: that is, they were significantly more likely to be available in urban than in rural areas. This finding holds across the range of sample medicines studied, and cannot be explained by price differences alone. While different private distribution networks for essential medicines may provide part of the explanation, this cannot explain why the urban bias in availability of imported medicines is also found in the public sector. Conclusions The findings suggest that enhanced local production may improve rural access to medicines. The potential benefits of local production and scope for their improvement are an important field for further research, and indicate a key policy area in which economic development and health care objectives may reinforce each other. PMID:24612518

  5. Estimated costs of production and potential prices for the WHO Essential Medicines List.

    Science.gov (United States)

    Hill, Andrew M; Barber, Melissa J; Gotham, Dzintars

    2018-01-01

    There are persistent gaps in access to affordable medicines. The WHO Model List of Essential Medicines (EML) includes medicines considered necessary for functional health systems. A generic price estimation formula was developed by reviewing published analyses of cost of production for medicines and assuming manufacture in India, which included costs of formulation, packaging, taxation and a 10% profit margin. Data on per-kilogram prices of active pharmaceutical ingredient exported from India were retrieved from an online database. Estimated prices were compared with the lowest globally available prices for HIV/AIDS, tuberculosis (TB) and malaria medicines, and current prices in the UK, South Africa and India. The estimation formula had good predictive accuracy for HIV/AIDS, TB and malaria medicines. Estimated generic prices ranged from US$0.01 to US$1.45 per unit, with most in the lower end of this range. Lowest available prices were greater than estimated generic prices for 214/277 (77%) comparable items in the UK, 142/212 (67%) in South Africa and 118/298 (40%) in India. Lowest available prices were more than three times above estimated generic price for 47% of cases compared in the UK and 22% in South Africa. A wide range of medicines in the EML can be profitably manufactured at very low cost. Most EML medicines are sold in the UK and South Africa at prices significantly higher than those estimated from production costs. Generic price estimation and international price comparisons could empower government price negotiations and support cost-effectiveness calculations.

  6. 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.

  7. 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.

  8. 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.

  9. Are agricultural and natural sources of bio-products important for modern regenerative medicine? A review

    Directory of Open Access Journals (Sweden)

    Maciej Nowacki

    2017-05-01

    Evolving trends in agriculture are likely to play a key role in the future development of a number of systemic and local medical procedures within tissue engineering and regenerative medicine. This is in addition to the use of bio-products derived from the natural environment which are found to deliver positive results in the treatment of prospective patients.

  10. 75 FR 50771 - Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products...

    Science.gov (United States)

    2010-08-17

    ... parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized... the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, and...

  11. 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.

  12. [Development of guidance for the approval process of brand-new medical products and regenerative medicine products].

    Science.gov (United States)

    Niimi, Shingo

    2015-01-01

    Ministry of Health, Labour and Weltare has been conducting development of guidance for the approval process of brand-new medical products/development of guidance for medical devices in collaboration with Ministry of Economy, Trade and Industry as part of measures to promote practical use of brand-new medical products since 2005. The objective of this project is to expedite the processes from developmental process of medical devices to approval review and to introduce the medical devices to medical front quickly.. Ministry of Health, Labour and Welfare side has been making guidance for the guide in approval process of brand-new medical products and regeneration medicine products to aim at acceleration and facilitation of development and approval process of innovative medical products. Twenty-two of the guidance have been issued as director of the evaluation and licensing division. The evaluation index about safety and efficacy required for medical devices and regenerative medicine products in progress were put together in these guidance and useful for medical devices developer to understand the point at the approved review. Therefore, I think that the evaluation index could also contribute to the efficient product development. The guidance about implantable artificial heart is issued as the representative example which was useful in the approved review.

  13. 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

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

    Science.gov (United States)

    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

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. [Phenotypic and genotypic characterization of probiotic bacterial strains used in medicinal products].

    Science.gov (United States)

    Wiatrzyk, Aldona; Polak, Maciej; Czajka, Urszula; Krysztopa-Grzybowska, Katarzyna; Lutyńska, Anna

    2013-01-01

    The optimization of quality testing strategy of products containing probiotics might allow to general improvement of its safer use in humans. The goal of the study was the evaluation of quality expressed by identity, colony forming unit (CFU) and antibiotic sensitivity ofprobiotics used in medicinal products available in Poland using the appropriate and validated procedures. The medicinal products containing L. rhamnosus, L. acidophilus, L. delbrueckii subsp. bulgaricus and B. animalis subsp. lactis, L. helveticus, and L. gasseri were tested for species identity performed with validated rep-PCR (BOXA 1R) method. The antimicrobial susceptibility of working seeds and strains isolated to 26 antibiotics were tested by disk diffusion and E-test methods using relevant references as recommended by EUCAST. The numbers of probiotic strains, expressed as cfu count per package, was done using plating plunge method. All strains tested, except B. lactis, were found to be resistant to trimethoprim-sulphamethoxazole, nalidixic acid, metronidazole, and colistin. B. lactis was resistant to aminoglycosides. L. rhamnosus strains were found to be resistant to vancomycin, (MIC > 256 microg/ml) similarly to ATCC strains (L. rhamnosus GG 53103 and 244). The sensitivity to other antibiotics was strain specific. The rep-PCR method was found species and strain specific. All products tested fulfilled declared countent as measured by cfu count/package. Quality of medicinal products containing probiotics was found undoubted and confirmed. The optimized strategy of quality monitoring of probiotics used in medicinal products can be used in dietary supplements and foodstuffs intended for particular nutritional uses.

  1. Trends in research productivity of residents applying for orthopedic sports medicine fellowship.

    Science.gov (United States)

    DeFroda, Steven F; Shah, Kalpit N; Safdar, Omar; Mulcahey, Mary K

    2018-02-01

    Though there are no research requirements to match into an orthopaedic sports medicine fellowship, many applicants are productive in research endeavors during residency. We hypothesize that the number of publications by Orthopaedic sports medicine applicants are increasing. A list of current and recent sports medicine fellows was compiled from publicly accessible information on sports medicine fellowship websites. Articles published while the fellow was a resident were identified via publicly available search engines. The following information was collected: year of fellowship and years of residency, fellowship program, geographic location of fellowship program, total number of publications (noting specifically first and last author publications), number of publications in high impact orthopaedic journals (AJSM, JBJS Am, JSES, or Arthroscopy). Overall, 189 fellowship-matched surgeons from 2010 - 2017 were identified. There were 746 publications (average of 3.95 per fellow), with 218 (29.2%) in high impact orthopaedic journals. Surgeons who completed their fellowship during the 2016-17 academic year, published on average 5.42 publications per fellow. Fellowship applicants in the Northeast region had the highest number of total publications (359 publications, 48.1% of all publications; 6.41 publications per fellow). Applicants were listed most often as middle authors (462 publications, 61.9%). There has been an overall increase in the number of publications among sports medicine fellowship applicants in the last several academic years. Fellowship programs in the northeast United States tended to match applicants with a higher number of publications.

  2. 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.

  3. Are agricultural and natural sources of bio-products important for modern regenerative medicine? A review.

    Science.gov (United States)

    Nowacki, Maciej; Nowacka, Katarzyna; Kloskowski, Tomasz; Pokrywczyńska, Marta; Tyloch, Dominik; Rasmus, Marta; Warda, Karolina; Drewa, Tomasz

    2017-05-11

    [b] Abstract Introduction and objectives[/b]. As tissue engineering and regenerative medicine have continued to evolve within the field of biomedicine, the fundamental importance of bio-products has become increasingly apparent. This true not only in cases where they are derived directly from the natural environment, but also when animals and plants are specially bred and cultivated for their production. [b]Objective.[/b] The study aims to present and assess the global influence and importance of selected bio-products in current regenerative medicine via a broad review of the existing literature. In particular, attention is paid to the matrices, substances and grafts created from plants and animals which could potentially be used in experimental and clinical regeneration, or in reconstructive procedures. [b]Summary.[/b] Evolving trends in agriculture are likely to play a key role in the future development of a number of systemic and local medical procedures within tissue engineering and regenerative medicine. This is in addition to the use of bio-products derived from the natural environment which are found to deliver positive results in the treatment of prospective patients.

  4. 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.

  5. 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

  6. THE PRODUCTION OF MEDICINES IN ROMANIA AFTER 1990. WHAT'S THE REASON FOR IMPORTS?

    Directory of Open Access Journals (Sweden)

    Unita Lucian

    2011-12-01

    Full Text Available Since 1990, Romania turned itself slowly but surely, from a large drugs producer, which has used to supplydrugs to the whole former Council for Mutual Economic Assistance Member States, and with a net positive trade balance in medicine sector, into a large drugs importer, trying hardly to attract investors which could produce medicines not only for the Romanian domestic market, but also for all other Eastern European markets, Ukraine, Russia and Turkey. This paper focuses on the empirical analisys of the medicines production sector in Romania after 1990, aiming to emphasises the factors which have mostly affected this industry, in correlation with different interests and reasons which determined the increasing imports of drugs during the last years, by underlying at the same time, the role of the new public authority in charge of supervising the distribution and import of medicines in Romania, The National Medicines Administration (NMA. The paper relevance relies in the fact that Romania registered during the last years drug imports of an average of 1.7 billion euros, while the drug exports were only around 0,1 billions euros, according to the computations made on the data provided by the Romanian Institute of National Statistics (INS. The most imported products are patent drugs, which are more expensive than those produced by the domestic manufactured. At the same time, Romania registered an increase of the pharmaceutical market of around 20% only since its EU integration, this market proven to be largely driven by expensive products. Our research conducted to the conclusion that the Romanian resort authorities have to immediately adopt measures meant to limit consumption of expensive drugs, on the one side, and to reinforce the domestic manufacturers on the other side, even by attracting major investors in this sector. We have also identified that there is a large competitiveness for Romanian medicine products on the international market, due

  7. [A contribution to the development of advertising in pharmacy II. Historical development of regulation of advertising of medicinal products].

    Science.gov (United States)

    Vranová, Vilma

    2012-10-01

    The article deals with the development of regulation of advertising of medicinal products in the Czech Lands of the Habsburg Monarchy and Czechoslovakia in the years 1775-1938. Advertising medicines had and has its specifics and its regulation had been addressed by specific standards and linked to other health laws and regulations. Regulation of advertising of medicinal products has undergone a long process from the initial total ban on advertising to the establishment of clear rules, some of which, such as restrictions on advertising prescription-only medicines only to the professional healthcare press, are still valid.

  8. Role of Medicinal Plants and Natural Products on Osteoporotic Fracture Healing

    Directory of Open Access Journals (Sweden)

    Mohd Azri Abd Jalil

    2012-01-01

    Full Text Available Popularly known as “the silent disease” since early symptoms are usually absent, osteoporosis causes progressive bone loss, which renders the bones susceptible to fractures. Bone fracture healing is a complex process consisting of four overlapping phases—hematoma formation, inflammation, repair, and remodeling. The traditional use of natural products in bone fractures means that phytochemicals can be developed as potential therapy for reducing fracture healing period. Located closely near the equator, Malaysia has one of the world’s largest rainforests, which are homes to exotic herbs and medicinal plants. Eurycoma longifolia (Tongkat Ali, Labisia pumila (Kacip Fatimah, and Piper sarmentosum (Kaduk are some examples of the popular ethnic herbs, which have been used in the Malay traditional medicine. This paper focuses on the use of natural products for treating fracture as a result of osteoporosis and expediting its healing.

  9. Role of medicinal plants and natural products on osteoporotic fracture healing.

    Science.gov (United States)

    Abd Jalil, Mohd Azri; Shuid, Ahmad Nazrun; Muhammad, Norliza

    2012-01-01

    Popularly known as "the silent disease" since early symptoms are usually absent, osteoporosis causes progressive bone loss, which renders the bones susceptible to fractures. Bone fracture healing is a complex process consisting of four overlapping phases-hematoma formation, inflammation, repair, and remodeling. The traditional use of natural products in bone fractures means that phytochemicals can be developed as potential therapy for reducing fracture healing period. Located closely near the equator, Malaysia has one of the world's largest rainforests, which are homes to exotic herbs and medicinal plants. Eurycoma longifolia (Tongkat Ali), Labisia pumila (Kacip Fatimah), and Piper sarmentosum (Kaduk) are some examples of the popular ethnic herbs, which have been used in the Malay traditional medicine. This paper focuses on the use of natural products for treating fracture as a result of osteoporosis and expediting its healing.

  10. Induced production of mycotoxins in an endophytic fungus from the medicinal plant Datura stramonium L.

    Science.gov (United States)

    Sun, Jieyin; Awakawa, Takayoshi; Noguchi, Hiroshi; Abe, Ikuro

    2012-10-15

    Epigenetic modifiers, including DNA methyltransferase (DNMT) or histone deacetylase (HDAC) inhibitors, are useful to induce the expression of otherwise dormant biosynthetic genes under standard laboratory conditions. We isolated several endophytic fungi from the medicinal plant Datura stramonium L., which produces pharmaceutically important tropane alkaloids, including scopolamine and hyoscyamine. Although none of the endophytic fungi produced the tropane alkaloids, supplementation of a DNMT inhibitor, 5-azacytidine, and/or a HDAC inhibitor, suberoylanilide hydroxamic acid, to the culture medium induced the production of mycotoxins, including alternariol, alternariol-5-O-methyl ether, 3'-hydroxyalternariol-5-O-methyl ether, altenusin, tenuazonic acid, and altertoxin II, by the endophytic fungus Alternaria sp. This is the first report of a mycotoxin-producing endophytic fungus from the medicinal plant D. stramonium L. This work demonstrates that treatments with epigenetic modifiers induce the production of mycotoxins, thus providing a useful tool to explore the biosynthetic potential of the microorganisms. Copyright © 2012 Elsevier Ltd. All rights reserved.

  11. 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.

  12. 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.

  13. 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

  14. A strategy for intensive production of molybdenum-99 isotopes for nuclear medicine using CANDU reactors.

    Science.gov (United States)

    Morreale, A C; Novog, D R; Luxat, J C

    2012-01-01

    Technetium-99m is an important medical isotope utilized worldwide in nuclear medicine and is produced from the decay of its parent isotope, molybdenum-99. The online fueling capability and compact fuel of the CANDU(®)(1) reactor allows for the potential production of large quantities of (99)Mo. This paper proposes (99)Mo production strategies using modified target fuel bundles loaded into CANDU fuel channels. Using a small group of channels a yield of 89-113% of the weekly world demand for (99)Mo can be obtained. Copyright © 2011 Elsevier Ltd. All rights reserved.

  15. [Approval of clinical trials of immunobiological medicinal products at the Paul Ehrlich Institute].

    Science.gov (United States)

    Krafft, H; Cichutek, K

    2005-02-01

    The GCP Directive 2001/20/EG has been implemented in Germany by the 12th Law Amending the Drug Law of 6 August 2004, thereby introducing new regulations for the performance of clinical trials. The amount of the required documentation has increased, but the assessment and the approval of clinical trials as well as scientific advice procedures (national or by the EMEA) allow the early discussion of many details of the development and the non-clinical and clinical testing of the medicinal product with the experts of the Paul Ehrlich Institute (PEI). This might shorten the times required for later marketing authorisation procedures. To facilitate these new tasks, the PEI has created a new central section "Approval of Clinical Trials", which is responsible for the assessment of the clinical trial applications and will coordinate the procedures within the institute. The main topics of clinical trial applications and the particularities of biological/biotechnological medicinal products such as allergens, blood products, vaccines, sera/mAb and products for cell and gene therapy as well as the differences from chemically defined products are discussed.

  16. 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.

  17. [Vigilance for veterinary medicinal products: Reports of adverse reactions in the year 2016].

    Science.gov (United States)

    Müntener, C R; Müntener, C; Kupper, J; Naegeli, H; Gassner, B

    2017-11-01

    A total of 253 reports of adverse reactions to veterinary medicinal products were received during the year 2016 representing a decrease of 13% compared to the previous year (292 reports). The majority of the reports described reactions affecting companion animals (178 dogs and 32 cats) as well as cattle (17 reports) and horses (10 reports). Most of the reactions reported were linked to the use of antiparasitics (145 reports), hormone products (26 reports) and antiinfectives (10 reports). 32 reports were generated from consultations with Tox Info Suisse in Zürich and involved mainly the excessive intake of flavoured tablets and, in some cases, the use of reconverted products (applied to another species than that authorized). Five signals were identified from the reports, which resulted in revisions of the product information in the sections addressing contraindications or adverse reactions.

  18. 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.

  19. 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

  20. 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.

  1. [Scientific production in clinical medicine and international collaboration networks in South American countries].

    Science.gov (United States)

    Huamaní, Charles; González A, Gregorio; Curioso, Walter H; Pacheco-Romero, José

    2012-04-01

    International collaboration is increasingly used in biomedical research. To describe the characteristics of scientific production in Latin America and the main international collaboration networks for the period 2000 to 2009. Search for papers generated in Latin American countries in the Clinical Medicine database of ISI Web of Knowledge v.4.10 - Current Contents Connect. The country of origin of the corresponding author was considered the producing country of the paper. International collaboration was analyzed calculating the number of countries that contributed to the generation of a particular paper. Collaboration networks were graphed to determine the centrality of each network. Twelve Latin American countries participated in the production of 253,362 papers. The corresponding author was South American in 79% of these papers. Sixteen percent of papers were on clinical medicine and 36% of these were carried out in collaboration. Brazil had the highest production (22,442 papers) and the lower percentage of international collaboration (31%). North America accounts for 63% of collaborating countries. Only 8% of collaboration is between South American countries. Brazil has the highest tendency to collaborate with other South American countries. Brazil is the South American country with the highest scientific production and indicators of centrality in South America. The most common collaboration networks are with North American countries.

  2. 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.

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

    Science.gov (United States)

    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

  4. 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

  5. [Vigilance for veterinary medicinal products: Reports of adverse reactions in the year 2015].

    Science.gov (United States)

    Müntener, C; Kupper, J; Naegeli, H; Gassner, B

    2016-11-01

    A total of 292 adverse reactions to veterinary medicinal products were reported during the year 2015. This represents an increase of 9% compared to the previous year (268 reports). Similar to previous years, most of the reactions reported were linked to the use of antiparasitics (55.1%), non-steroidal anti-inflammatory products (8.9%) or antiinfectives (9.3%). The affected animal species were primarily dogs (198 reports) and cats (42 reports), followed by cattle (31 reports) and horses (8 reports). Additional 42 reports were provided within the frame of consultations with Tox Info Suisse in Zürich and involved mainly the excessive intake of flavored tablets. Eight signals were identified from the reports received or the periodic safety update reports. They resulted in revisions of the product information in sections addressing contraindications, adverse reactions or withdrawal times.

  6. Investigation of specificity ensuring of quality of biological medicinal products on example of drugs Cortexin and Retinalamin

    Directory of Open Access Journals (Sweden)

    N. O. Vetiutneva

    2013-06-01

    Full Text Available Biological medical products nowadays are one of the most promising area at the pharmaceutical market. Biopharmaceutical market has significant benefits such as fast and effective development of production facilities, the development of more effective and safer medical products. The aim of our research was, on the example of medical products Cortexin and Retinalamin, examine the specifics of quality of biological medicinal products in the chain from production to sale. The objects of study - original biological medicines Cortexin and Retinalamin. Comparative, systematic, analytical methods and reviews were used. Biological medical products have fundamental differences from synthetic medicines, due to their source - alive cells which are usually used in their production process. Each production cycle results in a unique finished pharmaceutical products and minimal differences in the modes of production can significantly effect on the properties of biological medical products. Therefore, even if the physical, chemical and biological properties of the product thoroughly studied and described, it does not guarantee therapeutic equivalence of two biological products which are manufactured in different conditions. One of the most important issues today is the problem of maintaining properties and quality of biological medicines. These issues are actively resolving on the native pharmaceutical market: quality control system are developing and implementing in accordance with international standards in order to maintain maximum efficiency of biological medicines and to protect consumers from defective products. Biological products require special conditions of storage and transportation. In order to save physical, chemical and therapeutic properties, strict compliance with the relevant conditions of packaging, transport and intermediate storage, related to deviations in temperature during transportation and storage is needed. The production process

  7. 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....

  8. 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)

  9. 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.

  10. Probiotics, fibre and herbal medicinal products for functional and inflammatory bowel disorders.

    Science.gov (United States)

    Currò, Diego; Ianiro, Gianluca; Pecere, Silvia; Bibbò, Stefano; Cammarota, Giovanni

    2017-06-01

    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. 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.v174.11/issuetoc.

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

    DEFF Research Database (Denmark)

    Faeh, Andrea Beata

    2013-01-01

    The pharmaceutical sector in the European Union is innovative, but not innovative enough to compete on the world market. This article addresses this issue from the perspective of market harmonization, since the European Commission perceives – according to the ‘European 2020 Flagship Initiative...... – 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...

  12. Comparison of the backward overhead medicine ball throw to power production in college football players.

    Science.gov (United States)

    Mayhew, Jerry L; Bird, Michael; Cole, Mary L; Koch, Alex J; Jacques, Jeff A; Ware, John S; Buford, Brittney N; Fletcher, Kate M

    2005-08-01

    The purpose of this study was to determine the relationship of the backward overhead medicine ball (BOMB) throw to power production in college football players. Forty National Collegiate Athletic Association Division II college football players were studied at the end of an 8-week off-season conditioning program for power output determined from a countermovement vertical jump on a force plate and for maximal distance in the standing BOMB throw. Although the reliability of the BOMB test was high (interclass correlation coefficient = 0.86), there was a significant learning effect across 3 trials (p football players.

  13. An alternate approach to the production of radioisotopes for nuclear medicine applications.

    Science.gov (United States)

    D'Auria, John M; Keller, Roderich; Ladouceur, Keith; Lapi, Suzanne E; Ruth, Thomas J; Schmor, Paul

    2013-03-01

    There is a growing need for the production of radioisotopes for both diagnostic and therapeutic medical applications. Radioisotopes that are produced using the (n,γ) or (γ,n) reactions, however, typically result in samples with low specific activity (radioactivity∕gram) due to the high abundance of target material of the same element. One method to effectively remove the isotopic impurity is electro-magnetic mass separation. An Ion Source Test Facility has been constructed at TRIUMF to develop high-intensity, high-efficiency, reliable ion sources for purification of radioactive isotopes, particularly those used in nuclear medicine. In progress studies are presented.

  14. [Marketing of medicinal products in the European Community. The Mutual Recognition and Decentralised Procedures].

    Science.gov (United States)

    Bachmann, Peter

    2008-07-01

    The Mutual Recognition Procedure (MRP) and the Decentralised Procedure (DCP), which were first established in late 2005, can be regarded as the backbone for marketing authorisation of medicinal products in the European Community (EC) and the European Economic Area (EEA). Both procedures are compared and advantages and disadvantages are discussed. However, the focus is more related to current developments than the detailed comparison of both procedures. The role of the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMD(h)) and the decision making process in relation to the MRP and DCP is also discussed.

  15. 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.

  16. 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

  17. 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.

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

    Science.gov (United States)

    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.

  19. 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

  20. 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

  1. 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

  2. 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.

  3. 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.

  4. 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.

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

    Science.gov (United States)

    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.

  6. Publication Productivity of Faculty of Medicine, Mansoura University Indexed in PubMed.

    Science.gov (United States)

    Helal, Rm; Abou-ElWafa, Hs; El-Gilany, Ah

    2014-09-01

    Analysis of PubMed publications as an indicator of the research productivity of individual countries, regions, or institutions has recently become a field of interest. The aim was to assess the past trends in PubMed-indexed medical publications from Mansoura Faculty of Medicine and to have an idea about the current situation in medical research. PubMed was searched for publications affiliated to Mansoura from the end of the calendar year 2012 and earlier. Of 2798 papers related to Mansoura, 1756 publications were included in the analysis, and 1042 publications were excluded (false positives). The highest number of publications was in 2011 (10.6%, 187/1756) followed by 2012 (10.2%, 179/1756). There was an increase of the publication rate over 5-years period until it reaches 47.0% (826/1756) during the period from 2008 to 2012. The main high-producing department was Urology and Nephrology, which accounted for 35.9% (631/1756) of the total publications followed by Pediatrics and Parasitology. The median number of authors participated in the researches was four ranging from 1 to 23. Most of the publications were in the form of intervention/clinical trials (38.4%, 662/1756) followed by descriptive/cross-sectional study (38.3%, 659/1756). The median of the impact factor was 1.99 ranging from 0.27 to 53.3. The publication productivity of Mansoura Faculty of Medicine showed fluctuating pattern from the end of the calendar year 2012 and earlier. Future prospects for increasing research productivity should be considered to increase the number and quality of publications and academic staff participating in high-quality international researches.

  7. Regulatory acceptance of animal models of disease to support clinical trials of medicines and advanced therapy medicinal products.

    Science.gov (United States)

    Cavagnaro, Joy; Silva Lima, Beatriz

    2015-07-15

    The utility of animal models of disease for assessing the safety of novel therapeutic modalities has become an increasingly important topic of discussion as research and development efforts focus on improving the predictive value of animal studies to support accelerated clinical development. Medicines are approved for marketing based upon a determination that their benefits outweigh foreseeable risks in specific indications, specific populations, and at specific dosages and regimens. No medicine is 100% safe. A medicine is less safe if the actual risks are greater than the predicted risks. The purpose of preclinical safety assessment is to understand the potential risks to aid clinical decision-making. Ideally preclinical studies should identify potential adverse effects and design clinical studies that will minimize their occurrence. Most regulatory documents delineate the utilization of conventional "normal" animal species to evaluate the safety risk of new medicines (i.e., new chemical entities and new biological entities). Animal models of human disease are commonly utilized to gain insight into the pathogenesis of disease and to evaluate efficacy but less frequently utilized in preclinical safety assessment. An understanding of the limitations of the animal disease models together with a better understanding of the disease and how toxicity may be impacted by the disease condition should allow for a better prediction of risk in the intended patient population. Importantly, regulatory authorities are becoming more willing to accept and even recommend data from experimental animal disease models that combine efficacy and safety to support clinical development. Copyright © 2015 Elsevier B.V. All rights reserved.

  8. Analytical product study of germanium-containing medicine by different ICP-MS applications.

    Science.gov (United States)

    Krystek, Petra; Ritsema, Rob

    2004-01-01

    For several years organo-germanium containing medicine has been used for special treatments of e.g. cancer and AIDS. The active substances contain germanium as beta-carboxyethylgermanium sesquioxide ((GeCH2CH2COOH)203/"Ge-132"), spirogermanium, germanium-lactate-citrate or unspecified forms. For humans, germanium is not essential and in general the toxicity of the mentioned organo-germanium compounds is low. Acute and chronic toxic effects of inorganic germanium dioxide have been demonstrated. It is obvious that especially inorganic germanium has a higher potential of negative effects. Therefore, a widespread analytical product control is indispensable. Inductively coupled plasma mass spectrometry (ICP-MS) is the preferred technique and different applications were developed for controlling various parameters: (i) A speciation method using high performance liquid chromatography (HPLC) coupled with quadrupole (Q-) ICP-MS was developed for the identification of organo-germanium species in medicine. (ii) The nuclear magnetic resonance (NMR) technique was applied to confirm the molecular structure and to determine the molecule concentration. (iii) The total concentration of germanium in the medicine was determined in the diluted sample by high resolution (HR-) ICP-MS. (iv) For a general overview, a multi-element screening method of 56 elements with HR-ICP-MS was developed. The semi-quantitative mode was used for quantification and elements of higher abundance are reported. (v) Investigations about matrix-based interferences on masses of isotopes, which are generally determinable without remarkable problems. Isotopes like e.g. 85Rb, 88Sr, 89y, 90Zr, 93Nb and the isotopes of Ba are strongly interfered by different Ge-based molecules and need to be analysed in a higher resolution mode than used for other common matrices.

  9. The Microbial Quality Aspects and Decontamination Approaches for the Herbal Medicinal Plants and Products: An in-Depth Review.

    Science.gov (United States)

    Ghisleni, Daniela Dal Molim; Braga, Marina de Souza; Kikuchi, Irene Satiko; Braşoveanu, Mirela; Nemţanu, Monica R; Dua, Kamal; Pinto, Terezinha de Jesus Andreoli

    2016-01-01

    The present review article provides an overview of the published literature concerning microbial quality of medicinal plants and products and their decontamination methods. It is important to analyze different aspects regarding the cultivation, growing, harvesting, storage, manufacturing, and decontamination of medicinal plant products. Herbal medicinal plants bear a massive microbial load leading to contamination and mycotoxin, which needs to be considered, and properly controlled using suitable sterilization and decontamination methods. The main focus of this review is on the definition, advantages, disadvantages and applications of decontamination methods, particularly to show that one must consider the characteristics of the initial sample to be decontaminated. The effects of various methods (ozone, plasma, irradiation) on medicinal herbs and products treated for microbiological decontamination are dependent on factors related to microbial load (i.e., nature and amount of initial contamination), herb/product matrix (i.e., complexity of chemical composition, physical state - solid or liquid) and treatment conditions (i.e., time, irradiation dose, absence or presence of oxygen). In addition, it is important to accept some loss of the chemical compounds, while decreasing microbial load to acceptable limits according to official herbal pharmacopoeias and literature, thus ensuring a final product with quality, safety and therapeutic efficacy. The conclusion, which comes from this contribution, is that herbal medicine has more contaminants than a chemically welldefined drug, thus, good manufacturing practices should be followed.

  10. 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.

  11. 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...

  12. [Scientific productivity standards and the National Automous University of Mexico School of Medicine].

    Science.gov (United States)

    Martínez, Federico; Palomares, Alejandra; Piña, Enrique

    2004-01-01

    The scientific production at theNational Autonomous University of Mexico (Universidad Nacional Autónoma de México, UNAM) School of Medicine was analyzed during the period from 1999 to 2002. We found the following: 1) 94.83% of total international scientific papers was recovered; 2) mean impact factor had a value of 2.5, ca. the value reported by CONACYT, México, for the period 1998-2002; 3) percentage of corresponding authors was 58.83%, 27.80% of papers were national collaborations, 9.83% were international collaborations, and 3.37% corresponded to personal publications; 4) by using corresponding author and collaborations, academic leaders were identified; 5) there are differences among academic departments, and 6) basic research from the UNAM School of Medicine contributes 14% of national research and teaches ca. 2,450 students per year. It is proposed that this type of analysis should be used to establish the politics of science.

  13. 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.

  14. 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.

  15. [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.

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

    Science.gov (United States)

    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.

  17. 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.

  18. Contamination of herbal medicinal products marketed in Kaduna metropolis with selected pathogenic bacteria.

    Science.gov (United States)

    Abba, Danladi; Inabo, Helen I; Yakubu, Sabo E; Olonitola, Olayeni S

    2008-10-25

    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, measurement of some physical parameters, isolation and characterization of selected bacterial pathogens etc. The results showed that out of a total of 150, 70 (46.67%) herbal remedies were contaminated with Salmonella typhi, twenty nine (19.33%) with Shigella spp. Eighty eight (58.67%) and 98 (65.33%) were contaminated with Escherichia coli and Staphylococcus aureus, respectively. The total aerobic plate count results showed that the highest average count of > 5x10(7) cfu/g was found in 89 (59.33%) of the preparations, while average plate count of < or = 5x10(7) cfu/g was found in 42 (28%) and no bacterial count was obtained in 19 (12.67%) of the preparations. Correlation was positive (P = 0.01; r = +0.109) between the physical parameters tested and the bacterial load. Antibacterial activities result of some common antibiotics showed that all the antibiotics had activities on the test bacterial isolates at various minimum inhibitory concentrations. Most traditionally prepared herbal medications in Kaduna state are likely to be contaminated with a wide variety of potentially pathogenic bacteria. The quality assurance of these products should be thoroughly enforced and monitored in the production and distribution of herbal preparations.

  19. 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.

  20. 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

  1. [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.

  2. 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

  3. 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.

  4. The use of complementary and alternative medicine products in preceding two days among Finnish parents - a population survey

    Directory of Open Access Journals (Sweden)

    Hämeen-Anttila Katri P

    2011-11-01

    Full Text Available Abstract Background The use of complementary and alternative medicines (CAM has been extensively studied globally among adult and paediatric populations. Parents, as a group, had not been studied to assess their knowledge and attitude to CAM and general medicine use. This study is necessary since parents' attitude to medicine use is known to influence their child's attitude to medicine use later in life. We therefore aim to assess the extent and types of CAM use among Finnish parents, and to determine the factors that promote the CAM use. Also, we aim to determine parents' attitude to general medicine use. Methods Children less than 12 years old, as of spring 2007, were identified from the database of the Finnish Population Register Centre and were selected by random sampling. The parents of these children were identified and a questionnaire was sent to them. Only the parent who regularly takes care of the child's medicine was requested to fill the questionnaire. Cross-tabulations and Chi-square test were used to determine the associations between categorical variables. CAMs were defined as natural products that are not registered as medicines, such as homeopathic preparations, dietary food supplements, and traditional medicinal products. Results The response rate of the survey was 67% (n = 4032. The use of CAM was 31% in the preceding two days. The most commonly used CAM products were vitamins and minerals, followed by fish oils and fatty acids. Prescription and OTC medicines were used concomitantly with CAM by one-third of the parents. CAM was frequently used by parents over 30 years (33%, female parents (32%, highly educated parents (35%, and parents with high monthly net income (3000-3999 euros, 34%. The users of CAM had more negative attitudes towards medicines than non-users of CAM. Conclusions Our findings are in accordance with those of previous studies that women over 30 years of age with a high education and income typically use CAMs

  5. Establishing a Quality Control System for Stem Cell-Based Medicinal Products in China.

    Science.gov (United States)

    Yuan, Bao-Zhu

    2015-12-01

    Stem cell-based medicinal products (SCMPs) are emerging as novel therapeutic products. The success of its development depends on the existence of an effective quality control system, which is constituted by quality control technologies, standards, reference materials, guidelines, and the associated management system in accordance with regulatory requirements along product lifespan. However, a worldwide, effective quality control system specific for SCMPs is still far from established partially due to the limited understanding of stem cell sciences and lack of quality control technologies for accurately assessing the safety and biological effectiveness of SCMPs before clinical use. Even though, based on the existing regulations and current stem cell sciences and technologies, initial actions toward the goal of establishing such a system have been taken as exemplified by recent development of new "interim guidelines" for governing quality control along development of SCMPs and new development of the associated quality control technologies in China. In this review, we first briefly introduced the major institutions involved in the regulation of cell substrates and therapeutic cell products in China and the existing regulatory documents and technical guidelines used as critical references for developing the new interim guidelines. With focus only on nonhematopoietic stem cells, we then discussed the principal quality attributes of SCMPs as well as our thinking of proper testing approaches to be established with relevant evaluation technologies to ensure all quality requirements of SCMPs along different manufacturing processes and development stages. At the end, some regulatory and technical challenges were also discussed with the conclusion that combined efforts should be taken to promote stem cell regulatory sciences to establish the effective quality control system for SCMPs.

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

    Science.gov (United States)

    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.

  7. 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.

  8. Impact of animal health and welfare planning on medicine use, herd health and production in European organic dairy farms

    DEFF Research Database (Denmark)

    Ivemeyer, S; Smolders, G; Brinkmann, J

    2012-01-01

    medicine use through animal health and welfare planning (AHWP). Medicine use (excluding complementary treatments such as homeopathic remedies) was assessed as the total number of treatments and as the number of treatments of various disease categories (udder, fertility, metabolism, locomotion and others......Achieving and maintaining high herd health and welfare status and low veterinary medicine inputs are important aims in organic livestock farming. Therefore, an on-farm intervention study (CORE Organic ANIPLAN) was conducted on 128 organic dairy farms in seven European countries aiming at minimising...... be regarded as a feasible approach to minimising medicine use without the impairment of production and herd health under several organic dairy farming conditions in Europe....

  9. Simulation of multispectral multisource for device of consumer and medicine products analysis

    Science.gov (United States)

    Korolev, Timofey K.; Peretyagin, Vladimir S.

    2017-06-01

    One of the results of intensive development of led technology was the creation of a multi-component, managed devices and illumination/irradiation used in various fields of production (e.g., food industry analysis, food quality). The use of LEDs has become possible due to their structure determining spatial, energy, electrical, thermal and other characteristics. However, the development of the devices for illumination/irradiation require closer attention in the case if you want to provide precise illumination to the area of analysis, located at a specified distance from the radiation source. The present work is devoted to the development and modelling of a specialized source of radiation intended for solving problems of analysis of food products, medicines and water for suitability in drinking. In this work, we provided a mathematical model of spatial and spectral distribution of irridation from the source of infrared radiation ring structure. When you create this kind of source, you address factors such spectral component, the power settings, the spatial and energy components of the diodes.

  10. 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

    2018-02-22

    CT-P10 (TruximaTM) 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

  11. 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

  12. 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...

  13. 78 FR 51732 - The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant...

    Science.gov (United States)

    2013-08-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug...

  14. [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.

  15. 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

  16. 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.

  17. Indole-3-acetic acid production by endophytic Streptomyces sp. En-1 isolated from medicinal plants.

    Science.gov (United States)

    Lin, Lan; Xu, Xudong

    2013-08-01

    Plant-associated actinobacteria are rich sources of bioactive compounds including indole-derived molecules such as phytohormone indole-3-acetic acid (IAA). In view of few investigations concerning the biosynthesis of IAA by endophytic actinobacteria, this study evaluated the potential of IAA production in endophytic streptomycete isolates sourced from medicinal plant species Taxus chinensis and Artemisia annua. By HPLC analysis of IAA combined with molecular screening approach of iaaM, a genetic determinant of streptomycete IAA synthesis via indole-3-acetamide (IAM), our data showed the putative operation of IAM-mediated IAA biosynthesis in Streptomyces sp. En-1 endophytic to Taxus chinensis. Furthermore, using the co-cultivation system of model plant Arabidopsis thaliana and streptomycete, En-1 was found to be colonized intercellularly in the tissues of Arabidopsis, an alternative host, and the effects of endophytic En-1 inoculation on the model plant were also assayed. The phytostimulatory effects of En-1 inoculation suggest that IAA-producing Streptomyces sp. En-1 of endophytic origin could be a promising candidate for utilization in growth improvement of plants of economic and agricultural value.

  18. Berry Leaves: An Alternative Source of Bioactive Natural Products of Nutritional and Medicinal Value.

    Science.gov (United States)

    Ferlemi, Anastasia-Varvara; Lamari, Fotini N

    2016-06-01

    Berry fruits are recognized, worldwide, as "superfoods" due to the high content of bioactive natural products and the health benefits deriving from their consumption. Berry leaves are byproducts of berry cultivation; their traditional therapeutic use against several diseases, such as the common cold, inflammation, diabetes, and ocular dysfunction, has been almost forgotten nowadays. Nevertheless, the scientific interest regarding the leaf composition and beneficial properties grows, documenting that berry leaves may be considered an alternative source of bioactives. The main bioactive compounds in berry leaves are similar as in berry fruits, i.e., phenolic acids and esters, flavonols, anthocyanins, and procyanidins. The leaves are one of the richest sources of chlorogenic acid. In various studies, these secondary metabolites have demonstrated antioxidant, anti-inflammatory, cardioprotective, and neuroprotective properties. This review focuses on the phytochemical composition of the leaves of the commonest berry species, i.e., blackcurrant, blackberry, raspberry, bilberry, blueberry, cranberry, and lingonberry leaves, and presents their traditional medicinal uses and their biological activities in vitro and in vivo.

  19. Berry Leaves: An Alternative Source of Bioactive Natural Products of Nutritional and Medicinal Value†

    Science.gov (United States)

    Ferlemi, Anastasia-Varvara; Lamari, Fotini N.

    2016-01-01

    Berry fruits are recognized, worldwide, as “superfoods” due to the high content of bioactive natural products and the health benefits deriving from their consumption. Berry leaves are byproducts of berry cultivation; their traditional therapeutic use against several diseases, such as the common cold, inflammation, diabetes, and ocular dysfunction, has been almost forgotten nowadays. Nevertheless, the scientific interest regarding the leaf composition and beneficial properties grows, documenting that berry leaves may be considered an alternative source of bioactives. The main bioactive compounds in berry leaves are similar as in berry fruits, i.e., phenolic acids and esters, flavonols, anthocyanins, and procyanidins. The leaves are one of the richest sources of chlorogenic acid. In various studies, these secondary metabolites have demonstrated antioxidant, anti-inflammatory, cardioprotective, and neuroprotective properties. This review focuses on the phytochemical composition of the leaves of the commonest berry species, i.e., blackcurrant, blackberry, raspberry, bilberry, blueberry, cranberry, and lingonberry leaves, and presents their traditional medicinal uses and their biological activities in vitro and in vivo. PMID:27258314

  20. 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.

  1. Berry Leaves: An Alternative Source of Bioactive Natural Products of Nutritional and Medicinal Value

    Directory of Open Access Journals (Sweden)

    Anastasia-Varvara Ferlemi

    2016-06-01

    Full Text Available Berry fruits are recognized, worldwide, as “superfoods” due to the high content of bioactive natural products and the health benefits deriving from their consumption. Berry leaves are byproducts of berry cultivation; their traditional therapeutic use against several diseases, such as the common cold, inflammation, diabetes, and ocular dysfunction, has been almost forgotten nowadays. Nevertheless, the scientific interest regarding the leaf composition and beneficial properties grows, documenting that berry leaves may be considered an alternative source of bioactives. The main bioactive compounds in berry leaves are similar as in berry fruits, i.e., phenolic acids and esters, flavonols, anthocyanins, and procyanidins. The leaves are one of the richest sources of chlorogenic acid. In various studies, these secondary metabolites have demonstrated antioxidant, anti-inflammatory, cardioprotective, and neuroprotective properties. This review focuses on the phytochemical composition of the leaves of the commonest berry species, i.e., blackcurrant, blackberry, raspberry, bilberry, blueberry, cranberry, and lingonberry leaves, and presents their traditional medicinal uses and their biological activities in vitro and in vivo.

  2. Teaching dairy production medicine to entry-level veterinarians: the summer dairy institute model.

    Science.gov (United States)

    Nydam, Charles W; Nydam, Daryl V; Guard, Charles L; Gilbert, Robert O

    2009-01-01

    Food supply veterinarians who intend to enter dairy cattle practice or other related career activities are in need of up-graded skills to better serve the dairy industry as it continues to evolve. The time available for students to increase their abilities within the conventional professional curriculum is scarce, especially as those with food-supply interests are a minority of students competing for time and resources. The dairy industry has need of skilled veterinarians who are not only well versed in their traditional capabilities, but who also have an understanding of the complete picture of that industry as a "farm-to-fork" experience. Society at large also stands to benefit from the presence of skilled dairy veterinarians contributing to the production of safe, affordable dairy foodstuffs in a manner deemed sustainable and humane. Veterinarians in practice can and do acquire the necessary skills to make themselves relevant to their clients and consumers; however, better preparation of entry-level veterinarians could increase their value to their employers, clients, themselves, and society in a more timely manner. Cornell University's College of Veterinary Medicine developed the Summer Dairy Institute to provide an avenue for advancing the skills of new veterinarians as a means to address the current and future needs of the dairy industry. This article describes the need for, concept of, and experience with that program.

  3. 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.

  4. Lanthanides in Nuclear Medicine. The Production of Terbium-149 by Heavy Ion Beams

    CERN Document Server

    Dmitriev, S N; Zaitseva, N G; Maslov, O D; Molokanova, L G; Starodub, G Ya; Shishkin, S V; Shishkina, T V

    2001-01-01

    Among radioactive isotopes of lanthanide series elements, finding the increasing using in nuclear medicine, alpha-emitter {149}Tb (T_{1/2} = 4.118 h; EC 76.2 %; beta^+ 7.1 %; alpha 16.7 %) is considered as a perspective radionuclide for radioimmunotherapy. The aim of the present work is to study experimental conditions of the {149}Tb production in reactions Nd({12}C, xn){149}Dy (4.23 min; beta^+, EC)\\to {149}Tb when the Nd targets have been irradiated by heavy ions of carbon. On the basis of results of formation and decay of {149}Dy\\to{149}Tb evaluation of the {149}Tb activity, is made which can be received under optimum conditions (enriched {142}Nd target, {12}C ions with the energy 120 MeV and up to current 100 mu A, time of irradiating 8-10 hours). Under these conditions {149}Tb can be obtained up to 30 GBq (up to 0.8 Ci).

  5. [Practical Use Evaluation of Aluminum Packaging for Medicinal Products Based on Universal Design].

    Science.gov (United States)

    Ohtani, Kazuya; Hidaka, Takashi; Marubashi, Koichi; Takagi, Hirokazu; Kamimura, Naoki

    2015-01-01

    Many pharmacists have requested optimization of aluminum packaging of medicinal products in terms of usability. To improve operational efficiency of aluminum packaging, we used Universal Design (UD)-based approach, which enables products to be used properly and consistently regardless of users. The UD-pack used in this research is composed of a film that can be easily opened and torn linear. Here, we compared the UD-pack to conventional aluminum packaging by evaluating the practical use of each under the cooperation of 24 pharmacists. Following opening and removal of contents of one sample for both types of packaging, monitors were asked which type was easier to use in each case. Also, monitors were to repeat the opening and removal of contents of five samples in a row, and were asked the same question. Monitors were recorded by digital camera to measure the time required to finish the procedure for five samples in a row. After opening one sample, approximately 83% of monitors preferred the UD-pack, and after opening five samples, all (100%) preferred the UD-pack. Regarding the time required for opening five samples and removing the contents measured by analyzing the recorded video, the UD-pack significantly reduced the time required for all monitors. The average time ratio of the UD-pack to conventional aluminum packaging was approximately 59%, and no significant difference was observed between male and female pharmacists. Our results indicate the UD-pack improves ease of opening and removal of contents and increases efficiency of dispensing in a clinical setting compared with conventional aluminum packaging.

  6. 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.

  7. New European commission regulation on variations to the terms of marketing authorization for medicinal products and its impact on Croatian legislation.

    Science.gov (United States)

    Martinac, Adrijana Ilić; Tomić, Sinisa; Simicić, Mirna

    2010-09-01

    Variations introduced to medicinal product documentation must not affect the quality, efficacy, and safety of the product. Croatian Medicinal Products Act and accompanying ordinances are largely aligned with the EU regulations. The EU has now tried to simplify the issue of variations with a new Regulation, creating differences in the definition of and approach to resolving certain types of variations between Croatia and the EU. These differences could hinder the approval procedure for variations in Croatia, particularly for medicines already approved in the EU. Amending the Croatian Ordinance on medicines already authorised in the EU would be one way of maintaining the efficiency of the Croatian regulatory system.

  8. Herbal medicine IMOD suppresses LPS-induced production of proinflammatory cytokines in human dendritic cells

    NARCIS (Netherlands)

    Mirzaee, Saeedeh; Drewniak, Agata; Sarrami-Forooshani, Ramin; Kaptein, Tanja M.; Gharibdoost, Farhad; Geijtenbeek, Teunis B. H.

    2015-01-01

    Traditional medicines that stimulate or modulate the immune system can be used as innovative approaches to treat immunological diseases. The herbal medicine IMOD has been shown to strongly modulate immune responses in several animal studies as well as in clinical trials. However, little is known

  9. EURO-MED-STAT: monitoring expenditure and utilization of medicinal products in the European Union countries: a public health approach.

    Science.gov (United States)

    2003-09-01

    There is uncertainty about the level of utilization and expenditure for medicines in the European Union (EU), making assessment of their impact on public health difficult. Our aim is to develop indicators to monitor price, expenditure and utilization of medicinal products in the EU, so as to facilitate comparisons. There are four major tasks. Task 1: To catalogue data sources and available data in each EU Member State. Task 2: To assess the reliability and comparability of data among the EU Member States by ATC/DDD on country coverage, reimbursement, prescriptions, price category (e.g. wholesale, hospital, retail) and private versus public spending. Task 3: To develop Standard Operating Procedures for data management and to define clearly the proposed indicators in terms of objective, definition, description, rationale, and data collection. Task 4: To pool, compare and report the validated data according to the established indicators, using cardiovascular medicines as an example. Preliminary results from Tasks 1 and 2 are available and demonstrate the methodological difficulties in comparing data from different countries. Multiple data sources must be used. These cover different populations, and refer to different prices or costs. Nevertheless, useful data can be derived, illustrated by the example of lipid lowering medicines. The data shows that only five products are commonly available in all countries. Even when a medicine is available in all countries, there may be substantial differences in packages, which can hinder comparison. Data on utilization of statins shows high usage in Scandinavian countries and least in Italy. The preliminary results of EURO-MED-STAT show wide differences in availability, and use of medicines across Europe that may have substantial implications for public health.

  10. Technical protocol for laboratory tests of transformation of veterinary medicinal products and biocides in liquid manures. Version 1.0

    Energy Technology Data Exchange (ETDEWEB)

    Kreuzig, Robert [Technische Univ. Braunschweig (Germany). Inst. fuer Oekologische Chemie und Abfallanalytik

    2010-07-15

    The technical protocol under consideration describes a laboratory test method to evaluate the transformation of chemicals in liquid bovine and pig manures under anaerobic conditions and primarily is designed for veterinary medicinal products and biocides. The environmentally relevant entry routes into liquid manures occur via urine and feces of cattle and pigs in stable housings after excretion of veterinary medicinal products as parent compounds or metabolites and after the application of biocides in animal housings. Further entry routes such as solid dung application and direct dung pat deposition by production animals on pasture are not considered by this technical protocol. Thus, this technical protocol focused on the sampling of excrements from cattles and pigs kept in stables and fed under standard nutrition conditions. This approach additionally ensures that excrement samples are operationally free of any contamination by veterinary medicinal products and biocides. After the matrix characterization, reference-manure samples are prepared from the excrement samples by adding tap water to adjust defined dry substance contents typical for bovine or pig manures. This technical protocol comprehends a tiered experimental design in two parts: (a) Sampling of excrements and preparation of reference bovine and pig manures; (b) Testing of anaerobic transformation of chemicals in reference manures.

  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. Ethnoveterinary Medicine: The prospects of integrating medicinal ...

    African Journals Online (AJOL)

    Medicinal plants products are part of the natural products that have been in use in traditional medicine and also a source of novel drugs. Therefore, the use of medicinal plant products would be a rational alternative to synthetic drugs. Ethnobotanical surveys carried out in many parts of Kenya have revealed a lot of plants ...

  13. [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.

  14. Exploring Consumer and Patient Knowledge, Behavior, and Attitude Toward Medicinal and Lifestyle Products Purchased From the Internet: A Web-Based Survey

    OpenAIRE

    Assi, Sulaf; Thomas, Jordan; Haffar, Mohamed; Osselton, David

    2016-01-01

    BACKGROUND: In recent years, lifestyle products have emerged to help improve people's physical and mental performance. The Internet plays a major role in the spread of these products. However, the literature has reported issues regarding the authenticity of medicines purchased from the Internet and the impact of counterfeit medicines on public health. Little or no data are available on the authenticity of lifestyle products and actual toxicity associated with their use and misuse. OBJECTIVE: ...

  15. Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2002 – February 2003

    Directory of Open Access Journals (Sweden)

    V. Naidoo

    2003-07-01

    Full Text Available The Veterinary Pharmacovigilance and Medicines Information Centre is responsible for the monitoring of veterinary adverse drug reactions in South Africa. An overview of reports of suspected adverse drug reactions received by the centre during the period March 2002 to February 2003 is given. In total, 40 reports were received. This had declined from the previous year. Most reports involved suspected adverse reactions that occurred in dogs and cats. Most of the products implicated were Stock Remedies. The animal owner predominantly administered these products. Only 1 report was received from a veterinary pharmaceutical company. Increasing numbers of reports are being received from veterinarians.

  16. EFFECT OF USING SOME MEDICINAL PLANTS (ANISE, CHAMOMILE AND GINGER) ON PRODUCTIVE AND PHYSIOLOGICAL PERFORMANCE OF JAPANESE QUAIL

    International Nuclear Information System (INIS)

    ABU TALEB, A.M.; HAMODI, S.J.; EL AFIFI, SH.F.

    2008-01-01

    This experiment was conducted to evaluate the effects of adding medicinal plants to Japanese quail diet on their performance and some metabolic functions. Four hundred, one day old, unsexed Japanese quails were used in this study. Quails were divided equally into four groups of 100 birds each according to medicinal plant additives. Group one was control (without additives, and the other groups contained 0.3% from anise (group 2), chamomile (group 3) and ginger (group 4). The end of the experiment was terminated when birds were 6 weeks old. Body weight, feed intake, some organs weight and some blood parameters were measured.The results indicated that addition of medicinal plants (anise, chamomile and ginger) improved growth rate, carcass and the relative weights of spleen, ovary and testis. Also, significant increases were observed in RBC, WBC, Hb, PCV, total protein and globulin. There was reduction in cholesterol in treated groups as compared to the control.The present results confirmed the beneficial effects of dietary medicinal plants (anise, chamomile and ginger) to improve the health condition as well as the productive and physiological characteristics of quails

  17. PNRI Pioneering the Establishment and Operation of the Tc-99m Generator Production Facility for Nuclear Medicine Applications

    International Nuclear Information System (INIS)

    Bulos, Adelina DM.; Borras, Ma. Teresa L.; Ciocson, Gregory R.; Mascariñas, Rommel D.C.; Nuñez, Ivy Angelica A.; Dela Rosa, Alumanda M.

    2015-01-01

    In response to the increasing demand in the nuclear medicine sector in the Philippines, the Philippine Nuclear Research Institute (PNRI) initiated the establishment of a radioisotope production facility. To date, the most commonly used radioisotope in nuclear medicine, Technetium-99m or Tc-99m has been successfully produced in the new laboratory, the PNRI facility has already obtained a license to operate from the Philippine FDA. The new facility is envisioned to meet the country’s requirements for all the major medical radioisotope starting with the local production of Tc-99m and the most commonly used Tc-99m radiopharmaceuticals. At present, all radioisotope supplies in the country are sourced overseas at price that varies accordingly. With the establishment of the PNRI’s laboratories, we now have a GMP-grade Tc-99m generator facility capable of producing 50 Tc-99m generators per batch. Instead of Tc-99m being imported, it will be the parent Mo-99m that will be transferred to PNRI facility from Mo-99 processing facilities overseas, contained in specialized transport containers and via airfreight arrangements so it can be processed locally to make Tc-99m generators. But, to make radiopharmaceuticals, the other non-radioactive components are needed to be sourced from abroad. Thus, it has become imperative to also locally produce these non-radioactive components. All of these components, radioactive and non-radioactive, from the radiopharmaceutical finished products which are utilized in nuclear medicine caters for the diagnosis and detection of critical and non-critical human illnesses. The completion of this program is foreseen as another concrete validation on the capacity of the Philippine as a country that is at par with advanced nations on competency and expertise in the research and development of nuclear medicine application for better healthcare delivery and management. (author)

  18. Plant Secondary Metabolites in some Medicinal Plants of Mongolia Used for Enhancing Animal Health and Production

    Directory of Open Access Journals (Sweden)

    Makkar, HPS.

    2009-01-01

    Full Text Available The levels and activities of a number of plant secondary metabolites (PSMs are known to increase in response to increase in stress. The Mongolian plants considered to possess medicinal properties may contain novel compounds since they are exposed to severe conditions; such plants could become good candidates for modern drug discovery programmes. Information on distribution, palatability to livestock and opinion of local people on their nutritive and medicinal values was compiled for 15 plant materials from 14 plant species considered important for medicinal purposes. These plants were evaluated for nutritive value and PSMs: tannins, saponins, lectins, alkaloids and cyanogens. High levels of tannins were found in roots of Bergenia crassifolia and in leaves of B. crassifolia, Vaccinium vitisidaea and Rheum undulatum. High lectin activity (haemagglutination was present in B. crassifolia roots, and leaves of R. undulatum, Iris lacteal and Thymus gobicus contained weak lectin activity. Tanacetum vulgare, Serratula centauroids, Taraxacum officinale and Delphinum elatum leaves contained saponin activity (haemolysis. Alkaloids and cyanogens were not present in any of the samples. The paper discusses the known medicinal uses of these plants in light of the PSMs levels, and identifies plant samples for future applications in human and livestock health, welfare and safety.

  19. Analytical product study of germanium-containing medicine by different ICP-MS applications

    NARCIS (Netherlands)

    Krystek, Petra; Ritsema, Rob

    2004-01-01

    For several years organo-germanium containing medicine has been used for special treatments of e.g. cancer and AIDS. The active substances contain germanium as beta-carboxyethylgermanium sesquioxide ((GeCH2CH 2COO-H)2O3/"Ge-132"), spirogermanium, germanium-lactate-citrate or unspecified forms. For

  20. The Use of Herbal Drugs in Organic Animal Production: The Case of Ethnoveterinary Medicine in Central Anatolia Region

    Directory of Open Access Journals (Sweden)

    Çağrı Çağlar Sinmez

    2017-12-01

    Full Text Available Organic animal production is a natural breeding system in which animal health is protected by giving priority to alternative medicines and treatment as needed by applying appropriate management and feeding methods based on the physiological requirements of animals. Increasing numbers of strains resistant to antibiotics and antiparasitic drugs used in animal breeding have brought about the search for alternative herbal remedies that lead to drug residues in animal products and lead to important health problems in people consuming these products. In this study, it was aimed to evaluate the therapeutic and protective effects of herbal drugs used in organic animal production in ethnoveterinary medicine in the Central Anatolia Region. The material of the study collected as written and declared facts as well as visual data were obtained from animal breeders in the Central Anatolia Region. The results indicated that 30 herbal drugs were used for the treatment of internal diseases, surgical diseases, obstetric and gynecological problems and parasitic diseases in cattle, sheep, horse, poultry, bee, and dog species. Based on the evaluation of the facts that the use of all kinds of synthetic drugs, especially antibiotics, is prohibited or restricted in organic livestock, it can be said that natural herbal drugs instead of artificial substances will provide positive contributions in the protection and treatment of herd health.

  1. Forensic DNA barcoding and bio-response studies of animal horn products used in traditional medicine.

    Directory of Open Access Journals (Sweden)

    Dan Yan

    Full Text Available BACKGROUND: Animal horns (AHs have been applied to traditional medicine for more than thousands of years, of which clinical effects have been confirmed by the history. But now parts of AHs have been listed in the items of wildlife conservation, which limits the use for traditional medicine. The contradiction between the development of traditional medicine and the protection of wild resources has already become the common concern of zoophilists, traditional medical professionals, economists, sociologists. We believe that to strengthen the identification for threatened animals, to prevent the circulation of them, and to seek fertile animals of corresponding bioactivities as substitutes are effective strategies to solve this problem. METHODOLOGY/PRINCIPAL FINDINGS: A powerful technique of DNA barcoding based on the mitochondrial gene cytochrome c oxidase I (COI was used to identify threatened animals of Bovidae and Cervidae, as well as their illegal adulterants (including 10 species and 47 specimens. Meanwhile, the microcalorimetric technique was used to characterize the differences of bio-responses when those animal specimens acted on model organism (Escherichia coli. We found that the COI gene could be used as a universal primer to identify threatened animals and illegal adulterants mentioned above. By analyzing 223 mitochondrial COI sequences, a 100% identification success rate was achieved. We further found that the horns of Mongolian Gazelle and Red Deer could be exploited as a substitute for some functions of endangered Saiga Antelope and Sika Deer in traditional medicine, respectively. CONCLUSION/SIGNIFICANCE: Although it needs a more comprehensive evaluation of bioequivalence in order to completely solve the problem of substitutes for threatened animals, we believe that the identification (DNA barcoding of threatened animals combined with seeking substitutions (bio-response can yet be regarded as a valid strategy for establishing a balance

  2. Practical use of registered veterinary medicinal products in Macedonia in identifying the risk of developing of antimicrobial resistance

    Directory of Open Access Journals (Sweden)

    Velev Romel

    2013-07-01

    Full Text Available The use of antimicrobial agents is the key risk factor for the development and spread of antimicrobial resistance. It is therefore generally recognized that data on the usage of antimicrobial agents in food-producing animals are essential for identifying and quantifying the risk of developing and spreading of antimicrobial resistance in the food-chain. According to the WHO guidelines, the Anatomical Therapeutic Chemical system for the classification of veterinary medicines (ATC-vet is widely recognized as a classification tool. The aim of this work is to analyze the list of registered veterinary medicinal products in R. Macedonia and to evaluate the quality and practical use of this list according to the ATC-vet classification in order to identify the risk of developing and spreading of antimicrobial resistance.

  3. 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

  4. In silico drug metabolism and pharmacokinetic profiles of natural products from medicinal plants in the Congo basin.

    Science.gov (United States)

    Ntie-Kang, Fidele; Lifongo, Lydia L; Mbah, James A; Owono Owono, Luc C; Megnassan, Eugene; Mbaze, Luc Meva'a; Judson, Philip N; Sippl, Wolfgang; Efange, Simon M N

    2013-01-01

    Drug metabolism and pharmacokinetics (DMPK) assessment has come to occupy a place of interest during the early stages of drug discovery today. The use of computer modelling to predict the DMPK and toxicity properties of a natural product library derived from medicinal plants from Central Africa (named ConMedNP). Material from some of the plant sources are currently employed in African Traditional Medicine. Computer-based methods are slowly gaining ground in this area and are often used as preliminary criteria for the elimination of compounds likely to present uninteresting pharmacokinetic profiles and unacceptable levels of toxicity from the list of potential drug candidates, hence cutting down the cost of discovery of a drug. In the present study, we present an in silico assessment of the DMPK and toxicity profile of a natural product library containing ~3,200 compounds, derived from 379 species of medicinal plants from 10 countries in the Congo Basin forests and savannas, which have been published in the literature. In this analysis, we have used 46 computed physico-chemical properties or molecular descriptors to predict the absorption, distribution, metabolism and elimination and toxicity (ADMET) of the compounds. This survey demonstrated that about 45% of the compounds within the ConMedNP compound library are compliant, having properties which fall within the range of ADME properties of 95% of currently known drugs, while about 69% of the compounds have ≤ 2 violations. Moreover, about 73% of the compounds within the corresponding "drug-like" subset showed compliance. In addition to the verified levels of "drug-likeness", diversity and the wide range of measured biological activities, the compounds from medicinal plants in Central Africa show interesting DMPK profiles and hence could represent an important starting point for hit/lead discovery.

  5. [Current cases of falsified medicinal products within the competence of the Federal Institute for Drugs and Medical Devices (BfArM) : Case studies and extent].

    Science.gov (United States)

    Wittstock, Marcus; Paeschke, Norbert

    2017-11-01

    The nature of a falsification of a medicinal product can vary a lot. Therefore the means to detect them and the potential risk to patient safety can also be very different. The whole range of falsification will be described using observed cases from the Federal Institute for Drugs and Medical Devices (BfArM).Based on the relatively low number of detected cases of falsified medicines, the legal supply chain can still be regarded as safe. It has to be assumed that in the illegal supply chain, e. g. illegal internet trade, the majority of the offered medicinal products are not only falsifications due to illegal trade but because they are completely falsified. Therefore there is an especially high risk for the consumer to be harmed by medicinal products that do not fulfil the required specifications.The trend indicates that increased efforts will be necessary to keep the legal supply chain safe and to contain illegal trade with falsifications. The higher federal authorities BfArM, PEI and BVL are involved in this task by coordinating and ensuring the flow of information to the concerned authorities and stakeholders as well as informing the public. Increased efforts are also necessary due to the rising involvement of organised crime in the falsification of medicinal products. A package of measures was enacted with the Falsified Medicines Directive 2011/62/EU to protect the legal supply chain from falsified medicinal products.

  6. [Study on botanical pesticides and its application in production of traditional Chinese medicine].

    Science.gov (United States)

    Zhang, Peng; Li, Xi-Wen; Dong, Lin-Lin; Chen, Shi-Lin

    2016-10-01

    The issues including excessive pesticide residues and heavy metal contamination have become the bottle-neck in the development of Chinese herbal medicines. Compared with traditional chemical pesticides, biological pesticides, especially botanical pesticides, are more safe and environment-friendly, which were beneficial to the quality improvement Chinese medicinal materials. Though there exists a weak basic research and it is hard for promotion and regulation, the policy of good and the desire for botanical pesticides will accelerate its development, and replace traditional chemical pesticides gradually. This paper reviews the current situation of botanical pesticides, and gives some pertinence suggestions according to the existing problems and challenges. Research on botanical pesticides will become the key point to solve the problem of excessive pesticides residues and heavy metal contamination, and promote the healthy development of Chinese materia medica. Copyright© by the Chinese Pharmaceutical Association.

  7. 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

  8. General sale of non-prescription medicinal products: Comparing legislation in two European countries.

    OpenAIRE

    Lind, Johanna; Schafheutle, Ellen; Hägg, Annika Nordén; Sporrong, Sofia Kälvemark

    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 available in non-pharmacy outlets; The United Kingdom (UK) is a more established NPM market; both are guided by the same EU directives. OBJECTIVE: The aim of this study was to compare specific requir...

  9. Variable demand and productivity in diagnostic medicine: the customer experience with the scheduling of examinations

    Directory of Open Access Journals (Sweden)

    Leandro Ortigoza Martins

    2016-04-01

    Full Text Available From the perspective of marketing, diagnostic medicine services are perishable and demand is variable — characteristics that difficult the maximization of results. Service providers offer the exams through time scheduling system without, however, overcome the inefficiency caused by the no show customers. The objective of this research was to investigate the level of satisfaction of consumers of diagnostic medicine with the schedule, the acceptance of a new model without an appointment time and analyze three secondary dimensions common to the two models (no show, seasonality and timeout in customer satisfaction. This is a quantitative research with exploratory-descriptive design performed with 2,545 clients from a privately held diagnostic medicine in 2013. The results of the secondary dimensions indicated that customers tend to frequent establishments as the current seasonal and are sensitive to wait. As for the main dimensions (scheduling and demand free, there are different levels of acceptance, indicating that the two systems are complementary and not exclusive and therefore, the feasibility of adopting a hybrid model of operation, with the use of two templates.

  10. [Inspirations from natural products based drug research and development for Chinese medicine research--analysis of natural products recoded in TTD].

    Science.gov (United States)

    Chen, Xiu-Ping; Lu, Jin-Jian; Guo, Jia-Jie; Bao, Jiao-Lin; Xu, Wen-Shan; Ding, Qian; Wang, Yi-Tao

    2012-11-01

    Natural product is an important source of new drug research and development (R&D). Traditional Chinese medicine (TCM) innovation is the key step for its modernization and internationalization. However, due to the complexity of TCM, there are many difficulties and confusions in this process. Target-based drug discovery is the mainstream model and method of R&D. TTD, short for therapeutic target database, is developed by National University of Singapore. Besides a large amount of information on drug targets, the database also contains considerable information related to natural products. This paper briefly introduces the TTD, analyzes the natural products derived drugs/compounds recorded in TTD, which we think might provide some inspiration for the innovation of TCM.

  11. Simultaneous determination of multiple sesquiterpenes in Curcuma wenyujin herbal medicines and related products with one single reference standard.

    Science.gov (United States)

    Zhu, Jing-Jing; An, Yue-Wei; Hu, Guang; Yin, Guo-Ping; Zhang, Qi-Wei; Wang, Zhi-Min

    2013-02-06

    Some Curcuma species are widely used as herbal medicines. Sesquiterpenes are their important bioactive compounds and their quantitative analysis is generally accomplished by gas chromatography (GC) or high performance liquid chromatography (HPLC), but the instability and high cost of some sesquiterpene reference standards have limited their application. It is necessary to find a practicable means to control the quality of herbal medicines. Using one stable component contained in Curcuma species to determine multiple analogues should be a practical option. In this study, a simple HPLC method for determination of sesquiterpenes using relative response factors (RRFs) has been developed. The easily available and stable active component curdione was selected as the reference compound for calculating the RRFs of the other eight sesquiterpenes, including zedoarondiol (Zedo), isozedoarondiol (Isoz), aerugidiol (Aeru), (4S,5S)-(+)-germacrone-4,5-epoxide (Epox), curcumenone (Curc), neocurdione (Neoc), germacrone (Germ) and furanodiene (Fura). Their RRFs against curdione were between 0.131-1.301, with a good reproducibility. By using the RRFs, the quantification of sesquiterpenes in Curcuma wenyujin herbal medicines and related products was carried out. The method is especially useful for the determination of (4S,5S)-(+)-germacrone-4,5-epoxide, curcumenone, germacrone and furanodiene, which often are regarded as the principle components in Curcuma species, but unstable when were purified. It is an ideal means to analyze the components for which reference standards are not readily available.

  12. Family Medicine-Specific Practice-Based Research Network Productivity and Clinical and Translational Sciences Award Program Affiliation.

    Science.gov (United States)

    Haggerty, Treah; Cole, Allison M; Xiang, Jun; Mainous, Arch G; Seehusen, Dean

    2017-04-01

    Practice-based research networks (PBRNs) are groups of practices that work together to conduct research. Little is known about the degree to which PBRNs may be achieving success. This is the first general survey of family medicine-based PBRN directors in the United States and Canada to examine research productivity outcomes of PBRNs and explore the association between Clinical and Translational Science Awards (CTSA) program affiliation and PBRN outcomes. The Council of Academic Family Medicine Educational Research Alliance conducted the survey and e-mailed it to 102 PBRN directors from the Agency for Healthcare Research and Quality's registration. A total of 54 (56%) PBRN directors responded to the survey. PBRNs with an affiliation with a CTSA program were more likely to report completion of quality improvement research and participation in multiple PBRN collaboration research projects. PBRNs affiliated with CTSA programs were less likely to report maintaining funding as a significant barrier. CTSA involvement with PBRNs results in family physician scientists' completing research and disseminating this research through publication. Also, PBRNs with CTSA partnerships have more funding availability. PBRN partnership with a CTSA is beneficial in furthering research in family medicine.

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

    Science.gov (United States)

    Alameddine, Mohamad; Naja, Farah; Abdel-Salam, Sarah; Maalouf, Salwa; Matta, Claudia

    2011-08-28

    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. 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. 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. The current status quo with respect to the regulation of CAM products

  14. Inhibitory effect on nitric oxide production and free radical scavenging activity of Thai medicinal plants in osteoarthritic knee treatment.

    Science.gov (United States)

    Anuthakoengkun, Areeya; Itharat, Arunporn

    2014-08-01

    Thai medicine plants used for Osteoarthritis of knee (OA) treatment consist of twelve plants such as Crinumn asiaticum, Cleome viscosa, Drypetes roxburghii, Piper longum, Piper nigrum, Plumbago indica, Alpinia galanga, Curcuma aromatica, Globba malaccensis, Zingiber montanum, Zingiber officinale andZingiberzerumbet. They showedhighfrequency in OA formula. To investigate inhibitory effect on LPS-induced nitric oxide (NO) release from RAW264. 7 cell and free radical scavenging activity usingDPPH assay of these ethanolic plant extracts. Plant materials were extracted by maceration in 95% ethanol. Anti-inflammatory activity were tested on LPS-induced NO production. Free radical scavenging activity was performed by DPPH assay. All of ethanolic extracts exhibited potent inhibitory effect on NO release. The ethanolic extract of Z. zerumbet exhibited the highest inhibitory effect followed by Z. montanum and G. malaccensis, respectively. Except A. galanga and C. viscosa, all extracts possessed more influential than indomethacin (IC50 = 20.32±3.23 μLg/ml), a positive control. The investigation on antioxidant activity suggested that the ethanolic extracts of D. roxburghii, Z. officinale, Z. montanum, C. aromatic, A. galanga, P indica, G malaccensis, P nigrum exhibited antioxidant activity. By means ofD. roxburghii had the highest electron donating activity,followed by Z. officinale. Moreover both extracts were more effective than BHT apositive control (EC50 = 14.04±1.95 μg/ml). Thai medicinal plants had anti-inflammatory activity and could inhibit destruction of articular cartilage that corresponded to the traditional medicine and supported using these medicinal plants for OA treatment.

  15. The emerging landscape of reimbursement of regenerative medicine products in the UK: publications, policies and politics.

    Science.gov (United States)

    Mahalatchimy, Aurélie; Faulkner, Alex

    2017-09-01

    This paper aims to map the trends and analyze key institutional dynamics that constitute the policies for reimbursement of regenerative medicine (RM), especially in the UK. Two quantitative publications studies using Google Scholar and a qualitative study based on a larger study of 43 semi-structured interviews. Reimbursement has been a growing topic of publications specific to RM and independent from orphan drugs. Risk-sharing schemes receive attention among others for dealing with RM reimbursement. Trade organizations have been especially involved on RM reimbursement issues and have proposed solutions. The policy and institutional landscape of reimbursement studies in RM is a highly variegated and conflictual one and in its infancy.

  16. Local production of pharmaceuticals in Africa and access to essential medicines: 'Urban bias' in access to imported medicines in Tanzania and its policy implications

    NARCIS (Netherlands)

    P.G.M. Mujinja (Phares G.M.); M. Mackintosh (Maureen); M. Justin-Temu (Mary); M. Wuyts (Marc)

    2014-01-01

    textabstractBackground: International policy towards access to essential medicines in Africa has focused until recently on international procurement of large volumes of medicines, mainly from Indian manufacturers, and their import and distribution. This emphasis is now being challenged by renewed

  17. Quality evaluation of medicinal products and health foods containing chaste berry (Vitex agnus-castus) in Japanese, European and American markets.

    Science.gov (United States)

    Fukahori, Masahiro; Kobayashi, Shojiro; Naraki, Yoko; Sasaki, Takahiro; Oka, Hideki; Seki, Masaharu; Masada-Atsumi, Sayaka; Hakamatsuka, Takashi; Goda, Yukihiro

    2014-01-01

    The aim of present study was to evaluate the qualities of chaste berry (fruit of Vitex agnus-castus L.) preparations using HPLC fingerprint analysis. Seven medicinal products 1 from Japan and 6 from Europe, and 17 health foods, 6 from Japan and 11 from the United States were analyzed. HPLC profile and 26 authentic peaks were compared medicinal products and health foods. Whereas medicinal products had similar HPLC profiles, health foods had various profiles and each peak was also greatly different. The measured amounts of two markers in 5 traditional medicinal products, agnuside and casticin specified in the European Pharmacopoeia (EP), the U.S. Pharmacopoeia (USP) or the WHO monographs of chaste berry, were much lower than those in 2 medicinal products defined as "well-established use" by the European Medicines Agency. The amounts of two markers for 17 health foods differed in a great deal from 14-5054% and 3-1272%, respectively. Furthermore the amount ratios of two markers, agnuside/casticin, in about half of the health foods were remarkably larger than the standard crude drug and the ratios were closer to one of the related Chinese herbs, Vitex negundo L. It is concluded that a combination of HPLC fingerprints and the amount ratios of the marker compounds of chaste berry preparations serves as a useful tool to evaluate the qualities of these preparations.

  18. Active compounds in Chinese herbs and medicinal animal products which promote blood circulation via inhibition of Na+, K+-ATPase.

    Science.gov (United States)

    Tzen, Jason Tc; Chen, Ronald Jy; Chung, Tse-Yu; Chen, Yi-Ching; Lin, Nan-Hei

    2010-01-01

    The therapeutic effect of cardiac glycosides for congestive heart failure lies in their reversible inhibition on Na+, K+-ATPase located in human myocardium. Several steroid-like compounds containing a core structure similar to cardiac glycosides have been found in many Chinese herbs and medicinal animal products conventionally used to promote blood circulation. They are putatively responsible for the therapeutic effect of those medicinal products via the same mechanism of inhibiting Na+, K+-ATPase. Inhibitory potency on Na+, K+-ATPase by ginsenosides, one of the identified steroid-like compounds, is significantly affected by sugar attachment that might cause steric hindrance of their binding to Na+, K+-ATPase. Ginsenosides with sugar moieties attached only to the C-3 position of the steroid-like structure, equivalent to the sugar position in cardiac glycosides, substantially inhibit Na+, K+-ATPase. However, their inhibitory potency is abolished when sugar moieties are linked to the C-6 or C-20 position of the steroid-like structure. In contrast, no appreciable contents of steroid-like compounds are found in danshen, a well-known Chinese herb traditionally regarded as an effective medicine promoting blood circulation. Instead, magnesium lithospermate B (MLB), the major soluble ingredient in danshen, is assumed to be responsible for the therapeutic effect by inhibiting Na+, K+-ATPase in a manner comparable to cardiac glycosides. Neuroprotective effects of cardiac glycosides, ginsenosides and MLB against ischemic stroke were accordingly observed in a cortical brain slice-based assay model. Whether the neuroprotection is also triggered by inhibition of Na+, K+-ATPase remains to be investigated. Molecular modeling suggests that cardiac glycosides, ginsenosides and MLB presumably bind to the same extracellular pocket of the Na+, K+-ATPase alpha subunit.

  19. General sale of non-prescription medicinal products: Comparing legislation in two European countries.

    Science.gov (United States)

    Lind, Johanna; Schafheutle, Ellen; Hägg, Annika Nordén; Sporrong, Sofia Kälvemark

    2016-01-01

    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 available in non-pharmacy outlets; The United Kingdom (UK) is a more established NPM market; both are guided by the same EU directives. The aim of this study was to compare specific requirements under the legislation, rationales and outcomes regarding the sale of NPMs through non-pharmacy outlets between Sweden and the UK. The main method was analysis of legislative text and policy documents, conducted in 2012. Both countries had specified medicines available to the public in non-pharmacy outlets, but with restrictions on different factors, e.g. placement and package size of the NPMs. The main rationales for legislation were quality and patient safety. NPMs for 51 ailments were available in the UK, compared to 35 in Sweden. Sweden had more extensive requirements, probably due to the market being more recently deregulated, while the UK represented a more mature 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. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. [Peruvian scientific production in medicine and collaboration networks, analysis of the Science Citation Index 2000-2009].

    Science.gov (United States)

    Huamaní, Charles; Mayta-Tristán, Percy

    2010-09-01

    To describe the Peruvian scientific production in indexed journals in the Institute for Scientific Information (ISI) and the characteristics of the institutional collaborative networks. All papers published in the ISI database (Clinical Medicine collection) were included during 2000 to 2009 with at least one author with a Peruvian affiliation. The publication trend, address of corresponding author, type of article, institution, city (only for Peru), and country were evaluated. The collaborative networks were analized using the Pajek® software. 1210 papers were found, increasing from 61 in 2000 to 200 in 2009 (average of 121 articles/year). 30.4% articles included a corresponding author from a Peruvian institution. The average of authors per article was 8.3. Original articles represented 82.1% of total articles. Infectious diseases-related journals concentrated most of the articles. The main countries that collaborate with Peru are: USA (60.4%), England (12.9%), and Brazil (8.0%). Lima concentrated 94.7% of the publications and three regions (Huancavelica, Moquegua and Tacna) did not register any publication. Only two universities published more than one article/year and four institutions published more than 10 articles/year. Universidad Peruana Cayetano Heredia published 45% of the total number of articles, being the most productive institution and which concentrated the most number of collaborations with foreign institutions. The ministry of Health--including all dependencies--published 37.3% of the total number of publications. There is a higher level of collaboration with foreign institutions rather than local institutions. The Peruvian scientific production in medicine represented in the ISI database is very low but growing, and is concentrated in Lima and in a few institutions. The most productive Peruvian institutions collaborate more intensively with foreign journals rather than local institutions.

  1. X-ray imaging physics for nuclear medicine technologists. Part 1: Basic principles of x-ray production.

    Science.gov (United States)

    Seibert, J Anthony

    2004-09-01

    The purpose is to review in a 4-part series: (i) the basic principles of x-ray production, (ii) x-ray interactions and data capture/conversion, (iii) acquisition/creation of the CT image, and (iv) operational details of a modern multislice CT scanner integrated with a PET scanner. Advances in PET technology have lead to widespread applications in diagnostic imaging and oncologic staging of disease. Combined PET/CT scanners provide the high-resolution anatomic imaging capability of CT with the metabolic and physiologic information by PET, to offer a significant increase in information content useful for the diagnostician and radiation oncologist, neurosurgeon, or other physician needing both anatomic detail and knowledge of disease extent. Nuclear medicine technologists at the forefront of PET should therefore have a good understanding of x-ray imaging physics and basic CT scanner operation, as covered by this 4-part series. After reading the first article on x-ray production, the nuclear medicine technologist will be familiar with (a) the physical characteristics of x-rays relative to other electromagnetic radiations, including gamma-rays in terms of energy, wavelength, and frequency; (b) methods of x-ray production and the characteristics of the output x-ray spectrum; (c) components necessary to produce x-rays, including the x-ray tube/x-ray generator and the parameters that control x-ray quality (energy) and quantity; (d) x-ray production limitations caused by heating and the impact on image acquisition and clinical throughput; and (e) a glossary of terms to assist in the understanding of this information.

  2. Production of polyol oils from soybean oil by bioprocess and Philippines edible medicinal wild mushrooms

    Science.gov (United States)

    We have been trying to develop a bioprocess for the production of polyol oils directly from soybean oil. We reported earlier the polyol products produced from soybean oil by Acinetobacter haemolyticus A01-35 (NRRL B-59985) (Hou and Lin, 2013). The objective of this study is to identify the chemical ...

  3. 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.

  4. The contribution of AECL CommercialProducts to nuclear medicine and radiation processing

    International Nuclear Information System (INIS)

    Beddoes, J.M.

    1980-02-01

    A review is given of the technology of the uses of radiation equipment and radioisotopes, in which field Canada has long been a world leader. AECL CommercialProducts has pioneered many of the most important applications. The development and sale of Co-60 radiation teletherapy units for cancer treatment is a familiar example of such an application, and CommercialProducts dominates the world market. Another such example is the marketing of Mo-99, which is produced in the reactors at Chalk River, and from which the short-lived daughter Tc-99 is eluted as required for use in in-vivo diagnosis. New products coming into use for this purpose include Tl-201, I-123, Ga-67 and In-111, all produced in the TRIUMF cyclotron in Vancouver, while I-125 continues to be in demand for in-vitro radioimmunoassays. Radioisotopes continue to play an important part in manufacturing, where their well-known uses include controlling thickness, contents, etc., in production, and industrial radiography. The application of large industrial irradiators for the sterilization of medical products is now a major world industry for which Commercial Products is the main manufacturer. Isotopes are also used in products such as smoke detectors. Isotopes continue to find extensive use as tracers, both in industrial applications and in animal and plant biology studies. Some more recent uses include pest control by the 'sterile male' technique and neutron activation and delayed neutron counting in uranium assay. (auth)

  5. Carbazole Scaffold in Medicinal Chemistry and Natural Products: A Review from 2010-2015.

    Science.gov (United States)

    Tsutsumi, Lissa S; Gündisch, Daniela; Sun, Dianqing

    2016-01-01

    9H-carbazole is an aromatic molecule that is tricyclic in nature, with two benzene rings fused onto a 5-membered pyrrole ring. Obtained from natural sources or by synthetic routes, this scaffold has gained much interest due to its wide range of biological activity upon modifications, including antibacterial, antimalarial, anticancer, and anti-Alzheimer properties. This review reports a survey of the literature on carbazole-containing molecules and their medicinal activities from 2010 through 2015. In particular, we focus on their in vitro and in vivo activities and summarize structure-activity relationships (SAR), mechanisms of action, and/or cytotoxicity/selectivity findings when available to provide future guidance for the development of clinically useful agents from this template.

  6. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients

    DEFF Research Database (Denmark)

    Schulman, S; Angerås, U; Bergqvist, D

    2010-01-01

    The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its...... subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used...... in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials...

  7. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients

    DEFF Research Database (Denmark)

    Schulman, S; Angerås, U; Bergqvist, D

    2010-01-01

    a definition has been developed that should be applicable to all agents that interfere with hemostasis. The definition and the text that follows have been reviewed and approved by relevant co-chairs of the subcommittee and by the Executive Committee of the SSC. The intention is to seek approval......The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its...... subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used...

  8. Vision Technology for Automated Characterization of Parasite Eggs in a Medicinal Product

    DEFF Research Database (Denmark)

    Bruun, Johan Musaeus

    . In the present PhD project, a microscopy-based vision instrument has been developed to automate the characterization of egg suspension quantity and quality. The instrument uses digital image analysis and statistical classification to detect and count the eggs and to characterize the developmental stages......Eggs from the pig whipworm, Trichuris suis ova, constitute the active pharmaceutical ingredient in a drug candidate targeting immune-mediated diseases such as Crohn’s disease, multiple sclerosis, a.o. The drug candidate is currently being evaluated in clinical trials around the world...... of the larvae inside the eggs based on morphology and darkfield scattering. The novel application of this technology is described in a patent application. The assessed concentration and embryonation percentage is used in the preparation of medicinal doses for the patients. The instrument has been evaluated...

  9. Exploring Cancer Therapeutics with Natural Products from African Medicinal Plants, Part II: Alkaloids, Terpenoids and Flavonoids.

    Science.gov (United States)

    Nwodo, Justina N; Ibezim, Akachukwu; Simoben, Conrad V; Ntie-Kang, Fidele

    2016-01-01

    Cancer stands as second most common cause of disease-related deaths in humans. Resistance of cancer to chemotherapy remains challenging to both scientists and physicians. Medicinal plants are known to contribute significantly to a large population of Africa, which is to a very large extent linked to folkloric claims which is part of their livelihood. In this review paper, the potential of naturally occurring anti-cancer agents from African flora has been explored, with suggested modes of action, where such data is available. Literature search revealed plant-derived compounds from African flora showing anti-cancer and/or cytotoxic activities, which have been tested in vitro and in vivo. This corresponds to 400 compounds (from mildly active to very active) covering various compound classes. However, in this part II, we only discussed the three major compound classes which are: flavonoids, alkaloids and terpenoids.

  10. Toxicological, chemical and antibacterial evaluation of squill vinegar, a useful product in Persian Traditional Medicine

    Directory of Open Access Journals (Sweden)

    M. Bozorgi

    2017-01-01

    Full Text Available Background and objectives:  Squill [Drimia maritima (L. Stearn] is an important medicinal plant that has been used for medicinal purposes such as cardiovascular diseases and asthma since ancient times. Bufadienolides are the main compounds of this plant and are responsible for some reported adverse effects. In order to reduce adverse effects, different methods like boiling with vinegar were applied by traditional practitioners. In the present study, the acute oral toxicity, cytotoxic effects, proscillaridin A content and antibacterial properties of methanol and vinegar extracts of squill white variety were compared for exploring the efficacy of traditional processing method. Methods: Different doses of extracts (1000-5000 mg/kg were administered during oral gavage in rats to analyze the acute oral toxicity. Cytotoxicity against HT-29, Caco-2 and NIH3T3 cell lines and antibacterial activity (Staphylococcus aureus, Staphylococcus epidermidis, Bacillus subtilis, Pseudomonas aeruginosa, Klebsiella pneumoniae and Escherichia coli were investigated using MTT assay and conventional agar dilution method, respectively. Proscillaridin A content was evaluated in the extracts (vinager and methanol by a validated high performance liquid chromatography method. Results: During the in vivo research no death or observed effect occurred in animals that received the extracts. Our results showed that all of the extracts exhibited no cytotoxic effects in experimented cell lines (IC50>1000 μg/mL. Proscillaridin A was only detected in the methanol extract and no significant antibacterial effect was detected in methanol extract. Conclusion: According to results of the present study, processing squill with vinegar according to traditional experiences can reduce possible the side effects of bufadienolids.

  11. Metabolic engineering approaches for production of biochemicals in food and medicinal plants.

    Science.gov (United States)

    Wilson, Sarah A; Roberts, Susan C

    2014-04-01

    Historically, plants are a vital source of nutrients and pharmaceuticals. Recent advances in metabolic engineering have made it possible to not only increase the concentration of desired compounds, but also introduce novel biosynthetic pathways to a variety of species, allowing for enhanced nutritional or commercial value. To improve metabolic engineering capabilities, new transformation techniques have been developed to allow for gene specific silencing strategies or stacking of multiple genes within the same region of the chromosome. The 'omics' era has provided a new resource for elucidation of uncharacterized biosynthetic pathways, enabling novel metabolic engineering approaches. These resources are now allowing for advanced metabolic engineering of plant production systems, as well as the synthesis of increasingly complex products in engineered microbial hosts. The status of current metabolic engineering efforts is highlighted for the in vitro production of paclitaxel and the in vivo production of β-carotene in Golden Rice and other food crops. Copyright © 2014 Elsevier Ltd. All rights reserved.

  12. Screening of medicinal higher Basidiomycetes mushrooms from Turkey for lovastatin production.

    Science.gov (United States)

    Atli, Burcu; Yamac, Mustafa

    2012-01-01

    As a first attempt, a study was carried out to test for lovastatin production ability in local higher Basidiomycetes mushroom isolates from Turkey. An extended screening was performed for lovastatin production in yeast lactose agar medium, among a total of 136 macrofungi isolates from the Basidiomycetes Culture Collection of Eskisehir Osmangazi University. Lovastatin production was evaluated by disc diffusion method and was also confirmed by TLC and HPLC. Only six isolates were found to be lovastatin producers. The highest production of lovastatin was obtained from the extracts from Omphalotus olearius OBCC 2002 and Pleurotus ostreatus OBCC 1031. The lovastatin amount produced by commercial strains, Aspergillus terreus NRRL 255 (7.0 mg/L) and Penicillium citrinum NRRL 1841 (7.0 mg/L), was nearly comparable to the amount produced by Pleurotus ostreatus OBCC 1031 (5.8 mg/L) and Omphalotus olearius OBCC 2002 (4 mg/L).

  13. Antimicrobial resistance and the guidelines of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

    Science.gov (United States)

    Marion, H

    2012-04-01

    The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) is an international tripartite cooperation programme that brings together regulatory authorities and industry representatives from the European Union, Japan and the United States, with Australia, New Zealand and Canada as observers. VICH aims to improve international coordination and cooperation to achieve greater harmonisation of the requirements for veterinary product registration in the regions concerned. VICH develops harmonised data requirements, i.e., standards for the scientific studies on quality, safety and efficacy that are required to obtain a marketing authorisation for a veterinary medicinal product. It does this by publishing guidelines that provide uniform and consistent guidance for sponsors to follow in developing data for application dossiers as well as for post-marketing safety monitoring of veterinary medicinal products. Of the 49 VICH guidelines that have been developed so far, two guidelines in particular address issues related to antimicrobial resistance.

  14. How to achieve safe, high-quality clinical studies with non-Medicinal Investigational Products? A practical guideline by using intra-bronchial carbon nanoparticles as case study

    NARCIS (Netherlands)

    Berger, M; Kooyman, P.J.; Makkee, M.; van der Zee, J.S.; Sterk, P. J.; van Dijk, J.; Kemper, E. M.

    2016-01-01

    Background: Clinical studies investigating medicinal products need to comply with laws concerning good clinical practice (GCP) and good manufacturing practice (GMP) to guarantee the quality and safety of the product, to protect the health of the participating individual and to assure proper

  15. How to achieve safe, high-quality clinical studies with non-Medicinal Investigational Products? A practical guideline by using intra-bronchial carbon nanoparticles as case study

    NARCIS (Netherlands)

    Berger, M.; Kooyman, P. J.; Makkee, M.; van der Zee, J. S.; Sterk, P. J.; van Dijk, J.; Kemper, E. M.

    2016-01-01

    Clinical studies investigating medicinal products need to comply with laws concerning good clinical practice (GCP) and good manufacturing practice (GMP) to guarantee the quality and safety of the product, to protect the health of the participating individual and to assure proper performance of the

  16. A Just Distribution of Health Care in the Case of Orphan Medicinal Products: Aligning the Interests of European Economic Integration and National Welfare Policy

    DEFF Research Database (Denmark)

    Faeh, Andrea

    2012-01-01

    resources is concerned. The EU is very proactive in fostering research and development of medicinal products aimed at treating patients who suffer from rare diseases. The European incentive scheme (Regulation (EC) No. 141/2000) has been a considerable success but, although products are developed...

  17. Chamomile Flower, Myrrh, and Coffee Charcoal, Components of a Traditional Herbal Medicinal Product, Diminish Proinflammatory Activation in Human Macrophages.

    Science.gov (United States)

    Vissiennon, Cica; Hammoud, Dima; Rodewald, Steffen; Fester, Karin; Goos, Karl-Heinz; Nieber, Karen; Arnhold, Jürgen

    2017-07-01

    A traditional herbal medicinal product, containing myrrh, chamomile flower, and coffee charcoal, has been used in Germany for the relief of gastrointestinal complaints for decades. Clinical studies suggest its use in the maintenance therapy of inflammatory bowel disease. However, the pharmacological mechanisms underlying the clinical effects are not yet fully understood.The present study aims to elucidate immunopharmacological activities of myrrh, chamomile flower, and coffee charcoal by studying the influence of each plant extract on gene expression and protein release of activated human macrophages.The plant extracts effect on gene and protein expression of activated human monocyte-derived macrophages was investigated by microarray gene expression analysis and assessment of the release of pro- and anti-inflammatory mediators (TNF α , chemokine CXCL13, and interleukin-10) using an ELISA test system.The extracts of myrrh, chamomile flower, and coffee charcoal influenced gene expression of activated human macrophages within the cytokine/chemokine signaling pathway. Particularly, chemokine gene expression was suppressed. Subsequently, the production of CXCL13 and, to a minor extent, cytokine TNF α was inhibited by all herbal extracts. Chamomile flower and coffee charcoal extracts enhanced interleukin-10 release from activated macrophages. The observed effects on protein release were comparable to the effect of budesonide, which decreased TNF α and CXCL13 and enhanced interleukin-10 release.The components of the herbal medicinal product influence the activity of activated human macrophages on both gene and protein level. The induced alterations within chemokine/cytokine signaling could contribute to a positive effect on the immunological homeostasis, which is disturbed in patients with chronic intestinal inflammation. Georg Thieme Verlag KG Stuttgart · New York.

  18. Current concepts on integrative safety assessment of active substances of botanical, mineral or chemical origin in homeopathic medicinal products within the European regulatory framework.

    Science.gov (United States)

    Buchholzer, Marie-Luise; Werner, Christine; Knoess, Werner

    2014-03-01

    For active substances of botanical, mineral or chemical origin processed in homeopathic medicinal products for human use, the adequate safety principles as with other human medicinal products are applied in line with the European regulatory framework. In homeopathy, nonclinical safety assessment is facing a particular challenge because of a multitude and diversity of source materials used and due to rarely available toxicological data. Thus, current concepts applied by the national regulatory authority in Germany (BfArM) on integrative safety assessment of raw materials used in homeopathic medicinal products involve several evaluation approaches like the use of the Lowest Human Recommended Dose (LHRD), toxicological limit values, Threshold of Toxicological Concern (TTC), data from food regulation or the consideration of unavoidable environmental or dietary background exposure. This publication is intended to further develop and clarify the practical use of these assessment routes by exemplary application on selected homeopathic preparations. In conclusion, the different approaches are considered a very useful scientific and simultaneously pragmatic procedure in differentiated risk assessment of homeopathic medicinal products. Overall, this paper aims to increase the visibility of the safety issues in homeopathy and to stimulate scientific discussion of worldwide existing regulatory concepts on homeopathic medicinal products. Copyright © 2014 Elsevier Inc. All rights reserved.

  19. Amylase production by endophytic fungi Cylindrocephalum sp. isolated from medicinal plant Alpinia calcarata (Haw. Roscoe

    Directory of Open Access Journals (Sweden)

    V. H. Sunitha.

    2012-09-01

    Full Text Available Amylases are among the most important enzymes used in modern biotechnology particularly in the process involving starch hydrolysis. Fungal amylase has large applications in food and pharmaceutical industries. Considering these facts, endophytic fungi isolated from the plant Alpinia calcarata (Haw. Roscoe were screened for amylolytic activity on glucose yeast extract peptone agar (GYP medium. Among thirty isolates of endophytic fungi, isolate number seven identified as Cylindrocephalum sp. (Ac-7 showed highest amylolytic activity and was taken for further study. Influence of various physical and chemical factors such as pH, temperature, carbon and nitrogen sources on amylase production in liquid media were studied. The maximal amylase production was found to be at 30ºC and at pH 7.0 of the growth medium. Among the various carbon and nitrogen sources tested, maltose at 1.5% and Sodium nitrate at 0.3% respectively gave optimum amylase production.

  20. 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.

  1. Heat and light stresses affect metabolite production in the fruit body of the medicinal mushroom Cordyceps militaris.

    Science.gov (United States)

    Jiaojiao, Zhang; Fen, Wang; Kuanbo, Liu; Qing, Liu; Ying, Yang; Caihong, Dong

    2018-03-29

    Cordyceps militaris is a highly valued edible and medicinal fungus due to its production of various metabolites, including adenosine, cordycepin, N 6 -(2-hydroxyethyl)-adenosine, and carotenoids. The contents of these metabolites are indicative of the quality of commercially available fruit body of this fungus. In this work, the effects of environmental abiotic factors, including heat and light stresses, on the fruit body growth and metabolite production in C. militaris were evaluated during the late growth stage. The optimal growth temperature of C. militaris was 20 °C. It was found that a heat stress of 25 °C for 5-20 days during the late growth stage significantly promoted cordycepin and carotenoid production without affecting the biological efficiency. Light stress at 6000 lx for 5-20 days during the late growth stage significantly promoted cordycepin production but decreased the carotenoid content. Both heat and light stresses promoted N 6 -(2-hydroxyethyl)-adenosine production. In addition, gene expression analysis showed that there were simultaneous increases in the expression of genes encoding a metal-dependent phosphohydrolase (CCM_04437) and ATP phosphoribosyltransferase (CCM_04438) that are involved in the cordycepin biosynthesis pathway, which was consistent with the accumulation of cordycepin during heat stress for 5-20 days. A positive weak correlation between the cordycepin and adenosine contents was observed with a Pearson correlation coefficient of 0.338 (P < 0.05). The results presented herein provide a new strategy for the production of a superior quality fruit body of C. militaris and contribute to further elucidation of the effects of abiotic stress on metabolite accumulation in fungi.

  2. Automation drying unit molybdenum-zirconium gel radioisotope production technetium-99M for nuclear medicine

    International Nuclear Information System (INIS)

    Chakrova, Y.; Khromushin, I.; Medvedeva, Z.; Fettsov, I.

    2014-01-01

    Full text : Since 2001 the Institute of Nuclear Physics of the Republic of Kazakhstan has began production of radiopharmaceutical based on technetium-99m from irradiated reactor WWR-K of natural molybdenum, which allows to obtain a solution of technetium-99m of the required quality and high volume activity. In 2013 an automated system is started, which is unique and urgent task is to develop algorithms and software in Python, as well as the manufacture of certain elements of technological systems for automated production

  3. The Role of Biotechnology for Conservation and Biologically Active Substances Production of Rhodiola rosea: Endangered Medicinal Species

    Directory of Open Access Journals (Sweden)

    Krasimira Tasheva

    2012-01-01

    Full Text Available At present, more than 50 000 plant species are used in phytotherapy and medicine. About 2/3 of them are harvested from nature leading to local extinction of many species or degradation of their habitats. Biotechnological methods offer possibilities not only for faster cloning and conservation of the genotype of the plants but for modification of their gene information, regulation, and expression for production of valuable substances in higher amounts or with better properties. Rhodiola rosea is an endangered medicinal species with limited distribution. It has outstanding importance for pharmaceutical industry for prevention and cure of cancer, heart and nervous system diseases, and so forth. Despite the great interest in golden root and the wide investigations in the area of phytochemistry, plant biotechnology remained less endeavoured and exploited. The paper presents research on initiation of in vitro cultures in Rhodiola rosea and some other Rhodiola species. Achievements in induction of organogenic and callus cultures, regeneration, and micropropagation varied but were a good basis for alternative in vitro synthesis of the desired metabolites and for the development of efficient systems for micropropagation for conservation of the species.

  4. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients.

    Science.gov (United States)

    Schulman, S; Angerås, U; Bergqvist, D; Eriksson, B; Lassen, M R; Fisher, W

    2010-01-01

    The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials a definition has been developed that should be applicable to all agents that interfere with hemostasis. The definition and the text that follows have been reviewed and approved by relevant co-chairs of the subcommittee and by the Executive Committee of the SSC. The intention is to seek approval of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols.

  5. Bioactive Natural Products from Two Sudanese Medicinal Plants Diospyros mespiliformis and Croton zambesicus

    Directory of Open Access Journals (Sweden)

    Ietidal E. Mohamed

    2009-10-01

    Full Text Available Phytochemical investigations were performed in two plant species used in Sudanese traditional medicines to treat different illnesses, Diospyros mespiliformis and Croton zambesicus. The investigations revealed compounds of triterpenes (lupane series, one trihydroxyflavone and one diterpene. The compounds have been isolated and identified using various chromatographic and spectroscopic techniques. These were lupeol (1, betulinic acid (2, betulin (3 and lupenone (4 from Diospyros mespiliformis. Compounds 1, 2, 3 in addition to diterpene ent -kaurane-3β, 16β, 17-triol (5 and vitexin (6 were re-isolated from Croton zambesicus. However,compound 5 and 6 were isolated for the first time from this source.The pure isolated compounds and semi-synthesized acetates 1Ac, 2Ac and 3Ac, which were prepared from compounds 1, 2 and 3 respectively, were subjected to two bioassays: α- glucosidase enzyme inhibition assay and antioxidant activity. Compounds, 1, 1Ac, 3 and 4 showed a marked α-glucosidase inhibitory potential, while compound 6 exhibited strong antioxidant activity.

  6. Exercise is more than medicine: The working age population's well-being and productivity

    Directory of Open Access Journals (Sweden)

    Gisela Sjøgaard

    2016-06-01

    Conclusion: IPET does enhance health if an exercise program with evidenced efficacy is implemented by expert trainees with support of the employer. Accordingly, in every study group outcomes of improved health were documented and the effect sizes were of clinical relevance. Cost effectiveness estimates indicate acceptable cost relative to savings on health expenses and lost productivity.

  7. Application of microscopy in authentication of valuable Chinese medicine I--Cordyceps sinensis, its counterfeits, and related products.

    Science.gov (United States)

    Au, Dawn; Wang, Lijing; Yang, Dajian; Mok, Daniel K W; Chan, Albert S C; Xu, Hongxi

    2012-01-01

    Light and polarized microscope was applied to authenticate 32 Cordyceps and 6 artificial counterfeits and 8 fermented Cordyceps as well as 7 Cordyceps capsules available in Hong Kong markets. Results showed that transverse sections of stroma and powder of larvae can be used to differentiate C. sinensis from its counterfeits. The fermented Cordyceps are in powder form. Among the eight fermented Cordyceps collected, half of them were pure; three were a mixture of fermented Cordyceps and soya beans; one was a mixture of unknown plant tissues and soya beans. For the seven Cordyceps capsules, the powders of five samples were a mixture of fermented Cordyceps and soya beans; the powders of other two were a mixture of C. sinensis stroma powder and fermented Cordyceps. The study indicated that the microscopy is an unambiguous method that requests fewer sample for the authentication of valuable Chinese medicine-C. sinensis and its related products. Copyright © 2011 Wiley Periodicals, Inc.

  8. Detection and quantification of residues and metabolites of medicinal products in environmental compartments, food commodities and workplaces. A review.

    Science.gov (United States)

    Bottoni, Paola; Caroli, Sergio

    2015-03-15

    The toxicological assessment of medicinal products (MPs) and their residues and metabolites in the environment have become a challenging task worldwide. The contamination of environmental compartments, biota, workplace, foodstuff and feedstuff by residues and metabolites of these substances poses a risk to human health which is still far from being fully understood. On the other hand, existing analytical methods not always possess sufficient detection power to quantify residues of MPs at very low concentrations. This review sets forth some of the most significant contributions made in this field over the past decade with a special focus on novel fit-for-purpose analytical approaches for the detection, identification and quantification of these pollutants and the assessment of their noxious potential for human beings and the environment. Copyright © 2014 Elsevier B.V. All rights reserved.

  9. Evaluation of different agricultural wastes for the production of fruiting bodies and bioactive compounds by medicinal mushroom Cordyceps militaris.

    Science.gov (United States)

    Lin, Qunying; Long, Liangkun; Wu, Liangliang; Zhang, Fenglun; Wu, Shuling; Zhang, Weiming; Sun, Xiaoming

    2017-08-01

    In commercial production of Cordyceps militaris (a famous Chinese medicine), cereal grains are usually utilized as cultivation substrates. This study aimed to evaluate the efficiency of agricultural wastes as substitute materials in the low-cost production of C. militaris. Cottonseed shells (CS), corn cob particles (CCP), Italian poplar sawdusts (IPS) and substrates spent by Flammulina velutipes (SS) were employed to cultivate C. militaris, using rice medium as control. CS and CCP were suitable for fruit body formation of C. militaris, with yields of 22 and 20 g per bottle respectively. Fruit bodies grown on CCP showed the highest levels of cordycepin and adenosine, up to 9.45 and 5.86 mg g -1 respectively. The content of d-mannitol in fruit bodies obtained on CS was 120 mg g -1 (80% of the control group), followed by that on CCP, 100 mg g -1 . Fruit bodies cultivated on CCP displayed a high crude polysaccharide level of 26.9 mg g -1 , which was the closest to that of the control group (34.5 mg g -1 ). CS and CCP are effective substrates for the production of fruit bodies and bioactive compounds by C. militaris. This study provides a new approach to decreasing the cost of C. militaris cultivation and dealing with these agricultural wastes. © 2016 Society of Chemical Industry. © 2016 Society of Chemical Industry.

  10. Literature review of visual representation of the results of benefit-risk assessments of medicinal products.

    Science.gov (United States)

    Hallgreen, Christine E; Mt-Isa, Shahrul; Lieftucht, Alfons; Phillips, Lawrence D; Hughes, Diana; Talbot, Susan; Asiimwe, Alex; Downey, Gerald; Genov, Georgy; Hermann, Richard; Noel, Rebecca; Peters, Ruth; Micaleff, Alain; Tzoulaki, Ioanna; Ashby, Deborah

    2016-03-01

    The PROTECT Benefit-Risk group is dedicated to research in methods for continuous benefit-risk monitoring of medicines, including the presentation of the results, with a particular emphasis on graphical methods. A comprehensive review was performed to identify visuals used for medical risk and benefit-risk communication. The identified visual displays were grouped into visual types, and each visual type was appraised based on five criteria: intended audience, intended message, knowledge required to understand the visual, unintentional messages that may be derived from the visual and missing information that may be needed to understand the visual. Sixty-six examples of visual formats were identified from the literature and classified into 14 visual types. We found that there is not one single visual format that is consistently superior to others for the communication of benefit-risk information. In addition, we found that most of the drawbacks found in the visual formats could be considered general to visual communication, although some appear more relevant to specific formats and should be considered when creating visuals for different audiences depending on the exact message to be communicated. We have arrived at recommendations for the use of visual displays for benefit-risk communication. The recommendation refers to the creation of visuals. We outline four criteria to determine audience-visual compatibility and consider these to be a key task in creating any visual. Next we propose specific visual formats of interest, to be explored further for their ability to address nine different types of benefit-risk analysis information. Copyright © 2015 John Wiley & Sons, Ltd.

  11. Biotechnological production and applications of Cordyceps militaris, a valued traditional Chinese medicine.

    Science.gov (United States)

    Cui, Jian Dong

    2015-01-01

    Cordyceps militaris is a potential harborer of biometabolites for herbal drugs. For a long time, C. militaris has gained considerable significance in several clinical and biotechnological applications. Much knowledge has been gathered with regard to the C. militaris's importance in the genetic resources, nutritional and environmental requirements, mating behavior and biochemical pharmacological properties. The complete genome of C. militaris has recently been sequenced. This fungus has been the subject of many reviews, but few have focused on its biotechnological production of bioactive constituents. This mini-review focuses on the recent advances in the biotechnological production of bioactive compositions of C. militaris and the latest advances on novel applications from this laboratory and many others.

  12. Cultivation of Herbs and Medicinal Plants in Norway - Essential Oil Production and Quality Control

    OpenAIRE

    Rohloff, Jens

    2003-01-01

    Essential oils (EO) are plant secondary metabolites that are known for their fragrance and food flavour properties. They consist of a complex mixture of mono- and sesquiterpenes, phenyl propanoids and oxygenated compounds. EOs can be present in different plant organs and materials, and their storage is related to specialised secretory structures. The yield of EOs from plant raw materials by distillation or pressing may on average vary from 0.1 – 1%, thus restricting the major EO production to...

  13. [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.

  14. Giving Medicine to Children

    Science.gov (United States)

    ... Products For Consumers Home For Consumers Consumer Updates Articulos en Espanol Giving Medicine to Children Share Tweet ... right medicine and the right amount More in Articulos en Espanol Alimentos y Bebidas Cosméticos Dispositivos ...

  15. Co-production of hydrogen and methane from herbal medicine wastewater by a combined UASB system with immobilized sludge (H2 production) and UASB system with suspended sludge (CH4 production).

    Science.gov (United States)

    Sun, Caiyu; Hao, Ping; Qin, Bida; Wang, Bing; Di, Xueying; Li, Yongfeng

    2016-01-01

    An upflow anaerobic sludge bed (UASB) system with sludge immobilized on granular activated carbon was developed for fermentative hydrogen production continuously from herbal medicine wastewater at various organic loading rates (8-40 g chemical oxygen demand (COD) L(-1) d(-1)). The maximum hydrogen production rate reached 10.0 (±0.17) mmol L(-1) hr(-1) at organic loading rate of 24 g COD L(-1) d(-1), which was 19.9% higher than that of suspended sludge system. The effluents of hydrogen fermentation were used for continuous methane production in the subsequent UASB system. At hydraulic retention time of 15 h, the maximum methane production rate of 5.49 (±0.03) mmol L(-1) hr(-1) was obtained. The total energy recovery rate by co-production of hydrogen and methane was evaluated to be 7.26 kJ L(-1) hr(-1).

  16. APPLICATION OF PHYTOREMEDIATION FOR HERBAL MEDICINE WASTE AND ITS UTILIZATION FOR PROTEIN PRODUCTION

    Directory of Open Access Journals (Sweden)

    Danny Soetrisnanto

    2012-11-01

    Full Text Available Herbal industry in Indonesia is progressing very rapidly. Increasing number of herbal medicineindustries lead to an increase of the waste which are normally processed in anaerobic ponds by usingchemical and biological process. However this process are not economical feasible and therefore analternative method by using natural resource is required. Phytoremediation is an environmentalfriendly method to reduce contaminant using aquatic plant. This method uses water plant to reduceCOD and nutrients content in the waste. Since the waste still high content of nutrient, therefore it ispotential for medium growth of algae Spirulina. This study was aimed to evaluate the use of variousplant species (water hyacinth and lotus in decreasing contaminant and to determine optimal nutrientcomposition of the growth media. The phytoremediation was performed in 3-8 days and height ofliquid in the tank was maintained constant at 5 cm. The effluent of first phytoremediation wastransferred to second stage for cultivation of Spirulina with 15 days of cultivation time. The externalnutrients were added each 2 days and the concentration of biomass was measured for its opticaldensity. Spirulina grow well in herbal medicine waste that has been phytoremediation with lotus for 3days and had a CNP ratio amounted to 57.790 : 9.281 : 1 with a growth rate of 0.271/day. Industri obat di Indonesia tumbuh sangat cepat. Pertumbuhan inimengakibatkan meningkatnya limbah yang umumnya dilakukan dalam kolam anaerobik denganmenggunakan proses kimia dan biologi. Namun demikian, proses tersebut belum menunjukkan hasilekonomis sehingga diperlukan metode lain yang relatif aman dan ekonomis. Salah satu cara yangdapat digunakan adalah phytoremediasi mengguanakn tanaman air untuk mengurangi kandunganCOD dalam limbah dan nutrient. Dikarenakan limbah masih mengandung nutrient yang cukup banyak,maka limbah tersebut juga sangat potensial untuk digunakan sebagai medium mikroalga. Penelitianini

  17. Complement Levels and Haemate-Biochemical Parameters as ...

    African Journals Online (AJOL)

    Complement levels and haemato-biochemical parameters in West African Dwarf (WAD) and Borno White (BW) goats experimentally infected with Trypanosoma congolense were investigated. Parasitaemia was established in both breeds of goats by day 7 post-infection. Peak parasitaemia of 7.5 x 103/µL for WAD goats was ...

  18. Clinical Space Medicine Products as Developed by the Medical Operations Support Team (MOST)

    Science.gov (United States)

    Polk, James D.; Doerr, Harold K.; Hurst, Victor W., IV; Schmid, Josef

    2007-01-01

    Medical Operations Support Team (MOST) is introducing/integrating teaching practices associated with high fidelity human patient simulation into the NASA culture, in particular, into medical training sessions and medical procedure evaluations. Current/Future Products iclude: a) Development of Sub-optimal Airway Protocols for the International Space Station (ISS) using the ILMA; b) Clinical Core Competency Training for NASA Flight Surgeons (FS); c) Post-Soyuz Landing Clinical Training for NASA FS; d) Experimental Integrated Training for Astronaut Crew Medical Officers and NASA FS; and e) Private Clinical Refresher Training.

  19. Exploring Consumer and Patient Knowledge, Behavior, and Attitude Toward Medicinal and Lifestyle Products Purchased From the Internet: A Web-Based Survey.

    Science.gov (United States)

    Assi, Sulaf; Thomas, Jordan; Haffar, Mohamed; Osselton, David

    2016-07-18

    In recent years, lifestyle products have emerged to help improve people's physical and mental performance. The Internet plays a major role in the spread of these products. However, the literature has reported issues regarding the authenticity of medicines purchased from the Internet and the impact of counterfeit medicines on public health. Little or no data are available on the authenticity of lifestyle products and actual toxicity associated with their use and misuse. Our aim was to investigate consumer and patient attitudes toward the purchase of lifestyle products from the Internet, their knowledge of product authenticity and toxicity, and their experiences with counterfeit lifestyle products. A Web-based study was performed between May 2014 and May 2015. Uniform collection of data was performed through an anonymous online questionnaire. Participants were invited worldwide via email, social media, or personal communication to complete the online questionnaire. A total of 320 participants completed the questionnaire. The results of the questionnaire showed that 208 (65.0%) participants purchased lifestyle products from the Internet mainly due to convenience and reduced cost. More than half (55.6%, 178/320) of participants purchased cosmetic products, whereas only a minority purchased medicinal products. Yet, 62.8% (201/320) of participants were aware of the presence of counterfeit lifestyle products from the Internet, and 11.9% (38/320) experienced counterfeit products. In only 0.9% (3/320) of those cases were counterfeit lifestyle products reported to authorities. Moreover, 7.2% (23/320) of the participants experienced adverse effects due to counterfeit lifestyle products. In summary, patients experienced counterfeit lifestyle products that resulted in adverse effects on their health. Although certain adverse effects were reported in this study, counterfeit products were underreported to authorities. Further public awareness campaigns and patient education are

  20. Exploring Consumer and Patient Knowledge, Behavior, and Attitude Toward Medicinal and Lifestyle Products Purchased From the Internet: A Web-Based Survey

    Science.gov (United States)

    Thomas, Jordan

    2016-01-01

    Background In recent years, lifestyle products have emerged to help improve people’s physical and mental performance. The Internet plays a major role in the spread of these products. However, the literature has reported issues regarding the authenticity of medicines purchased from the Internet and the impact of counterfeit medicines on public health. Little or no data are available on the authenticity of lifestyle products and actual toxicity associated with their use and misuse. Objective Our aim was to investigate consumer and patient attitudes toward the purchase of lifestyle products from the Internet, their knowledge of product authenticity and toxicity, and their experiences with counterfeit lifestyle products. Methods A Web-based study was performed between May 2014 and May 2015. Uniform collection of data was performed through an anonymous online questionnaire. Participants were invited worldwide via email, social media, or personal communication to complete the online questionnaire. A total of 320 participants completed the questionnaire. Results The results of the questionnaire showed that 208 (65.0%) participants purchased lifestyle products from the Internet mainly due to convenience and reduced cost. More than half (55.6%, 178/320) of participants purchased cosmetic products, whereas only a minority purchased medicinal products. Yet, 62.8% (201/320) of participants were aware of the presence of counterfeit lifestyle products from the Internet, and 11.9% (38/320) experienced counterfeit products. In only 0.9% (3/320) of those cases were counterfeit lifestyle products reported to authorities. Moreover, 7.2% (23/320) of the participants experienced adverse effects due to counterfeit lifestyle products. Conclusions In summary, patients experienced counterfeit lifestyle products that resulted in adverse effects on their health. Although certain adverse effects were reported in this study, counterfeit products were underreported to authorities. Further

  1. A preliminary study for the production of high specific activity radionuclides for nuclear medicine obtained with the isotope separation on line technique.

    Science.gov (United States)

    Borgna, F; Ballan, M; Corradetti, S; Vettorato, E; Monetti, A; Rossignoli, M; Manzolaro, M; Scarpa, D; Mazzi, U; Realdon, N; Andrighetto, A

    2017-09-01

    Radiopharmaceuticals represent a fundamental tool for nuclear medicine procedures, both for diagnostic and therapeutic purposes. The present work aims to explore the Isotope Separation On-Line (ISOL) technique for the production of carrier-free radionuclides for nuclear medicine at SPES, a nuclear physics facility under construction at INFN-LNL. Stable ion beams of strontium, yttrium and iodine were produced using the SPES test bench (Front-End) to simulate the production of 89 Sr, 90 Y, 125 I and 131 I and collected with good efficiency on suitable targets. Copyright © 2017 Elsevier Ltd. All rights reserved.

  2. Polysaccharide production by submerged and solid-state cultures from several medicinal higher Basidiomycetes.

    Science.gov (United States)

    Montoya, Sandra; Sanchez, Oscar Julian; Levin, Laura

    2013-01-01

    Polysaccharides produced by microorganisms represent an industrially unexploited market. An important number of polysaccharides have been isolated from fungi, especially mushrooms, with many interesting biological functions, such as antitumor, hypoglycemic, and immunostimulating activities. In the search of new sources of fungal polysaccharides, the main goal of this research was to test the ability of several species of basidiomycetes, among them various edible mushrooms, to produce both extracellular polysaccharides (EPSs) and intracellular polysaccharides (IPSs). Among 10 species screened for production of EPSs in submerged cultures with glucose, soy oil, and yeast extract, the best results were obtained with Ganoderma lucidum (0.79 g/L EPS) and Pleurotus ostreatus (0.75 g/L EPS). Agitation strongly improved EPS production in most of the studied strains. Eight of 10 species assayed successfully developed basidiomes during synthetic "bag-log" cultivation on a substrate consisting of oak sawdust and corn bran. This work describes for the first time the environmental factors required for fruiting of 4 species under such conditions: Schizophyllum commune, Ganoderma applanatum, Trametes versicolor, and T. trogii. IPSs were extracted from the carpophores. The IPS content of the carpophores varied from 1.4% (G. applanatum) up to 5.5% and 6% in G. lucidum and Grifola frondosa, respectively.

  3. Potential hypersensitivity due to the food or food additive content of medicinal products in Spain.

    Science.gov (United States)

    Audicana Berasategui, M T; Barasona Villarejo, M J; Corominas Sánchez, M; De Barrio Fernández, M; García Avilés, M C; García Robaina, J C; Gastaminza Lasarte, G; Laguna Martínez, J J; Lobera Labairu, T; López San Martín, M; Martín Lázaro, J; Moreno Rodilla, E; Ortega Rodríguez, N; Torres Jaén, M J

    2011-01-01

    The Drug Allergy Committee of the Spanish Society of Allergology and Clinical Immunology reviewed the allergenic potential of several substances of food origin that are found in the composition of some drugs. Despite recent legislation on labeling, many labels do not clearly state whether the drug contains raw material (active ingredients, excipient, or other manufacturing intermediate) with an origin in any of the substances in the list of the 14 groups of food allergens that are subject to mandatory declaration. The objective of legislation is that the drug package, the Summary of Product Characteristics, and the patient information leaflet clearly state the food content in order to improve the safety of allergic patients. Therefore, any food or allergen derivative that must be declared should be clearly stated on the drug label. Of all the evaluated products, egg and milk derivatives are the most frequently discussed in literature reviews. The natural or synthetic origin of potentially allergenic substances such as lysozyme, casein, lactose, albumin, phosphatide, and aromatic essences should be clearly stated. Providing this information has 2 clear advantages. First, allergic reactions to drugs in patients with food allergy could be avoided (if the substances have a natural origin). Second, prescription would improve by not restricting drugs containing synthetic substances (which do not usually induce allergic reactions).

  4. Gamma irradiation of medicinally important plants and the enhancement of secondary metabolite production.

    Science.gov (United States)

    Vardhan, P Vivek; Shukla, Lata I

    2017-09-01

    The profitable production of some important plant-based secondary metabolites (ginsenosides, saponins, camptothecin, shikonins etc.) in vitro by gamma irradiation is a current area of interest. We reviewed different types of secondary metabolites, their mode of synthesis and effect of γ-radiation on their yield for different plants, organs and in vitro cultures (callus, suspension, hairy root). Special effort has been made to review the biochemical mechanisms underlying the increase in secondary metabolites. A comparison of yield improvement with biotic and abiotic stresses was made. Phenolic compounds increase with γ-irradiation in whole plants/plant parts; psoralen content in the common herb babchi (Psoralea corylifolia) was increased as high as 32-fold with γ-irradiation of seeds at 20 kGy. The capsaicinoids, a phenolic compound increased about 10% with 10 kGy in paprika (Capsicum annum L.). The in vitro studies show all the three types of secondary metabolites are reported to increase with γ-irradiation. Stevioside, total phenolic and flavonoids content were slightly increased in 15 Gy-treated callus cultures of stevia (Stevia rebaudiana Bert.). In terpenoids, total saponin and ginsenosides content were increased 1.4- and 1.8-fold, respectively, with 100 Gy for wild ginseng (Panax ginseng Meyer) hairy root cultures. In alkaloids, camptothecin yield increased as high as 20-fold with 20 Gy in callus cultures of ghanera (Nothapodytes foetida). Shikonins increased up to 4-fold with 16 Gy in suspension cultures of purple gromwell (Lithospermum erythrorhizon S.). The enzymes associated with secondary metabolite production were increased with γ-irradiation of 20 Gy; namely, phenylalanine ammonia-lyase (PAL) for phenolics, chalcone synthase (CHS) for flavonoids, squalene synthase (SS), squalene epoxidase (SE) and oxidosqualene cyclases (OSC) for ginsenosides and PHB (p-hydroxylbenzoic acid) geranyl transferase for shikonins. An increase in secondary

  5. How to achieve safe, high-quality clinical studies with non-Medicinal Investigational Products? A practical guideline by using intra-bronchial carbon nanoparticles as case study.

    Science.gov (United States)

    Berger, M; Kooyman, P J; Makkee, M; van der Zee, J S; Sterk, P J; van Dijk, J; Kemper, E M

    2016-08-19

    Clinical studies investigating medicinal products need to comply with laws concerning good clinical practice (GCP) and good manufacturing practice (GMP) to guarantee the quality and safety of the product, to protect the health of the participating individual and to assure proper performance of the study. However, there are no specific regulations or guidelines for non-Medicinal Investigational Products (non-MIPs) such as allergens, enriched food supplements, and air pollution components. As a consequence, investigators will avoid clinical research and prefer preclinical models or in vitro testing for e.g. toxicology studies. 1) briefly review the current guidelines and regulations for Investigational Medicinal Products; 2) present a standardised approach to ensure the quality and safety of non-MIPs in human in vivo research; and 3) discuss some lessons we have learned. We propose a practical line of approach to compose a clarifying product dossier (PD), comprising the description of the production process, the analysis of the raw and final product, toxicological studies, and a thorough risk-benefit-analysis. This is illustrated by an example from a human in vivo research model to study exposure to air pollutants, by challenging volunteers with a suspension of carbon nanoparticles (the component of ink cartridges for laser printers). With this novel risk-based approach, the members of competent authorities are provided with standardised information on the quality of the product in relation to the safety of the participants, and the scientific goal of the study.

  6. Methodology for environmental risk assessment associated with the use of veterinary medicinal products

    Directory of Open Access Journals (Sweden)

    Ioana Valentina Tihulca

    2013-05-01

    Full Text Available Environmental risk assessment (ERA is mandatory for all new applications for centralized marketing authorization or national regardless of their legal basis. ERA aims to protect the environment. Risk assessment has two phases of veterinary product evaluation possible role of exposure and its effects. Phase I of the ERA isbased on filling a decision tree with 19 questions. If the answers to these questions do not stop the assessment at this stage then is advancing to Phase II. It uses a two stage approach stage A and stage B. The first stage, stage A, studies using simple, less expensive studies. I f the assessment is not complete, then is appealed to Step B to drill ERA. If there is still a risk indicator after filling and assessment in stage B, then, to mitigate risk, is recommended the file discussing and of the proposals for additional data.

  7. The safety of herbal medicinal products derived from Echinacea species: a systematic review.

    Science.gov (United States)

    Huntley, Alyson L; Thompson Coon, Joanna; Ernst, Edzard

    2005-01-01

    Echinacea spp. are native to North America and were traditionally used by the Indian tribes for a variety of ailments, including mouth sores, colds and snake-bites. The three most commonly used Echinacea spp. are E. angustifolia, E. pallida and E. purpurea. Systematic literature searches were conducted in six electronic databases and the reference lists of all of the papers located were checked for further relevant publications. Information was also sought from the spontaneous reporting programmes of the WHO and national drug safety bodies. Twenty-three manufacturers of echinacea were contacted and asked for data held on file. Finally our own departmental files were searched. No language restrictions were imposed. Combination products and homeopathic preparations were excluded. Data from clinical studies and spontaneous reporting programmes suggest that adverse events with echinacea are not commonly reported. Gastrointestinal upsets and rashes occur most frequently. However, in rare cases, echinacea can be associated with allergic reactions that may be severe. Although there is a large amount of data that investigates the efficacy of echinacea, safety issues and the monitoring of adverse events have not been focused on. Short-term use of echinacea is associated with a relatively good safety profile, with a slight risk of transient, reversible, adverse events. The association of echinacea with allergic reactions is supported by the present evaluation. While these reactions are likely to be rare, patients with allergy or asthma should carefully consider their use of echinacea. The use of echinacea products during pregnancy and lactation would appear to be ill-advised in light of the paucity of data in this area.

  8. First identification of natural products from the African medicinal plant Zamioculcas zamiifolia - A drought resistant survivor through millions of years.

    Science.gov (United States)

    Le Moullec, Angharad; Juvik, Ole Johan; Fossen, Torgils

    2015-10-01

    Zamioculcas zamiifolia, an unusually drought resistant medicinal plant native to tropical east Africa and subtropical southeast Africa, including the countries Kenya, Malawi, Mozambique, South-Africa, Tanzania and Zimbabwe, is described as a living fossil which may have evolved as early as 42 million years ago. It belongs to the notoriously toxic family Araceae giving it, through association, a reputation for being toxic; despite little or no systematic evidence exists to support this claim. As an ancient plant it has sustained substantial climate changes and attacks from millions of generations of pathogenic microorganisms, which encouraged search for novel natural products from this source. Seven natural products have been characterized from leaves and petioles of Z. zamiifolia, including the novel main compound of the leaves, apigenin 6-C-(6″-(3-hydroxy-3-methyl-glutaroyl)-ß-glucopyranoside). The structure determinations were based on extensive use of 2D NMR spectroscopic techniques and high-resolution mass spectrometry. Initial toxicological experiment on extracts from Z. zamiifolia using brine shrimp lethality assay did not indicate lethality to the shrimps providing disproving evidence for the assumption of Z. zamiifolia's toxic character. Copyright © 2015 Elsevier B.V. All rights reserved.

  9. The Application of Lean Manufacturing for Operation Improvement: A Case Study of Black Cough Medicine Production in Indonesia

    Directory of Open Access Journals (Sweden)

    Pramadona Pramadona

    2013-09-01

    Full Text Available Nowadays, the pharmaceutical industry has a market tends to be unstable and volatile in meeting customer needs. This is due to the economic crisis that occurred in different parts of the world. The pharmaceutical industry currently uses good manufacturing practices (cGMP to ensure that products are consistently produced and controlled according to the required standards. Pharmaceutical industry slowly started to move from cGMP to lean manufacturing that focused on reducing operating costs while ensuring compliance. The purpose of this paper is to analyze the usage of lean manufacturing instead of the usage of cGMP to eliminate wastes. To conduct this study, literature review and company visit has been done. This analysis was applied by using value stream mapping (VSM and 7-wastes methodology to analyze the problems in the OBH (Black Cough Medicine production line one of the pharmaceutical industry in Bandung, Indonesia. For the improvement, the lean manufacturing approach has been carried out and the future VSM has been developed. Finding reveals that the application of lean manufacturing in the cGMP environment helps the company to eliminate wastes in reducing lead time and cycle time in the manufacturing process. Keywords: pharmaceutical industry, cGMP, lean manufacturing, value stream mapping, 7-wastes.

  10. 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.

  11. Safety of Herbal Medicinal Products: Echinacea and Selected Alkylamides Do Not Induce CYP3A4 mRNA Expression

    Directory of Open Access Journals (Sweden)

    Maryam Modarai

    2011-01-01

    Full Text Available A major safety concern with the use of herbal medicinal products (HMP is their interactions with conventional medicines, which are often mediated via the cytochrome P450 (CYP system. Echinacea is a widely used over-the-counter HMP, with proven immunomodulatory properties. Its increasing use makes research into its safety an urgent concern. Previously, we showed that Echinacea extracts and its alkylamides (thought to be important for Echinacea's immunomodulatory activity mildly inhibit the enzymatic activity of the main drug metabolising CYP isoforms, but to this date, there is insufficient work on its ability to alter CYP expression levels. We now report for the first time the effect of a commercial Echinacea extract (Echinaforce and four Echinacea alkylamides on the transcription of the major drug metabolizing enzyme CYP3A4. HepG2 cells were exposed for 96 h to clinically relevant concentrations of Echinaforce (22, 11.6 and 1.16 μg mL−1 or the alkylamides (1.62 and 44 nM. CYP3A4 mRNA levels were quantified using real-time reverse transcription polymerase chain reaction (RT-PCR. Neither Echinaforce nor the alkylamides produced any significant changes in the steady-state CYP3A4 mRNA levels, under these conditions. In contrast, treatment with 50 μM rifampicin resulted in a 3.8-fold up-regulation over the vehicle control. We conclude that Echinaforce is unlikely to affect CYP3A4 transcriptional levels, even at concentrations which can inhibit the enzymatic activity of CYP3A4. Overall, our data provides further evidence for the lack of interactions between Echinacea and conventional drugs.

  12. Production and radiochemical separation of 203Pb radioisotope for nuclear medicine

    International Nuclear Information System (INIS)

    Szuecs, Z.; Takacs, S.; Andrasi, D.; Kovacs, B.

    2012-01-01

    Complete text of publication follows. The heavy metal pollution due to their industrial production, waste repository or accident as the cyanide spill in river Tisza in 2002, increase the scientific interest for using an ideal trace isotope for monitoring these type of events. The lead is one of the most toxic and commonly used heavy metal, its poisoning is often deadly because very difficult to recognize and identify. The neuro-scientific study of biodegradation effect of lead could be an impressive scientific field of application of 203 Pb radioisotope. However the targeted radionuclide therapy especially the α-emitting radioisotope therapy is also strongly interested to find an ideal tracer for the 213 Bi and 212 Pb therapy. Therefore the 203 Pb is a potential radioisotope for this role due to its radiation behaviour and as heavy metal element. The 203 Tl(p,n) 203 Pb nuclear reaction was chosen for the production. The irradiation was done at the compact cyclotron of Atomki with proton beam 14.5 MeV energy and beam current of 7 μAs. The thickness of the target material was 840 μm, the irradiation time was 3 hours and the produced activity was 40 MBq at EOB. It corresponds to 1.87 MBq/μAh physical yield of the reaction which correlating with the cross section curve. A new technique was developed for target preparation. The metal Tl was pressed into a copper backing and covered with a HAWAR foil with thickness of 11 μm. The covering foil saved the surface of the Tl from the oxidation and also transferred the dissipating heat to the cooling He gas. The back side of the target was cooled with pressured cold water. The irradiated Tl target was pressed out from the copper backing, which had only the thickness of 0.2 mm. Then the Thallium was dissolved in nitric acid. The excess acid was evaporated slowly. The nitrate form was transferred to chloride form by 8 mol/dm 3 HCl and the Thallium was kept in 3+ oxidation stage by hydrogen peroxide. The separation was

  13. Medicinal smokes.

    Science.gov (United States)

    Mohagheghzadeh, Abdolali; Faridi, Pouya; Shams-Ardakani, Mohammadreza; Ghasemi, Younes

    2006-11-24

    All through time, humans have used smoke of medicinal plants to cure illness. To the best of our knowledge, the ethnopharmacological aspects of natural products' smoke for therapy and health care have not been studied. Mono- and multi-ingredient herbal and non-herbal remedies administered as smoke from 50 countries across the 5 continents are reviewed. Most of the 265 plant species of mono-ingredient remedies studied belong to Asteraceae (10.6%), followed by Solanaceae (10.2%), Fabaceae (9.8%) and Apiaceae (5.3%). The most frequent medical indications for medicinal smoke are pulmonary (23.5%), neurological (21.8%) and dermatological (8.1%). Other uses of smoke are not exactly medical but beneficial to health, and include smoke as a preservative or a repellent and the social use of smoke. The three main methods for administering smoke are inhalation, which accounts for 71.5% of the indications; smoke directed at a specific organ or body part, which accounts for 24.5%; ambient smoke (passive smoking), which makes up the remaining 4.0%. Whereas inhalation is typically used in the treatment of pulmonary and neurological disorders and directed smoke in localized situations, such as dermatological and genito-urinary disorders, ambient smoke is not directed at the body at all but used as an air purifier. The advantages of smoke-based remedies are rapid delivery to the brain, more efficient absorption by the body and lower costs of production. This review highlights the fact that not enough is known about medicinal smoke and that a lot of natural products have potential for use as medicine in the smoke form. Furthermore, this review argues in favor of medicinal smoke extended use in modern medicine as a form of drug delivery and as a promising source of new active natural ingredients.

  14. Culinary-Medicinal Mushroom Products as a Potential Source of Vitamin D.

    Science.gov (United States)

    Bernas, Emilia; Jaworska, Grażyna

    2017-01-01

    The incidence of vitamin D deficiency has increased in recent years, mainly in Europe. The consumption of processed mushrooms may play an important role in preventing diseases associated with vitamin D deficiency. We determined the effects of 2 kinds of freezing (blast, cryogenic), canning (mild and strong brine), and drying (air-drying, freeze-drying) on the retention of vitamin D2 and ergosterol in Agaricus bisporus. Fresh and processed A. bisporus mushrooms can be a good dietary source of vitamin D2. After 12 months of storage, canned mushrooms retained the largest amount of vitamin D2 and ergosterol, whereas the smallest amount was retained in dried mushrooms. Cryogenic freezing resulted in higher levels of vitamin D2, whereas ergosterol levels were higher using air-blast freezing. The drying method had a significant effect only on ergosterol levels, which were higher in the case of freeze-drying. Room temperature gave the best results for storing dried mushrooms. In canned mushrooms, the type of brine had an effect only on levels of vitamin D2; retention was higher using the strong brine. Retention of vitamin D2 was higher at cool temperatures, whereas room temperature resulted in higher retention of ergosterol in the canned products.

  15. Acute phase reactants, challenge in the near future of animal production and veterinary medicine.

    Science.gov (United States)

    Gruys, E; Toussaint, M J M; Upragarin, N; Van, Ederen A M; Adewuyi, A A; Candiani, D; Nguyen, T K A; Sabeckiene, J

    2005-10-01

    The future of acute phase proteins (APPs) in science is discussed in this paper. Many functions and associated pathological processes of APPs are unknown. Extrahepatic formation in local tissues needs attention. Local serum amyloid A (SAA) formation may be involved in deposition of AA-amyloid induced by conformational change of SAA resulting in amyloid formation, having tremendous food safety implications. Amyloidogenesis is enhanced in mouse fed beta pleated sheet-rich proteins. The local amyloid in joints of chicken and mammary corpora amylacea is discussed. Differences in glycosylation of glycoproteins among the APPs, as has been shown for alpha1-acid glycoprotein, have to be considered. More knowledge on the reactivity patterns may lead to implication of APPs in the diagnostics and staging of a disease. Calculation of an index from values of several acute phase variables increases the power of APPs in monitoring unhealthy individuals in animal populations. Vaccinations, just as infections in eliciting acute phase response seem to limit the profitability of vaccines because acute phase reactions are contra-productive in view of muscle anabolism. Interest is focused on amino acid patterns and vitamins in view of dietary nutrition effect on sick and convalescing animals. When inexpensive methodology such as liquid phase methods (nephelometry, turbidimetry) or protein array technology for rapid APP measurement is available, APPs have a future in routine diagnostics. Specific groups of patients may be screened or populations monitored by using APP.

  16. Occupational health experience in the production and distribution of radionuclides used in medicine

    International Nuclear Information System (INIS)

    Gaburo, J.C.; Sanches, M.P.; Gian, M.A.A.

    1994-01-01

    A brief description of the main operations performed in the Radioisotope Production Facility at IPEN-CNEN/SP is presented. This facility is provided with hot cells which must be periodically replaced due to deterioration by reagent processing and hard treatment to which they are submitted. When the lifetime of these hot cells are at their limit, leaking of airborne materials arises bringing forth incorporation by workers. As a safe control, a series of procedures have been implemented in a program of internal monitoring by urine sampling and external monitoring by film badge. From this program it became possible to evaluate the radiation dose received by workers. The results obtained within the last 10 years where analyzed against the lifetime of the hot cells and studies were made to verify possible explicit or implicit relations between doses and the natural stress of these hot cells. In the distribution of the effective dose equivalent among 304 workers submitted for individual monitoring of internal exposure by urine samples, some significant exposures higher than 4.5 mSv. The sum of effective doses and doses from external exposures can lead to levels close to regulatory limits. The internal effective dose equivalent is small when compared with whole body external dose equivalent, however it is not negligible

  17. Ten-year trends in family medicine residency productivity and staffing: impact of electronic health records, resident duty hours, and the medical home.

    Science.gov (United States)

    Lesko, Sarah; Hughes, Lauren; Fitch, Wes; Pauwels, Judith

    2012-02-01

    Electronic health records (EHRs), resident duty hour restrictions, and Patient-centered Medical Home (PCMH) innovations have all impacted the clinical practices of residency programs over the past decade. The University of Washington Family Medicine Network (UWFMN) residencies have collaborated for 10 years in collecting and comparing data regarding the productivity and operations of their training programs to identify the program-level effects of such changes. Based on five survey results from 2000 to 2010, this study examines changes in faculty and resident productivity and staffing models of UWFMN residency training clinics using a standardized methodology, specifically describing the productivity impact of EHR changes and duty hour restrictions and the implementation of the PCMH by residencies. Data were systematically collected via standardized questionnaire, evaluated for quality, clarified, and then analyzed. Resident productivity decreased over the 10-year interval, with resident total yearly patient visits down 17.2%. Core family medicine faculty productivity was highly variable among programs, and nonphysician provider visits increased. Faculty part-time status increased. Front office, medical assistant, and nursing staffing grew significantly, but other administrative staff decreased, resulting in minimal change in total non-provider staffing. A majority of programs engaged in PCMH initiatives in 2010 and had implemented an EHR. Physician productivity in UWFMN residency programs decreased for all resident physicians from 2000 to 2010, likely due to a combination of decreased resident duty hours and other clinical practice changes. Productivity trends have implications for the structure and training requirements for family medicine residency programs.

  18. Synthetic seed production and physio-biochemical studies in Cassia angustifolia Vahl. - a medicinal plant.

    Science.gov (United States)

    Bukhari, N A W; Siddique, Iram; Perveen, K; Siddiqui, I; Alwahibi, M S

    2014-09-01

    Synthetic seed technology is an alternative to traditional micropropagation for production and delivery of cloned plantlets. Synthetic seeds were produced by encapsulating nodal segments of C. angustifolia in calcium alginate gel. 3% (w/v) sodium alginate and 100 mM CaCl2 · 2H2O were found most suitable for encapsulation of nodal segments. Synthetic seeds cultured on half strength Murashige and Skoog medium supplemented with thidiazuron (5.0 μM) + indole-3-acetic acid (1.0 μM) produced maximum number of shoots (10.9 ± 0.78) after 8 weeks of culture exhibiting (78%) in vitro conversion response. Encapsulated nodal segments demonstrated successful regeneration after different period (1-6 weeks) of cold storage at 4 °C. The synthetic seeds stored at 4 °C for a period of 4 weeks resulted in maximum conversion frequency (93%) after 8 weeks when placed back to regeneration medium. The isolated shoots when cultured on half strength Murashige and Skoog medium supplemented with 1.0 μM indole-3-butyric acid (IBA), produced healthy roots and plantlets with well-developed shoot and roots were successfully hardened off in plastic pots containing sterile soilrite inside the growth chamber and gradually transferred to greenhouse where they grew well with 85% survival rate. Growth performance of 2 months old in vitro-raised plant was compared with in vivo seedlings of the same age. Changes in the content of photosynthetic pigments, net photosynthetic rate (PN), superoxide dismutase and catalase activity in C. angustifolia indicated the adaptation of micropropagated plants to ex vitro conditions.

  19. Global scientific production of robotic surgery in medicine: A 20-year survey of research activities.

    Science.gov (United States)

    Fan, Guoxin; Zhou, Zhi; Zhang, Hailong; Gu, Xin; Gu, Guangfei; Guan, Xiaofei; Fan, Yunshan; He, Shisheng

    2016-06-01

    Robot-assisted surgery operations are being performed more frequently in the world these years. In order to have a macroscopic view of publication activities about robotic surgery, the first bibliometric analysis was conducted to investigate the publication distributions of robotic surgery. The original articles about robotic surgery were extracted from the Science Citation Index Expanded (SCI-E) on Web of Science and analyzed concerning their distributions. We also explored the potential correlations between publications of different countries and their Gross Domestic Product (GDP). The total number of original articles retrieved from SCI-E was 3362 from 1994 to 2015. The number of original articles published in the last decade has a burgeoning increase of 572.87% compared with that published in the former decade. The leading country was USA who have published 1402 pieces of articles (41.701%), followed by Germany with 342 (10.173%). The journal published the highest number of original articles was Journal of Endourology with 237 (7.049%), followed by Surgical Endoscopy and Other Interventional Techniques (188, 5.592%). There was strong correlations between publication numbers and GDP of different countries (r(2) = 0.889, p research activities has the potential to guide future trend in the field of robotic surgery. There is a skyrocket trend of robotic surgery in medical research over the last two decades, and countries with high GDP tend to make more contributions to the medical field of robotic surgery. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  20. Evaluation of the Potential Use of Agricultural and Forestial Waste in Spawn Production of Medicinal Mushroom (Ganoderma lucidum

    Directory of Open Access Journals (Sweden)

    M Tavana

    2013-10-01

    Full Text Available Spawn quality plays an important role in successful production of medicinal mushrooms. In this study, firstly, to determine the optimum temperature for mycelia growth of G. lucidum, four basal media, including seeds of wheat, barley, millet and Abies sp. wood chip were studied separately at 25±1˚C and 29±1˚C. In the second section, in order to achieve suitable the mycelia growth, barley, wheat and millet seeds were mixed with different ratios of agriculture waste including wheat bran (10, 20 and 30% dry weight and millet peel (20, 40 and 60% dry weight and also Abies sp wood chips (20, 30, 50 and 60% dry weight as forestial waste. In the final section, several forestial waste including sawdusts (Platanus orientalis, Acer sp, Robinia peseudoacacia, Ailanthus altissima, Fagus orientals, Alnus subcordata and Populas alba were used as medium for spawn production. In the first experiment, a higher mycelia growth rate (8.92 mm/day was obtained by applying wheat seed at 29±1˚C. In the second experiment, the results showed that higher mycelia growth rate was obtained by using wheat with 10% wheat bran (9.66 mm/day. In the final section of spawn production, R. peseudoacacia sawdust (C/N=25.84 was generated higher growth rate (9.36 mm/day. Also, using supplements containing nitrogen (N such as sawdust and bran, encourage mycelium growth and with increasing C/N ratios more than 61.3 decreased growth rate due to reduce N amount.

  1. AccessMedicine – eine perfekte Lernunterlage für das Medizinstudium / AccessMedicine – a perfect learning aid for the medical curriculum (Product Review

    Directory of Open Access Journals (Sweden)

    Schmalstieg, Burhard

    2008-09-01

    Full Text Available AccessMedicine (http://www.accessmedicine.com/features.aspx is an innovative online resource that provides students, residents, clinicians, researchers, and other health professionals with access to more than 50 medical book titles, updated content, thousands of photos and illustrations, interactive self-assessment, case files, diagnostic tools, a comprehensive search platform, and the possibility to download content to mobile devices. Updated frequently and expanded continuously, AccessMedicine provides fast and direct access to the information necessary for completing evaluations, diagnoses and case management decisions, as well as pursuing research or medical education. The newly designed homepage reflects the diversity of AccessMedicine users, allowing individuals to customize their own view of the site through their personal profile. Now users can decide whether they prefer a rich view of available features, a comprehensive list of McGraw-Hill's leading medical textbooks or a powerful advanced search interface as their homepage with a top-level tabbed navigation, semantic search engine, and recent updates and enhancements available on all views. Following an interview with university professor Dr. Richard März from the Medical University Vienna, department for Research and International Relations and Special Unit for Medical Education. Interview was carried out by Mr. Burkhard Schmalstieg, Senior Sales Executive for McGraw-Hill.

  2. Antimycobacterial natural products from Moroccan medicinal plants: Chemical composition, bacteriostatic and bactericidal profile of Thymus satureioides and Mentha pulegium essential oils

    Directory of Open Access Journals (Sweden)

    Marwa Chraibi

    2016-10-01

    Conclusions: It is clearly evident from the results obtained that the Moroccan medicinal plants have great potential to be used as anti-tuberculosis agents. These findings may help scientists to undertake several research projects to discover useful natural product as new anti-tuberculosis drug.

  3. Nuclear Medicine

    Science.gov (United States)

    ... Parents/Teachers Resource Links for Students Glossary Nuclear Medicine What is nuclear medicine? What are radioactive tracers? ... funded researchers advancing nuclear medicine? What is nuclear medicine? Nuclear medicine is a medical specialty that uses ...

  4. Certification, agricultural waste, organic production, herbal medicine and biotechnology in the conception of farmers of the State of Goiás

    Directory of Open Access Journals (Sweden)

    Sabrina Lucas Ribeiro Freitas

    Full Text Available ABSTRACT The organic production system aims not at the intensive exploitation of resources, but the correct management of waste, the use of alternative treatments of animal diseases, and the utilization of some biotechnologies to assist in production. This is an exploratory study to evaluate the way farmers perceive the certification of their farms, the organic agricultural production, waste control, and the use of herbal medicine and biotechnologies in their properties. Fifteen farmers from the Dom Fernando Gomes dos Santos (GI settlement, in Itaberaí, participated in the study, besides 15 farmers (GII who are not participants in agrarian reform programs from different municipalities in the state of Goiás. Information was collected using questionnaires that addressed issues related to certification of farms, production of waste, organic agricultural production, herbal medicine, and biotechnology. Most farmers of GI and GII were unfamiliar with farm certification. Most GII farmers knew about agricultural waste, but few GI farmers knew its meaning. Most farmers of the two groups were familiar with the term organic agricultural production. More GII farmers were familiar with herbal medicines than GI. In both groups the term biotechnology was unknown to most people. It was concluded that this lack of knowledge by the majority of farmers about most topics presented shows the need to plan and execute actions to assist in the dissemination of information among farmers, settlers or not, using practical and functional strategies.

  5. Commentary: considerations for using the 'Trials within Cohorts' design in a clinical trial of an investigational medicinal product.

    Science.gov (United States)

    Bibby, Anna C; Torgerson, David J; Leach, Samantha; Lewis-White, Helen; Maskell, Nick A

    2018-01-08

    The 'trials within cohorts' (TwiC) design is a pragmatic approach to randomised trials in which trial participants are randomly selected from an existing cohort. The design has multiple potential benefits, including the option of conducting multiple trials within the same cohort. To date, the TwiC design methodology been used in numerous clinical settings but has never been applied to a clinical trial of an investigational medicinal product (CTIMP). We have recently secured the necessary approvals to undertake the first CTIMP using the TwiC design. In this paper, we describe some of the considerations and modifications required to ensure such a trial is compliant with Good Clinical Practice and international clinical trials regulations. We advocate using a two-stage consent process and using the consent stages to explicitly differentiate between trial participants and cohort participants who are providing control data. This distinction ensured compliance but had consequences with respect to costings, recruitment and the trial assessment schedule. We have demonstrated that it is possible to secure ethical and regulatory approval for a CTIMP TwiC. By including certain considerations at the trial design stage, we believe this pragmatic and efficient methodology could be utilised in other CTIMPs in future.

  6. Determination of the Marker Diarylheptanoid Phytoestrogens in Curcuma comosa Rhizomes and Selected Herbal Medicinal Products by HPLC-DAD.

    Science.gov (United States)

    Yingngam, Bancha; Brantner, Adelheid; Jinarat, Damrongsak; Kaewamatawong, Rawiwun; Rungseevijitprapa, Wandee; Suksamrarn, Apichart; Piyachaturawat, Pawinee; Chokchaisiri, Ratchanaporn

    2018-01-01

    A method for quantification of diarylheptanoids in Curcuma comosa rhizomes and selected pharmaceutical preparations was established by using HPLC-diode array detector (DAD). The chromatographic separation of three diarylheptanoids [(3S)-1-(3,4-dihydroxy-phenyl)-7-phenyl-(6E)-6-hepten-3-ol (1), (3R)-1,7-diphenyl-(4E,6E)-4,6-heptadien-3-ol (2), and (3S)-1,7-diphenyl-(6E)-6-hepten-3-ol (3)] was performed on a Luna C 18 analytical column using gradient elution with 0.5% acetic acid in water and acetonitrile with a flow rate of 1 mL/min and a column temperature of 35°C. The calibration curves for the analytes showed good linearity (R 2 >0.999), high precision (relative standard deviation (RSD) <2%) and acceptable recovery (98.35-103.90%, RSD <2%). The limit of detection (LOD) and limit of quantification (LOQ) were 0.06-0.22 and 0.18-0.69 µg/mL, respectively. The results of all validated parameters were within the limits according to the International Conference on Harmonization (ICH) Guidelines. The established method was successfully applied for qualitative and quantitative determination of the three constituents in different samples of C. comosa and some commercial products in capsules. The simplicity, rapidity, and reliability of the method could be useful for the fingerprint analysis and standardization of diarylheptanoids, which are responsible for the estrogenic activity in raw materials and herbal medicinal products of C. comosa.

  7. In-vivo biological activity and glycosylation analysis of a biosimilar recombinant human follicle-stimulating hormone product (Bemfola compared with its reference medicinal product (GONAL-f.

    Directory of Open Access Journals (Sweden)

    Renato Mastrangeli

    Full Text Available Recombinant human follicle-stimulating hormone (r-hFSH is widely used in fertility treatment. Although biosimilar versions of r-hFSH (follitropin alfa are currently on the market, given their structural complexity and manufacturing process, it is important to thoroughly evaluate them in comparison with the reference product. This evaluation should focus on how they differ (e.g., active component molecular characteristics, impurities and potency, as this could be associated with clinical outcome. This study compared the site-specific glycosylation profile and batch-to-batch variability of the in-vivo bioactivity of Bemfola, a biosimilar follitropin alfa, with its reference medicinal product GONAL-f. The focus of this analysis was the site-specific glycosylation at asparagine (Asn 52 of the α-subunit of FSH, owing to the pivotal role of Asn52 glycosylation in FSH receptor (FSHR activation/signalling. Overall, Bemfola had bulkier glycan structures and greater sialylation than GONAL-f. The nominal specific activity for both Bemfola and GONAL-f is 13,636 IU/mg. Taking into account both the determined potency and the nominal amount the average specific activity of Bemfola was 14,522 IU/mg (105.6% of the nominal value, which was greater than the average specific activity observed for GONAL-f (13,159 IU/mg; 97.3% of the nominal value; p = 0.0048, although this was within the range stated in the product label. A higher batch-to-batch variability was also observed for Bemfola versus GONAL-f (coefficient of variation: 8.3% vs 5.8%. A different glycan profile was observed at Asn52 in Bemfola compared with GONAL-f (a lower proportion of bi-antennary structures [~53% vs ~77%], and a higher proportion of tri-antennary [~41% vs ~23%] and tetra-antennary structures [~5% vs <1%]. These differences in the Asn52 glycan profile might potentially lead to differences in FSHR activation. This, together with the greater bioactivity and higher batch-to-batch variability

  8. In vitro culture and production of syringin and rutin in Saussurea involucrata (Kar. et Kir.) - an endangered medicinal plant.

    Science.gov (United States)

    Kuo, Chao-Lin; Agrawal, Dinesh-Chandra; Chang, Hung-Chi; Chiu, Ya-Ting; Huang, Chu-Peng; Chen, Yi-Lin; Huang, Shih-Hung; Tsay, Hsin-Sheng

    2015-12-01

    Saussurea involucrata (Kar. et Kir.) commonly known as 'snow lotus' or 'Xue Lian' is an important plant in the traditional Chinese system of medicine. The plant contains flavonoids such as syringin and rutin. These compounds have been reported to be anti-rheumatic, anti-inflammatory and dilate blood vessels, lower blood pressure, prevent cardiovascular diseases, enhance immunity, and act as anti-aging, anti-cancer, and anti-fatigue agents. The species has become endangered due to the excessive collection of S. involucrata plants in the wild, slower plant growth and ecological destruction of natural habitats. There is a severe shortage of plant material, while the market demand is ever increasing. Hence, it is very important to apply tissue culture technique for plant propagation and production of the bioactive compounds of this species. Multiple shoot induction and proliferation in shoot base explants derived from in vitro raised seedlings of S. involucrata was achieved on 3/4 strength of Murashige and Skoog's (MS) basal medium (MSBM) supplemented with 1.0 mg/L -1 BA and 1.5 mg/L -1 NAA. Rooting was induced in 100 % shoots cultured on 1/2X MSBM supplemented with 1.0 mg/L -1 IBA for one week and then transfer to auxin free medium. The plantlets could be acclimatized successfully by sachet technique and established in the greenhouse. Maximum callus induction and proliferation in leaf segments was achieved on 1/2X MSBM supplemented with 0.5 mg/L -1 BA, 0.5 mg/L -1 NAA, 0.4 % gelrite and on incubation at 20 °C. Container closures had an influence on the quality and quantity of callus and production of the active compounds. The HPLC analysis showed much higher syringin content in in vitro shoots and callus as compared to commercially available market crude drug. The present study describes an in vitro culture protocol of Saussurea involucrata. The bioactive compounds, syringin and rutin could be produced through tissue culture technique without sacrificing the

  9. Resistance to Antibiotics and Antifungal Medicinal Products: Can Complementary and Alternative Medicine Help Solve the Problem in Common Infection Diseases? The Introduction of a Dutch Research Consortium

    Directory of Open Access Journals (Sweden)

    Esther T. Kok

    2015-01-01

    Full Text Available The increase of antibiotic resistance worldwide, rising numbers of deaths and costs associated with this, and the fact that hardly any new antimicrobial drugs have been developed during the last decade have increased the interest in Complementary and Alternative Medicine (CAM therapeutic interventions, if proven safe and effective. Observational studies on clinical CAM practices demonstrate positive effects of treatment of infections with CAM therapies (clinical effects, patient satisfaction in combination with small percentages of antibiotics prescription. However, Cochrane reviews and other studies demonstrate that in most instances the quality of clinical trials on CAM treatment of infections is currently too low to provide sufficient evidence. Therefore a Dutch consortium on (in vitro and clinical scientific research on CAM and antibiotic resistance has been formed. The aim and objective of the consortium is to establish an enduring partnership and to develop expertise to further develop and investigate safe and effective CAM treatments for infectious diseases of humans (and animals. A first ongoing project on the development of safe and effective biobased CAM antimycotics in women with (recurrent vaginal candidiasis infection is introduced.

  10. Notes on a New Productive Strain of King Oyster Mushroom, Pleurotus eryngii (Higher Basidiomycetes), a Prized Italian Culinary-Medicinal Mushroom.

    Science.gov (United States)

    Venturella, Giuseppe; Palazzolo, Eristanna; Saiano, Filippo; Gargano, Maria Letizia

    2015-01-01

    In this paper, the authors provide data on a culinary-medicinal, host-specific variety of P. eryngii species-complex that is known in Italy as "cardoncello". A species description, the techniques of isolation of a new strain (C-142-c), and the preparation of the substratum are illustrated. Data on the productivity of substratum inoculated with C-142-c strain and the nutritional value of cultivated "cardoncello" mushrooms are also provided.

  11. What is a food and what is a medicinal product in the European Union? Use of the benchmark dose (BMD) methodology to define a threshold for "pharmacological action".

    Science.gov (United States)

    Lachenmeier, Dirk W; Steffen, Christian; el-Atma, Oliver; Maixner, Sibylle; Löbell-Behrends, Sigrid; Kohl-Himmelseher, Matthias

    2012-11-01

    The decision criterion for the demarcation between foods and medicinal products in the EU is the significant "pharmacological action". Based on six examples of substances with ambivalent status, the benchmark dose (BMD) method is evaluated to provide a threshold for pharmacological action. Using significant dose-response models from literature clinical trial data or epidemiology, the BMD values were 63mg/day for caffeine, 5g/day for alcohol, 6mg/day for lovastatin, 769mg/day for glucosamine sulfate, 151mg/day for Ginkgo biloba extract, and 0.4mg/day for melatonin. The examples for caffeine and alcohol validate the approach because intake above BMD clearly exhibits pharmacological action. Nevertheless, due to uncertainties in dose-response modelling as well as the need for additional uncertainty factors to consider differences in sensitivity within the human population, a "borderline range" on the dose-response curve remains. "Pharmacological action" has proven to be not very well suited as binary decision criterion between foods and medicinal product. The European legislator should rethink the definition of medicinal products, as the current situation based on complicated case-by-case decisions on pharmacological action leads to an unregulated market flooded with potentially illegal food supplements. Copyright © 2012 Elsevier Inc. All rights reserved.

  12. [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

  13. Integrative Medicine in Preventive Medicine Education

    Science.gov (United States)

    Jani, Asim A.; Trask, Jennifer; Ali, Ather

    2016-01-01

    During 2012, the USDHHS’s Health Resources and Services Administration funded 12 accredited preventive medicine residencies to incorporate an evidence-based integrative medicine curriculum into their training programs. It also funded a national coordinating center at the American College of Preventive Medicine, known as the Integrative Medicine in Preventive Medicine Education (IMPriME) Center, to provide technical assistance to the 12 grantees. To help with this task, the IMPriME Center established a multidisciplinary steering committee, versed in integrative medicine, whose primary aim was to develop integrative medicine core competencies for incorporation into preventive medicine graduate medical education training. The competency development process was informed by central integrative medicine definitions and principles, preventive medicine’s dual role in clinical and population-based prevention, and the burgeoning evidence base of integrative medicine. The steering committee considered an interdisciplinary integrative medicine contextual framework guided by several themes related to workforce development and population health. A list of nine competencies, mapped to the six general domains of competence approved by the Accreditation Council of Graduate Medical Education, was operationalized through an iterative exercise with the 12 grantees in a process that included mapping each site’s competency and curriculum products to the core competencies. The competencies, along with central curricular components informed by grantees’ work presented elsewhere in this supplement, are outlined as a roadmap for residency programs aiming to incorporate integrative medicine content into their curricula. This set of competencies adds to the larger efforts of the IMPriME initiative to facilitate and enhance further curriculum development and implementation by not only the current grantees but other stakeholders in graduate medical education around integrative medicine

  14. Hurdles in tissue engineering/regenerative medicine product commercialization: a pilot survey of governmental funding agencies and the financial industry.

    Science.gov (United States)

    Bertram, Timothy A; Tentoff, Edward; Johnson, Peter C; Tawil, Bill; Van Dyke, Mark; Hellman, Kiki B

    2012-11-01

    The Tissue Engineering and Regenerative Medicine International Society of the Americas (TERMIS-AM) Industry Committee conducted a semiquantitative opinion survey in 2010 to delineate potential hurdles to commercialization perceived by the TERMIS constituency groups that participate in the stream of technology commercialization (academia, start-up companies, development-stage companies, and established companies). A significant hurdle identified consistently by each group was access to capital for advancing potential technologies into development pathways leading to commercialization. A follow-on survey was developed by the TERMIS-AM Industry Committee to evaluate the financial industry's perspectives on investing in regenerative medical technologies. The survey, composed of 15 questions, was developed and provided to 37 investment organizations in one of three sectors (governmental, private, and public investors). The survey was anonymous and confidential with sector designation the only identifying feature of each respondent's organization. Approximately 80% of the survey was composed of respondents from the public (n=14) and private (n=15) sectors. Each respondent represents one investment organization with the potential of multiple participants participating to form the organization's response. The remaining organizations represented governmental agencies (n=8). Results from this survey indicate that a high percentage ($2MM into regenerative medical companies at the different stages of a company's life cycle. Investors recognized major hurdles to this emerging industry, including regulatory pathway, clinical translation, and reimbursement of these new products. Investments in regenerative technologies have been cyclical over the past 10-15 years, but investors recognized a 1-5-year investment period before the exit via Merger and Acquisition (M&A). Investors considered musculoskeletal products and their top technology choice with companies in the clinical stage

  15. 77 FR 52744 - Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop

    Science.gov (United States)

    2012-08-30

    ... and European Medicines Agency (EMA) Orphan Drug Designation programs, the FDA Humanitarian Use Device... morning session, of which approximately 30 teams (up to 90 participants) may register for the one-on-one... conducted in partnership with the European Organisation for Rare Disease (EURODIS), Genetic Alliance, and...

  16. Impact of animal health and welfare planning on medicine use, herd health and production in European organic dairy farms

    NARCIS (Netherlands)

    Ivemeyer, S.; Smolders, E.A.A.; Brinkmann, J.; Gratzer, E.; Hansen, B.; Henriksen, B.I.F.; Huber, J.; Leeb, C.; March, S.; Mejdell, C.; Nicholas, P.; Roderick, S.; Stöger, E.; Vaarst, M.; Whistance, L.K.; Winckler, C.; Walkenhorst, M.

    2012-01-01

    Achieving and maintaining high herd health and welfare status and low veterinary medicine inputs are important aims in organic livestock farming. Therefore, an on-farm intervention study (CORE Organic ANIPLAN) was conducted on 128 organic dairy farms in seven European countries aiming at minimising

  17. Mechanisms on spasmolytic and anti-inflammatory effects of a herbal medicinal product consisting of myrrh, chamomile flower, and coffee charcoal.

    Science.gov (United States)

    Vissiennon, Cica; Goos, Karl-Heinz; Arnhold, Jürgen; Nieber, Karen

    2017-05-01

    Inflammatory bowel disease or irritable bowel syndrome are chronic gastrointestinal disorders which are associated with a lifelong therapeutic need. The disease results in physical, psychological, and social problems with an impact on partnership, sexuality, education, and career. Thus, the number of patients and health care professionals relying on traditional and complementary medicines and especially phytotherapy for the treatment of these chronic conditions is increasing over recent years. One traditional herbal medicinal product consisting of chamomile flower, myrrh, and coffee charcoal has been widely used in clinical practice within this indication area. Long-term experience and an increasing understanding of the pharmacological mechanisms substantiate its application and clinical effectiveness. Mainly the spasmolytic and anti-inflammatory effects provide a rationale for its therapeutic application. In addition, synergistic effects between the herbal components contribute to the overall effect of this medication.

  18. Traditional Chinese Nootropic Medicine Radix Polygalae and Its Active Constituent Onjisaponin B Reduce β-Amyloid Production and Improve Cognitive Impairments.

    Science.gov (United States)

    Li, Xiaohang; Cui, Jin; Yu, Yang; Li, Wei; Hou, Yujun; Wang, Xin; Qin, Dapeng; Zhao, Cun; Yao, Xinsheng; Zhao, Jian; Pei, Gang

    2016-01-01

    Decline of cognitive function is the hallmark of Alzheimer's disease (AD), regardless of the pathological mechanism. Traditional Chinese medicine has been used to combat cognitive impairments and has been shown to improve learning and memory. Radix Polygalae (RAPO) is a typical and widely used herbal medicine. In this study, we aimed to follow the β-amyloid (Aβ) reduction activity to identify active constituent(s) of RAPO. We found that Onjisaponin B of RAPO functioned as RAPO to suppress Aβ production without direct inhibition of β-site amyloid precursor protein cleaving enzyme 1 (BACE1) and γ-secretase activities. Our mechanistic study showed that Onjisaponin B promoted the degradation of amyloid precursor protein (APP). Further, oral administration of Onjisaponin B ameliorated Aβ pathology and behavioral defects in APP/PS1 mice. Taken together, our results indicate that Onjisaponin B is effective against AD, providing a new therapeutic agent for further drug discovery.

  19. Traditional Chinese Nootropic Medicine Radix Polygalae and Its Active Constituent Onjisaponin B Reduce β-Amyloid Production and Improve Cognitive Impairments.

    Directory of Open Access Journals (Sweden)

    Xiaohang Li

    Full Text Available Decline of cognitive function is the hallmark of Alzheimer's disease (AD, regardless of the pathological mechanism. Traditional Chinese medicine has been used to combat cognitive impairments and has been shown to improve learning and memory. Radix Polygalae (RAPO is a typical and widely used herbal medicine. In this study, we aimed to follow the β-amyloid (Aβ reduction activity to identify active constituent(s of RAPO. We found that Onjisaponin B of RAPO functioned as RAPO to suppress Aβ production without direct inhibition of β-site amyloid precursor protein cleaving enzyme 1 (BACE1 and γ-secretase activities. Our mechanistic study showed that Onjisaponin B promoted the degradation of amyloid precursor protein (APP. Further, oral administration of Onjisaponin B ameliorated Aβ pathology and behavioral defects in APP/PS1 mice. Taken together, our results indicate that Onjisaponin B is effective against AD, providing a new therapeutic agent for further drug discovery.

  20. Imaging and development of medicines

    International Nuclear Information System (INIS)

    Syrota, A.

    2000-01-01

    The last developments in medical imaging allow visualization of medicines in organism. Today, these techniques: positron emission tomography (PET) and single photon emission computed tomography (SPECT) play an essential role in the production and the development of new medicines. The medicinal substances labelled with radioisotopes permit to improve the understanding of medicines' action mode. The spectacular advances were observed in the field of medicines acting on the brain (F.M.)

  1. Aerospace Medicine

    Science.gov (United States)

    Michaud, Vince

    2015-01-01

    NASA Aerospace Medicine overview - Aerospace Medicine is that specialty area of medicine concerned with the determination and maintenance of the health, safety, and performance of those who fly in the air or in space.

  2. Nuclear Medicine.

    Science.gov (United States)

    Badawi, Ramsey D.

    2001-01-01

    Describes the use of nuclear medicine techniques in diagnosis and therapy. Describes instrumentation in diagnostic nuclear medicine and predicts future trends in nuclear medicine imaging technology. (Author/MM)

  3. Nuclear medicine

    International Nuclear Information System (INIS)

    Casier, Ph.; Lepage, B.

    1998-01-01

    Except for dedicated devices for mobile nuclear cardiology for instance, the market is set on variable angulation dual heads cameras. These cameras are suited for all general applications and their cost effectiveness is optimized. Now, all major companies have such a camera in their of products. But, the big question in nuclear medicine is about the future of coincidence imaging for the monitoring of treatments in oncology. Many companies are focused on WIP assessments to find out the right crustal thickness to perform both high energy FDG procedures and low energy Tc procedures, with the same SPECT camera. The classic thickness is 3/8''. Assessments are made with 1/2'', 5/8'' or 3/4'' crystals. If FDG procedures proved to be of great interest in oncology, it may lead to the design of a dedicated SPECT camera with a 1'' crustal. Due to the short half of FDG, it may be the dawning of slip ring technology. (e.g. Varicam from Elscint). The three small heads camera market seems to be depressed. Will the new three large heads camera unveiled by Picker, reverse that trend? The last important topic in nuclear medicine is the emergence of new flat digital detectors to get rid of the old bulky ones. Digirad is the first company to manufacture a commercial product based on that technology. Bichron, Siemens and General Electric are working on that development, too. But that technology is very expensive and the market for digital detection in nuclear medicine is not as large as the market in digital detection in radiology. (author)

  4. Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union

    Science.gov (United States)

    Jokura, Yoji; Yano, Kazuo

    2017-01-01

    Abstract Legislation for expedited‐approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited‐approval pathways, and obligations to collect and report post‐marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time‐limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre‐ or post‐marketing clinical data. Expedited‐approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post‐marketing study for conditional and time‐limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited‐approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. PMID

  5. Medicines from Marine Invertebrates

    Science.gov (United States)

    Davies-Coleman, Mike

    2011-01-01

    Few of us realise that the oceans of the world are a relatively untapped reservoir of new natural product-derived medicines to combat the many diseases that plague humanity. We explore the role that an unremarkable sea snail and sea squirt are playing in providing us with new medicines for the alleviation of chronic pain and cancer respectively.…

  6. Nuclear energy and medicine

    International Nuclear Information System (INIS)

    1988-01-01

    The applications of nuclear energy on medicine, as well as the basic principles of these applications, are presented. The radiological diagnosis, the radiotherapy, the nuclear medicine, the radiological protection and the production of radioisotopes are studied. (M.A.C.) [pt

  7. Investigations of residue of veterinary medicines and environmental contaminants during production cycle of Petrovska klobasa as part of compulsory parameters for food safety

    Directory of Open Access Journals (Sweden)

    Janković Vesna

    2012-01-01

    Full Text Available A significant factor in the protection of consumer health is the systematic and constant implementation of control for the presence of residue of biologically active substances and their metabolites in raw materials and in primary products of animal origin. As regards meat, an essential aspect of security is definitely the control of possible residue of veterinary medicines and environmental contaminants. In that respect, the objective of the national project entitled „Development of technology for drying and fermentation of the sausage petrovačka kobasica (Petrovská klobása - registered geographic origin under controlled conditions“, Number TR - 20037, was to protect the product petrovačka kobasica (Petrovská klobása with the appropriate appellation. A part of the compulsory investigations also included the establishing of the presence of residue of veterinary medicines and environmental contaminants in raw materials and in the finished product, which was also the aim of this work. [Projekat Ministarstva nauke Republike Srbije, br. TR-20037: Petrovská klobása - oznaka geografskog porekla u kontrolisanim uslovima

  8. The Impact of Efflux Pump Inhibitors on the Activity of Selected Non-Antibiotic Medicinal Products against Gram-Negative Bacteria

    Directory of Open Access Journals (Sweden)

    Agnieszka E. Laudy

    2017-01-01

    Full Text Available The potential role of non-antibiotic medicinal products in the treatment of multidrug-resistant Gram-negative bacteria has recently been investigated. It is highly likely that the presence of efflux pumps may be one of the reasons for the weak activity of non-antibiotics, as in the case of some non-steroidal anti-inflammatory drugs (NSAIDs, against Gram-negative rods. The activity of eight drugs of potential non-antibiotic activity, active substance standards, and relevant medicinal products were analysed with and without of efflux pump inhibitors against 180 strains of five Gram-negative rod species by minimum inhibitory concentration (MIC value determination in the presence of 1 mM MgSO4. Furthermore, the influence of non-antibiotics on the susceptibility of clinical strains to quinolones with or without PAβN (Phe-Arg-β-naphthylamide was investigated. The impacts of PAβN on the susceptibility of bacteria to non-antibiotics suggests that amitriptyline, alendronate, nicergoline, and ticlopidine are substrates of efflux pumps in Gram-negative rods. Amitriptyline/Amitriptylinum showed the highest direct antibacterial activity, with MICs ranging 100–800 mg/L against all studied species. Significant decreases in the MIC values of other active substances (acyclovir, atorvastatin, and famotidine tested with pump inhibitors were not observed. The investigated non-antibiotic medicinal products did not alter the MICs of quinolones in the absence and in the presence of PAβN to the studied clinical strains of five groups of species.

  9. Kitchen chemistry: A scoping review of the diversionary use of pharmaceuticals for non-medicinal use and home production of drug solutions.

    Science.gov (United States)

    Van Hout, Marie Claire

    2014-01-01

    Misuse of pharmaceuticals is of increasing drug policy and public health concern. A scoping review was conducted on the diversionary use of pharmaceuticals for non-medicinal use and home production of drug solutions. The research question was broad: What is known from the existing literature about the diversion of pharmaceuticals for non-medicinal use and for home production of drug solutions? The scoping process centred on the systematic selection, collection, and summarization of extant knowledge within this broad thematic remit. One hundred and thirty-four records were grouped into discrete thematic categories namely: non medicinal use and tampering with pharmaceuticals, oral misuse of codeine cough syrups, homemade drug solutions, and home-produced drug-related harms in the narrative review design. Forms of abuse of codeine cough syrup include mixtures with alcohol or soft drinks ('Purple Drank'), with kratom leaves ('Kratom cocktails'), or chemically altered to extract dextromorphan ('Lemon Drop'). Production of homemade opiates ('Cheornaya', 'Kolyosa', Himiya', 'Braun', 'Krokodil'), methamphetamine ('Vint', 'Pervitin'), methcathinone ('Jeff'), and cathinone ('Boltushka') are described. Displacement patterns between the non-medical use of pharmaceuticals, commercial, and homemade drugs appear dependent on availability of opiates, prescribing practices, supervision of substitution drug dosing, availability of cheap ingredients, policing, and awareness of harms. Adverse health and social consequences relate to the use of unknown and contaminated (end) substances, injecting practices, redosing, medical complications, and death. The review highlights a public health imperative requiring a multidisciplinary approach to quantify potential impact and required integrated policy responses incorporating international regulation, enforcement, health surveillance and service delivery. Copyright © 2014 John Wiley & Sons, Ltd.

  10. Risk-based approach to developing a national residue sampling plan for testing under European Union regulation for veterinary medicinal products and coccidiostat feed additives in domestic animal production.

    Science.gov (United States)

    Danaher, Martin; Shanahan, Conor; Butler, Francis; Evans, Rhodri; O'Sullivan, Dan; Glynn, Denise; Camon, Tim; Lawlor, Peadar; O'Keeffe, Michael

    2016-07-01

    A ranking system for veterinary medicinal products and coccidiostat feed additives has been developed as a tool to be applied in a risk-based approach to the residue testing programme for foods of animal origin in the Irish National Residue Control Plan (NRCP). Three characteristics of substances that may occur as residues in food are included in the developed risk ranking system: Potency, as measured by the acceptable daily intake assigned by the European Medicines Agency Committee for Medicinal Products for Veterinary Use, to each substance; Usage, as measured by the three factors of Number of Doses, use on Individual animals or for Group treatment, and Withdrawal Period; and Residue Occurrence, as measured by the number of Non-Compliant Samples in the NRCP. For both Number of Doses and Non-Compliant Samples, data for the 5-year period 2008-12 have been used. The risk ranking system for substances was developed for beef cattle, sheep and goats, pigs, chickens and dairy cattle using a scoring system applied to the various parameters described above to give an overall score based on the following equation: Potency × Usage (Number of Doses + Individual/Group Use + Withdrawal Period) × Residue Occurrence. Applying this risk ranking system, the following substances are ranked very highly: antimicrobials such as amoxicillin (for all species except pigs), marbofloxacillin (for beef cattle), oxytetracycline (for all species except chickens), sulfadiazine with trimethoprim (for pigs and chickens) and tilmicosin (for chickens); antiparasitic drugs, such as the benzimidazoles triclabendazole (for beef and dairy cattle), fenbendazole/oxfendazole (for sheep/goats and dairy cattle) and albendazole (for dairy cattle), the avermectin ivermectin (for beef cattle), and anti-fluke drugs closantel and rafoxanide (for sheep/goats); the anticoccidials monensin, narasin, nicarbazin and toltrazuril (for chickens). The risk ranking system described is a relatively simple system

  11. Deep structures and their possible impact on sediment deposition and natural gas production, Medicine River area, west-central Alberta : stratigraphic framework review

    Energy Technology Data Exchange (ETDEWEB)

    Chen, D.; Parks, K.; Langenberg, W.; Berhane, M.; Stewart, S. [Alberta Energy and Utilities Board, Calgary, AB (Canada)]|[Alberta Geological Survey, Edmonton, AB (Canada)

    2005-10-15

    The abundant oil, gas, coal and mineral resources of the Medicine River area in west-central Alberta, which includes the Red Deer-Buck Lake area, have drawn the attention of the petroleum industry, academia and governments for half a century. In recent years, the focus of exploration in the area has shifted from conventional oil and gas toward drilling for shallow unconventional gas such as coalbed methane (CBM). Approximately 9400 oil and gas wells have been drilled and several oilfields have been found in the study area, in addition to large amounts of groundwater and CBM resources. Previous studies have shown that deep structures in the area vary greatly, act differently and have a significant impact on sedimentation. However, the detailed structural and isopach maps are lacking. For that reason, this study reviewed the structural framework and natural gas distribution in the area of the Medicine and Blindman rivers. The study generated 12,600 new, internally consistent stratigraphic picks, 15 structural cross-sections, and more than 80 structural and isopach contour maps. Distinct geological relations such as variations in thickness were highlighted as they related to the boundaries of individual structural blocks. The purpose of the study was to identify deep structures and the interaction between the deep structures and existing reservoirs. Possible controls on the distribution of unconventional gas in the Medicine River area were also examined. A stratigraphic framework was established through a detailed well-log correlation and geological mapping. Geophysical logs were also used extensively during the study. Cross-sectional analysis of the maps helped define the basement blocks and lineaments. Major structural features that may have impacted on depositional process and hydrocarbon accumulation were also documented. Gas production from the Devonian, Mississippian, Jurassic and Cretaceous was shown to have a certain relationship with the deep structures. To

  12. Authenticity analyses of Rhizoma Paridis using barcoding coupled with high resolution melting (Bar-HRM) analysis to control its quality for medicinal plant product.

    Science.gov (United States)

    Duan, Bao-Zhong; Wang, Ya-Ping; Fang, Hai-Lan; Xiong, Chao; Li, Xi-Wen; Wang, Ping; Chen, Shi-Lin

    2018-01-01

    Rhizoma Paridis (Chonglou) is a commonly used and precious traditional Chinese medicine. Paris polyphylla Smith var. yunnanensis (Franch.) Hand. -Mazz. and Paris polyphylla Smith var . chinensis (Franch.) Hara are the two main sources of Chonglou under the monograph of Rhizoma Paridis in Chinese Pharmacopoeia. In the local marketplace, however, this medicine is prone to be accidentally contaminated, deliberately substituted or admixed with other species that are similar to Rhizoma Paridis in shape and color. Consequently, these adulterations might compromise quality control and result in considerable health concerns for consumers. This study aims to develop a rapid and sensitive method for accurate identification of Rhizoma Paridis and its common adulterants. DNA barcoding coupled with high resolution melting analysis was applied in this research to distinguish Rhizoma Paridis from its adulteration. The internal transcribed spacer 2 (ITS2) barcode was selected for HRM analysis to produce standard melting profile of the selected species. DNA of the tested herbal medicines was isolated and their melting profiles were generated and compared with the standard melting profile of P. polyphylla var. chinensis . The results indicate that the ITS2 molecular regions coupled with HRM analysis can effectively differentiate nine herbal species, including two authentic origins of Chonglou and their seven common adulterants. Ten herbal medicines labeled "Chonglou" obtained from a local market were collected and identified with our methods, and their sequence information was analyzed to validate the accuracy of HRM analysis. DNA barcoding coupled with HRM analysis is a accurate, reliable, rapid, cost-effective and robust tool, which could contribute to the quality control of Rhizoma Paridis in the supply chain of the natural health product industry (NHP).

  13. Nuclear medicine

    International Nuclear Information System (INIS)

    Lentle, B.C.

    1986-01-01

    Several growth areas for nuclear medicine were defined. Among them were: cardiac nuclear medicine, neuro-psychiatric nuclear medicine, and cancer diagnosis through direct tumor imaging. A powerful new tool, Positron Emission Tomography (PET) was lauded as the impetus for new developments in nuclear medicine. The political environment (funding, degree of autonomy) was discussed, as were the economic and scientific environments

  14. [The Destruction of Pharmaceutical Products as an Element of the Efficiency of State Control (Supervision) Over the Circulation of Medicines].

    Science.gov (United States)

    Bidarova, F N

    2015-01-01

    The modern system of state quality control over medicine makes it possible to reveal and withdraw drugs, that do not meet the requirements. However the problem of the turnover of substandard andfake drug and their destruction in the Russian Federation is still urgent. to evaluate the effectiveness of state quality control over medicine and the practice offake medicine destruction. data of the official websites of the Ministry of Health of the Russian Federation and the Republic of North Ossetia--Alania, Russian Sanitary Inspection, National Center of Quality control and Certification of Drugs were included in the investigation. Method of unrepeated samples was used in sociological investigations. 225 questionnaires have been worked out. The research was carried out in the North-Ossetian State Medical academy during the periodfrom 2013 to 2015 with the help of the National Center of Quality Control and Certification of Drugs. The shortcomings of the state quality control over the rules of fake drug destruction were studied. It was found out that the mechanism ofpermanent data collection monitoring of revealing, moving and destruction of substandard and fake drug destruction has not been determined. The ineffectiveness of controlling measures under the condition of critical legal base deficiency has been confirmed. The analysis of terminology characterizing the order of fake drug destruction was carried out. deficiencies related to the implementation of the state quality control over the fake drug destruction rules revealed during the course of investigations prove the necessity of adopting measures in creating new model of controlfunctions, increasing the results of activity.

  15. Formulation of an aloe-based product according to Iranian traditional medicine and development of its analysis method.

    Science.gov (United States)

    Moein, Elham; Hajimehdipoor, Homa; Toliyat, Tayebeh; Choopani, Rasool; Hamzeloo-Moghadam, Maryam

    2017-08-29

    Currently, people are more interested to traditional medicine. The traditional formulations should be converted to modern drug delivery systems to be more acceptable for the patients. In the present investigation, a poly herbal medicine "Ayarij-e-Faiqra" (AF) based on Iranian traditional medicine (ITM) has been formulated and its quality control parameters have been developed. The main ingredients of AF including barks of Cinnamomum zeylanicum Blume and Cinnamomum cassia J. Presl, the rhizomes of Nardostachys jatamansi DC., the fruits of Piper cubeba L.f., the flowers of Rosa damascena Herrm., the oleo gum resin of Pistacia terebinthus L. and Aloe spp. dried juice were powdered and used for preparing seven tablet formulations of the herbal mixture. Flowability of the different formulated powders was examined and the best formulations were selected (F6&F7). The tablets were prepared from the selected formulations compared according to the physical characteristics and finally, F7 was selected and coated. Physicochemical characters of core and coated AF tablets were determined and the HPLC method for quantitation of aloin as a marker of tablets was selected and verified according to selectivity, linearity, precision, recovery, LOD and LOQ. The results showed that core and coated AF tablets were in agreement with USP requirements for herbal drugs. They had acceptable appearance, disintegration time, friability, hardness, dissolution behavior, weight variation and content uniformity. The amount of aloin in tablets was found 123.1 mg/tab. The HPLC method for aloin determination in AF tablets was verified according to selectivity, linearity (5-500 μg/ml, r 2 :0.9999), precision (RSD: 1.62%), recovery (108.0%), LOD & LOQ (0.0053 & 0.0161 μg/ml). The formulated tablets could be a good substitute for powder and capsules of AF in ITM clinics with a feasible and precise method for its quality control. Ayarij-e-Faiqra formulation.

  16. Heart failure - medicines

    Science.gov (United States)

    CHF - medicines; Congestive heart failure - medicines; Cardiomyopathy - medicines; HF - medicines ... will need to take most of your heart failure medicines every day. Some medicines are taken once ...

  17. Speeding Access to Vaccines and Medicines in Low- and Middle-Income Countries: A Case for Change and a Framework for Optimized Product Market Authorization.

    Directory of Open Access Journals (Sweden)

    Vincent Ahonkhai

    Full Text Available The United Nations Millennium Development Goals galvanized global efforts to alleviate suffering of the world's poorest people through unprecedented public-private partnerships. Donor aid agencies have demonstrably saved millions of lives that might otherwise have been lost to disease through increased access to quality-assured vaccines and medicines. Yet, the introduction of these health interventions in low- and middle-income countries (LMICs continues to face a time lag due to factors which remain poorly understood.A recurring theme from our partnership engagements was that an optimized regulatory process would contribute to improved access to quality health products. Therefore, we investigated the current system for medicine and vaccine registration in LMICs as part of our comprehensive regulatory strategy. Here, we report a fact base of the registration timelines for vaccines and drugs used to treat certain communicable diseases in LMICs. We worked with a broad set of stakeholders, including the World Health Organization's prequalification team, national regulatory authorities, manufacturers, procurers, and other experts, and collected data on the timelines between first submission and last approval of applications for product registration sub-Saharan Africa. We focused on countries with the highest burden of communicable disease and the greatest need for the products studied. The data showed a typical lag of 4 to 7 years between the first regulatory submission which was usually to a regulatory agency in a high-income country, and the final approval in Sub-Saharan Africa. Two of the three typical registration steps which products undergo before delivery in the countries involve lengthy timelines. Failure to leverage or rely on the findings from reviews already performed by competent regulatory authorities, disparate requirements for product approval by the countries, and lengthy timelines by manufacturers to respond to regulatory queries

  18. Natural products as potential human ether-a-go-go-related gene channel inhibitors - outcomes from a screening of widely used herbal medicines and edible plants.

    Science.gov (United States)

    Schramm, Anja; Jähne, Evelyn A; Baburin, Igor; Hering, Steffen; Hamburger, Matthias

    2014-08-01

    Inhibition of the human ether-a-go-go-related gene channel is the single most important risk factor leading to acquired long QT syndrome. Drug-induced QT prolongation can cause severe cardiac complications, including arrhythmia, and is thus a liability in drug development. Considering the importance of the human ether-a-go-go-related gene channel as an antitarget and the daily intake of plant-derived foods and herbal products, surprisingly few natural products have been tested for channel blocking properties. In an assessment of possible human ether-a-go-go-related gene liabilities, a selection of widely used herbal medicines and edible plants (vegetables, fruits, and spices) was screened by means of a functional two-microelectrode voltage-clamp assay with Xenopus oocytes. The human ether-a-go-go-related gene channel blocking activity of selected extracts was investigated with the aid of a high-performance liquid chromatography-based profiling approach, and attributed to tannins and alkaloids. Major European medicinal plants and frequently consumed food plants were found to have a low risk for human ether-a-go-go-related gene toxicity. Georg Thieme Verlag KG Stuttgart · New York.

  19. 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.

  20. 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).

  1. 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

  2. Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs.

    Science.gov (United States)

    Giannuzzi, Viviana; Landi, Annalisa; Bosone, Enrico; Giannuzzi, Floriana; Nicotri, Stefano; Torrent-Farnell, Josep; Bonifazi, Fedele; Felisi, Mariagrazia; Bonifazi, Donato; Ceci, Adriana

    2017-09-11

    The research and development process in the field of rare diseases is characterised by many well-known difficulties, and a large percentage of orphan medicinal products do not reach the marketing approval.This work aims at identifying orphan medicinal products that failed the developmental process and investigating reasons for and possible factors influencing failures. Drugs designated in Europe under Regulation (European Commission) 141/2000 in the period 2000-2012 were investigated in terms of the following failures: (1) marketing authorisation failures (refused or withdrawn) and (2) drugs abandoned by sponsors during development.Possible risk factors for failure were analysed using statistically validated methods. This study points out that 437 out of 788 designations are still under development, while 219 failed the developmental process. Among the latter, 34 failed the marketing authorisation process and 185 were abandoned during the developmental process. In the first group of drugs (marketing authorisation failures), 50% reached phase II, 47% reached phase III and 3% reached phase I, while in the second group (abandoned drugs), the majority of orphan medicinal products apparently never started the development process, since no data on 48.1% of them were published and the 3.2% did not progress beyond the non-clinical stage.The reasons for failures of marketing authorisation were: efficacy/safety issues (26), insufficient data (12), quality issues (7), regulatory issues on trials (4) and commercial reasons (1). The main causes for abandoned drugs were efficacy/safety issues (reported in 54 cases), inactive companies (25.4%), change of company strategy (8.1%) and drug competition (10.8%). No information concerning reasons for failure was available for 23.2% of the analysed products. This analysis shows that failures occurred in 27.8% of all designations granted in Europe, the main reasons being safety and efficacy issues. Moreover, the stage of development

  3. Discovery of discriminatory quality control markers for Chinese herbal medicines and related processed products by combination of chromatographic analysis and chemometrics methods: Radix Scutellariae as a case study.

    Science.gov (United States)

    Wang, Fei; Wang, Bo; Wang, Long; Xiong, Zi-Yue; Gao, Wen; Li, Ping; Li, Hui-Jun

    2017-05-10

    The processing procedure of traditional Chinese herbal medicines (CHMs) plays an essential role in clinical applications. However, little progress has been made on the quality control of crude and processed products. The present work, taking Radix Scutellariae (RS), wine-processed RS and carbonized RS as a typical case, developed a comprehensive strategy integrating chromatographic analysis and chemometric methods for quality evaluation and discrimination of crude RS and its processed products. Chemical fingerprints were established by high-performance liquid chromatography coupled with photodiode array detector and quadrupole time-of-flight mass spectrometry, and similarity analyses were calculated based on eleven common characteristic peaks. Subsequently, four chemical markers were discovered by back propagation-artificial neural network (BP-ANN) modeling. The selected markers were quantified by the 'single standard to determine multi-components' (SSDMC) method, and then the quantitative data were subjected to principal component analysis (PCA) and partial least-squares discriminant analysis (PLS-DA). Furthermore, support vector machine (SVM) was employed to predict the different processed products of RS. Finally, a hotmap visualization was conducted for clarifying the distribution of major flavonoids among different drugs. Collectively, the proposed strategy might be well-acceptable for quality control of CHMs and their related processed products from the processing mechanism-based perspective. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Diabetes Medicines

    Science.gov (United States)

    Diabetes means your blood glucose, or blood sugar, levels are too high. If you can't control your diabetes with wise food choices and physical activity, you may need diabetes medicines. The kind of medicine you take depends ...

  5. Herbal Medicine

    Science.gov (United States)

    ... for its scent, flavor, or therapeutic properties. Herbal medicines are one type of dietary supplement. They are ... and fresh or dried plants. People use herbal medicines to try to maintain or improve their health. ...

  6. Cultivation of medicinal caterpillar fungus, Cordyceps militaris (Ascomycetes), and production of cordycepin using the spent medium from levan fermentation.

    Science.gov (United States)

    Wu, Fang-Chen; Chen, Yi-Lin; Chang, Shu-Ming; Shih, Ing-Lung

    2013-01-01

    A process of tandem cultivation for the production of green and invaluable bioproducts (levan and Cordycepes militaris) useful for medical applications has been successfully developed. The process involves first cultivating Bacillus subtilis strain natto in sucrose medium to produce levan, followed by the subsequent cultivation of C. militaris in liquid- and solid-state cultures using the spent medium from levan fermentation as substrates. The factors affecting the cell growth and production of metabolites of C. militaris were investigated, and the various metabolites produced in the culture filtrate, mycelia, and fruiting body were analyzed. In addition, cordycepin was prepared from the solid waste medium of C. militaris. This is an excellent example in the development of cost effective biorefineries that maximize useful product formation from the available biomass. The preparation of cordycepin from solid waste medium of C. militaris using a method with high extraction efficiency and minimum solvent usage is also environmentally friendly.

  7. THE BIG PICTURE ON SMALL MEDICINE: THE STATE OF NANOMEDICINE PRODUCTS APPROVED FOR USE OR IN CLINICAL TRIALS

    Science.gov (United States)

    Etheridge, Michael L.; Campbell, Stephen A.; Erdman, Arthur G.; Haynes, Christy L.; Wolf, Susan M.; McCullough, Jeffrey

    2015-01-01

    Developments in nanomedicine are expected to provide solutions to many of modern medicine’s unsolved problems, so it is no surprise that literature is flush with articles discussing the subject. However, existing reviews tend to focus on specific sectors of nanomedicine or take a very forward looking stance and fail to provide a complete perspective on the current landscape. This article provides a more comprehensive and contemporary inventory of nanomedicine products. A keyword search of literature, clinical trial registries, and the Web, yielded 247 nanomedicine products that are approved or in various stages of clinical study. Specific information on each was gathered, so the overall field could be described based on various dimensions, including: FDA classification, approval status, nanoscale size, treated condition, nanostructure, and others. In addition to documenting the large number of nanomedicine products already in human use, this study indentifies some interesting trends forecasting the future of nanomedicine. PMID:22684017

  8. Considering context in academic medicine: differences in demographic and professional characteristics and in research productivity and advancement metrics across seven clinical departments.

    Science.gov (United States)

    Warner, Erica T; Carapinha, René; Weber, Griffin M; Hill, Emorcia V; Reede, Joan Y

    2015-08-01

    To understand the disciplinary contexts in which faculty work, the authors examined demographics, professional characteristics, research productivity, and advancement across seven clinical departments at Harvard Medical School (HMS) and nationally. HMS analyses included faculty from seven clinical departments-anesthesiology, medicine, neurology, pediatrics, psychiatry, radiology, and surgery-in May 2011 (N = 7,304). National analyses included faculty at 141 U.S. medical schools in the same seven departments as of December 31, 2011 (N = 91,414). The authors used chi-square and Wilcoxon Mann-Whitney tests to compare departmental characteristics. Heterogeneity in demographics, professional characteristics, and advancement across departments was observed in HMS and national data. At HMS, psychiatry had the highest percentage of underrepresented minority faculty at 6.6% (75/1,139). In anesthesiology, 24.2% (128/530) of faculty were Asian, whereas in psychiatry only 7.9% (90/1,139) were (P clinical departments at HMS and nationally. The context in which faculty work, of which department is a proxy, should be accounted for in research on faculty career outcomes and diversity inclusion in academic medicine.

  9. Correcting India's Chronic Shortage of Drug Inspectors to Ensure the Production and Distribution of Safe, High-Quality Medicines.

    Science.gov (United States)

    Kadam, Abhay B; Maigetter, Karen; Jeffery, Roger; Mistry, Nerges F; Weiss, Mitchell G; Pollock, Allyson M

    2016-04-27

    Good drug regulation requires an effective system for monitoring and inspection of manufacturing and sales units. In India, despite widespread agreement on this principle, ongoing shortages of drug inspectors have been identified by national committees since 1975. The growth of India's pharmaceutical industry and its large export market makes the problem more acute. The focus of this study is a case study of Maharashtra, which has 29% of India's manufacturing units and 38% of its medicines exports. India's regulations were reviewed, comparing international, national and state inspection norms with the actual number of inspectors and inspections. Twenty-six key informant interviews were conducted to ascertain the causes of the shortfall. In 2009-2010, 55% of the sanctioned posts of drug inspectors in Maharashtra were vacant. This resulted in a shortfall of 83%, based on the Mashelkar Committee's recommendations. Less than a quarter of the required inspections of manufacturing and sales units were undertaken. The Indian Drugs and Cosmetics Act and its Rules and Regulations make no provisions for drug inspectors and workforce planning norms, despite the growth and increasing complexity of India's pharmaceutical industry. The Maharashtra Food and Drug Administration (FDA) falls short of the Mashelkar Committee's recommended workforce planning norms. Legislation and political and operational support are required to produce needed changes. © 2016 by Kerman University of Medical Sciences

  10. Modeling below-ground biomass to improve sustainable management of Actaea racemosa, a globally important medicinal forest product

    Science.gov (United States)

    James L. Chamberlain; Gabrielle Ness; Christine J. Small; Simon J. Bonner; Elizabeth B. Hiebert

    2013-01-01

    Non-timber forest products, particularly herbaceous understory plants, support a multi-billion dollar industry and are extracted from forests worldwide for their therapeutic value. 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...

  11. Criteria for permission of radiosterilized products to application in medicine; Zasady dopuszczania wyrobow sterylizowanych radiacyjnie do stosowania w medycynie

    Energy Technology Data Exchange (ETDEWEB)

    Achmatowicz, T. [Instytut Lekow, Warsaw (Poland)

    1997-10-01

    The criteria being used in Poland for permission of radiosterilized medical materials to commercial application result from regulations being in force. The international regulations are also taken into account. The all criteria and procedure needed for any product become accepted for radiosterilization and commercial medical use have been presented and discussed. 1 tab.

  12. Short communication: Influence of pasteurization on the active compounds in medicinal plants to be used in dairy products

    DEFF Research Database (Denmark)

    Jäger, Anna Katharina; Saaby, Lasse; Kudsk, Dorte Søndergaard

    2010-01-01

    Interest from the dairy industry in adding herbal drugs to milk and yogurt products raises the question of whether these plant materials can be pasteurized. Root material of Rhodiola rosea, Eleutherococcus senticosus, and Panax ginseng, all plants with adaptogenic activities, was pasteurized...

  13. Screening of Indonesian medicinal plants for inhibitor activity on nitric oxide production of RAW264.7 cells and antioxidant activity.

    Science.gov (United States)

    Choi, Eun-Mi; Hwang, Jae-Kwan

    2005-03-01

    Traditional Indonesian medicinal plants were screened for their inhibitory effects on the nitric oxide (NO) production in lipopolysaccharide (LPS)-stimulated RAW264.7 macrophages and for the antioxidant activity through the evaluation of free radical scavenging effect and reducing power. The results of screening indicated that 50 methanolic extracts inhibited (>50%) lipopolysaccharides (LPS)-induced NO release from RAW264.7 cells at 50 microg/ml, with 18 having greater than 100% inhibition. At 200 microg/ml, 61 methanol extracts exhibited inhibitory activity (>50%), with 45 showing greater than 100% inhibition. In addition, the free radical scavenging effects of 6 methanolic extracts were found to be more than 50% for extract concentration of 0.5 mug/ml. The results indicate that the extracts contain active compounds that inhibit NO release and scavenge free radical.

  14. Emission of β+ Particles Via Internal Pair Production in the 0+ – 0+ Transition of 90Zr: Historical Background and Current Applications in Nuclear Medicine Imaging

    Directory of Open Access Journals (Sweden)

    Marco D'Arienzo

    2013-03-01

    Full Text Available 90Y is traditionally considered as a pure β– emitter. However, the decay of this radionuclide has a minor branch to the 0+ first excited state of 90Zr at 1.76 MeV, that is followed by a β+/β– emission. This internal pair production has been largely studied in the past because it is generated by a rare electric monopole transition (E0 between the states 0+/0+ of 90Zr. The positronic emission has been recently exploited for nuclear medicine applications, i.e. positron emission tomography (PET acquisitions of 90Y-labelled radiopharmaceuticals, widely used as therapeutic agents in internal radiation therapy. To date, this topic is gaining increasing interest in the radiation dosimetry community, as the possibility of detecting β+ emissions from 90Y by PET scanners may pave the way for an accurate patient-specific dosimetry. This could lead to an explosion in scientific production in this field. In the present paper the historical background behind the study of the internal pair production of the 0+/0+ transition of 90Zr is presented along with most up to date measured branch ratio values. An overview of most recent studies that exploit β+ particles emitted from 90Y for PET acquisitions is also provided.

  15. Extracts of Canadian first nations medicinal plants, used as natural products, inhibit neisseria gonorrhoeae isolates with different antibiotic resistance profiles.

    Science.gov (United States)

    Cybulska, Paulina; Thakur, Sidharath D; Foster, Brian C; Scott, Ian M; Leduc, Renée I; Arnason, John T; Dillon, Jo-Anne R

    2011-07-01

    Neisseria gonorrhoeae (Ng) has developed resistance to most antimicrobial agents and the antibiotics recommended for therapy are restricted, for the most part, to third generation cephalosporins. In order to investigate new potential sources of antimicrobial agents, the antibacterial properties of 14 Canadian plants used in traditional First Nations' medicine were tested against Ng isolates having differing antimicrobial susceptibility profiles. Ethanolic extracts of 14 Canadian botanicals, analyzed by high-performance liquid chromatography, were tested for their antimicrobial activity (disc diffusion and/or agar dilution assays) against susceptible Ng reference strains and a panel of 28 Ng isolates with various antimicrobial resistance profiles. Extracts of Arctostaphylos uva ursi (kinnikinnick or bearberry), Hydrastis canadensis (goldenseal), Prunus serotina (black cherry), and Rhodiola rosea (roseroot) inhibited the growth of all Ng isolates with minimum inhibitory concentrations of 32 μg/mL, 4 to 32 μg/mL, 16 to >32 μg/mL, and 32 to 64 μg/mL, respectively. Extracts of Acorus americanus (sweet flag), Berberis vulgaris (barberry), Cimicifuga racemosa (black cohosh), Equisetum arvense (field horsetail), Gaultheria procumbens (wintergreen), Ledum groenlandicum (Labrador tea), Ledum palustre (marsh Labrador tea), Oenothera biennis (common evening primrose), Sambucus nigra (elderberry), and Zanthoxylum americanum (prickly ash) had weak or no antimicrobial activity against the Ng isolates with minimum inhibitory concentrations ≥256 μg/mL. The phytochemical berberine from H. canadensis inhibited the growth of all Ng isolates. The phytochemicals, salidroside and rosavin, present in R. rosea, also showed inhibitory activity against Ng strains. Canadian botanicals represent a potential source of novel compounds which inhibit Ng, including isolates resistant to antibiotics.

  16. Population awareness of risks related to medicinal product use in Vientiane Capital, Lao PDR: a cross-sectional study for public health improvement in low and middle income countries.

    Science.gov (United States)

    Caillet, Céline; Sichanh, Chanvilay; Syhakhang, Lamphone; Delpierre, Cyrille; Manithip, Chanthanom; Mayxay, Mayfong; Lapeyre-Mestre, Maryse; Newton, Paul N; Roussin, Anne

    2015-06-27

    While essential medicines have been made more available in all but the most remote areas in low and middle income countries (L/MICs) over the past years, inappropriate and incorrect use of good quality medicines remains a key impediment for public health. In addition, as medicines have a potential to cause harm (medicine risks), adequate awareness by medicine users of the risks of adverse reactions is essential, especially as self-medication is common in L/MICs. This study aimed to investigate the awareness of Lao residents regarding medicine risks in Vientiane Capital, Lao People's Democratic Republic. Face-to-face interviews using structured questionnaires of 144 residents older than 16 years were carried out in 12 randomly selected villages out of the 146 villages of Vientiane Capital with at least one health facility. The respondents were mainly (85.0 %) the heads of households or their husband/spouse . The majority of the respondents were unaware (61.8 %) of medicine risks. Compared to residents living in the urban district of Xaysetha, living in peri-urban and even more in rural areas were identified as factors associated with being unaware of medicine risks [adjusted odds ratio (aOR) =3.3, 95 % Confidence Interval (CI) = 1.1-9.4]) and aOR =7.5 (95 % CI = 2.3-24.2), respectively]. In addition, more than half of the respondents had never heard of poor quality medicines, with a higher rate in rural/peri-urban compared to urban districts (55.6 % vs 38.9 %, respectively, p = 0.02). Finally, approximately one third of all respondents thought that traditional medicines could not cause harm. Overall, these results suggest a lack of awareness about medicinal product risks. Differences according to the place of residence are apparent and could be partly explained by a lower level of training of healthcare providers in contact with the population in the rural districts in particular. Communication on medicinal product risks to patients through well-trained healthcare

  17. 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.

  18. Automated Enrichment, Transduction, and Expansion of Clinical-Scale CD62L+ T Cells for Manufacturing of Gene Therapy Medicinal Products

    Science.gov (United States)

    Priesner, Christoph; Aleksandrova, Krasimira; Esser, Ruth; Mockel-Tenbrinck, Nadine; Leise, Jana; Drechsel, Katharina; Marburger, Michael; Quaiser, Andrea; Goudeva, Lilia; Arseniev, Lubomir; Kaiser, Andrew D.; Glienke, Wolfgang; Koehl, Ulrike

    2016-01-01

    Multiple clinical studies have demonstrated that adaptive immunotherapy using redirected T cells against advanced cancer has led to promising results with improved patient survival. The continuously increasing interest in those advanced gene therapy medicinal products (GTMPs) leads to a manufacturing challenge regarding automation, process robustness, and cell storage. Therefore, this study addresses the proof of principle in clinical-scale selection, stimulation, transduction, and expansion of T cells using the automated closed CliniMACS® Prodigy system. Naïve and central memory T cells from apheresis products were first immunomagnetically enriched using anti-CD62L magnetic beads and further processed freshly (n = 3) or split for cryopreservation and processed after thawing (n = 1). Starting with 0.5 × 108 purified CD3+ T cells, three mock runs and one run including transduction with green fluorescent protein (GFP)-containing vector resulted in a median final cell product of 16 × 108 T cells (32-fold expansion) up to harvesting after 2 weeks. Expression of CD62L was downregulated on T cells after thawing, which led to the decision to purify CD62L+CD3+ T cells freshly with cryopreservation thereafter. Most important in the split product, a very similar expansion curve was reached comparing the overall freshly CD62L selected cells with those after thawing, which could be demonstrated in the T cell subpopulations as well by showing a nearly identical conversion of the CD4/CD8 ratio. In the GFP run, the transduction efficacy was 83%. In-process control also demonstrated sufficient glucose levels during automated feeding and medium removal. The robustness of the process and the constant quality of the final product in a closed and automated system give rise to improve harmonized manufacturing protocols for engineered T cells in future gene therapy studies. PMID:27562135

  19. Productivity, Physicochemical Changes, and Antioxidant Activity of Shiitake Culinary-Medicinal Mushroom Lentinus edodes (Agaricomycetes) Cultivated on Lignocellulosic Residues.

    Science.gov (United States)

    Gaitán-Hernández, Rigoberto; Zavaleta, Marco Antonio Barradas; Aquino-Bolaños, Elia Nora

    2017-01-01

    The effects of substrate and strain on productivity, physicochemical characteristics, and compounds with antioxidant activity were evaluated in basidiomes of the shiitake mushroom, Lentinus edodes. Strains IE-245 and IE-256 and the substrates oak wood shavings (OW), sorghum stubble (SS), and sugar cane bagasse (SC) were used. Productivity was evaluated by measuring biological efficiency (BE), production rate (PR), and yield. Total sugars, total soluble solids, pH, titratable acidity, color parameters, total phenolics, flavonoids, ascorbic acid, and antioxidant activity of the basidiomes were measured. BE, PR and yield were higher with the combination IE-256/SS, at 103.71%, 1.32%, and 34.57%, respectively. The largest amount of total sugars (17.61 mg glucose · g-1 dry weight) was found with combination IE-256/SS. Variation was observed in basidiome color; the lowest luminosity (L*) value (darkest color) was found in the IE-256 strain on the OW substrate (L* = 30.45), whereas that of the IE-245 strain on the SC substrate was the lightest in color (L* = 57.00). The largest amounts of total phenolics were recorded in the IE-256 strain on the OW (6.50 mg gallic acid equivalents [GAE] · g-1 dry weight) and the SS substrates (5.85 mg GAE · g-1 dry weight). The best antioxidant activity was obtained with IE-256-0.80, 0.65, and 0.59 μmol Trolox equivalents · g dry weight-1-on the OW, SC, and SS substrates, respectively. Based on the values of BE, PR, and yield, IE-256/SS was the most productive. Substrate and strain, and their interactions, influenced the physicochemical characteristics of the basidiomes and the amounts of compounds with antioxidant activity they contained.

  20. Development and validation of a combined methodology for assessing the total quality control of herbal medicinal products--application to oleuropein preparations.

    Directory of Open Access Journals (Sweden)

    Nikolaos Lemonakis

    Full Text Available Oleuropein (OE is a secoiridoid glycoside, which occurs mostly in the Oleaceae family presenting several pharmacological properties, including antioxidant, cardio-protective, anti-atherogenic effects etc. Based on these findings OE is commercially available, as Herbal Medicinal Product (HMP, claimed for its antioxidant effects. As there are general provisions of the medicine regulating bodies e.g. European Medicines Agency, the quality of the HMP's must always be demonstrated. Therefore, a novel LC-MS methodology was developed and validated for the simultaneous quantification of OE and its main degradation product, hydroxytyrosol (HT, for the relevant OE claimed HMP's. The internal standard (IS methodology was employed and separation of OE, HT and IS was achieved on a C18 Fused Core column with 3.1 min overall run time employing the SIM method for the analytical signal acquisition. The method was validated according to the International Conference on Harmonisation requirements and the results show adequate linearity (r(2 > 0.99 over a wide concentration range [0.1-15 μg/mL (n=12] and a LLOQ value of 0.1 μg/mL, for both OE and HT. Furthermore, as it would be beneficial to control the quality taking into account all the substances of the OE claimed HMP's; a metabolomics-like approach has been developed and applied for the total quality control of the different preparations employing UHPLC-HRMS-multivariate analysis (MVA. Four OE-claimed commercial HMP's have been randomly selected and MVA similarity-based measurements were performed. The results showed that the examined samples could also be differentiated as evidenced according to their scores plot. Batch to batch reproducibility between the samples of the same brand has also been determined and found to be acceptable. Overall, the developed combined methodology has been found to be an efficient tool for the monitoring of the HMP's total quality. Only one OE HMP has been found to be consistent

  1. Incidence of Adverse Reactions to Medicinal Products in Josina Machel Central Hospital during the Year of 2014

    Directory of Open Access Journals (Sweden)

    Mateus Sebastião João Fernandes

    2016-04-01

    Full Text Available Introduction: The lack of knowledge regarding the incidence of adverse drug reactions in the hospital setting and their impact on morbidity and mortality is, nowadays, a major health problem in Angola. In the last years, notifications of adverse drug reactions have been practically null, namely at a hospital level. It is of great importance to characterize the incidence of adverse drug reactions occurring in a hospital setting, in order to implement measures towards improving the quality of healthcare services. Material and Methods: We conducted a descriptive, prospective observational study to characterize the incidence of adverse drug reactions (ADRs in patients admitted to the Central Hospital “Josina Machel” in Luanda during the year 2014. An intensive monitoring through active search for adverse reactions possibly related with the drugs prescribed to patients was performed. Results: Of a total of 2041 hospitalized patients, 175 had adverse drug reactions. The incidence rate was 4.74% in the medicine service (n = 1077 and 12.86% in the therapy service (n = 964. A total of 209 adverse drug reactions were identified, averaging 1,2 adverse drug reactions per patient. The highest incidence rate of adverse drug reactions was recorded in patients aged between 18 and 35 years old, with 79 patients (45.14%. With regard to therapeutic class, it was found that antimicrobials were the drugs most commonly associated with adverse reactions, with 71 notifications (40.57%, followed by analgesics, antipyretics and anti-inflammatory steroids with 20,00%. Quinine and artesunate were the antimicrobials most frequently implicated in causing an adverse drug reaction, with 25 (14.29% and 15 (8.57% notifications respectively. In the group of anti-inflammatory drugs, diclofenac stood out with 13 notifications (7.43%. The most common clinical manifestations were skin rash, which corresponded to 23,44% of the total number of adverse drug reactions, followed by

  2. Radioisotopes in nuclear medicine

    International Nuclear Information System (INIS)

    Samuel, A.M.

    2002-01-01

    Full text: A number of advances in diverse fields of science and technology and the fruitful synchronization of many a new development to address the issues related to health care in terms of prognosis and diagnosis resulted in the availability of host of modern diagnostic tools in medicine. Nuclear medicine, a unique discipline in medicine is one such development, which during the last four decades has seen exponential growth. The unique contribution of this specialty is the ability to examine the dynamic state of every organ of the body with the help of radioactive tracers. This tracer application in nuclear medicine to monitor the biological molecules that participate in the dynamic state of body constituents has led to a whole new approach to biology and medicine. No other technique has the same level of sensitivity and specificity as obtained in radiotracer technique in the study of in-situ chemistry of body organs. As modem medicine becomes oriented towards molecules rather than organs, nuclear medicine will be in the forefront and will become an integral part of a curative process for regular and routine application. Advances in nuclear medicine will proceed along two principal lines: (i) the development of improved sensitive detectors of radiation, powerful and interpretable data processing, image analysis and display techniques, and (ii) the production of exotic and new but useful radiopharmaceuticals. All these aspects are dealt with in detail in this talk

  3. Clinical Translation of Cell Therapy, Tissue Engineering, and Regenerative Medicine Product in Malaysia and Its Regulatory Policy.

    Science.gov (United States)

    Bt Hj Idrus, Ruszymah; Abas, Arpah; Ab Rahim, Fazillahnor; Saim, Aminuddin Bin

    2015-12-01

    With the worldwide growth of cell and tissue therapy (CTT) in treating diseases, the need of a standardized regulatory policy is of paramount concern. Research in CTT in Malaysia has reached stages of clinical trials and commercialization. In Malaysia, the regulation of CTT is under the purview of the National Pharmaceutical Control Bureau (NPCB), Ministry of Health (MOH). NPCB is given the task of regulating CTT, under a new Cell and Gene Therapy Products framework, and the guidelines are currently being formulated. Apart from the laboratory accreditation, researchers are advised to follow Guidelines for Stem Cell Research and Therapy from the Medical Development Division, MOH, published in 2009.

  4. Traditional medicine use and the anaesthetist

    African Journals Online (AJOL)

    GD Nethathe

    This review considers traditional medicine, with an emphasis on traditional African medicine and its influence on perioperative care. Western and Eastern herbal remedies are widely used. The paucity of good quality evidence concerning these medicinal products has led to only some of the effects of these medicines being ...

  5. 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

  6. A Brief Account of the Discovery of the Fetal/Placental Unit for Estrogen Production in Equine and Human Pregnancies: Relation to Human Medicine.

    Science.gov (United States)

    Raeside, James I

    2017-09-01

    The role of steroids in human medicine is well recognized, but the major contributions made by the large domestic animals as a source of material in the discovery, isolation, and determination of the structure of the steroid hormones is less well appreciated. After a brief reminder of the early efforts to obtain a reliable source of steroids for clinical use, the narrative here is to outline one example where success was ultimately achieved for estrogen replacement therapy. Whereas knowledge of the high concentrations of estrogens in urine of pregnant women and mares dates from the late 1920s, it was not until the 1940s that the latter was shown to be a practical source. Initially, the placenta was held to be responsible, but the involvement of the fetus in each case was eventually established. The remarkable enlargement of the human fetal adrenal glands and the fetal gonads in the horse, with characteristic features of steroid secreting tissues, suggested their participation. Ultimately, it was 16-hydroxylation by the fetal liver that resulted in estriol being the major estrogen type, by far, in late human pregnancy. In the mare, the pattern of estrogen production reflected that of the growth and later regression of the fetal gonads. The characteristic production ring-B, unsaturated estrogens in the mare is derived from an alternative pathway involving retention of the additional double bond in the biosynthesis of equilin.

  7. Arbuscular mycorrhizal fungi are an alternative to the application of chemical fertilizer in the production of the medicinal and aromatic plant Coriandrum sativum L.

    Science.gov (United States)

    Oliveira, Rui S; Ma, Ying; Rocha, Inês; Carvalho, Maria F; Vosátka, Miroslav; Freitas, Helena

    2016-01-01

    The widespread use of agrochemicals is detrimental to the environment and may exert harmful effects on human health. The consumer demand for organic food plants has been increasing. There is thus a rising need for alternatives to agrochemicals that can foster sustainable plant production. The aim of this study was to evaluate the potential use of an arbuscular mycorrhizal (AM) fungus as an alternative to application of chemical fertilizer for improving growth performance of the medicinal and aromatic plant Coriandrum sativum. Plants were inoculated with the AM fungus Rhizophagus irregularis BEG163 and/or supplemented with a commercial chemical fertilizer (Plant Marvel, Nutriculture Bent Special) in agricultural soil. Plant growth, nutrition, and development of AM fungus were assessed. Plants inoculated with R. irregularis and those supplemented with chemical fertilizer displayed significantly improved growth performances when compared with controls. There were no significant differences in total fresh weight between plants inoculated with R. irregularis or those supplemented with chemical fertilizer. Leaf chlorophyll a + b (82%), shoot nitrogen (44%), phosphorus (254%), and potassium (27%) concentrations increased in plants inoculated with R. irregularis compared to controls. Application of chemical fertilizer inhibited root mycorrhizal colonization and the length of the extraradical mycelium of R. irregularis. Inoculation with R. irregularis was equally or more efficient than application of chemical fertilizer in promoting growth and nutrition of C. sativum. AM fungi may thus contribute to improve biologically based production of food plants and reduce the dependence on agrochemicals in agriculture.

  8. A Combined LC-MS Metabolomics- and 16S rRNA Sequencing Platform to Assess Interactions between Herbal Medicinal Products and Human Gut Bacteria in Vitro: a Pilot Study on Willow Bark Extract

    Directory of Open Access Journals (Sweden)

    Eva-Maria Pferschy-Wenzig

    2017-12-01

    Full Text Available Herbal preparations are complex mixtures of natural products, many of which are able to reach the distal gut due to low oral bioavailability. There, they can influence the microbial communities, and can be metabolized into potentially absorbable bioactive compounds by the intestinal bacteria. This aspect has often been disregarded when searching for the active principles of medicinal plants and herbal medicinal products. The aim of this study was to establish an interdisciplinary platform to unravel interactions of herbal medicine and intestinal microbiota, using a combined LC-MS metabolomics and 16S rRNA microbiome sequencing approach. Willow bark extract (WBE, a herbal medicinal product with a long history of traditional use and a well-established anti-inflammatory activity, was incubated with human fecal suspension under anoxic conditions. Samples were taken after 0.5, 4, and 24 h of incubation. Microbiome analyses revealed that incubation with WBE had a marked effect on microbial community composition and functions. For example, the proportion of Bacteroides sp. was clearly enhanced when the fecal sample used in this study was incubated with WBE. LC-MS analysis showed that WBE constituents were readily metabolized by fecal bacteria. Numerous microbial metabolites could be annotated, allowing the construction of putative microbial degradation pathways for the main groups of WBE constituents. We suggest that studies of this type help to increase the knowledge on bioactive principles of medicinal plants, since gut microbial metabolites might have been underestimated as a source of bioactive compounds in the past.

  9. [Expedition medicine].

    Science.gov (United States)

    Donlagić, Lana

    2009-01-01

    Expedition and wildeness medicine is a term that combines rescue medicine, sport medicine as well as more specific branches as polar or high altitude medicine. It is being intensively studied both at the reaserch institutes and on expeditions. Ophtalmologists are concentrated on the reaserch of HARH (High Altitude Retinal Hemorrhage), neurologists on HACE reaserch (High Altitude Cerebral Edema), psychologists are developing tests to decsribe cognitive functions and many physicians are being trained to work in extreme enviroment. The result of all this effort are numerous new findings in pathophysiology and therapy of altitude illness, increased security on expedition and further development of expeditionism.

  10. Nuclear medicine

    International Nuclear Information System (INIS)

    Anon.

    1993-01-01

    The area of nuclear medicine, the development of artificially produced radioactive isotopes for medical applications, is relatively recent. Among the subjects covered in a lengthy discussion are the following: history of development; impact of nuclear medicine; understanding the most effective use of radioisotopes; most significant uses of nuclear medicine radioimmunoassays; description of equipment designed for use in the field of nuclear medicine (counters, scanning system, display systems, gamma camera); description of radioisotopes used and their purposes; quality control. Numerous historical photographs are included. 52 refs

  11. Traditional Medicinal Plant Extracts and Natural Products with Activity against Oral Bacteria: Potential Application in the Prevention and Treatment of Oral Diseases

    Directory of Open Access Journals (Sweden)

    Enzo A. Palombo

    2011-01-01

    Full Text Available Oral diseases are major health problems with dental caries and periodontal diseases among the most important preventable global infectious diseases. Oral health influences the general quality of life and poor oral health is linked to chronic conditions and systemic diseases. The association between oral diseases and the oral microbiota is well established. Of the more than 750 species of bacteria that inhabit the oral cavity, a number are implicated in oral diseases. The development of dental caries involves acidogenic and aciduric Gram-positive bacteria (mutans streptococci, lactobacilli and actinomycetes. Periodontal diseases have been linked to anaerobic Gram-negative bacteria (Porphyromonas gingivalis, Actinobacillus, Prevotella and Fusobacterium. Given the incidence of oral disease, increased resistance by bacteria to antibiotics, adverse affects of some antibacterial agents currently used in dentistry and financial considerations in developing countries, there is a need for alternative prevention and treatment options that are safe, effective and economical. While several agents are commercially available, these chemicals can alter oral microbiota and have undesirable side-effects such as vomiting, diarrhea and tooth staining. Hence, the search for alternative products continues and natural phytochemicals isolated from plants used as traditional medicines are considered as good alternatives. In this review, plant extracts or phytochemicals that inhibit the growth of oral pathogens, reduce the development of biofilms and dental plaque, influence the adhesion of bacteria to surfaces and reduce the symptoms of oral diseases will be discussed further. Clinical studies that have investigated the safety and efficacy of such plant-derived medicines will also be described.

  12. Combination of gamma radiation and essential oils from medicinal plants in managing Tribolium castaneum contamination of stored products

    International Nuclear Information System (INIS)

    Ahmadi, Mehrdad; Abd-alla, Adly Mohamed M.; Moharramipour, Saeid

    2013-01-01

    Effectiveness of management of insect infestation of stored products with essential oils as viable alternatives to synthetic insecticides can be enhanced with gamma radiation. We studied effects of sublethal doses of essential oils from Rosmarinus officinalis (L.) and Perovskia atriplicifolia (Benth) (safe natural insecticides) in combination with gamma radiation on mortality of adults of Tribolium castaneum (Herbst). The insects were subjected to two radiation doses and two concentrations of the essential oils in the air. This combined treatment increased the mortality, which was also 3–6 times higher than could be expected from the sum of the effects of each of the treatments. The synergistic effect was more pronounced in the case of R. officinalis (L.) than in the case of P. atriplicifolia (Benth). The experiments have shown that the known insecticidal effectiveness of the essential oils can be enhanced by preliminary irradiation. Possible approaches to implementation of the combined treatment are discussed. - Highlights: • The mortality of T. castaneum increased with an increase of the radiation dose. • R. officinalis was more toxic to T. castaneum than P. atriplicifolia. • Gamma radiation and essential oils could be used as combined methods in IPM. • Combination of radiation with essential oils made a synergistic effect. • The synergistic effect of the R–G was much more appropriate from P–G

  13. Nuclear Medicine in China

    International Nuclear Information System (INIS)

    Jin, S.

    1998-01-01

    Nuclear Medicine in China was established in 1956, when the first course, Biomedical Applications of Isotopes, was offered in our country by the Peking Union Medical College (PUMC). In 1958, several courses in Clinical Nuclear Medicine brought up the first generation of Nuclear Medicine physicians in China. 99m Tc and 113m In generators were supplied in 1972. The first gamma camera was imported in 1972 and the first homemade gamma camera was installed in 1977. The Chinese Journal of Nuclear Medicine commenced publication in 1981. The first single photon emission computed tomography (SPECT) camera was imported in 1983. At present, there are 800 Nuclear Medicine departments in China with a total of 6,000 staff. Beijing and Shanghai each have a cyclotron of 30 MeV, imported from Belgium, consequently gallium-68, thallium-201, indium-111, iodine-123 are all available for production. There is currently one operating PET camera facility in China, in the Shandong province. A second PET/cyclotron facility is currently being developed in the Nuclear Medicine Department, Huashan Hospital, Shanghai Medical University. The most common clinical Nuclear Medicine applications are in oncological, cardiovascular, cerebrovascular and neuropsychiatric disorders

  14. Vulnerable Medicine

    Science.gov (United States)

    Bochner, Arthur P.

    2009-01-01

    In "Narrative Medicine: Honoring the Stories of Illness," Rita Charon paints an original and humane portrait of what it can mean to be a doctor, to live a life immersed in sickness and dedicated to wellness. Charon drops the veil, inviting readers to look at the secret, subjective, emotional face of medicine, a zone of self-censored feelings and…

  15. Occupational medicine and toxicology

    Directory of Open Access Journals (Sweden)

    Fischer Axel

    2006-02-01

    Full Text Available Abstract This editorial is to announce the Journal of Occupational Medicine and Toxicology, a new Open Access, peer-reviewed, online journal published by BioMed Central. Occupational medicine and toxicology belong to the most wide ranging disciplines of all medical specialties. The field is devoted to the diagnosis, prevention, management and scientific analysis of diseases from the fields of occupational and environmental medicine and toxicology. It also covers the promotion of occupational and environmental health. The complexity of modern industrial processes has dramatically changed over the past years and today's areas include effects of atmospheric pollution, carcinogenesis, biological monitoring, ergonomics, epidemiology, product safety and health promotion. We hope that the launch of the Journal of Occupational Medicine and Toxicology will aid in the advance of these important areas of research bringing together multi-disciplinary research findings.

  16. A novel three-stage light irradiation strategy in the submerged fermentation of medicinal mushroom Ganoderma lucidum for the efficient production of ganoderic acid and Ganoderma polysaccharides.

    Science.gov (United States)

    Zhang, Wei; Tang, Ya-Jie

    2008-01-01

    A novel three-stage light irradiation strategy in the submerged fermentation of medicinal mushroom Ganoderma lucidum for the efficient production of bioactive metabolites ganoderic acid (GA) and Ganoderma polysaccharides was developed. Significance of light quality, i.e., blue light (390-500 nm, lambda(max) = 470 nm), red light (560-700 nm, lambda(max) = 625 nm), and white light (400-740 nm, lambda(max) = 550 nm), was studied at first. Interestingly, there was a gradual decrease trend of GA content after the culture of day 2 when the maximal GA content was obtained, while GA content decreased slowly under white light irradiation after day 6. The dark environment was favorable to the specific GA biosynthesis (i.e., GA content) before day 6, and after that the optimum was white light irradiation. A relatively lower irradiation density of white light (i.e., 0.94 and 2.82 W/m(2)) was beneficial for the specific GA biosynthesis before day 6, while GA content was higher under higher irradiation density of white light (i.e., 4.70 and 9.40 W/m(2)) at the later-stage of cultivation. 4.70 W/m(2) white light irradiation culture was the best from the viewpoint of GA accumulation. Therefore, a two-stage light irradiation strategy by combing the first 2 days dark culture with the following 4.70 W/m(2) white light irradiation culture was developed. The highest GA production in the two-stage culture was 276.0 +/- 12.5 mg/L, which was increased by 19% compared to 4.70 W/m(2) white light irradiation culture (i.e., 232.4 +/- 15.8 mg/L) and by 178% compared to the dark culture (i.e., 99.4 +/- 1.0 mg/L). Although there still existed a gradual decrease trend of GA content after day 2 when the maximal GA content was obtained in the two-stage culture. Following three-stage light irradiation strategy was further demonstrated in order to turn around the sharp decrease of GA content after day 2. The first-stage was the 2-day dark culture; the second-stage was the following six-day 0.94 W/m(2

  17. Traditional, complementary, and alternative medicine: Focusing on research into traditional Tibetan medicine in China.

    Science.gov (United States)

    Song, Peipei; Xia, Jufeng; Rezeng, Caidan; Tong, Li; Tang, Wei

    2016-07-19

    As a form of traditional, complementary, and alternative medicine (TCAM), traditional Tibetan medicine has developed into a mainstay of medical care in Tibet and has spread from there to China and then to the rest of the world. Thus far, research on traditional Tibetan medicine has focused on the study of the plant and animal sources of traditional medicines, study of the histology of those plants and animals, chemical analysis of traditional medicines, pharmacological study of those medicines, and evaluation of the clinical efficacy of those medicines. A number of papers on traditional Tibetan medicines have been published, providing some evidence of the efficacy of traditional Tibetan medicine. However, many traditional Tibetan medicines have unknown active ingredients, hampering the establishment of drug quality standards, the development of new medicines, commercial production of medicines, and market availability of those medicines. Traditional Tibetan medicine must take several steps to modernize and spread to the rest of the world: the pharmacodynamics of traditional Tibetan medicines need to be determined, the clinical efficacy of those medicines needs to be verified, criteria to evaluate the efficacy of those medicines need to be established in order to guide their clinical use, and efficacious medicines need to be acknowledged by the pharmaceutical market. The components of traditional Tibetan medicine should be studied, traditional Tibetan medicines should be screened for their active ingredients, and techniques should be devised to prepare and manufacture those medicines.

  18. Use Medicines Safely

    Science.gov (United States)

    ... Medicines Safely Print This Topic En español Use Medicines Safely Browse Sections The Basics Overview Prescription Medicines ... Medicines 1 of 7 sections The Basics: Prescription Medicines There are different types of medicine. The 2 ...

  19. American Academy of Podiatric Sports Medicine

    Science.gov (United States)

    ... newspapers. Our G.R.E.A.T. Team! Sports Medicine & Footwear Info Dr. Blakes Healing Sole Girls on the Run Joint Commission on Sports Medicine & Science Medical Fitness Association IRRA Runblogger Running Product ...

  20. Improving the Fermentation Production of the Individual Key Triterpene Ganoderic Acid Me by the Medicinal Fungus Ganoderma lucidum in Submerged Culture

    Directory of Open Access Journals (Sweden)

    Gao-Qiang Liu

    2012-10-01

    Full Text Available Enhanced ganoderic acid Me (GA-Me, an important anti-tumor triterpene yield was attained with the medicinal fungus Ganoderma lucidum using response surface methodology (RSM. Interactions were studied with three variables, viz. glucose, peptone and culture time using a Central Composite Design (CCD. The CCD contains a total of 20 experiments with the first 14 experiments organized in a fractional factorial design, with the experimental trails from 15 to 20 involving the replications of the central points. A polynomial model, describing the relationships between the yield of GA-Me and the three factors in a second-order equation, was developed. The model predicted the maximum GA-Me yield of 11.9 mg·L−1 for glucose, peptone, culture time values of 44.4 g·L−1, 5.0 g·L−1, 437.1 h, respectively, and a maximum GA-Me yield of 12.4 mg·L−1 was obtained in the validation experiment, which represented a 129.6% increase in titre compared to that of the non-optimized conditions. In addition, 11.4 mg·L−1 of GA-Me was obtained in a 30-L agitated fermenter under the optimized conditions, suggesting the submerged culture conditions optimized in the present study were also suitable for GA-Me production on a large scale.

  1. Evaluation of relative isotopic abundance measurements in a quadrupole time-of-flight mass spectrometer for elemental composition determination of natural products in traditional Chinese medicine.

    Science.gov (United States)

    Wu, Zhi-Jun; Huo, Jia-Li; Chen, Jian-Zhong; Li, Na; Fang, Dong-Mei; Chen, Xiao-Zhen; Zhang, Guo-Lin; Wang, Jian-Hua; Xu, Xiao-Ying

    2013-01-01

    The relative isotopic abundance (RIA) measurement errors of a quadrupole time-of-flight (Q-ToF) instrument incorporating analog-to-digital converter detectors were systemically evaluated by stochastically collecting about 200 data in positive ion mass spectrometry (MS) mode. Errors varied with peak intensities at definite spectral acquisition rates but were very close, even if peak intensities changed sharply at different spectral acquisition rates with the same concentration. Intensity thresholds were systematically defined at 1 Hz of spectral acquisition rates. RIA measurement errors were also evaluated using peak area. It seemed that peak area was better adapted for the high-intensity ions while peak intensity was suited for very low-intensity ions. Several known compounds were selected for RIA measurements for product ions in tandem mass spectropmetry (MS/MS) mode. An extract of a representative traditional Chinese medicinal, Paederia scandens was analyzed with high-performance liquid chromatography-electrospray ionization-QToF-MS/MS. The unique elemental compositions of some compounds could not be identified even with exact masses and MS/MS spectra of measured and reference compounds. RIA errors, especially of (M+2)M(-1), provided vital information for determining the elemental composition.

  2. [Analysis of the decision to buy medicine in light of the existence of generic products: a study in the city of Belo Horizonte, Brazil].

    Science.gov (United States)

    Sousa, Caissa Veloso E; Mesquita, Jose Marcos Carvalho de; Lara, José Edson

    2013-11-01

    The scope of this study is to identify the factors that influence the consumer's decision when buying medicine. Prior to the Generics Act (Lei dos Genéricos), consumers had at their disposal two product purchase options in the private market, namely buying a reference drug and a similar one. Generic drugs are part of a public policy which was intended to broaden access to medication by the general population at more accessible costs, while maintaining the same quality as the reference drug, as ensured by bioequivalence tests from the national health surveillance agency ANVISA. Nevertheless, a question arises as to whether the potential consumer knows the difference between generic, similar and reference drugs, especially when taking into account the decision at the moment of purchase. In order to fulfill the proposed objective, a survey was conducted with 403 residents in Belo Horizonte, Brazil. The data gathered was tabulated and analyzed using factor analysis and crosstab. The results made it possible to infer that there is a strong predisposition among consumers to accept the suggestions of the pharmacists and/or salesman, and a significant portion of the population is confused at the moment of purchase.

  3. Identification and determination of related substances of ceftaroline fosamil in medicinal product by high performance liquid chromatography with diode array detection and tandem mass spectrometry.

    Science.gov (United States)

    Karpiuk, Izabela; Michalska, Katarzyna; Bus, Katarzyna; Kiljan, Monika; Tyski, Stefan

    2017-10-25

    Ceftaroline fosamil, the prodrug of ceftaroline, is an advanced-generation cephalosporin antibacterial agent approved for treatment in the European Union in 2012. The drug is dedicated to curing complicated skin and soft tissue infections and community-acquired pneumonia. The developed analytical method of high performance liquid chromatography (HPLC) followed by diode array detector (DAD) set at 243nm was used to identify and determine degradation products of ceftaroline fosamil. The elaborated method demonstrated good selectivity and linearity [r>0.998 for the range 0.8-1.2mg/mL (80-120%) and r>0.997 for the range 0.005-0.015mg/mL (0.5-1.5%)]. Limit of detection (LOD) and limit of quantification (LOQ) values were equal to 0.15μg/mL and 0.5μg/mL, respectively. The forced decomposition of ceftaroline fosamil carried out under acidic, basic, oxidative, photolytic and thermal conditions revealed the high sensitivity of ceftaroline on photodegradation and thermolysis processes. Representative ceftaroline samples were selected and analysed by LC coupled with electrospray ionisation time-of-flight mass spectrometry (LC-ESI-Q-TOF-MS) to identify the related substances that appeared under stress conditions. The LC-DAD method was transferred without any modification to LC-MS/MS system, allowing it to correlate results back to the LC-DAD method. Eight unknown signals were detected in the photolytic and thermal stress solutions for ceftaroline fosamil. The evaluated method was applied to the analysis of a medicinal product containing ceftaroline fosamil - Zinforo™, 600mg, powder for concentrate for solution for infusion. Moreover, the optimised conditions allowed for the successful separation of eight cephalosporin antibiotics possessing a molecular structure similar to ceftaroline (cefepime, cefapirin, ceftazidime, cefpirome, cefalonium, cefotaxime, cefquinome, cefalotin). Copyright © 2017 Elsevier B.V. All rights reserved.

  4. 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.

  5. Phenols, alkaloids and terpenes from medicinal plants with antihypertensive and vasorelaxant activities. A review of natural products as leads to potential therapeutic agents.

    Science.gov (United States)

    Maione, Francesco; Cicala, Carla; Musciacco, Giulia; De Feo, Vincenzo; Amat, Anibal G; Ialenti, Armando; Mascolo, Nicola

    2013-04-01

    Numerous studies support the cardiovascular effects of medicinal plants. This review examines plants whose antihypertensive and vasorelaxant effects have been scientifically validated. Our study selected only chemically characterized plants whose mode of action had already been investigated. The aim of the paper is to provide a quick way to identify medicinal plants and their constituents with antihypertensive and vasorelaxant activities.

  6. Alternative Medicine

    Science.gov (United States)

    ... valid therapies, delaying proven treatment for serious conditions. Holistic Treatments Holistic medicine is a system of health care ... techniques including meditation, biofeedback and relaxation training. While holistic treatments can be part of a good physical regimen, ...

  7. Farmed fish welfare-suffering assessment and impact on product quality

    Directory of Open Access Journals (Sweden)

    Bianca Maria Poli

    2010-01-01

    Full Text Available Fish welfare, suffering and the perception of pain were debated, together with several factors reducing infra vitam welfare of farmed fish (genetic, environment, density, malnutrition, starvation, cataracts, deformities, vaccination side effects, transport, handling, confinement, crowding, harvesting, killing method. Behavioural and physiological stress responses were considered as indicators of welfare reduction. The effects of pre-slaughter management practices, and the most commonly used stunning/slaughtering methods on welfare and quality reduction of farmed fish were discussed. A number of indicators can be used to assess fish welfare-suffering, both in a scientific and practical context, such as behavioural, haematic, cellular, tissue post mortem fish stress and quality indicators, but none of them are optimal. The best strategy for a reliable assessment of fish welfare/suffering and their impact on product quality is a multidisciplinary approach that takes into account animal behaviour and the different biochemical and physiological ante mortem and post mortem processes involved: several components, all influenced in a similar way by the same condition, suggest real welfare and quality reduction.

  8. Nuclear medicine

    International Nuclear Information System (INIS)

    Chamberlain, M.J.

    1986-01-01

    Despite an aggressive, competitive diagnostic radiology department, the University Hospital, London, Ontario has seen a decline of 11% total (in vivo and in the laboratory) in the nuclear medicine workload between 1982 and 1985. The decline of in vivo work alone was 24%. This trend has already been noted in the U.S.. Nuclear medicine is no longer 'a large volume prosperous specialty of wide diagnostic application'

  9. Nuclear medicine

    International Nuclear Information System (INIS)

    Blanquet, Paul; Blanc, Daniel.

    1976-01-01

    The applications of radioisotopes in medical diagnostics are briefly reviewed. Each organ system is considered and the Nuclear medicine procedures pertinent to that system are discussed. This includes, the principle of the test, the detector and the radiopharmaceutical used, the procedure followed and the clinical results obtained. The various types of radiation detectors presently employed in Nuclear Medicine are surveyed, including scanners, gamma cameras, positron cameras and procedures for obtaining tomographic presentation of radionuclide distributions [fr

  10. 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.

  11. Extracts of edible and medicinal plants in inhibition of growth, adherence, and cytotoxin production of Campylobacter jejuni and Campylobacter coli.

    Science.gov (United States)

    Castillo, Sandra L; Heredia, Norma; Contreras, Juan F; García, Santos

    2011-08-01

    Campylobacter spp. is recognized as one of the most common cause of food-borne bacterial gastroenteritis in humans. Campylobacter infection causes campylobacteriosis, which can range from asymptomatic to dysentery-type illnesses with severe complications, such as Guillian-Barre syndrome. Epidemiological studies have revealed that consumption of poultry products is an important risk factor of this disease. Adherence and cytotoxic activity of the bacteria to host mucosal surfaces have been proposed to be critical steps in pathogenesis. Innovative tools for controlling Campylobacter, such as natural products from plants, represent good alternatives for use in foods or as therapeutic agents. In this study, 28 edible or medicinal plants species were analyzed for their bactericidal effects on the growth of Campylobacter jejuni and C. coli. The extracts of Acacia farnesiana, Artemisia ludoviciana, Opuntia ficus-indica, and Cynara scolymus were the most effective against these microorganisms at minimal bactericidal concentrations (MBCs) of 0.3, 0.5, 0.4, and 2.0 mg/mL, respectively. No effect on growth was detected with lower concentrations of extract (25%, 50%, or 75% of the MBC) added to the media. The effect of each extract (75% of the MBC) on adherence and cytotoxicity of C. jejuni and C. coli was evaluated in Vero cells. Adherence of Campylobacter to Vero cells was significantly affected by all the extracts. Cytotoxic activity of bacterial cultures was inhibited by A. farnesiana and A. ludoviciana. These plant extracts are potential candidates to be studied for controlling Campylobacter contamination in foods and the diseases associated with this microorganism. Innovative tools for controlling Campylobacter, such as natural products from plants, represent good alternatives for use in foods or as therapeutic agents. The extracts of Acacia farnesiana, Artemisia ludoviciana, Opuntia ficus-indica, and Cynara scolymus

  12. [Falsified medicines in parallel trade].

    Science.gov (United States)

    Muckenfuß, Heide

    2017-11-01

    The number of falsified medicines on the German market has distinctly increased over the past few years. In particular, stolen pharmaceutical products, a form of falsified medicines, have increasingly been introduced into the legal supply chain via parallel trading. The reasons why parallel trading serves as a gateway for falsified medicines are most likely the complex supply chains and routes of transport. It is hardly possible for national authorities to trace the history of a medicinal product that was bought and sold by several intermediaries in different EU member states. In addition, the heterogeneous outward appearance of imported and relabelled pharmaceutical products facilitates the introduction of illegal products onto the market. Official batch release at the Paul-Ehrlich-Institut offers the possibility of checking some aspects that might provide an indication of a falsified medicine. In some circumstances, this may allow the identification of falsified medicines before they come onto the German market. However, this control is only possible for biomedicinal products that have not received a waiver regarding official batch release. For improved control of parallel trade, better networking among the EU member states would be beneficial. European-wide regulations, e. g., for disclosure of the complete supply chain, would help to minimise the risks of parallel trading and hinder the marketing of falsified medicines.

  13. Development of a novel regulatory pharmacovigilance prioritisation system: an evaluation of its performance at the UK Medicines and Healthcare products Regulatory Agency.

    Science.gov (United States)

    Seabroke, Suzie; Wise, Lesley; Waller, Patrick

    2013-10-01

    The prioritisation of drug safety issues for further evaluation or regulatory action is critical to ensure that acceptable timelines and appropriate resource allocation are defined to meet public health and regulatory obligations. Our objective was to develop, pilot and implement a novel tool for prioritising pharmacovigilance issues within the Medicines and Healthcare products Regulatory Agency (MHRA). An initial system was developed empirically and then piloted over a 10-month period in the pharmacovigilance signal management meeting at the MHRA that discusses potential pharmacovigilance issues, and determines, through consensus, their priority and a timescale for action. The priority assigned by the tool was compared with the priority decided by collective judgement at the meeting. Once an acceptable level of concordance between the tool and the meeting had been achieved, the finalised tool was implemented into routine use at the MHRA, with an evaluation of its performance conducted after the first year. The Regulatory Pharmacovigilance Prioritisation System (RPPS) tool prioritises pharmacovigilance issues according to the following four broad categories, each with four inputs: strength of evidence, public health implications, agency regulatory obligations and public perceptions. A weighted scoring system links the inputs to a pre-defined number of points where if a threshold is reached then the points are awarded. The overall priority is determined by the sum of all points obtained from each of the inputs. The pilot study included a total of 73 pharmacovigilance issues during the 10-month study period, with an overall exact agreement between the RPPS priority and the collective judgement of the meeting of 60.3 %. Where exact agreement was not obtained, the RPPS generally prioritised the issues slightly higher than the meeting. Over the first year following implementation, the RPPS achieved an overall exact agreement of 82.2 %. Following the pilot study and

  14. Effect of Medicinal Plant By-products Supplementation to Total Mixed Ration on Growth Performance, Carcass Characteristics and Economic Efficacy in the Late Fattening Period of Hanwoo Steers

    Directory of Open Access Journals (Sweden)

    S. J. Lee

    2015-12-01

    Full Text Available This study was conducted to evaluate the effect of medicinal plant by-products (MPB supplementation to a total mixed ration (TMR on growth, carcass characteristics and economic efficacy in the late fattening period of Hanwoo steers. Twenty seven steers (body weight [BW], 573±57 kg were assigned to 3 treatment groups so that each treatment based on BW contained 9 animals. All groups received ad libitum TMR throughout the feeding trial until slaughter (from 24 to 30 months of age and treatments were as follows: control, 1,000 g/kg TMR; treatment 1 (T1, 970 g/kg TMR and 30 g/kg MPB; treatment 2 (T2, 950 g/kg TMR and 50 g/kg MPB. Initial and final BW were not different among treatments. Resultant data were analyzed using general linear models of SAS. Average daily gain and feed efficiency were higher (p<0.05 for T1 than control, but there was no difference between control and T2. Plasma albumin showed low-, intermediate- and high-level (p<0.05 for control, T1 and T2, whereas non-esterified fatty acid was high-, intermediate- and high-level (p<0.05 for control, T1 and T2, respectively. Carcass weight, carcass rate, backfat thickness and rib eye muscle area were not affected by MPB supplementation, whereas quality and yield grades were highest (p<0.05 for T1 and T2, respectively. Daily feed costs were decreased by 0.5% and 0.8% and carcass prices were increased by 18.1% and 7.6% for T1 and T2 compared to control, resulting from substituting TMR with 30 and 50 g/kg MPB, respectively. In conclusion, the substituting TMR by 30 g/kg MPB may be a potential feed supplement approach to improve economic efficacy in the late fattening period of Hanwoo steers.

  15. 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.

  16. Spotlight on medicinal chemistry education.

    Science.gov (United States)

    Pitman, Simone; Xu, Yao-Zhong; Taylor, Peter; Turner, Nicholas; Coaker, Hannah; Crews, Kasumi

    2014-05-01

    The field of medicinal chemistry is constantly evolving and it is important for medicinal chemists to develop the skills and knowledge required to succeed and contribute to the advancement of the field. Future Medicinal Chemistry spoke with Simone Pitman (SP), Yao-Zhong Xu (YX), Peter Taylor (PT) and Nick Turner (NT) from The Open University (OU), which offers an MSc in Medicinal Chemistry. In the interview, they discuss the MSc course content, online teaching, the future of medicinal chemistry education and The OU's work towards promoting widening participation. SP is a Qualifications Manager in the Science Faculty at The OU. She joined The OU in 1993 and since 1998 has been involved in the Postgraduate Medicinal Chemistry provision at The OU. YX is a Senior Lecturer in Bioorganic Chemistry at The OU. He has been with The OU from 2001, teaching undergraduate courses of all years and chairing the master's course on medicinal chemistry. PT is a Professor of Organic Chemistry at The OU and has been involved with the production and presentation of The OU courses in Science and across the university for over 30 years, including medicinal chemistry modules at postgraduate level. NT is a Lecturer in Analytical Science at The OU since 2009 and has been involved in the production of analytical sciences courses, as well as contributing to the presentation of a number of science courses including medicinal chemistry.

  17. Travel medicine

    Science.gov (United States)

    Aw, Brian; Boraston, Suni; Botten, David; Cherniwchan, Darin; Fazal, Hyder; Kelton, Timothy; Libman, Michael; Saldanha, Colin; Scappatura, Philip; Stowe, Brian

    2014-01-01

    Abstract Objective To define the practice of travel medicine, provide the basics of a comprehensive pretravel consultation for international travelers, and assist in identifying patients who might require referral to travel medicine professionals. Sources of information Guidelines and recommendations on travel medicine and travel-related illnesses by national and international travel health authorities were reviewed. MEDLINE and EMBASE searches for related literature were also performed. Main message Travel medicine is a highly dynamic specialty that focuses on pretravel preventive care. A comprehensive risk assessment for each individual traveler is essential in order to accurately evaluate traveler-, itinerary-, and destination-specific risks, and to advise on the most appropriate risk management interventions to promote health and prevent adverse health outcomes during travel. Vaccinations might also be required and should be personalized according to the individual traveler’s immunization history, travel itinerary, and the amount of time available before departure. Conclusion A traveler’s health and safety depends on a practitioner’s level of expertise in providing pretravel counseling and vaccinations, if required. Those who advise travelers are encouraged to be aware of the extent of this responsibility and to refer all high-risk travelers to travel medicine professionals whenever possible. PMID:25500599

  18. Metabolomic profiling of liquid Echinacea medicinal products with in vitro inhibitory effects on cytochrome P450 3A4 (CYP3A4).

    Science.gov (United States)

    Modarai, Maryam; Yang, Min; Suter, Andy; Kortenkamp, Andreas; Heinrich, Michael

    2010-03-01

    ECHINACEA is a popular and widely used herbal medicinal product and consequently, studies of its interactions with conventional drugs are of particular importance. We have shown that ECHINACEA preparations and some common alkylamides weakly inhibit several cytochrome P450 (CYP) isoforms, with considerable variation in potency. We now report a detailed analysis of six commercial ECHINACEA liquid preparations, with emphasis on the metabolomic characterisation of the ECHINACEA compounds responsible for inhibiting CYP3A4. We separated each preparation into its ethanol- and water-soluble components, and then used (1)H-NMR together with multivariate data analysis and partial least square regression analysis to investigate the nature of the compounds responsible for CYP3A4 inhibition. The results implicated alkylamides in the CYP3A4 inhibitory activity of ECHINACEA. One of the commercial preparations (Echinaforce(R)) was further fractionated using solid phase extraction. Analysis by (1)H-NMR and mass spectroscopy (LC/MS, tandem MS, accurate mass) identified dodeca-2 E,4 E,8 Z,10 E/Z-tetraenoic acid (alkylamide 1) and a new compound (putative molecular formula C (18)H (36) NO (+)) as major components of the inhibitory fractions. In addition, the alkylamide content of all six preparations was determined by reverse phase HPLC. Levels of alkylamides 1 and 3 (undeca-2 E,4 E/ Z-diene-8,10-diynoic acid isobutylamide), correlated well with CYP3A4 inhibition. The acetylene tetradeca-8 Z-ene-11,13-diyn-2-one was shown to be present in the E. PURPUREA as well as the E. PALLIDA extracts. E. PURPUREA unlike E. PALLIDA was thought to not contain significant amounts of acetylenes. Our results directly confirm the role of alkylamides in the inhibition of CYP3A4 by ECHINACEA and uncovered a new compound which may also be involved. Extensive differences in the composition of the commercially available preparations were found. This will inevitably impact on the product efficacy, safety and

  19. Children's (Pediatric) Nuclear Medicine

    Medline Plus

    Full Text Available ... News Physician Resources Professions Site Index A-Z Children's (Pediatric) Nuclear Medicine Children’s (pediatric) nuclear medicine imaging ... the limitations of Children's Nuclear Medicine? What is Children's (Pediatric) Nuclear Medicine? Nuclear medicine is a branch ...

  20. Children's (Pediatric) Nuclear Medicine

    Medline Plus

    Full Text Available ... Physician Resources Professions Site Index A-Z Children's (Pediatric) Nuclear Medicine Children’s (pediatric) nuclear medicine imaging uses ... limitations of Children's Nuclear Medicine? What is Children's (Pediatric) Nuclear Medicine? Nuclear medicine is a branch of ...

  1. Children's (Pediatric) Nuclear Medicine

    Medline Plus

    Full Text Available ... Resources Professions Site Index A-Z Children's (Pediatric) Nuclear Medicine Children’s (pediatric) nuclear medicine imaging uses small ... of Children's Nuclear Medicine? What is Children's (Pediatric) Nuclear Medicine? Nuclear medicine is a branch of medical ...

  2. Children's (Pediatric) Nuclear Medicine

    Science.gov (United States)

    ... Professions Site Index A-Z Children's (Pediatric) Nuclear Medicine Children’s (pediatric) nuclear medicine imaging uses small amounts ... Children's Nuclear Medicine? What is Children's (Pediatric) Nuclear Medicine? Nuclear medicine is a branch of medical imaging ...

  3. General Nuclear Medicine

    Science.gov (United States)

    ... Resources Professions Site Index A-Z General Nuclear Medicine Nuclear medicine imaging uses small amounts of radioactive ... of General Nuclear Medicine? What is General Nuclear Medicine? Nuclear medicine is a branch of medical imaging ...

  4. Children's (Pediatric) Nuclear Medicine

    Medline Plus

    Full Text Available ... Professions Site Index A-Z Children's (Pediatric) Nuclear Medicine Children’s (pediatric) nuclear medicine imaging uses small amounts ... Children's Nuclear Medicine? What is Children's (Pediatric) Nuclear Medicine? Nuclear medicine is a branch of medical imaging ...

  5. Special Section: Complementary and Alternative Medicine (CAM):Quiz on Complementary and Alternative Medicine

    Science.gov (United States)

    ... Special Section CAM Quiz on Complementary and Alternative Medicine Past Issues / Winter 2009 Table of Contents For ... low back pain. True False Complementary and alternative medicine (CAM) includes: Meditation Chiropractic Use of natural products, ...

  6. Control of the development and prevalence of antimicrobial resistance in bacteria of food animal origin in Japan: a new approach for risk management of antimicrobial veterinary medicinal products in Japan.

    Science.gov (United States)

    Asai, Tetsuo; Hiki, Mototaka; Ozawa, Manao; Koike, Ryoji; Eguchi, Kaoru; Kawanishi, Michiko; Kojima, Akemi; Endoh, Yuuko S; Hamamoto, Shuichi; Sakai, Masato; Sekiya, Tatsuro

    2014-03-01

    Antimicrobial agents are essential for controlling bacterial disease in food-producing animals and contribute to the stable production of safe animal products. The use of antimicrobial agents in these animals affects the emergence and prevalence of antimicrobial resistance in bacteria isolated from animals and animal products. As disease-causing bacteria are often transferred from food-producing animals to humans, the food chain is considered a route of transmission for the resistant bacteria and/or resistance genes. The Food Safety Commission of Japan (FSC) has been assessing the risk posed to human health by the transmission of antimicrobial-resistant bacteria from livestock products via the food chain. In addition to the FSC's risk assessments, the Japanese Ministry of Agriculture, Forestry and Fisheries has developed risk-management guidelines to determine feasible risk-management options for the use of antimicrobial veterinary medicinal products during farming practices. This report includes information on risk assessment and novel approaches for risk management of antimicrobial veterinary medicinal products for mitigating the risk of development and prevalence of antimicrobial resistance in bacteria originating from food-producing animals in Japan.

  7. Technetium in chemistry and nuclear medicine

    International Nuclear Information System (INIS)

    Deutsch, E.; Nicolini, M.; Wagner, H.N.

    1983-01-01

    This volume explores the potential of technetium radiopharmaceuticals in clinical nuclear medicine. The authors examine the capabilities of synthetic inorganic chemists to synthesize technetium radiopharmaceuticals and the specific requirements of the nuclear medicine practitioner. Sections cover the chemistry of technetium, the production of radiopharmaceuticals labeled with technetium, and the use of technetium radiopharmaceuticals in nuclear medicine

  8. Toxicities by herbal medicines with emphasis to traditional Chinese medicine.

    Science.gov (United States)

    Efferth, Thomas; Kaina, Bernd

    2011-12-01

    It is estimated that three quarters of the world population rely on herbal and traditional medicine as a basis for primary health care. Therefore, it is one of the most important and challenging tasks for scientists working in drug research to investigate the efficacy of herbal medicine, to dissect favorable from adverse effects, to identify active principles in medicinal plants and to ban poisonous plants or contaminations from herbal mixtures. In the present review, some problems are critically discussed. Botanical misidentification or mislabeling of plant material can play a role for toxic reactions in humans. Some plant descriptions in traditional herbal medicine (e.g. traditional Chinese medicine) have changed over time, which may lead to unintended intoxication by using wrong plants. A problem is also the contamination of herbals with microorganisms, fungal toxins such as aflatoxin, with pesticides and heavy metals. Unprofessional processing, which differs from safe traditional preparation represents another potential source for herbal poisoning. Unwanted effects of herbal products may also develop by the interaction of herbs with conventional drugs upon concomitant intake. The art of herbal medicine is to dissect pharmacologically and therapeutically valuable herbal drugs from harmful and toxic ones and to develop combinations of medicinal plants as safe and efficient herbal remedies. Standardization and strict control measures are necessary to monitor sustainable high quality of herbal products and to exclude contaminations that badly affect patients consuming herbal medicine.

  9. Medicinal Mushrooms

    NARCIS (Netherlands)

    Lindequist, U.; Won Kim, H.; Tiralongo, E.; Griensven, van L.J.L.D.

    2014-01-01

    Since beginning of mankind nature is the most important source of medicines. Bioactive compounds produced by living organisms can be used directly as drugs or as lead compounds for drug development. Besides, the natural material can be used as crude drug for preparation of powder or extracts. Plants

  10. Medicinal Plants.

    Science.gov (United States)

    Phillipson, J. David

    1997-01-01

    Highlights the demand for medicinal plants as pharmaceuticals and the demand for health care treatments worldwide and the issues that arise from this. Discusses new drugs from plants, anticancer drugs, antiviral drugs, antimalarial drugs, herbal remedies, quality, safety, efficacy, and conservation of plants. Contains 30 references. (JRH)

  11. Predictive medicine

    NARCIS (Netherlands)

    Boenink, Marianne; ten Have, Henk

    2015-01-01

    In the last part of the twentieth century, predictive medicine has gained currency as an important ideal in biomedical research and health care. Research in the genetic and molecular basis of disease suggested that the insights gained might be used to develop tests that predict the future health

  12. Bioenergetic medicine

    Science.gov (United States)

    Swerdlow, Russell H

    2014-01-01

    Here we discuss a specific therapeutic strategy we call ‘bioenergetic medicine’. Bioenergetic medicine refers to the manipulation of bioenergetic fluxes to positively affect health. Bioenergetic medicine approaches rely heavily on the law of mass action, and impact systems that monitor and respond to the manipulated flux. Since classically defined energy metabolism pathways intersect and intertwine, targeting one flux also tends to change other fluxes, which complicates treatment design. Such indirect effects, fortunately, are to some extent predictable, and from a therapeutic perspective may also be desirable. Bioenergetic medicine-based interventions already exist for some diseases, and because bioenergetic medicine interventions are presently feasible, new approaches to treat certain conditions, including some neurodegenerative conditions and cancers, are beginning to transition from the laboratory to the clinic. Linked Articles This article is part of a themed issue on Mitochondrial Pharmacology: Energy, Injury & Beyond. To view the other articles in this issue visit http://dx.doi.org/10.1111/bph.2014.171.issue-8 PMID:24004341

  13. Personalized medicine

    DEFF Research Database (Denmark)

    Bendtzen, Klaus

    2013-01-01

    engineered anti-TNF-alpha antibody constructs now constitute one of the heaviest medicinal expenditures in many countries. All currently used TNF antagonists may dramatically lower disease activity and, in some patients, induce remission. Unfortunately, however, not all patients respond favorably, and safety...

  14. Technology and medicine.

    Science.gov (United States)

    Booth, C

    1985-05-22

    Technology, which is older than science, has been of vital importance in the development of modern medicine. Even so, there are voices of dissent to be heard. The disenchantment with technology expressed by Aldous Huxley in Brave new world has been echoed by contemporary writers on the technology of modern medicine. Medicine is seen by some to have been dehumanized by technology, and techniques that are expensive are thought to be consuming a greater proportion of health resources than they deserve. The practice of medicine has, nevertheless, been transformed by modern technology and diagnostic techniques and therapeutic measures undreamed of a few short decades ago are now commonplace. There is no reason why these developments should be any more dehumanizing than the use of similar techniques in modern transportation or communication, nor is their expense out of proportion when compared with other demands on the nation's purse. British workers have been at the forefront of many recent advances. Yet, even though the National Health Service provides a ready market for the products of British medical technology, the nation depends to an inordinate degree on imported products. In the development of appropriate medical technology there is an urgent need for better communication between inventors, scientists, industrialists and the National Health Service. At the same time there is an equal need for improved evaluation of untried techniques. The pressure for a central integrating body to coordinate resources could well be supported by the establishment of evaluation units in the different health authorities in this country.

  15. Clinical effects produced by a standardized herbal medicinal product of Hibiscus sabdariffa on patients with hypertension. A randomized, double-blind, lisinopril-controlled clinical trial.

    Science.gov (United States)

    Herrera-Arellano, Armando; Miranda-Sánchez, Judith; Avila-Castro, Pedro; Herrera-Alvarez, Sara; Jiménez-Ferrer, Jesús Enrique; Zamilpa, Alejandro; Román-Ramos, Rubén; Ponce-Monter, Héctor; Tortoriello, Jaime

    2007-01-01

    Hibiscus sabdariffa L. (Malvaceae) has been used in different countries as an antihypertensive. Pharmacological work has demonstrated that this effect is probably produced by a diuretic activity and inhibition of the angiotensin-converting enzyme (ACE). Two clinical trials have confirmed the antihypertensive effect using watery infusions, in which a natriuretic effect was also detected. To compare therapeutic effectiveness, tolerability, and safety, as well as the effect on serum electrolytes and the ACE inhibitory effect of a herbal medicinal product prepared from the dried extract of H. sabdariffa calyxes (HsHMP) with those of lisinopril on patients with hypertension (HT), a randomized, controlled, and double-blind clinical trial was conducted. Patients of either sex, 25 - 61 years of age, with hypertension stage I or II, were daily treated for 4 weeks with the HsHMP, 250 mg of total anthocyanins per dose (experimental group), or 10 mg of lisinopril (control group). Outcome variables included effectiveness (diastolic blood pressure [DBP] reduction, >or= 10 mmHg), safety (absence of pathological modifications in the biochemical tests of hepatic and renal function), tolerability (absence of intense side effects), effect on serum electrolytes, and effect on ACE activity. Basal analysis included 193 subjects (100 in the experimental group), while outcome variable analysis integrated 171. Results showed that the experimental treatment decreased blood pressure (BP) from 146.48/97.77 to 129.89/85.96 mmHg, reaching an absolute reduction of 17.14/11.97 mmHg (11.58/12.21%, p < 0.05). The experimental treatment showed therapeutic effectiveness of 65.12 % as well as tolerability and safety of 100 %. BP reductions and therapeutic effectiveness were lower than those obtained with lisinopril (p < 0.05). Under the experimental treatment, the serum chlorine level increased from 91.71 to 95.13 mmol/L (p = 0.0001), the sodium level showed a tendency to decrease (from 139.09 to 137

  16. Essentials of nuclear medicine physics and instrumentation

    CERN Document Server

    Powsner, Rachel A; Powsner, Edward R

    2013-01-01

    An excellent introduction to the basic concepts of nuclear medicine physics This Third Edition of Essentials of Nuclear Medicine Physics and Instrumentation expands the finely developed illustrated review and introductory guide to nuclear medicine physics and instrumentation. Along with simple, progressive, highly illustrated topics, the authors present nuclear medicine-related physics and engineering concepts clearly and concisely. Included in the text are introductory chapters on relevant atomic structure, methods of radionuclide production, and the interaction of radiation with matter. Fu

  17. [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.

  18. [Medicine after Galen].

    Science.gov (United States)

    Mazzini, Innocenzo

    2012-01-01

    The article briefly traces the history of medicine in late antiquity, from Galen's death to the end of VIth century until the early VII century AD; it examines the medical literature, medical writers, anonymous literary production - synthesis of previous literature - recipe books and collections of simple drugs, comments, specialist books and literature in translation, the main characteristics of medical practice and training, and finally the influence of Christianity on the formation of scientific thought and on the new vocabulary of medical language.

  19. Environmental medicine

    International Nuclear Information System (INIS)

    Steneberg, A.

    1996-01-01

    'Environmental medicine' deals with the manifold health problems from environmental factors of chemical, physical and psychosocial origin that are possible or have been observed. The book gives insight into the current state of knowledge of environmental medicine institutions, possibilities of diagnosis and therapeutic methods. It offers a systematic overview of pollutant sources and pollutant effects and points out, inter alia, syndromes that are discussed in connection with environmental factors: not only allergies and carcinogenous diseases but also symptom complexes that are hard to diagnose by ordinary methods such as the sick-building syndrome, multiple sensitivity to chemicals, electrosensitivity, amalgam intoxications, disorders due to wood preservatives and fungal diseases. The lingering course of a disease and a set of symptoms varying from one patient to another are the rule, not the exception, because environmental diseases are due above all to the chronic uptake of low pollutant doses (orig./MG) [de

  20. Transfusion Medicine

    Directory of Open Access Journals (Sweden)

    Smit Sibinga CT

    2013-07-01

    Full Text Available Cees Th. Smit Sibinga ID Consulting, Zuidhorn, The NetherlandsTransfusion Medicine is a bridging science, spanning the evidence-based practice at the bedside with the social sciences in the community.     Transfusion Medicine starts at the bedside. Surprisingly, only recently that has become rediscovered with the development of ‘patient blood management’ and ‘patient centered’ approaches to allow the growth of an optimal and rational patient care through supportive hemotherapy – safe and effective, affordable and accessible.1    Where transfusion of blood found its origin in the need of a patient, it has drifted away for a long period of time from the bedside and has been dominated for almost a century by laboratory sciences. At least the first ten editions of the famous and well reputed textbook Mollison’s Blood Transfusion in Clinical Medicine contained only a fraction on the actual bedside practice of transfusion medicine and did not focus at all on patient blood management.2    This journal will focus on all aspects of the transfusion chain that immediately relate to the bedside practice and clinical use of blood and its components, and plasma derivatives as integral elements of a human transplant tissue. That includes legal and regulatory aspects, medical, ethical and cultural aspects, pure science and pathophysiology of disease and the impact of transfusion of blood, as well as aspects of the epidemiology of blood transfusion and clinical indications, and cost-effectiveness. Education through timely and continued transfer of up to date knowledge and the application of knowledge in clinical practice to develop and maintain clinical skills and competence, with the extension of current educational approaches through e-learning and accessible ‘apps’ will be given a prominent place.

  1. 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...

  2. Transfusion medicine

    International Nuclear Information System (INIS)

    Murawski, K.; Peetoom, F.

    1986-01-01

    These proceedings contain 24 selections, including papers presented at the conference of American Red Cross held in May 1985, on the Subject of transfusion medicine. Some of the titles are: Fluosol/sup R/-DA in Radiation Therapy; Expression of Cloned Human Factor VIII and the Molecular Basis of Gene Defects that Cause Hemophilia; DNA-Probing Assay in the Detection of Hepatitis B Virus Genome in Human Peripheral Blood Cells; and Monoclonal Antibodies: Convergence of Technology and Application

  3. Medicinal Herbs Affecting Gray Hair in Iranian Traditional Medicine.

    Science.gov (United States)

    Rameshk, Maryam; Khandani, Shahram Kalantari; Raeiszadeh, Mahboobeh

    2016-05-01

    The presence of hair plays an important role in people's overall physical appearance and self-perception. As a result of increased life expectancy, the desire to look youthful plays a bigger role than ever.The use of medicinal plants is as old as mankind and the market will face many new products containing natural oils and herbs in coming years. In traditional Iranian medicine, many plants and herbal formulations are reported for hair growth as well as the improvement in hair quality. The aim of this article is to introduce effective medicinal plants in traditional Iranian medicine to prevent gray hair and advocate them as the new products. The present investigation is an overview study and has been codified by library search in the main sources of traditional Iranian medicine. In traditional Iranian medicine, three types of formulations are proposed to prevent gray hair, namely (i) treatment compounds, (ii) preventive compounds, and (iii) hair dyes to color gray hairs. Our search showed that the main parts of a plant that is used in the treatment and preventive compounds are seeds and fruits. These are primarily in the form of topical oil or oral compound (electuary). The majority of plant parts used in hair dyes is from the fruit and/or leaves. Natural products are highly popular and the use of plant extracts in formulations is on the rise. This is because synthetic based product may cause health hazards with several side effects. Considering the increased popularity of herbal drugs in hair care, it is worthwhile to conduct systemic investigation on the production and efficacy of these drugs. We trust that our investigation would encourage the use of traditional Iranian medicine in future hair care products.

  4. First principles of Hamiltonian medicine.

    Science.gov (United States)

    Crespi, Bernard; Foster, Kevin; Úbeda, Francisco

    2014-05-19

    We introduce the field of Hamiltonian medicine, which centres on the roles of genetic relatedness in human health and disease. Hamiltonian medicine represents the application of basic social-evolution theory, for interactions involving kinship, to core issues in medicine such as pathogens, cancer, optimal growth and mental illness. It encompasses three domains, which involve conflict and cooperation between: (i) microbes or cancer cells, within humans, (ii) genes expressed in humans, (iii) human individuals. A set of six core principles, based on these domains and their interfaces, serves to conceptually organize the field, and contextualize illustrative examples. The primary usefulness of Hamiltonian medicine is that, like Darwinian medicine more generally, it provides novel insights into what data will be productive to collect, to address important clinical and public health problems. Our synthesis of this nascent field is intended predominantly for evolutionary and behavioural biologists who aspire to address questions directly relevant to human health and disease.

  5. Productivity

    DEFF Research Database (Denmark)

    Spring, Martin; Johnes, Geraint; Hald, Kim Sundtoft

    Productivity is increasingly critical for developed economies. It has always been important: as Paul Krugman puts it, “Productivity isn’t everything, but in the long run it is almost everything. A country’s ability to improve its standard of living over time depends almost entirely on its ability...... to raise its output per worker”(Krugman, 1994). Analyses of productivity have, by and large, been the preserve of economists. Operations Management (OM) is rooted in a similar concern for the efficient use of scarce resources; Management Accounting (MA) is concerned with the institutionalised measurement...... and management of productivity. Yet the three perspectives are rarely connected. This paper is a sketch of a literature review seeking to identify, contrast and reconcile these three perspectives. In so doing, it aims to strengthen the connections between policy and managerial analyses of productivity....

  6. Pregnancy and Medicines

    Science.gov (United States)

    Not all medicines are safe to take when you are pregnant. Some medicines can harm your baby. That includes over-the- ... care provider before you start or stop any medicine. Not using medicine that you need may be ...

  7. Buying & Using Medicine Safely

    Science.gov (United States)

    ... health professionals to make the best medicine choices, buy safely, and use medicine so it's as safe ... Antibiotics and Antibiotic Resistance Buying Medicines Over the Internet BeSafeRx: Know Your Online Pharmacy Buying Medicine from ...

  8. Complementary and Alternative Medicine

    Science.gov (United States)

    ... for Educators Search English Español Complementary and Alternative Medicine KidsHealth / For Teens / Complementary and Alternative Medicine What's ... a replacement. How Is CAM Different From Conventional Medicine? Conventional medicine is based on scientific knowledge of ...

  9. Medical doctors profile in Ethiopia: production, attrition and retention. In memory of 100-years Ethiopian modern medicine & the new Ethiopian millennium.

    Science.gov (United States)

    Berhan, Yifru

    2008-01-01

    Although the practice of western medicine in Ethiopia dates back to the time of King Libne Dengel (1520-1535), organized and sustainable modern medical practice started after the battle of Adwa (1896). To review hospitals construction, medical doctors production and attrition, and to suggest alternative medical doctors retention mechanisms in the public sector and production scale up options. In this article, 100 years Ethiopian modern medical history is revised from old and recent medical chronicles. Until December 2006 primary data was collected from 87 public hospitals. Much emphasis is given to medical doctors profile (1906-2006), hospitals profile (1906-2005), medical doctors to population and hospitals ratio (1965-2006), Ethiopian public medical schools 42 years attainment (1964-2006), annual attrition rate (1984-2006), organizational structure of medical faculties & university hospitals, medical doctors remuneration by the Ministry of Health (MOH), Ministry of Education (MOE), NGOs and private health institutions. This article also addresses the way forward from physician training and retention perspectives, multiple alternate mechanisms to increase physicians' motivation to work in government institutions and reveres the loss. Medical doctors production scale up option is also given much emphasis. Most data are presented using line and bar graphs. Literature review showed that the first three hospitals were constructed in 1896 (Russian hospital), 1903 (Harar Ras Mekonnen hospital) and 1906 (Menelik II hospital). In 2005, 139 hospitals (87 public and 52 others) were reported. Remarkable hospital construction was done between 1935 and 1948, and recently between 1995 and 2005; however, in the latter case, private hospitals construction took the lions share. By the time MOH was established (1948), 110 Ethiopian and expatriate medical doctors were working, mainly in the capital, and 46 hospitals constructed. Physician number increment was very slow till 1980 at

  10. 21 CFR 26.4 - Product coverage.

    Science.gov (United States)

    2010-04-01

    ...), investigational medicinal products/new drugs, human radiopharmaceuticals, and medicinal gases are also excluded... this subpart will apply to medicinal products for human or animal use, intermediates and starting...

  11. Personalized medicine

    DEFF Research Database (Denmark)

    Bendtzen, Klaus

    2013-01-01

    engineered anti-TNF-alpha antibody constructs now constitute one of the heaviest medicinal expenditures in many countries. All currently used TNF antagonists may dramatically lower disease activity and, in some patients, induce remission. Unfortunately, however, not all patients respond favorably, and safety...... of TNF antagonists as this allows therapies tailored according to individual requirements rather than the current universal approach to diagnosis. The objective of the present review is to discuss the reasons for recommending theranostics to implement an individualized use of TNF antagonists...

  12. Mountain medicin

    DEFF Research Database (Denmark)

    Bay, Bjørn; Hjuler, Kasper Fjellhaugen

    2016-01-01

    Travelling to high altitudes is an increasingly popular form of recreational holiday. Individual medical advice may be essential for certain groups of individuals such as patients with chronic disorders, pregnant women or children. This is the second part in a series of two articles on mountain...... medicine. The first part covered high-altitude physiology and medical aspects of objective alpine dangers and the increased exposure to ultraviolet radiation. This part covers altitude sickness, fluid balance, nutrition, and precautions for patients with pre-existing medical conditions, pregnant women...

  13. Deadly medicine.

    Science.gov (United States)

    Bachrach, Susan

    2007-01-01

    This article discusses the methods the United States Holocaust Memorial Museum used to make an exhibition on the complex history of Nazi eugenics accessible to the museum's mass public and at the same time, provocative for special audiences consisting of professionals and students from the biomedical fields. Deadly Medicine: Creating the Master Race showed how both eugenics and related "euthanasia" programs in Nazi Germany helped pave the road to the Holocaust. The exhibition implicitly evoked the present-day appeal of biological explanations for human behavior and of new visions of human perfection. Educational programs used the exhibition as a springboard for discussions of bioethics and medical ethics.

  14. Armenian medicine and diseases of the kidney.

    Science.gov (United States)

    Eknoyan, Garabed

    2009-01-01

    The history of Armenian medicine is that of the common practice of medicine in caring for the sick through the ages, using mainly local medicinal herbs and natural products. Over the years, its practitioners persistently collected and recorded an expanding body of information on therapeutics and put it to use for the daily medical care of ordinary folks. Armenian medicine developed around the church and monasteries, which flourished during episodic periods of peace in an otherwise tumultuous and warring region. However, unlike the monastic medicine that developed in Europe, Armenian medicine maintained the rationality it had acquired from Greek medicine, and never resorted to magic, myth or amulets. Nor did it acquire or import saints. Armenian medicine is a classic example of the evolving art of therapeutics, whose record is preserved in extant manuscripts, saved over the centuries in monasteries, and now preserved in accessible collections.

  15. [The role of German official medicines control laboratories in combating counterfeit medicines].

    Science.gov (United States)

    Wiegard, Andrea; Heuermann, Matthias

    2017-11-01

    An official medicines control laboratory (OMCL) provides an important contribution to combat counterfeit and illegal medicines. The OMCL supports the competent authorities in controlling the quality of authorised medicinal products in the legal supply chain. For detecting counterfeit medicines in the legal supply chain, a risk-based approach in choice of products is conducted. Furthermore, the OMCL analyses suspicious medicines from the illegal supply chain for any other authority. The chemical analysis of a suspicious sample is needed to identify such a sample as a counterfeit medicine. The analytical results are fundamental for the evaluation of the legal status of the product and for the assessment of it's inherent hazard to public health. The global market of illegal medicines is rapidly changing. Therefore a good national and international working liaison and co-operation between laboratories and authorities is obligatory to protect public health. The OMCL provides important knowledge of new trends in counterfeit and illegal medicines. Hence, it is an essential part in surveillance of medicinal products. The efficient networking enables prompt official interventions. Thus, risks for the public health by substandard medicines were reduced. Beside the chemical analysis, the OMCL can help to raise public awareness about counterfeit and illegal medicines. In Germany, the risk of counterfeit medicines reaching patients through the legal supply chain is still low, but the possibility cannot be ignored.

  16. Off-Label Prescription of Genetically Modified Organism Medicines in Europe : Emerging Conflicts of Interest?

    NARCIS (Netherlands)

    Schagen, Frederik H. E.; Hoeben, Rob C.; Hospers, Geke A. P.

    2014-01-01

    Recently, the first human medicine containing a genetically modified organism (GMO medicine) was authorized for use in the European market. Just as any medicinal product, the market authorization for a GMO medicine contains a precise description of the therapeutic use for which the medicinal product

  17. Nuclear medicine

    International Nuclear Information System (INIS)

    James, A.E. Jr.; Squire, L.F.

    1977-01-01

    The book presents a number of fundamental imaging principles in nuclear medicine. The fact that low radiation doses are sufficient for the study of normal and changed physiological functions of the body is an important advancement brought about by nuclear medicine. The possibility of quantitative investigations of organs and organ regions and of an assessment of their function as compared to normal values is a fascinating new diagnostic dimension. The possibility of comparing the findings with other pathological findings and of course control in the same patient lead to a dynamic continuity with many research possibilities not even recognized until now. The limits of nuclear scanning methods are presented by the imprecise structural information of the images. When scintiscans are compared with X-ray images or contrast angiography, the great difference in the imaging of anatomical details is clearly seen. But although the present pictures are not optimal, they are a great improvement on the pictures that were considered clinically valuable a few years ago. (orig./AJ) [de

  18. World Health Organization Ranking of Antimicrobials According to Their Importance in Human Medicine: A Critical Step for Developing Risk Management Strategies to Control Antimicrobial Resistance From Food Animal Production.

    Science.gov (United States)

    Collignon, Peter C; Conly, John M; Andremont, Antoine; McEwen, Scott A; Aidara-Kane, Awa; Agerso, Yvonne; Andremont, Antoine; Collignon, Peter; Conly, John; Dang Ninh, Tran; Donado-Godoy, Pilar; Fedorka-Cray, Paula; Fernandez, Heriberto; Galas, Marcelo; Irwin, Rebecca; Karp, Beth; Matar, Gassan; McDermott, Patrick; McEwen, Scott; Mitema, Eric; Reid-Smith, Richard; Scott, H Morgan; Singh, Ruby; DeWaal, Caroline Smith; Stelling, John; Toleman, Mark; Watanabe, Haruo; Woo, Gun-Jo

    2016-10-15

    Antimicrobial use in food animals selects for antimicrobial resistance in bacteria, which can spread to people. Reducing use of antimicrobials-particularly those deemed to be critically important for human medicine-in food production animals continues to be an important step for preserving the benefits of these antimicrobials for people. The World Health Organization ranking of antimicrobials according to their relative importance in human medicine was recently updated. Antimicrobials considered the highest priority among the critically important antimicrobials were quinolones, third- and fourth-generation cephalosporins, macrolides and ketolides, and glycopeptides. The updated ranking allows stakeholders in the agriculture sector and regulatory agencies to focus risk management efforts on drugs used in food animals that are the most important to human medicine. In particular, the current large-scale use of fluoroquinolones, macrolides, and third-generation cephalosporins and any potential use of glycopeptides and carbapenems need to be addressed urgently. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  19. Interpretive Medicine

    Science.gov (United States)

    Reeve, Joanne

    2010-01-01

    Patient-centredness is a core value of general practice; it is defined as the interpersonal processes that support the holistic care of individuals. To date, efforts to demonstrate their relationship to patient outcomes have been disappointing, whilst some studies suggest values may be more rhetoric than reality. Contextual issues influence the quality of patient-centred consultations, impacting on outcomes. The legitimate use of knowledge, or evidence, is a defining aspect of modern practice, and has implications for patient-centredness. Based on a critical review of the literature, on my own empirical research, and on reflections from my clinical practice, I critique current models of the use of knowledge in supporting individualised care. Evidence-Based Medicine (EBM), and its implementation within health policy as Scientific Bureaucratic Medicine (SBM), define best evidence in terms of an epistemological emphasis on scientific knowledge over clinical experience. It provides objective knowledge of disease, including quantitative estimates of the certainty of that knowledge. Whilst arguably appropriate for secondary care, involving episodic care of selected populations referred in for specialist diagnosis and treatment of disease, application to general practice can be questioned given the complex, dynamic and uncertain nature of much of the illness that is treated. I propose that general practice is better described by a model of Interpretive Medicine (IM): the critical, thoughtful, professional use of an appropriate range of knowledges in the dynamic, shared exploration and interpretation of individual illness experience, in order to support the creative capacity of individuals in maintaining their daily lives. Whilst the generation of interpreted knowledge is an essential part of daily general practice, the profession does not have an adequate framework by which this activity can be externally judged to have been done well. Drawing on theory related to the

  20. Conservation Medicine, Ecology of Diseases and Veterinary Medicine

    Directory of Open Access Journals (Sweden)

    Rosa María Viviana Gómez Carrillo

    2014-08-01

    Full Text Available Conservation Medicine, Ecology of Diseases and Veterinary Medicine are intertwined in investigative processes and provide solutions to problems affecting both human and animal health. On this issue, it is known that infectious diseases affect the welfare of humans and animals; in this regard, it has been found that 75 %  of zoonotic diseases have origins in wild animals and 60 % of infectious diseases in humans are zoonotic. The foregoing puts at risk human populations because of emerging and reemerging diseases; also it affects livestock production by reducing the quality and quantity of products and manages to disrupt wildlife populations by decimating the species, which can sometimes reach extinction.

  1. [Ecological protection of medicinal woody plants].

    Science.gov (United States)

    Yan, Xiufeng

    2003-09-01

    Medicinal woody plants, especially medicinal tall trees, play a same important role in forest structure, ecological balance and timber production as other tree species in forest, and due to their additional medicinal values overuse of these trees is more intensive than others. Many medicinal materials are destructively obtained from plants such as roots or bark used as medicinal materials. The contradiction between the utilization and protection of medicinal woody plants becomes more and more incisive. In the present paper, based on the analysis of the utilized situation and specialty of medicinal woody plants, the trouble between the plants protection and utilization was observed, the method to solve it and the fundamental research work needs to be developed were discussed. The following aspects of researches were suggested to be conducted: (a) study on the distribution in organs, seasonal and age variations, and correlation with environmental factors of principal medicinal compositions in mature trees to clear the optimum of harvest and cultivation conditions; (b) study on the distribution in organs, seasonal and age variations, and correlation with environmental factors of principal medicinal compositions in saplings, especially the time course of the variation in medicinal compositions and biomass to achieve the optimal tree ages for the balance between biomass and production of medicinal products during saplings development; (c) study on the influence and regulation of environmental factors on medicinal compounds production in woody plants to look for the optimal cultivated conditions for optimizing the accumulation of biomass and medicinal chemicals; (d) further study on the regulatory mechanism of the induced production of main medicinal compositions by ecological factors at protein (key enzyme) and gene level to accumulate fundamental data for the enhancement of quality and quantity, and approach of new accesses to medicinal products using biological

  2. Marketing medicine.

    Science.gov (United States)

    Mellsop, G

    1988-02-10

    Medical etiquette has always discouraged advertising. Indeed, the profession as a whole has tended to view the idea of marketing medicine as at best, a trifle infra dig. Maintenance of this attitude has been helped by an ostrich like approach to the realities of private practice, and to the activities of drug companies, which have contributed significantly to our therapeutic abilities. The moves to corporatise and privatise institutions have raised the level of concern of our New Zealand medical profession. It is not self evident that the marketing concept as currently understood by the business community and by politicians is familiar to the medical profession. There must also be at least a level of suspicion that the business and financial world is insufficiently sensitive to the nuances and complexities of health service delivery. This paper will briefly explore those two viewpoints and consider the feasibility of any attempt to marry them.

  3. Narrativ medicin

    DEFF Research Database (Denmark)

    Hvas, Lotte; Getz, Linn

    2015-01-01

    Dagens allmänmedicin påverkas av ett växande managementtänkandetillsammans med fragmenterande ekonomiska incitament.Vårdens kvaliteter evalueras med nya metoder som ”värdebaseradvård” där värde räknas i kronor och ören. Produktion går före etik,och det intersubjektiva mötet mellan patient och läk...... läkare håller påatt nedvärderas. Perspektiven från narrativ medicin kan bidra tillatt visa vad som står på spel. Vilken blir annars berättelsen omallmänmedicinen?...

  4. production

    African Journals Online (AJOL)

    answered satisfactorily. An additional important factor in discouraging collaborative work in animal and grassland production is, without doubt, the complexity of work in this field compared with much of that in the individual discipline and, in particular, the com- plexity of work on forage as a source of nutrients for live- stock.

  5. Comercialização de plantas medicinais no contexto da cadeia produtiva em Minas Gerais Commercialization of medicinal plants in the context of the productive chain in Minas Gerais

    Directory of Open Access Journals (Sweden)

    M.R.M. Souza

    2012-01-01

    Full Text Available A Política Nacional de Práticas Integrativas e Complementares no Sistema Único de Saúde (SUS contribuiu para o incremento do uso e conhecimento das plantas medicinais brasileiras, incentivando e respaldando o cultivo por agricultores familiares e a inserção no mercado. O Programa de Desenvolvimento de Plantas Medicinais prioriza ações em toda a cadeia produtiva do cultivo à distribuição. O conhecimento da demanda e dos padrões de qualidade adequados permite que distribuidores e consumidores possam tomar decisões sobre a aquisição e oferta dos produtos medicinais. Entretanto, há carência de informações e tecnologias na cadeia produtiva, o que desfavorece o seu pleno desenvolvimento, condizente com o potencial de geração de renda e promoção da saúde. O objetivo deste trabalho foi identificar e analisar o padrão atual de obtenção e comercialização de plantas medicinais no Mercado Central de Belo Horizonte. Foram realizadas entrevistas semi-estruturadas com amostra representativa de 9 comerciantes das 23 lojas de plantas medicinais do Mercado Central, de acordo com o critério de acessibilidade descrito por Berquó. Os resultados demonstraram a precariedade desse setor quanto à obtenção das plantas medicinais, principalmente pela falta de conhecimento e informações na aquisição e venda dos produtos pelos consumidores e vendedores, respectivamente.The National Politic Integrative and complementary Practices in Health System (SUS contributed to the increased use and knowledge of Brazilian medicinal plants, which encourages and supports the growing of family farmers and their integration in efficient markets. The Program for the Development of Medicinal Plants prioritizes actions in the entire production chain from cultivation to distribution. Knowledge of demand and adequate quality standards allows distributors and consumers to make decisions on the acquisition and supply of medicinal products. However, there is a

  6. Statistical optimization of polysaccharide production by submerged cultivation of Lingzhi or Reishi medicinal mushroom, Ganoderma lucidum (W.Curt.: Fr.) P. Karst. MTCC 1039 (Aphyllophoromycetideae).

    Science.gov (United States)

    Baskar, Gurunathan; Sathya, Shree Rajesh K Lakshmi Jai; Jinnah, Riswana Begum; Sahadevan, Renganathan

    2011-01-01

    Response surface methodology was employed to optimize the concentration of four important cultivation media components such as cottonseed oil cake, glucose, NH4Cl, and MgSO4 for maximum medicinal polysaccharide yield by Lingzhi or Reishi medicinal mushroom, Ganoderma lucidum MTCC 1039 in submerged culture. The second-order polynomial model describing the relationship between media components and polysaccharide yield was fitted in coded units of the variables. The higher value of the coefficient of determination (R2 = 0.953) justified an excellent correlation between media components and polysaccharide yield, and the model fitted well with high statistical reliability and significance. The predicted optimum concentration of the media components was 3.0% cottonseed oil cake, 3.0% glucose, 0.15% NH4Cl, and 0.045% MgSO4, with the maximum predicted polysaccharide yield of 819.76 mg/L. The experimental polysaccharide yield at the predicted optimum media components was 854.29 mg/L, which was 4.22% higher than the predicted yield.

  7. The regulation of herbal medicines in Australia

    International Nuclear Information System (INIS)

    Briggs, David R.

    2002-01-01

    Complementary medicines, including herbal medicines in Australia are regulated under therapeutics goods legislation. Based on risk, Australia has developed a two tiered approach to the regulation of therapeutic goods. Listed medicines are considered to be of lower risk than Registered medicines. Most, but not all, complementary medicines are Listed medicines. Managing the risk associated with therapeutic goods, including complementary medicines, is exerted through the processes of licensing of manufacturers; pre-market assessment of products; and post-market regulatory activity. Herbal medicines may be associated with low or high risk depending on the toxicity of ingredients, proposed dosage, appropriateness of the indications and claims for self-diagnosis and management and the potential for adverse reactions. Registered medicines are individually evaluated for safety, quality and efficacy before they are released onto the market. Listed medicines are individually assessed by the Therapeutic Goods Administration for compliance with legislation, they are not evaluated before release. They may only be formulated from ingredients that have undergone pre-market evaluation for safety and quality and are considered low risk. Listed complementary medicines may only carry indications and claims for the symptomatic relief of non-serious conditions, health maintenance, health enhancement and risk reduction. An important feature of risk management in Australia is that early market access for low risk complementary medicines is supported by appropriate post-market regulatory activity

  8. Children's (Pediatric) Nuclear Medicine

    Medline Plus

    Full Text Available ... Resources Professions Site Index A-Z Children's (Pediatric) Nuclear Medicine Children’s (pediatric) nuclear medicine imaging uses small amounts ... of Children's Nuclear Medicine? What is Children's (Pediatric) Nuclear Medicine? Nuclear medicine is a branch of medical imaging ...

  9. Nanoscience in veterinary medicine.

    Science.gov (United States)

    Scott, N R

    2007-08-01

    Nanotechnology, as an enabling technology, has the potential to revolutionize veterinary medicine. Examples of potential applications in animal agriculture and veterinary medicine include disease diagnosis and treatment delivery systems, new tools for molecular and cellular breeding, identity preservation of animal history from birth to a consumer's table, the security of animal food products, major impact on animal nutrition scenarios ranging from the diet to nutrient uptake and utilization, modification of animal waste as expelled from the animal, pathogen detection, and many more. Existing research has demonstrated the feasibility of introducing nanoshells and nanotubes into animals to seek and destroy targeted cells. Thus, building blocks do exist and are expected to be integrated into systems over the next couple of decades on a commercial basis. While it is reasonable to presume that nanobiotechnology industries and unique developments will revolutionize veterinary medicine in the future, there is a huge concern, among some persons and organizations, about food safety and health as well as social and ethical issues which can delay or derail technological advancements.

  10. [Arsenic - Poison or medicine?].

    Science.gov (United States)

    Kulik-Kupka, Karolina; Koszowska, Aneta; Brończyk-Puzoń, Anna; Nowak, Justyna; Gwizdek, Katarzyna; Zubelewicz-Szkodzińska, Barbara

    2016-01-01

    Arsenic (As) is commonly known as a poison. Only a few people know that As has also been widely used in medicine. In the past years As and its compounds were used as a medicine for the treatment of such diseases as diabetes, psoriasis, syphilis, skin ulcers and joint diseases. Nowadays As is also used especially in the treatment of patients with acute promyelocytic leukemia. The International Agency for Research on Cancer (IARC) has recognized arsenic as an element with carcinogenic effect evidenced by epidemiological studies, but as previously mentioned it is also used in the treatment of neoplastic diseases. This underlines the specificity of the arsenic effects. Arsenic occurs widely in the natural environment, for example, it is present in soil and water, which contributes to its migration to food products. Long exposure to this element may lead to liver damages and also to changes in myocardium. Bearing in mind that such serious health problems can occur, monitoring of the As presence in the environmental media plays a very important role. In addition, the occupational risk of As exposure in the workplace should be identified and checked. Also the standards for As presence in food should be established. This paper presents a review of the 2015 publications based on the Medical database like PubMed and Polish Medical Bibliography. It includes the most important information about arsenic in both forms, poison and medicine. This work is available in Open Access model and licensed under a CC BY-NC 3.0 PL license.

  11. Research medicine

    International Nuclear Information System (INIS)

    Anon.

    1984-01-01

    In Section I of this annual report, a brief summary of work is presented by the Research Medicine Group. The major emphasis has been the study of the blood system in man with a special emphasis on the examination of platelet abnormalities in human disease. New programs of major importance include the study of aging or dementia of the Alzheimer's type. A differential diagnosis technique has been perfected using positron emission tomography. Studies on the biochemical basis of schizophrenia have proceeded using radioisotope studies which image physiological and biochemical processes. In the investigation of atherosclerosis, techniques have been developed to measure blood perfusion of the heart muscle by labelling platelets and lipoproteins. Progress is reported in a new program which uses NMR for both imaging and spectroscopic studies in humans. The group has determined through an epidemiological study that bubble chamber and cyclotron workers who have been exposed to high electromagnetic fields for two decades have no significant increases in the prevalence of 21 diseases as compared with controls

  12. Taking Medicines Safely After Alcohol or Drug Abuse Recovery

    Science.gov (United States)

    ... Insurance & Bills Self Care Working With Your Doctor Drugs, Procedures & Devices Over-the-counter Products Procedures & Devices ... for OthersFood PoisoningAcute Bronchitis Home Your Health Resources Drugs, Procedures & Devices Prescription Medicines Taking Medicines Safely after ...

  13. Chapter 5. Assessing the Aquatic Hazards of Veterinary Medicines

    Science.gov (United States)

    In recent years, there has been increasing awareness of the widespread distribution of low concentrations of veterinary medicine products and other pharmaceuticals in the aquatic environment. While aquatic hazard for a select group of veterinary medicines has received previous s...

  14. Medicines and You: A Guide for Older Adults

    Science.gov (United States)

    ... Tobacco Products Drugs Home Drugs Resources for You Medicines and You: A Guide for Older Adults Share ... What You Need to Know About Your Prescription Medicines The following questions will help you get the ...

  15. Antibacterial activity of five Peruvian medicinal plants against Pseudomonas aeruginosa

    Directory of Open Access Journals (Sweden)

    Gabriela Ulloa-Urizar

    2015-11-01

    Conclusions: The results of the present study scientifically validate the inhibitory capacity of the five medicinal plants attributed by their common use in folk medicine and contribute towards the development of new treatment options based on natural products.

  16. [Role of academic social networks in disseminating the scientific production of researchers in biology/medicine: the example of ResearchGate].

    Science.gov (United States)

    Boudry, Christophe; Bouchard, Aline

    2017-01-01

    Over time, academic social networks are more and more used by researchers, especially thanks to the possibilities of sharing articles they offer. The objective of the present study was to evaluate the proportion, the typology (pre-print, post-print author/publisher) and the legality of the full-text publications deposited by researchers on ResearchGate which is widely used by the medical and biological community, using a sample of 1,500 randomly selected articles in PubMed and published between 2013 and 2015. To compare, the access to the full-text of the 1500 articles via PubMed and PubMed Central has been assessed, putting into evidence the important role ResearchGate plays for providing full-texts of articles in biology/medicine. It also puts academic social networks into perspective in relation to open-access repositories and open access. © 2017 médecine/sciences – Inserm.

  17. Medicines by Design

    Science.gov (United States)

    ... Order Search the NIGMS Website Search the NIGMS Website NIGMS Home Research Funding Research Training News & Meetings Science Education About NIGMS NIGMS Home > Science Education > Medicines By Design Medicines By Design Spotlight Nature's Medicine Cabinet A ...

  18. Cough & Cold Medicine Abuse

    Science.gov (United States)

    ... Videos for Educators Search English Español Cough & Cold Medicine Abuse KidsHealth / For Teens / Cough & Cold Medicine Abuse ... resfriado Why Do People Use Cough and Cold Medicines to Get High? There's an ingredient in many ...

  19. Children's (Pediatric) Nuclear Medicine

    Medline Plus

    Full Text Available ... What are the limitations of Children's Nuclear Medicine? What is Children's (Pediatric) Nuclear Medicine? Nuclear medicine is ... this time is PET/MRI. top of page What are some common uses of the procedure? Children's ( ...

  20. Taking multiple medicines safely

    Science.gov (United States)

    ... medlineplus.gov/ency/patientinstructions/000883.htm Taking multiple medicines safely To use the sharing features on this ... directed. Why You May Need More Than One Medicine You may take more than one medicine to ...

  1. Managing Your Medicines

    Science.gov (United States)

    ... Disease Venous Thromboembolism Aortic Aneurysm More Managing Your Medicines Updated:Mar 8,2018 If you have heart ... Weight • Tools & Resources Heart Insight Supplement: Know Your Medicines Keeping track of your medicines can be overwhelming. ...

  2. Cold medicines and children

    Science.gov (United States)

    ... page: //medlineplus.gov/ency/patientinstructions/000942.htm Cold medicines and children To use the sharing features on ... children younger than age 4. About OTC Cold Medicines Cold medicines do not cure or shorten a ...

  3. Medicine safety and children

    Science.gov (United States)

    ... drain. Also, DO NOT toss medicines in the trash. DO NOT take your medicine in front of ... Accessed January 13, 2017. US Food and Drug Administration. How to dispose of unused medicines. FDA.gov. ...

  4. Depression - stopping your medicines

    Science.gov (United States)

    ... this page: //medlineplus.gov/ency/patientinstructions/000570.htm Depression - stopping your medicines To use the sharing features ... prescription medicines you may take to help with depression, anxiety, or pain. Like any medicine, there are ...

  5. Complementary and Integrative Medicine

    Science.gov (United States)

    ... medical treatments that are not part of mainstream medicine. When you are using these types of care, it may be called complementary, integrative, or alternative medicine. Complementary medicine is used together with mainstream medical ...

  6. Medicines, excipients and dietary intolerances.

    Science.gov (United States)

    2016-08-01

    Medicinal products contain not only active drugs but also other ingredients included for a variety of purposes and collectively known as excipients.(1) People who wish to avoid a specific substance because of an allergy or intolerance may ask a healthcare professional about the constituents of a medicine and whether an alternative is available. In a previous article we discussed the issues facing people who wish to avoid certain substances for religious or cultural reasons.(2) Here, we provide an overview of several dietary conditions and the pharmaceutical issues that need to be considered by healthcare professionals advising on the suitability of a medicine. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  7. Obstetric medicine

    Directory of Open Access Journals (Sweden)

    L. Balbi

    2013-05-01

    Full Text Available BACKGROUND Obstetric assistance made major advances in the last 20 years: improved surgical technique allows quicker caesarean sections, anaesthesiology procedures such as peripheral anaesthesia and epidural analgesia made safer operative assistance, remarkably reducing perioperative morbidity and mortality, neonatology greatly improved the results of assistance to low birth weight newborns. A new branch of medicine called “obstetric medicine” gained interest and experience after the lessons of distinguished physicians like Michael De Swiet in England. All together these advances are making successful pregnancies that 20 years ago would have been discouraged or even interrupted: that’s what we call high risk pregnancy. High risk of what? Either complications of pregnancy on pre-existing disease or complications of pre-existing disease on pregnancy. Nowadays, mortality in pregnancy has a medical cause in 80% of cases in Western countries (Confidential Enquiry on Maternal Deaths, UK, 2004. DISCUSSION The background is always changing and we have to take in account of: increase of maternal age; widespread use of assisted fertilization techniques for treatment of infertility; social feelings about maternity desire with increasing expectations from medical assistance; immigration of medically “naive” patients who don’t know to have a chronic disease, but apt and ready to conceive; limited knowledge of feasibility of drug use in pregnancy which may induce both patients and doctors to stopping appropriate drug therapy in condition of severe disease. Preconception counseling, planning the pregnancy, wise use of drugs, regular follow-up throughout the pregnancy and, in selected cases, preterm elective termination of pregnancy may result in excellent outcome both for mother and foetus. CONCLUSIONS Highly committed and specifically trained physicians are required to counsel these patients and to plan their treatment before and during pregnancy.

  8. Quantitative analysis of heavy metals in medicinal plants collected from environmentally diverse locations in India for use in a novel phytopharmaceutical product.

    Science.gov (United States)

    Sadhu, Ananya; Upadhyay, Prabhat; Singh, Praveen K; Agrawal, Aruna; Ilango, Kaliappan; Karmakar, Dipankar; Singh, Gur Prit Inder; Dubey, Govind Prasad

    2015-08-01

    It is important to monitor the quality of the phytopharmaceutical product as its therapeutic potential depends on standardized delivery of active ingredients present in the botanical source. Minimal presence of toxic impurities like heavy metals (HMs) is warranted to ensure product safety and prevent hazardous health impacts. In the present study, conducted as part of the development of a novel phytopharmaceutical product, the chemical profile of 13 heavy metals (Fe, Cu, Mn, Zn, Ni, Co, Mo, V, Cr, As, Pb, Hg, and Cd) was studied in the whole plant, fruit, and rhizome of Bacopa monnieri, Hippophae rhamnoides, and Dioscorea bulbifera, respectively, from environmentally diverse regions in India. Most samples had HM profiles within permissible limits as established by regulatory authorities, with the exception of Cd and Hg in low-altitude regions. This study indicates geographical regions in India suitable for procuring raw materials to develop and manufacture phytopharmaceutical products.

  9. Medicine and civilization; Iyaku to bunmei

    Energy Technology Data Exchange (ETDEWEB)

    Yamakawa, K. [Science Univ. of Tokyo, Tokyo (Japan). Faculty of Pharmaceutical Science

    1995-01-01

    When the human beings got together and have become to build a racial society, the civilization has become to prosper there. The medicine has carried out an important role from ancient times as the materials necessary for the human society, and therefore a great number of the crude drug such as the plant, animal and mineral has been used and were handed down. It can be said even that the human history has continued walking together with the medicine. The modern chemistry and modern pharmacy have been established after the 19th century has come. As a medical treatment drug for a disease and an external injury, the modern medicine has become to be recognized as the medicinal materials having efficacy, and moreover not as the faith and magic. The Industrial Revolution come into the world in Europe has been advanced by the mechanization and chemical engineering. The medicine production has become to be performed in an organic chemical industry, and consequently the products have been shifted gradually from the natural medicines such as the crude drugs to the synthetic medicines. The modern medicine has become to have a relation with from a scientific technology to the all information culture in human society. From a medicinal injury case of the investigational new drug occurred recently and so forth, in the medical treatment, the ethics and philosophy of the medicine and drug are strongly searched for.

  10. [Issues of large scale tissue culture of medicinal plant].

    Science.gov (United States)

    Lv, Dong-Mei; Yuan, Yuan; Zhan, Zhi-Lai

    2014-09-01

    In order to increase the yield and quality of the medicinal plant and enhance the competitive power of industry of medicinal plant in our country, this paper analyzed the status, problem and countermeasure of the tissue culture of medicinal plant on large scale. Although the biotechnology is one of the most efficient and promising means in production of medicinal plant, it still has problems such as stability of the material, safety of the transgenic medicinal plant and optimization of cultured condition. Establishing perfect evaluation system according to the characteristic of the medicinal plant is the key measures to assure the sustainable development of the tissue culture of medicinal plant on large scale.

  11. Medicines for osteoporosis

    Science.gov (United States)

    ... Teriparatide (Forteo); Denosumab (Prolia); Low bone density - medicines; Osteoporosis - medicines ... when: A bone density test shows you have osteoporosis, even if you have not had a fracture ...

  12. Medicines for sleep

    Science.gov (United States)

    Benzodiazepines; Sedatives; Hypnotics; Sleeping pills; Insomnia - medicines; Sleep disorder - medicines ... are commonly used to treat allergies. While these sleep aids are not addictive, your body becomes used ...

  13. Essential Medicines Are More Available than Other Medicines around the Globe

    Science.gov (United States)

    Bazargani, Yaser T.; Ewen, Margaret; de Boer, Anthonius; Leufkens, Hubert G. M.; Mantel-Teeuwisse, Aukje K.

    2014-01-01

    Background The World Health Organization (WHO) promotes the development of national Essential Medicines Lists (EMLs) in order to improve the availability and use of medicines considered essential within health care systems. However, despite over 3 decades of international efforts, studies show an inconsistent pattern in the availability of essential medicines. We evaluated and compared the availability of essential medicines, and medicines not included in national EMLs, at global and regional levels. Methods Medicine availability in the public and private sector were calculated based on data obtained from national and provincial facility-based surveys undertaken in 23 countries using the WHO/HAI methodology. The medicines were grouped according to their inclusion (‘essential’) or exclusion (termed ‘non-essential’) in each country’s EML current at the time of the survey. Availability was calculated for originator brands, generics and any product type (originator brands or generics) and compared between the two groups. Results were aggregated by WHO regions, World Bank country income groups, a wealth inequality measure, and therapeutic groups. Findings Across all sectors and any product type, the median availability of essential medicines was suboptimal at 61·5% (IQR 20·6%–86·7%) but significantly higher than non-essential medicines at 27·3% (IQR 3·6%–70·0%). The median availability of essential medicines was 40·0% in the public sector and 78·1% in the private sector; compared to 6·6% and 57·1% for non-essential medicines respectively. A reverse trend between national income level categories and the availability of essential medicines was identified in the public sector. Interpretation EMLs have influenced the provision of medicines and have resulted in higher availability of essential medicines compared to non-essential medicines particularly in the public sector and in low and lower middle income countries. However, the availability of

  14. Natural and Synthetic Colloids in Veterinary Medicine.

    Science.gov (United States)

    Brooks, Aimee; Thomovsky, Elizabeth; Johnson, Paula

    2016-06-01

    This review article covers basic physiology underlying the clinical use of natural and artificial colloids as well as provide practice recommendations. It also touches on the recent scrutiny of these products in human medicine and how this may have an effect on their use in veterinary medicine. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Researching the life stages of medicines: Introduction

    NARCIS (Netherlands)

    van der Geest, S.; Chamberlain, K.

    2011-01-01

    This introduction presents the concept of ‘biography’ or ‘life stages’ of medicines as an ordering principle and analytical tool for the study of medicines as social, commercial and symbolic objects. The first stages, production and marketing, which have been largely neglected by social scientists,

  16. Produção de frutos para uso medicinal em Bromelia antiancatha (caraguatá: fundamentos para um extrastivismo sustentável Fruit production for medicinal use in Bromelia antiacantha ("caraguatá": foundations for sustainable extraction

    Directory of Open Access Journals (Sweden)

    S. Filippon

    2012-01-01

    preparation of syrup for the treatment of respiratory disorders. In this context, the aim of this study was to quantify the production of fruits and to find strategies for the possible management of natural populations of B. antiacantha. A total of 39 inflorescences were observed from January/2008 to August/2008 distributed in a secondary forest area at FLONA (National Forest, Três Barras, Santa Catarina State. In this same area, B. antiacantha individuals were accompanied by demographic studies from 2001 to 2008. The inflorescences presented on average 0.68 m of length, mean number of 187 fruits/inflorescence, mean diameter of fruits of 1.9 cm and mean weight of inflorescences of 3.6 kg. The mean number of usable fruits was 157 fruits/inflorescence and the mean weight of these fruits was 2.5 Kg. The estimated harvest for 2005 was 146 Kg of fruits ha-1 and for 2008, 80 kg of fruits ha-1, and the net income from the syrup production could reach R$ 1168.00 per hectare per year. The results showed that the management of B. antiacantha consists in an economically interesting activity and that this possibility complements the income of local communities where the species occurs, besides increasing the value of forest areas.

  17. Plasma product treatment in various types of von Willebrand's disease.

    Science.gov (United States)

    Berntorp, E

    1994-01-01

    Four different virus-inactivated factor VIII concentrates (Haemate P, Behring; Profilate, Alpha, FVIII-VHP-vWF, CRTS), near-pure von Willebrand factor (Facteur Willebrand, CRTS) or one recombinant FVIII preparation (Recombinate, Baxter) were given to one or more patients with different forms of von Willebrand's disease. Duke bleeding time, VIII:C, vWF:Ag, RC of activity, and the multimeric pattern of plasma vWF were monitored. Both Duke bleeding time and the multimeric pattern were normalized after treatment with Haemate P, FVIII-VHP-vWF, or Facteur Willebrand, and to a lesser extent after Profilate. Except in one case, the reduction in bleeding time lasted longer after Haemate P than after the other concentrates. Recombinate had no effect on primary hemostasis, and the half-life of VIII:C was very short. If prompt hemostasis is required, and when pharmacological correction of the defect is impossible, we recommend a concentrate containing both FVIII and the full complement of vWF multimers, but for prophylactic treatment pure von Willebrand factor may be used.

  18. Medicinal Herbs Affecting Gray Hair in Iranian Traditional Medicine

    OpenAIRE

    Rameshk, Maryam; Khandani, Shahram Kalantari; Raeiszadeh, Mahboobeh

    2016-01-01

    Background: The presence of hair plays an important role in people?s overall physical appearance and self-perception. As a result of increased life expectancy, the desire to look youthful plays a bigger role than ever.The use of medicinal plants is as old as mankind and the market will face many new products containing natural oils and herbs in coming years. In traditional Iranian medicine, many plants and herbal formulations are reported for hair growth as well as the improvement in hair qua...

  19. Correcting India’s Chronic Shortage of Drug Inspectors to Ensure the Production and Distribution of Safe, High-Quality Medicines

    Science.gov (United States)

    Kadam, Abhay B.; Maigetter, Karen; Jeffery, Roger; Mistry, Nerges F.; Weiss, Mitchell G.; Pollock, Allyson M.

    2016-01-01

    Background: Good drug regulation requires an effective system for monitoring and inspection of manufacturing and sales units. In India, despite widespread agreement on this principle, ongoing shortages of drug inspectors have been identified by national committees since 1975. The growth of India’s pharmaceutical industry and its large export market makes the problem more acute. Methods: The focus of this study is a case study of Maharashtra, which has 29% of India’s manufacturing units and 38% of its medicines exports. India’s regulations were reviewed, comparing international, national and state inspection norms with the actual number of inspectors and inspections. Twenty-six key informant interviews were conducted to ascertain the causes of the shortfall. Results: In 2009-2010, 55% of the sanctioned posts of drug inspectors in Maharashtra were vacant. This resulted in a shortfall of 83%, based on the Mashelkar Committee’s recommendations. Less than a quarter of the required inspections of manufacturing and sales units were undertaken. The Indian Drugs and Cosmetics Act and its Rules and Regulations make no provisions for drug inspectors and workforce planning norms, despite the growth and increasing complexity of India’s pharmaceutical industry. Conclusion: The Maharashtra Food and Drug Administration (FDA) falls short of the Mashelkar Committee’s recommended workforce planning norms. Legislation and political and operational support are required to produce needed changes PMID:27694680

  20. Medicinal Product Use Reglandin D-(+ - Cloprostenol, Synthetic Analogue of Prostaglandins F2α Natural Body in Fighting with Anestrus Lute (CL in Cattle

    Directory of Open Access Journals (Sweden)

    George Florea Tobă

    2011-05-01

    Full Text Available The studies made by us are based on fundamental biological role of prostaglandin modulator of hormonal actions, influxs nerve transmission and cellular ionic exchange. One of the main actions of PGF2α is luteolyse, a process that includes the secretion of progesterone and regression yellow body. PGF2α is a luteolitic for almost species: cow, buffalo, sow, mare, sheep, rabbits, guinea pigs, hamsters and rats, except primates. At present it is considered that PGF2α have their specific receptors, which are fixed and through their model would enable guanidine monophosphate or cyclic GMP's Goldberg. The effect of ocitocic luteolitic and pharmacodynamics basis of PGF2α, used in breeding biotechnologies and hormonal therapy. In medicine veterinary prostaglandines are used after 1973. Were injected with 2 ml Reglandin (150 mg D-(+ - cloprostenol 24 women diagnosed with corpus luteum anestris and 22 females (87.5% came in to oestrus at a mean of 59 hours, and after an average interval of 70 hours.şi were artificially inseminated (AI a total of 20 female (83.33%.

  1. Possibilities for production of medicinal aromatic plants on the spoil bank of the Pljevlja coal mine. Mogucnost gajenja ljekovitog i aromaticnog bilja na jalovistu rudnika uglja - Pljevlja

    Energy Technology Data Exchange (ETDEWEB)

    Memic, M.; Bajovic, L. (Rudnik Uglja Pljevlja (Yugoslavia))

    1990-01-01

    Presents results obtained from experimental recultivation of the Potrlica surface coal mine spoil bank (810 m elevation, continental climate) during 1986-1990. Two experimental fields - Potrlica-I (600 m[sup 2]) and Potrlica-II (300 m[sup 2]) - were prepared by spreading a 10-20 cm thick layer of low-quality soil over the marly waste of the spoil bank. Soil composition was: 2.10% and 74% Ca, 4.5% and 0.70% humus, l3.5% and 5.5% P[sub 2]O[sub 5] and 23.0% and 6.0% K[sub 2]O in Potrlica-I and II respectively. Soil pH values were 7.2 and 7.60; 500 kg/ha NPK (15:15:15) were spread. Seventeen species of aromatic and medicinal plants were grown. After four years the plants were classified into 3 groups (thriving, satisfactory and non-thriving). It was found that the following plants can yield satisfactory crops and profits: valeriana officinalis, hyssopus officinalis, artemis dracunculus, cynaris scolimus, foenculum vulgare and malva silvestris. Unsatisfactory results were obtained with melisa officinalis, coriandrum sativum, pimpinela anisum and angelica archangelica. Experiments will be continued.

  2. Folk Medicine, Folk Healing

    Directory of Open Access Journals (Sweden)

    Mustafa SEVER

    2015-12-01

    Full Text Available Folk medicine and folk healing may be defined codified, regulated, taught openly and practised widely, and benefit from thousands of years of experience. On the other hand, it may be highly secretive, mystical and extremely localized, with knowledge of its practices passed on orally. Folk medicine and traditional medical practices emerged as a result of the reactions of primitive men against natural events and their ways of comparing and exchanging the medical practices of relevant communities with their own practices. Magic played an important role in shaping the practices. Folk medicine is the solutions developed by societies against material and moral disorders starting from the mythic period until today. Folk healer, on the other hand, is the wisest and the most respectable person in the society, in terms of materiality and morale. This person has the power of identifying and curing the diseases, disorders, consequently the origin of these diseases and disorders, and the skill of using various drugs for the treatment of the diseases and disorders or applying the practices with the help of information and practices acquired from the tradition. The Turks having rich and deep rooted culture. The Turkısh folk medicine and folk healing that contain rich cultural structure in themselves survive until today by being fed by different sources. Before Islam, the Turks used to believe that there were white and black possessors, ancestors’ spirits (arvaks and their healthy and peaceful life depended on getting on with these spirits. They also believed that diseases were caused when they could no more keep in with possessors and spirits, or when they offended and annoyed them. In such an environment of belief, the visible diseases caused by material reasons were generally cured with products obtained from plants, mines and animals in the region or drugs that were made out of their combinations. On the other hand, in invisible diseases associated with

  3. Regenerative Medicine Build-Out.

    Science.gov (United States)

    Terzic, Andre; Pfenning, Michael A; Gores, Gregory J; Harper, C Michel

    2015-12-01

    Regenerative technologies strive to boost innate repair processes and restitute normative impact. Deployment of regenerative principles into practice is poised to usher in a new era in health care, driving radical innovation in patient management to address the needs of an aging population challenged by escalating chronic diseases. There is urgency to design, execute, and validate viable paradigms for translating and implementing the science of regenerative medicine into tangible health benefits that provide value to stakeholders. A regenerative medicine model of care would entail scalable production and standardized application of clinical grade biotherapies supported by comprehensive supply chain capabilities that integrate sourcing and manufacturing with care delivery. Mayo Clinic has rolled out a blueprint for discovery, translation, and application of regenerative medicine therapies for accelerated adoption into the standard of care. To establish regenerative medical and surgical service lines, the Mayo Clinic model incorporates patient access, enabling platforms and delivery. Access is coordinated through a designated portal, the Regenerative Medicine Consult Service, serving to facilitate patient/provider education, procurement of biomaterials, referral to specialty services, and/or regenerative interventions, often in clinical trials. Platforms include the Regenerative Medicine Biotrust and Good Manufacturing Practice facilities for manufacture of clinical grade products for cell-based, acellular, and/or biomaterial applications. Care delivery leverages dedicated interventional suites for provision of regenerative services. Performance is tracked using a scorecard system to inform decision making. The Mayo Clinic roadmap exemplifies an integrated organization in the discovery, development, and delivery of regenerative medicine within a growing community of practice at the core of modern health care. Regenerative medicine is at the vanguard of health care

  4. Regenerative Medicine Build-Out

    Science.gov (United States)

    Pfenning, Michael A.; Gores, Gregory J.; Harper, C. Michel

    2015-01-01

    Summary Regenerative technologies strive to boost innate repair processes and restitute normative impact. Deployment of regenerative principles into practice is poised to usher in a new era in health care, driving radical innovation in patient management to address the needs of an aging population challenged by escalating chronic diseases. There is urgency to design, execute, and validate viable paradigms for translating and implementing the science of regenerative medicine into tangible health benefits that provide value to stakeholders. A regenerative medicine model of care would entail scalable production and standardized application of clinical grade biotherapies supported by comprehensive supply chain capabilities that integrate sourcing and manufacturing with care delivery. Mayo Clinic has rolled out a blueprint for discovery, translation, and application of regenerative medicine therapies for accelerated adoption into the standard of care. To establish regenerative medical and surgical service lines, the Mayo Clinic model incorporates patient access, enabling platforms and delivery. Access is coordinated through a designated portal, the Regenerative Medicine Consult Service, serving to facilitate patient/provider education, procurement of biomaterials, referral to specialty services, and/or regenerative interventions, often in clinical trials. Platforms include the Regenerative Medicine Biotrust and Good Manufacturing Practice facilities for manufacture of clinical grade products for cell-based, acellular, and/or biomaterial applications. Care delivery leverages dedicated interventional suites for provision of regenerative services. Performance is tracked using a scorecard system to inform decision making. The Mayo Clinic roadmap exemplifies an integrated organization in the discovery, development, and delivery of regenerative medicine within a growing community of practice at the core of modern health care. Significance Regenerative medicine is at the

  5. A Just Distribution of Health Care in the Case of Orphan Medicinal Products: Aligning the Interests of European Economic Integration and National Welfare Policy

    DEFF Research Database (Denmark)

    Faeh, Andrea

    2012-01-01

    Since market integration measures touch upon issues that are the sole responsibility of the Member States, the efforts of the European Union (EU) to achieve a harmonised internal market clash, in some areas, with national welfare policy. Such a conflict exists where the allocation of health resou...... access to the product in a timely and equitable manner....

  6. TRADITIONAL CHINESE HERBAL MEDICINE

    NARCIS (Netherlands)

    ZHU, YP; WOERDENBAG, HJ

    1995-01-01

    Herbal medicine, acupuncture and moxibustion, and massage and the three major constituent parts of traditional Chinese medicine. Although acupuncture is well known in many Western countries, Chinese herbal medicine, the mos important part of traditional Chinese medicine, is less well known in the

  7. Neutron use in nuclear medicine

    Energy Technology Data Exchange (ETDEWEB)

    Guidez, J.; May, R.; Moss, R. [HFR-Unit, European Commission, IAM, Petten (Netherlands); Askienazy, S. [Departement Central de Medicine Nucleaire et Biophysique, Saint Antoine Hospital, Paris (France); Hildebrand, J. [Neurology Department, Erasmus Hospital, Brussels (Belgium)

    1999-07-01

    Neutrons produced by research reactors are being used in nuclear medicine and other medical applications in several ways. The High Flux Reactor (HFR) based in Petten (The Netherlands), owned by the European Commission, has been working increasingly in this field of health care for the European citizen. On the basis of this experience, a survey has been carried out on the main possibilities of neutrons used in nuclear medicine. The most important and most well known is the production of radioisotopes for diagnosis and therapy. Ten million patients receive nuclear medicine in Europe each year, with more than 8 million made with the products issued from research reactors. The survey of the market and the techniques (cyclotron, PET) shows that this market will continue to increase in the future. The direct use of reactors in medicine is actually made by the Boron Neutron capture Therapy (BNCT) for the treatment of glioblastoma, which kills about 15.000 people in Europe each year. For this promising technique, HFR is the most advanced for experimental possibilities and treatment studies. Medical research is also made in other promising fields: the use beam tubes for characterizing of prostheses and bio-medical materials, alpha-immuno therapy products, new types of radioisotopes, new types of illness to be treated by BNCT, etc. (author)

  8. Neutron use in nuclear medicine

    International Nuclear Information System (INIS)

    Guidez, J.; May, R.; Moss, R.; Askienazy, S.; Hildebrand, J.

    1999-01-01

    Neutrons produced by research reactors are being used in nuclear medicine and other medical applications in several ways. The High Flux Reactor (HFR) based in Petten (The Netherlands), owned by the European Commission, has been working increasingly in this field of health care for the European citizen. On the basis of this experience, a survey has been carried out on the main possibilities of neutrons used in nuclear medicine. The most important and most well known is the production of radioisotopes for diagnosis and therapy. Ten million patients receive nuclear medicine in Europe each year, with more than 8 million made with the products issued from research reactors. The survey of the market and the techniques (cyclotron, PET) shows that this market will continue to increase in the future. The direct use of reactors in medicine is actually made by the Boron Neutron capture Therapy (BNCT) for the treatment of glioblastoma, which kills about 15.000 people in Europe each year. For this promising technique, HFR is the most advanced for experimental possibilities and treatment studies. Medical research is also made in other promising fields: the use beam tubes for characterizing of prostheses and bio-medical materials, alpha-immuno therapy products, new types of radioisotopes, new types of illness to be treated by BNCT, etc. (author)

  9. In vitro microrhizomes induction and genetic stability of a medicinal plant Acorus calamus L. towards germplasm conservation through synthetic seed production

    Directory of Open Access Journals (Sweden)

    Satyajit KANUNGO

    2012-11-01

    Full Text Available Germplasm conservation through in vitro multiplication is one of the important mass cloning method to protect endangered medicinal plants. Synthetic seed technology offers potential advantages by increased efficiency for in vitro propagation in terms of space, labour, time and overall experimental costs. In vitro shoot formation (3.1±0.34 shoots per in vitro raised explants with shoot length of 2.9±0.11 cm of Acorus calamus (Bach was achieved after 4 weeks of culture in Murashige & Skoog (MS media supplemented with 4 mg l-1 BAP and 1 mg l-1 IAA with 30g sucrose l-1. Highest number of shoot multiplication per explant was recorded in 8 mg l-1 BAP and 2mg l-1 IAA and successful profuse rooting was observed in 1 mg l-1 IBA (3.6±0.2 roots per explant with an average root length of 4.7±0.6 cm. Synthetic seeds of in vitro raised microrhizomes were produced in a artificial matrix containing 3% (w/v sodium alginate prepared in MS basal medium for 20 min and dropped in to 3% (w/v calcium chloride solution for 30 min for polymerization. The encapsulated microrhizomes were stored at cold (10ºC in dark condition with different storage intervals of 3 and 6 months to evaluate the effect of storage duration and germination of zygotic embryos in A. calamus. From the RAPD analysis of both in vivo and in vitro regenerated plants it was observed that there were no significant variation of DNA profiles, thus ensuring the genetic stability of the plants and regeneration of true to type plants.

  10. Personalized laboratory medicine

    DEFF Research Database (Denmark)

    Pazzagli, M.; Malentacchi, F.; Mancini, I.

    2015-01-01

    Developments in "omics" are creating a paradigm shift in Laboratory Medicine leading to Personalised Medicine. This allows the increasing in diagnostics and therapeutics focused on individuals rather than populations. In order to investigate whether Laboratory Medicine is able to implement new...... diagnostic tools and expertise and commands proper state-of-the-art knowledge about Personalized Medicine and Laboratory Medicine in Europe, the joint Working Group "Personalized Laboratory Medicine" of the EFLM and ESPT societies compiled and conducted the Questionnaire "Is Laboratory Medicine ready...... for the era of Personalized Medicine?". 48 laboratories from 18 European countries participated at this survey. The answers of the participating Laboratory Medicine professionals indicate that they are aware that Personalized Medicine can represent a new and promising health model. Whereas they are aware...

  11. Evaluation of the Effects of Some Brazilian Medicinal Plants on the Production of TNF- α and CCL2 by THP-1 Cells.

    Science.gov (United States)

    Gusman, Grasielle S; Campana, Priscilla R V; Castro, Luciano C; Castilho, Rachel O; Teixeira, Mauro M; Braga, Fernão C

    2015-01-01

    Several plant species are traditionally used in Brazil to treat various inflammatory diseases. Tumor necrosis factor- (TNF-) α and chemokine (C-C motif) ligand 2 (CCL2) are key inflammatory mediators in diseases like rheumatoid arthritis and atherosclerosis, respectively; nevertheless, only a few extracts have been assayed against these targets. We herein report the effect of 19 plant extracts on TNF-α and CCL2 release by lipopolysaccharide- (LPS-) stimulated THP-1 cells, a human monocytic leukemia cell line, along with their radical scavenging activity on DPPH. The extracts of Caryocar brasiliense, Casearia sylvestris, Coccoloba cereifera, and Terminalia glabrescens inhibited TNF-α production in a concentration-dependent manner. Fractionation of these extracts potentiated the anti-TNF-α effect, which was shown to concentrate in polar fractions, mainly composed by polyphenols. Significant CCL2 inhibition was elicited by Lippia sidoides and Terminalia glabrescens extracts, whose fractionation resulted in highly active low polar fractions. All assayed extracts showed strong radical scavenging activity, but antioxidant activity did not correlate with inhibition of TNF-α or CCL2 production. Our results allowed identifying extracts with selective capacity to block cytokine production; therefore, further purification of these extracts may yield molecules that could be useful in the treatment of chronic inflammatory diseases.

  12. Production and Metabolism of Indole Acetic Acid in Root Nodules and Symbiont (Rhizobium undicola Isolated from Root Nodule of Aquatic Medicinal Legume Neptunia oleracea Lour.

    Directory of Open Access Journals (Sweden)

    Pallab Kumar Ghosh

    2015-01-01

    Full Text Available Indole acetic acid is a phytohormone which plays a vital role in plant growth and development. The purpose of this study was to shed some light on the production of IAA in roots, nodules, and symbionts of an aquatic legume Neptunia oleracea and its possible role in nodular symbiosis. The symbiont (N37 was isolated from nodules of this plant and identified as Rhizobium undicola based on biochemical characteristics, 16S rDNA sequence homology, and DNA-DNA hybridization results. The root nodules were found to contain more IAA and tryptophan than root; however, no detectable amount of IAA was found in root. The IAA metabolizing enzymes IAA oxidase, IAA peroxidase (E.C.1.11.1.7, and polyphenol oxidase (E.C.1.14.18.1 were higher in root than nodule but total phenol and IAA content were reversed. The strain N37 was found to produce copious amount of IAA in YEM broth medium with tryptophan and reached its stationary phase at 20 h. An enrichment of the medium with mannitol, ammonium sulphate, B12, and 4-hydroxybenzaldehyde was found to promote the IAA production. The presence of IAA metabolizing enzymes and IAA production with PGPR traits including ACC deaminase activity of the symbionts was essential for plant microbe interaction and nodule function.

  13. Evaluation of the Effects of Some Brazilian Medicinal Plants on the Production of TNF-α and CCL2 by THP-1 Cells

    Directory of Open Access Journals (Sweden)

    Grasielle S. Gusman

    2015-01-01

    Full Text Available Several plant species are traditionally used in Brazil to treat various inflammatory diseases. Tumor necrosis factor- (TNF- α and chemokine (C-C motif ligand 2 (CCL2 are key inflammatory mediators in diseases like rheumatoid arthritis and atherosclerosis, respectively; nevertheless, only a few extracts have been assayed against these targets. We herein report the effect of 19 plant extracts on TNF-α and CCL2 release by lipopolysaccharide- (LPS- stimulated THP-1 cells, a human monocytic leukemia cell line, along with their radical scavenging activity on DPPH. The extracts of Caryocar brasiliense, Casearia sylvestris, Coccoloba cereifera, and Terminalia glabrescens inhibited TNF-α production in a concentration-dependent manner. Fractionation of these extracts potentiated the anti-TNF-α effect, which was shown to concentrate in polar fractions, mainly composed by polyphenols. Significant CCL2 inhibition was elicited by Lippia sidoides and Terminalia glabrescens extracts, whose fractionation resulted in highly active low polar fractions. All assayed extracts showed strong radical scavenging activity, but antioxidant activity did not correlate with inhibition of TNF-α or CCL2 production. Our results allowed identifying extracts with selective capacity to block cytokine production; therefore, further purification of these extracts may yield molecules that could be useful in the treatment of chronic inflammatory diseases.

  14. Radiation physics for nuclear medicine

    CERN Document Server

    Hoeschen, Christoph

    2011-01-01

    The field of nuclear medicine is expanding rapidly, with the development of exciting new diagnostic methods and treatments. This growth is closely associated with significant advances in radiation physics. In this book, acknowledged experts explain the basic principles of radiation physics in relation to nuclear medicine and examine important novel approaches in the field. The first section is devoted to what might be termed the "building blocks" of nuclear medicine, including the mechanisms of interaction between radiation and matter and Monte Carlo codes. In subsequent sections, radiation sources for medical applications, radiopharmaceutical development and production, and radiation detectors are discussed in detail. New frontiers are then explored, including improved algorithms for image reconstruction, biokinetic models, and voxel phantoms for internal dosimetry. Both trainees and experienced practitioners and researchers will find this book to be an invaluable source of up-to-date information.

  15. A AUTORREGULAMENTAÇÃO DA PUBLICIDADE DE MEDICAMENTOS E PRODUTOS DE SAÚDE NA AMÉRICA LATINA: UMA ANÁLISE DOS CÓDIGOS DEONTOLÓGICOS DO SETOR PUBLICITÁRIO NA AMÉRICA LATINA | THE SELF-REGULATION OF MEDICINES AND HEALTH PRODUCTS ADVERTISING IN LATIN AMERICA: AN ANALYSIS OF THE ADVERTISING SECTOR CODES OF ETHICS IN LATIN AMERICA

    Directory of Open Access Journals (Sweden)

    Dhione Oliveira Santana

    2016-08-01

    Full Text Available This paper aims to investigate the advertising self-regulation of medicines and health products (Products and Services have the same meaning in this research present in the ethical codes of the advertising industry in Latin America. To do so, it was seek through content analysis, identify, classify and categorize the standards present in the advertising industry codes governing the publicity of medicines and health products. Ethical codes are present in nine countries in Latin America with seven of them are referred to medicines and health products, and only five have specific rules for the sector. In summary, the analyzed codes present in its generality, lenient rules to the sector, bringing instructions mainly to the content of the messages and it must therefore, national and professionals in the health sector codes and/or the pharmaceutical industry rules, act with stiffness in control advertising of medicines and health products.

  16. Nanotechnology in respiratory medicine.

    Science.gov (United States)

    Omlor, Albert Joachim; Nguyen, Juliane; Bals, Robert; Dinh, Quoc Thai

    2015-05-29

    Like two sides of the same coin, nanotechnology can be both boon and bane for respiratory medicine. Nanomaterials open new ways in diagnostics and treatment of lung diseases. Nanoparticle based drug delivery systems can help against diseases such as lung cancer, tuberculosis, and pulmonary fibrosis. Moreover, nanoparticles can be loaded with DNA and act as vectors for gene therapy in diseases like cystic fibrosis. Even lung diagnostics with computer tomography (CT) or magnetic resonance imaging (MRI) profits from new nanoparticle based contrast agents. However, the risks of nanotechnology also have to be taken into consideration as engineered nanomaterials resemble natural fine dusts and fibers, which are known to be harmful for the respiratory system in many cases. Recent studies have shown that nanoparticles in the respiratory tract can influence the immune system, can create oxidative stress and even cause genotoxicity. Another important aspect to assess the safety of nanotechnology based products is the absorption of nanoparticles. It was demonstrated that the amount of pulmonary nanoparticle uptake not only depends on physical and chemical nanoparticle characteristics but also on the health status of the organism. The huge diversity in nanotechnology could revolutionize medicine but makes safety assessment a challenging task.

  17. Growing with dinosaurs: natural products from the Cretaceous relict Metasequoia glyptostroboides Hu & Cheng-a molecular reservoir from the ancient world with potential in modern medicine.

    Science.gov (United States)

    Juvik, Ole Johan; Nguyen, Xuan Hong Thy; Andersen, Heidi Lie; Fossen, Torgils

    2016-01-01

    After the sensational rediscovery of living exemplars of the Cretaceous relict Metasequoia glyptostroboides -a tree previously known exclusively from fossils from various locations in the northern hemisphere, there has been an increasing interest in discovery of novel natural products from this unique plant source. This article includes the first complete compilation of natural products reported from M. glyptostroboides during the entire period in which the tree has been investigated (1954-2014) with main focus on the compounds specific to this plant source. Studies on the biological activity of pure compounds and extracts derived from M. glyptostroboides are reviewed for the first time. The unique potential of M. glyptostroboides as a source of bioactive constituents is founded on the fact that the tree seems to have survived unchanged since the Cretaceous era. Since then, its molecular defense system has resisted the attacks of millions of generations of pathogens. In line with this, some recent landmarks in Metasequoia paleobotany are covered. Initial spectral analysis of recently discovered intact 53 million year old wood and amber of Metasequoia strongly indicate that the tree has remained unchanged for millions of years at the molecular level.

  18. Understanding the productive author who published papers in medicine using National Health Insurance Database: A systematic review and meta-analysis.

    Science.gov (United States)

    Chien, Tsair-Wei; Chang, Yu; Wang, Hsien-Yi

    2018-02-01

    Many researchers used National Health Insurance database to publish medical papers which are often retrospective, population-based, and cohort studies. However, the author's research domain and academic characteristics are still unclear.By searching the PubMed database (Pubmed.com), we used the keyword of [Taiwan] and [National Health Insurance Research Database], then downloaded 2913 articles published from 1995 to 2017. Social network analysis (SNA), Gini coefficient, and Google Maps were applied to gather these data for visualizing: the most productive author; the pattern of coauthor collaboration teams; and the author's research domain denoted by abstract keywords and Pubmed MESH (medical subject heading) terms.Utilizing the 2913 papers from Taiwan's National Health Insurance database, we chose the top 10 research teams shown on Google Maps and analyzed one author (Dr. Kao) who published 149 papers in the database in 2015. In the past 15 years, we found Dr. Kao had 2987 connections with other coauthors from 13 research teams. The cooccurrence abstract keywords with the highest frequency are cohort study and National Health Insurance Research Database. The most coexistent MESH terms are tomography, X-ray computed, and positron-emission tomography. The strength of the author research distinct domain is very low (Gini < 0.40).SNA incorporated with Google Maps and Gini coefficient provides insight into the relationships between entities. The results obtained in this study can be applied for a comprehensive understanding of other productive authors in the field of academics.

  19. Preparation of culinary-medicinal king oyster mushroom Pleurotus eryngii-fermented products with high ergothioneine content and their taste quality.

    Science.gov (United States)

    Chen, Shih-Yu; Ho, Kung-Jui; Liang, Chih-Hung; Tsai, Ching-Hsuan; Huang, Ling-Yi; Mau, Jeng-Leun

    2012-01-01

    Pleurotus eryngii (DC. : Fr.) Ouel. was used in solid-state fermentation to develop novel mushroom products with a high amount of ergothioneine. The correlation coefficients between ergothioneine content and biomass were 0.8878 and 0.9206 for fermented adlay and buckwheat, respectively. Using optimal conditions, Pleurotus-fermented adlay and buckwheat (PFA and PFB) with the ergothioneine contents of 795.5 and 786.1 mg/ kg, respectively, were prepared. However, mycelia contained the highest ergothioneine content of 1514.6 mg/kg. As a result of SSF by P. eryngii, PFA and PFB contained more taste components than adlay and buckwheat, as evidenced by higher contents of total sugars and polyols, total free amino acids and monosodium glutamate-like components, and total and flavor 5'-nucleotides. In addition, PFB and buckwheat showed comparable equivalent umami concentration (EUC) values, whereas PFA showed a higher EUC value than adlay. Overall, Pleurotus-fermented products with a high amount of ergothioneine will be a novel functional food.

  20. STARTING A NEW MEDICINE STUDY.

    Science.gov (United States)

    Aston, Jeff; Wilson, Keith; Terry, David

    2016-09-01

    their carers. The main barriers being the targeted conditions included in the service, consent and exclusion of undertaking an NMS consultation with a carer. Further research is required to establish and evaluate a paediatric specific medication review service for children/young people and their parents/carers when a new long-term medicine has been prescribed. This research will support the recent research recommendation of the National Institute of Health and Care Excellence.3. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/