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.


    of thromboembolic complications does exist while receiving Haemate P, as it does with any FVIII replacement therapy, the incidence of such complications has remained notably low. Given the robust data that have accumulated for the use of Haemate P, dosing recommendations are also described in this review...

  2. The Traditional Medicine and Modern Medicine from Natural Products

    Directory of Open Access Journals (Sweden)

    Haidan Yuan


    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.

  3. The Traditional Medicine and Modern Medicine from Natural Products. (United States)

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


    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.

  4. Research Productivity of Sports Medicine Fellowship Faculty


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


    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...

  5. 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.

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

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


    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.

  7. traditional medicinal uses of small mammal products

    African Journals Online (AJOL)

    Dr. Nelson Boniface

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

  8. Medicinal plants: production and biochemical characterization

    International Nuclear Information System (INIS)

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


    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

  9. Medicinal Product Regulation: Portugal׳s Framework. (United States)

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


    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.

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

    International Nuclear Information System (INIS)


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

  11. [Review on community herbal monographs for traditional herbal medicinal products]. (United States)

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


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

  12. [Technology transfer to the facility for production of medicines]. (United States)

    Beregovykh, V V; Spitskiĭ, O P


    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.

  13. New veterinary medicinal products authorised by centralised procedure

    Directory of Open Access Journals (Sweden)

    Simona Sturzu


    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.

  14. Regulation of Cell and Gene Therapy Medicinal Products in Taiwan. (United States)

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


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

  15. Regulatory and clinical aspects of psychotropic medicinal products bioequivalence. (United States)

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


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

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

    NARCIS (Netherlands)

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


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

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


    ZHYLA M.I.


    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.

  18. 75 FR 65293 - Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for... (United States)


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

  19. PCMO L01-Setting Specifications for Biological Investigational Medicinal Products. (United States)

    Krause, Stephan O


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

  20. [Research strategies for feed additives and veterinary medicines from side products of Chinese medicine resources industrialization]. (United States)

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


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

  1. European regulatory tools for advanced therapy medicinal products. (United States)

    Flory, Egbert; Reinhardt, Jens


    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.

  2. Conditional approval: Japan lowers the bar for regenerative medicine products. (United States)

    Sipp, Douglas


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

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

    Directory of Open Access Journals (Sweden)

    Elena Gabriela Oltean


    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.

  4. Modern radioisotope production technologies for medicine

    International Nuclear Information System (INIS)

    Bechtold, V.; Schweickert, H.


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

  5. Should Anthroposophic Medicinal Products Be Regulated in Europe? (United States)

    Michaux, Geneviève


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

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


    Söyleriz, Yüksel


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

  7. Brazilian scientific production on herbal medicines used in dentistry

    Directory of Open Access Journals (Sweden)

    R.D. Castro


    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.

  8. Turning Regenerative Medicine Breakthrough Ideas and Innovations into Commercial Products. (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


    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.

  9. Fighting trafficking of falsified and substandard medicinal products in Russia. (United States)

    Fayzrakhmanov, N F


    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

  10. Submerged cultivation of medicinal mushrooms: bioprocesses and products (review). (United States)

    Elisashvili, Vladimir


    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

  11. 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, ...


    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...

  13. Economic aspects of radionuclide production for nuclear medicine

    International Nuclear Information System (INIS)

    Le Gallic, Y.; Prospert, J.


    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

  14. Readability assessment of package inserts of biological medicinal products from the European medicines agency website. (United States)

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


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

  15. Date fruit: chemical composition, nutritional and medicinal values, products. (United States)

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


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

  16. Search for bioactive natural products from medicinal plants of Bangladesh. (United States)

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


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

  17. Implementation of Plasma Fractionation in Biological Medicines Production


    Mousavi Hosseini, Kamran; Ghasemzadeh, Mehran


    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...

  18. [Safety monitoring of cell-based medicinal products (CBMPs)]. (United States)

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


    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.

  19. Medicinal and commercial uses of ostrich products in Tanzania. (United States)

    Magige, Flora; Røskaft, Eivin


    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

  20. Quality of natural product clinical trials: a comparison of those published in alternative medicine versus conventional medicine journals. (United States)

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


    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.

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

    Directory of Open Access Journals (Sweden)

    Wu Guosheng


    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.

  2. Regulating Medicines in Croatia: Five-year Experience of Agency for Medicinal Products and Medical Devices (United States)

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


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

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

    Directory of Open Access Journals (Sweden)

    Mazroi Arani Navid


    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.

  4. 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


    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.

  5. Good manufacturing practices for medicinal products for human use. (United States)

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


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

  6. Good manufacturing practices for medicinal products for human use (United States)

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


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

  7. Selected non-timber forest products with medicinal applications from Jilin Province in China (United States)

    Yao Ge Huang; Branka Barl; Gerald. Ivanochko


    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...

  8. Compensation and Production in Family Medicine by Practice Ownership

    Directory of Open Access Journals (Sweden)

    Alison C. Essary


    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.

  9. Medicines (United States)

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

  10. [Classification of cell-based medicinal products and legal implications: An overview and an update]. (United States)

    Scherer, Jürgen; Flory, Egbert


    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.

  11. Production of 111In for diagnosis in nuclear medicine

    International Nuclear Information System (INIS)

    Osso Junior, J.A.


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

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

    International Nuclear Information System (INIS)

    Frier, M.


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

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


    Videikaitė, Lina


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

  14. Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use. (United States)

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


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

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

    Directory of Open Access Journals (Sweden)

    Andjelkovic Jelena


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

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

    Kroes, Burt H


    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. [Interpretation of the concept of 'medicinal product' in relation to herb- and cannabinoid-based products]. (United States)

    Zsigmond, Ferge


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

  18. Advanced therapy medicinal products: current and future perspectives. (United States)

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


    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),, 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

  19. Medicinal and aromatic crops: Production, Phytochemistry, and Utilization (United States)

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

  20. Use of herbal medicinal products among children and adolescents in Germany (United States)


    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. (United States)

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


    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, 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. [Analysis of difficult problems on European Union laws and regulations of traditional herbal medicinal products]. (United States)

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


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

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

    DEFF Research Database (Denmark)

    Kohli, Vishv Priya

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

  4. [Regulatory requirements regarding cell-based medicinal products for human and veterinary use - a comparison]. (United States)

    Kuhlmann-Gottke, Johanna; Duchow, Karin


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

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

    NARCIS (Netherlands)

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


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

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

    International Nuclear Information System (INIS)

    Welch, M.J.


    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

  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


    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.


    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


    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: Dehydropyrrolizidine alkaloids and aristolochic acid (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 ...

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

  12. Regulatory structures for gene therapy medicinal products in the European Union. (United States)

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


    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.

  13. General sale of non-prescription medicinal products

    DEFF Research Database (Denmark)

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


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

  14. Medicinal and dietary supplements: specialty forest products with a long tradition (United States)

    James L. Chamberlain; A.L. Hammett


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

  15. 21st century natural product research and drug development and traditional medicines. (United States)

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


    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.

  16. In situ biomolecule production by bacteria; a synthetic biology approach to medicine. (United States)

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


    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.

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

    Directory of Open Access Journals (Sweden)

    Fusako Nishigaki


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

    NARCIS (Netherlands)

    Montforts MHMM; CSR


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

  19. Bar-HRM for Authentication of Plant-Based Medicines: Evaluation of Three Medicinal Products Derived from Acanthaceae Species. (United States)

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


    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.

  20. Study of Scientific Production of Community Medicines' Department Indexed in ISI Citation Databases. (United States)

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


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

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

    Directory of Open Access Journals (Sweden)

    Xiwen Li


    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.

  2. The remote supervisory and controlling experiment system of traditional Chinese medicine production based on Fieldbus (United States)

    Zhan, Jinliang; Lu, Pei


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

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

    Directory of Open Access Journals (Sweden)

    Norman Ratcliffe


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

  4. Honey: an effective regenerative medicine product in wound management. (United States)

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


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

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

    DEFF Research Database (Denmark)

    Polur, Honey; Joshi, Tejal; Workman, Christopher


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

  6. The Brazilian market of herbal medicinal products and the impacts of the new legislation on traditional medicines. (United States)

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


    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

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

    Directory of Open Access Journals (Sweden)

    Kleen Joachim L


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

  8. Communication in production animal medicine: modelling a complex interaction with the example of dairy herd health medicine. (United States)

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


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

  9. Innovation, productivity, and pricing: Capturing value from precision medicine technology in Canada. (United States)

    Emery, J C Herbert; Zwicker, Jennifer D


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

  10. Efficacy and Safety of Pomegranate Medicinal Products for Cancer (United States)

    Vlachojannis, Christian


    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

  11. [Investigation on production process quality control of traditional Chinese medicine--Banlangen granule as an example]. (United States)

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


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

  12. Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany. (United States)

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


    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.

  13. Risk assessment on the use of herbal medicinal products containing pyrrolizidine alkaloids. (United States)

    Allgaier, Clemens; Franz, Stephanie


    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.

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

    African Journals Online (AJOL)



    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 ...

  15. Modeling belowground biomass of black cohosh, a medicinal forest product. (United States)

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


    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...

  16. Alternative Blood Products and Clinical Needs in Transfusion Medicine


    Whitsett, Carolyn; Vaglio, Stefania; Grazzini, Giuliano


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

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

    Directory of Open Access Journals (Sweden)

    Andreia Corciovă


    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.

  18. Efficacy and Safety of Pomegranate Medicinal Products for Cancer


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


    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 ...

  19. [Scientific advice by the national and European approval authorities concerning advanced therapy medicinal products]. (United States)

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


    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.

  20. 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


    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.

  1. Quality transitivity and traceability system of herbal medicine products based on quality markers. (United States)

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


    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.

  2. Cyclotron Production of Radionuclides for Nuclear Medicine at Academic Centers (United States)

    Lapi, Suzanne


    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.

  3. Studies on saponin production in tropical medicinal plants Maesa argentea and Maesa lanceolata (United States)

    Faizal, Ahmad; Geelen, Danny


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

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

    Directory of Open Access Journals (Sweden)

    B Nandagopal


    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.

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

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


    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.

  6. 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.


    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.

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

    Directory of Open Access Journals (Sweden)

    Maksimović Zoran


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

  8. Research and development for botanical products in medicinals and food supplements market. (United States)

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


    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.

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

    Directory of Open Access Journals (Sweden)

    Marco Miroddi


    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.

  10. [Assessing research productivity in Department of Internal Medicine, University of Zagreb, School of Medicine and University Hospital Centre Zagreb]. (United States)

    Petrak, Jelka; Sember, Marijan; Granić, Davorka


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

  11. Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines. (United States)

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


    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.

  12. [Translational/regulatory science researches of NIHS for regenerative medicine and cellular therapy products]. (United States)

    Sato, Yoji


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

  13. Material science as basis for nuclear medicine: Holmium irradiation for radioisotopes production (United States)

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


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


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


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

  15. 75 FR 50771 - Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products... (United States)


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

  16. Worldwide withdrawal of medicinal products because of adverse drug reactions: a systematic review and analysis. (United States)

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


    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.

  17. 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


    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

  18. Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe. (United States)

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


    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

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

    Directory of Open Access Journals (Sweden)

    Vidushi S. Neergheen-Bhujun


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

  20. Underestimating the toxicological challenges associated with the use of herbal medicinal products in developing countries. (United States)

    Neergheen-Bhujun, Vidushi S


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

  1. Application of plant cell and tissue culture for the production of phytochemicals in medicinal plants. (United States)

    Pant, Bijaya


    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.

  2. Evolution of European Union legislation of herbal medicinal products and its transposition to national legislation in 1965-2007: case Finland. (United States)

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


    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.

  3. Medicinal plants and natural products in amelioration of arsenic toxicity: a short review. (United States)

    Bhattacharya, Sanjib


    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.

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

    DEFF Research Database (Denmark)

    Faeh, Andrea Beata


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

  5. Restrictions on the reimbursement policy with regard to retail marketing of medicinal products in Poland. (United States)

    Zimmermann, Agnieszka


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

  6. Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products. (United States)

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


    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.

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

    Directory of Open Access Journals (Sweden)

    Stroetmann, Karl A.


    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

  8. Application of plant metabonomics in quality assessment for large-scale production of traditional Chinese medicine. (United States)

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


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

  9. Application of Metabolomics to Quality Control of Natural Product Derived Medicines. (United States)

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


    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.

  10. Restrictions on the conduct of advertising of medicinal products in Poland and their violations. (United States)

    Czerw, Aleksandra; Marek, Ewelina Maria


    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.

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

    International Nuclear Information System (INIS)

    Cornet, L.


    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

  12. [Establishment of design space for production process of traditional Chinese medicine preparation]. (United States)

    Xu, Bing; Shi, Xin-Yuan; Qiao, Yan-Jiang; Wu, Zhi-Sheng; Lin, Zhao-Zhou


    The philosophy of quality by design (QbD) is now leading the changes in the drug manufacturing mode from the conventional test-based approach to the science and risk based approach focusing on the detailed research and understanding of the production process. Along with the constant deepening of the understanding of the manufacturing process, the design space will be determined, and the emphasis of quality control will be shifted from the quality standards to the design space. Therefore, the establishment of the design space is core step in the implementation of QbD, and it is of great importance to study the methods for building the design space. This essay proposes the concept of design space for the production process of traditional Chinese medicine (TCM) preparations, gives a systematic introduction of the concept of the design space, analyzes the feasibility and significance to build the design space in the production process of traditional Chinese medicine preparations, and proposes study approaches on the basis of examples that comply with the characteristics of traditional Chinese medicine preparations, as well as future study orientations.

  13. Translating cell-based regenerative medicines from research to successful products: challenges and solutions. (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


    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.

  14. The Opportunities Map at Cornell University: finding direction in dairy production medicine. (United States)

    Mitchell, Hilda M; Nydam, Daryl V; Reyher, Kristen; Gilbert, Robert O


    Discussion between faculty and interested students revealed the existence of a multitude of opportunities in dairy production medicine at the College of Veterinary Medicine at Cornell University. Many of these were not well known to students, or even to some of the faculty, and the means of accessing specific learning experiences were sometimes obscure. Together, an informal group of faculty, students, and alumni set about cataloging available educational opportunities, resulting in a 31-page publication referred to as the "Opportunities Map." Essentially a student handbook for production medicine students, the Opportunities Map at Cornell helps guide the travel of food animal-interested students through the curriculum without missing the important highlights along the way. The map was originally developed to chronicle the opportunities and resources available to students, but it has also been used to foster face-to-face communications between students and faculty, to welcome incoming students with production animal interests, and to provide a baseline description for further discussion about the curriculum.

  15. 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. (United States)

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


    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.

  16. 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 (United States)

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


    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

  17. The production and recovery of 77Br at Los Alamos for nuclear medicine studies

    International Nuclear Information System (INIS)

    Grant, P.M.; Whipple, R.E.; Barnes, J.W.; Bentley, G.E.; Wanek, P.M.; O'Brien, H.A. Jr.


    A procedure for the synthesis and isolation of 77 Br for nuclear medicine research has been developed at LASL. Metallic Mo targets are irradiated at LAMPF with medium-energy protons at high beam current. Following dissolution, volatilization, precipitation, and ion exchange techniques, 77 Br is recovered with a (91 +- 7)% chemical yield and is completely free of all other radioactive species with the exception of small levels of 76 Br and 82 Br. Ci-quantity production capabilities have been demonstrated, and the product is proving successful for the labelling of diverse radiopharmaceuticals. Future improvements in the process are also discussed. (author)

  18. Safety concerns of herbal products and traditional Chinese herbal medicines: dehydropyrrolizidine alkaloids and aristolochic acid. (United States)

    Stegelmeier, Bryan L; Brown, Ammon W; Welch, Kevin D


    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.

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

    Directory of Open Access Journals (Sweden)

    Chun-Tao Che


    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.

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

    Berger, A; Schüle, S; Flory, E


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

  1. 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.


    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

  2. Evaluation of phytochemicals from medicinal plants of Myrtaceae family on virulence factor production by Pseudomonas aeruginosa. (United States)

    Musthafa, Khadar Syed; Sianglum, Wipawadee; Saising, Jongkon; Lethongkam, Sakkarin; Voravuthikunchai, Supayang Piyawan


    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.

  3. Condensed tannins in extracts from European medicinal plants and herbal products. (United States)

    Ropiak, Honorata M; Ramsay, Aina; Mueller-Harvey, Irene


    Medicinal plant materials are not usually analysed for condensed tannins (CT). Thirty commercially available European medicinal plants and herbal products were screened for CT and fourteen CT samples were analysed in detail. This is also the first comprehensive CT analysis of pine buds, walnut leaves, heather flowers and great water dock roots. Acetone/water extracts contained between 3.2 and 25.9 g CT/100g of extract, had CT with mean degrees of polymerisation of 2.9 to 13.3, procyanidin/prodelphinidin ratios of 1.6/98.4 to 100/0 and cis/trans flavan-3-ol ratios of 17.7/82.3 to 97.3/2.7. The majority of samples contained procyanidins, four contained A-type linkages (blackthorn flowers, heather flowers, bilberry leaves and cowberry leaves) and one sample also had galloylated procyanidins (great water dock roots). Copyright © 2015 Elsevier B.V. All rights reserved.

  4. The early career researcher's toolkit: translating tissue engineering, regenerative medicine and cell therapy products. (United States)

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


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

  5. Spontaneously Reported Adverse Reactions for Herbal Medicinal Products and Natural Remedies in Sweden 2007-15: Report from the Medical Products Agency. (United States)

    Svedlund, Erika; Larsson, Maria; Hägerkvist, Robert


    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.

  6. Does the development of new medicinal products in the European Union address global and regional health concerns?

    Directory of Open Access Journals (Sweden)

    Álvarez-Martín Elena


    Full Text Available Abstract Background Since 1995, approval for many new medicinal products has been obtained through a centralized procedure in the European Union. In recent years, the use of summary measures of population health has become widespread. We investigated whether efforts to develop innovative medicines are focusing on the most relevant conditions from a global public health perspective. Methods We reviewed the information on new medicinal products approved by centralized procedure from 1995 to 2009, information that is available to the public in the European Commission Register of medicinal products and the European Public Assessment Reports from the European Medicines Agency. Morbidity and mortality data were included for each disease group, according to the Global Burden of Disease project. We evaluated the association between authorized medicinal products and burden of disease measures based on disability-adjusted life years (DALYs in the European Union and worldwide. Results We considered 520 marketing authorizations for medicinal products and 338 active ingredients. New authorizations were seen to increase over the period analyzed. There was a positive, high correlation between DALYs and new medicinal product development (ρ = 0.619, p = 0.005 in the European Union, and a moderate correlation for middle-low-income countries (ρ = 0.497, p = 0.030 and worldwide (ρ = 0.490, p = 0.033. The most neglected conditions at the European level (based on their attributable health losses were neuropsychiatric diseases, cardiovascular diseases, respiratory diseases, sense organ conditions, and digestive diseases, while globally, they were perinatal conditions, respiratory infections, sense organ conditions, respiratory diseases, and digestive diseases. Conclusions We find that the development of new medicinal products is higher for some diseases than others. Pharmaceutical industry leaders and policymakers are invited to consider the implications of this

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

    Ancans, Janis


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

  8. 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.


    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

  9. [The use of medicinal products "off-label use" in the pediatric population--the border risk, or reasonable diligence?]. (United States)

    Zajdel, Justyna


    Any medicinal product marketed in the country has its registration, under which are strictly defined indications and the extent to which a product can be used. It is of significance that the use of the product which is registered in the given range produces an effect similar to or identical to that effect, which is obtained after applying the product having a registration in a given indication. Relied on to justify the use of a medicinal product or medical product "off-label use" in Poland, there is also the fact that the same product has a registration in a particular indication in another EU member state or outside the Community. It is worth noting that the medicinal product may be used in therapeutic management of omitting or reducing the principles resulting from the SPC. However, this applies only to cases where the use of the medicinal product "off-label use" dictated by the necessity of saving life or health of the patient, and the previous ways and methods of treatment with the use of registered medicines have proved ineffective or insufficient to achieve the desired therapeutic effect.

  10. 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


    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....

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

    Directory of Open Access Journals (Sweden)

    Fernanda Paula R. Santana


    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.

  12. 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


    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)

  13. Probiotics, fibre and herbal medicinal products for functional and inflammatory bowel disorders (United States)

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


    Functional bowel disorders (FBD), mainly irritable bowel syndrome (IBS) and functional constipation (FC, also called chronic idiopathic constipation), are very common worldwide. Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, although less common, has a strong impact on patients' quality of life, as well as being highly expensive for our healthcare. A definite cure for those disorders is still yet to come. Over the years, several therapeutic approaches complementary or alternative to traditional pharmacological treatments, including probiotics, prebiotics, synbiotics, fibre and herbal medicinal products, have been investigated for the management of both groups of diseases. However, most available studies are biased by several drawbacks, including small samples and poor methodological quality. Probiotics, in particular Saccharomyces boulardii and Lactobacilli (among which Lactobacillus rhamnosus), synbiotics, psyllium, and some herbal medicinal products, primarily peppermint oil, seem to be effective in ameliorating IBS symptoms. Synbiotics and fibre seem to be beneficial in FC patients. The probiotic combination VSL#3 may be effective in inducing remission in patients with mild‐to‐moderate ulcerative colitis, in whom Escherichia coli Nissle 1917 seems to be as effective as mesalamine in maintaining remission. No definite conclusions can be drawn as to the efficacy of fibre and herbal medicinal products in IBD patients due to the low number of studies and the lack of randomized controlled trials that replicate the results obtained in the individual studies conducted so far. Thus, further, well‐designed studies are needed to address the real role of these therapeutic options in the management of both FBD and IBD. Linked Articles This article is part of a themed section on Principles of Pharmacological Research of Nutraceuticals. To view the other articles in this section visit

  14. Reactor production and processing of radioisotopes for therapeutic applications in nuclear medicine

    International Nuclear Information System (INIS)

    Knapp, F.F. Jr.; Mirzadeh, S.; Beets, A.L.


    Nuclear reactors continue to play an important role in providing radioisotopes for nuclear medicine. Many reactor-produced radioisotopes are ''neutron rich'' and decay by beta-emission and are thus of interest for therapeutic applications. This talk discusses the production and processing of a variety of reactor-produced radioisotopes of current interest, including those produced by the single neutron capture process, double neutron capture and those available from beta-decay of reactorproduced radioisotopes. Generators prepared from reactorproduced radioisotopes are of particular interest since repeated elution inexpensively provides many patient doses. The development of the alumina-based W-188/Re-188 generator system is discussed in detail

  15. Refurbishing of a Freeze Drying Machine, used in Nuclear Medicine for Radiopharmaceuticals Production

    International Nuclear Information System (INIS)

    Gaytan-Gallardo, E.; Desales-Galeana, G.


    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

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

    Mahalatchimy, A


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

  17. Homeopathic medicinal products for preventing and treating acute respiratory tract infections in children. (United States)

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


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

  18. Hospital structure and technical efficiency in the production of nuclear medicine. Doctoral thesis

    International Nuclear Information System (INIS)

    Wilson, G.W.


    The relationship of hospital structure to production efficiency is explored. The hospital subindustry on which this research centers is nuclear medicine. The hypotheses generated were that technical efficiency is reduced by increased competitive intensity, by a lack of profit incentive, by a broader service range, and by in-house training of technical personnel. Most data employed in the study were gathered from the American College of Radiology and the Energy Research and Development Administration Census of Nuclear Medicine. More specific information came from questionnaires sent to 2,050 short-term general hospitals known to have a nuclear medicine facility. Of the responses 1,362 were usable for the study. A major study finding was that over half of the variations observed in technical efficiency were attributable to the structural elements being studied. The research indicated that competition for staff physicians has a role in reducing technical efficiency; that the output effect of in-house manpower training was relatively unimportant; and that profit incentives do have a significant impact. It is suggested that increased technical efficiency could be achieved through reduced competitive intensity, stronger profit orientation, and reduced service range. A bibliography is included

  19. 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


    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.

  20. Advanced Therapy Medicinal Products and Exemptions to the Regulation 1394/2007: How Confident Can We be? An Exploratory Analysis. (United States)

    Van Wilder, Philippe


    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.

  1. In vitro propagation and withaferin A production in Withania ashwagandha, a rare medicinal plant of India. (United States)

    Mir, Bilal Ahmad; Mir, Shabir Ahmad; Koul, Sushma


    Withania ashwagandha, belonging to the family Solanaceae, is an important medicinal herb of India with restricted geographic distribution. It is a rich source of withaferin A (WA) and other bioactive withanolides. In the present study a rapid in vitro mass propagation protocol of W. ashwagandha was developed from nodal explants. Nodal explants were cultured on MS medium supplemented with various concentrations and combinations of plant growth regulators (PGRs). The highest number of regenerated shoots per ex-plant (33 ± 2.7) and highest WA (13.4 ± 1.15 mg/g of DW) production was obtained on MS medium supplemented with 5.0 μM 6-benzyladenine (BA) and 1.0 μM Kinetin (Kn). In vitro raised shoots were further rooted on half-strength MS medium containing 2.0 μM Indole-3-butyric acid (IBA) and analyzed for WA production. The rooted plantlets when transferred to poly bags in the greenhouse showed 90 % survival frequency. Levels of WA were higher in the in vitro and ex vitro derived shoot and root tissues as compared to field grown mother plants. In an attempt to further maximize WA production, shoot cultures were further grown in liquid MS medium supplemented with 5.0 μM 6-benzyladenine (BA) and 1.0 μM Kinetin (Kn). Root cultures were grown on half strength MS liquid medium fortified with 2.0 μM of IBA. WA production in the liquid cultures was significantly higher compared to the static composition of the same media. This protocol, first of its kind in this plant, can be successfully employed for conservation, proliferation and large-scale production of WA. The regenerated plants can also be used in traditional medicine as an alternative to naturally collected plants.

  2. The production of radionuclides for nuclear medicine from a compact, low-energy accelerator system. (United States)

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


    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

  3. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications. (United States)

    Riboh, Jonathan C; Saltzman, Bryan M; Yanke, Adam B; Cole, Brian J


    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

  4. Development of a Database for Study Data in Registration Applications for Veterinary Medicinal Products

    Directory of Open Access Journals (Sweden)

    Anke Finnah


    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

  5. 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


    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.

  6. Medicinal mushroom Ganoderma lucidum in the production of special beer types

    Directory of Open Access Journals (Sweden)

    Leskošek-Čukalović Ida I.


    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.

  7. Animals and their products utilized as medicines by the inhabitants surrounding the Ranthambhore National Park, India

    Directory of Open Access Journals (Sweden)

    Jaroli DP


    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.

  8. Three-Dimensional Printing of Medicinal Products and the Challenge of Personalized Therapy. (United States)

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


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

  9. Medicinal Plants Based Products Tested on Pathogens Isolated from Mastitis Milk

    Directory of Open Access Journals (Sweden)

    Claudia Pașca


    Full Text Available Bovine mastitis a major disease that is commonly associated with bacterial infection. The common treatment is with antibiotics administered intramammary into infected quarters of the udder. The excessive use of antibiotics leads to multidrug resistance and associated risks for human health. In this context, the search for alternative drugs based on plants has become a priority in livestock medicine. These products have a low manufacturing cost and no reports of antimicrobial resistance to these have been documented. In this context, the main objective of this study was to determine the antimicrobial effect of extracts and products of several indigenous, or acclimatized plants on pathogens isolated from bovine mastitis. A total of eleven plant alcoholic extracts and eight plant-derived products were tested against 32 microorganisms isolated from milk. The obtained results have shown an inhibition of bacterial growth for all tested plants, with better results for Evernia prunastri, Artemisia absinthium, and Lavandula angustifolia. Moreover, E. prunastri, Populus nigra, and L. angustifolia presented small averages of minimum inhibitory and bactericidal concentrations. Among the plant-derived products, three out of eight have shown a strong anti-microbial effect comparable with the effect of florfenicol and enrofloxacin, and better than individual plant extracts possibly due to synergism. These results suggest an important anti-microbial effect of these products on pathogens isolated from bovine mastitis with a possible applicability in this disease.

  10. Structure, control and regulation of the formal market for medicinal plants' products in Nigeria. (United States)

    Oguntade, Adegboyega E; Oluwalana, Isaac B


    There are informal and formal markets for medicinal plants' products in Nigeria. The formal market is subject to the national regulatory framework for Food and Drug Administration and Control. It is relatively new and underdeveloped. This study was designed to appraise this market with special emphasis on the market participants, market structure, marketing functions performed, conduct of sellers in the market and; standards and regulations to which the market is subject. Information used for this study was collected through personal interviews and interactions with key participants in the market; especially the officials of regulatory agency. The market structure was analysed in terms of the share of market controlled by participants and product types. Concentration Ratios (CR2 and CR4) were used to assess the market share. Marketing functions being performed were described in terms of the exchange, physical and facilitating functions while the conduct was described in terms of pricing and promotional strategies. The regulatory framework under which the market operates was appraised. The market was highly concentrated with a CR2 and CR4 of 58.5% and 80.8 %; respectively. Imported products accounted for only 12.3% of the market. The predominant modes of presentation of the product were capsule (41.6%) and liquid (36.2%). About 20.77% of the products were classified as multivitamins, 13.85% were antibiotics while 10.77% addressed sexual dysfunctional problems. These products were regulated under the Food and Drug Administration and Control (NAFDAC) decrees, 1993-1999. Only 2.3% of the products have received full registration status while the others were only listed.

  11. Giving information on medicinal products to the general public--in search of a definition to safeguard the patient. (United States)

    Faeh, Andrea


    Information on medicinal products is vital for enabling patients to give informed consent to the use of a specific product. Within the European Union (EU) the debate about how much information about prescription-only medicinal products should be made available to patients has gone on for the past five years with no definite conclusion yet. This contribution assesses the current legislation and the ongoing debate in order to identify the challenges and the prospect of new legislation, and consider its potential implications for the scope for advertising and for patient safety.

  12. From discovery to approval of an advanced therapy medicinal product-containing stem cells, in the EU. (United States)

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


    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.

  13. Sustainability of a public system for plasma collection, contract fractionation and plasma-derived medicinal product manufacturing. (United States)

    Grazzini, Giuliano; Ceccarelli, Anna; Calteri, Deanna; Catalano, Liviana; Calizzani, Gabriele; Cicchetti, Americo


    In Italy, the financial reimbursement for labile blood components exchanged between Regions is regulated by national tariffs defined in 1991 and updated in 1993-2003. Over the last five years, the need for establishing standard costs of healthcare services has arisen critically. In this perspective, the present study is aimed at defining both the costs of production of blood components and the related prices, as well as the prices of plasma-derived medicinal products obtained by national plasma, to be used for interregional financial reimbursement. In order to analyse the costs of production of blood components, 12 out 318 blood establishments were selected in 8 Italian Regions. For each step of the production process, driving costs were identified and production costs were. To define the costs of plasma-derived medicinal products obtained by national plasma, industrial costs currently sustained by National Health Service for contract fractionation were taken into account. The production costs of plasma-derived medicinal products obtained from national plasma showed a huge variability among blood establishments, which was much lower after standardization. The new suggested plasma tariffs were quite similar to those currently in force. Comparing the overall costs theoretically sustained by the National Health Service for plasma-derived medicinal products obtained from national plasma to current commercial costs, demonstrates that the national blood system could gain a 10% cost saving if it were able to produce plasma for fractionation within the standard costs defined in this study. Achieving national self-sufficiency through the production of plasma-derived medicinal products from national plasma, is a strategic goal of the National Health Service which must comply not only with quality, safety and availability requirements but also with the increasingly pressing need for economic sustainability.

  14. Food effects in paediatric medicines development for products Co-administered with food. (United States)

    Batchelor, Hannah; Kaukonen, Ann Marie; Klein, Sandra; Davit, Barbara; Ju, Rob; Ternik, Robert; Heimbach, Tycho; Lin, Wen; Wang, Jian; Storey, David


    A small amount of food is commonly used to aid administration of medicines to children to improve palatability and/or swallowability. However the impact of this co-administered food on the absorption and subsequent pharmacokinetic profile of the drug is unknown. Existing information on food effects is limited to standard protocols used to evaluate the impact of a high fat meal in an adult population using the adult medication. In the absence of a substantial body of data, there are no specific guidelines available during development of paediatric products relating to low volumes of potentially low calorie food. This paper brings together expertise to consider how the impact of co-administered food can be risk assessed during the development of a paediatric medicine. Two case studies were used to facilitate discussions and seek out commonalities in risk assessing paediatric products; these case studies used model drugs that differed in their solubility, a poorly soluble drug that demonstrated a positive food effect in adults and a highly soluble drug where a negative food effect was observed. For poorly soluble drugs risk assessments are centred upon understanding the impact of food on the in vivo solubility of the drug which requires knowledge of the composition of the food and the volumes present within the paediatric gastrointestinal tract. Further work is required to develop age appropriate in vitro and in silico models that are representative of paediatric populations. For soluble drugs it is more important to understand the mechanisms that may lead to a food effect, this may include interactions with transporters or the impact of the food composition on gastro-intestinal transit or even altered gastric motility. In silico models have the most promise for highly soluble drug products although it is essential that these models reflect the relevant mechanisms involved in potential food effects. The development of appropriate in vitro and in silico tools is

  15. Animal-derived natural products of Sowa Rigpa medicine: Their pharmacopoeial description, current utilization and zoological identification. (United States)

    Yeshi, Karma; Morisco, Paolo; Wangchuk, Phurpa


    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.

  16. Non-timber forest products marketing systems and market players in southwest Virginia: crafts, medicinal and herbal, and specialty wood products (United States)

    S.M. Greene; A.L. Hammett; S. Kant


    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...

  17. The cultural production of Bioterapia: psychic healing and the natural medicine movement in Slovakia. (United States)

    Rubens, D; Gyurkovics, D; Hornacek, K


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

  18. Risks in production and utilisation of labelled compounds for nuclear medicine. 2. Benefits and risks of utilization of 99mTc generator in nuclear medicine

    International Nuclear Information System (INIS)

    Olteanu-Chiper, D.; Barna, C.; Gard, E.; Negoita, N.


    The growth of radioisotope applications in nuclear medicine, imposed the reduction of the radiation effects and so, the reduction of associated risk of these applications. The utilization of radioactive isotopes for investigations in nuclear medicine is conditioned by the chemical behaviour and the means of detection of the emitted radiation on one hand, and by the radiation doses received by the patient, on the other hand. In these conditions, the nuclear medicine uses only the radioisotopes which are short half-time and low radiation energy, but high enough to be detected from the exterior of human body, 99m Tc being the most favourable for utilization in diagnostic purpose. This advantage is increased by the multiple possibilities to obtain different chemical forms with 99m Tc included, which permit the production of a large variety of radiopharmaceutical products, having a specific localization in the human body (organ-targets), thus allowing the diagnosis of numerous diseases. In the work the benefits and risks of the 99m Tc-Generator utilization in the nuclear medicine are shown and the utilization technique in these applications is presented . The 99m Tc-Generator is a compact chromatographic system, with lead shielding, which permits the elution of a sterile, pyrogen-free, injectable sodium pertechnetate solution, from an aluminium chromatographic column which keeps the 99 Mo. The 99m Tc-Generator system ensures the operator protection. The radioactive solution with 99m Tc is obtained in a closed vial, within lead shielding, the irradiation or contamination risks being mostly reduced. The utilization of 99m Tc in scintigraphic exam for diagnostic medicine implies a labelling operation with 99m Tc chemically bounded in forms appropriate to the target-organ and than the intravenously injection in doses dependent on the specific scintigraphic investigation or examination. (authors)

  19. Herbal medicinal products versus botanical-food supplements in the European market: state of art and perspectives. (United States)

    Bilia, Anna Rita


    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.

  20. Regulation (EC No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations

    Directory of Open Access Journals (Sweden)

    Lehmann Birka


    Full Text Available Abstract Before any medicinal product is authorised for use in adults, it must undergo extensive pharmaceutical consistency and stability tests, toxicological tests and clinical trials to ensure that it is of high quality, safe and effective. The same approach may not always be applied to medicinal products used to treat children. Studies showed that over 50% of the medicinal products used in children may not have been tested for use in this age group. The absence of suitable authorised medicinal products to treat conditions in children results from the fact that pharmaceutical companies do not adapt medicinal products to the needs of the paediatric population. This leaves health care professionals with no alternative other than to use medicinal products "off-label" and to use unauthorised products with the associated risks of inefficacy and/or adverse reactions. The Regulation (EC No 1901/2006 sets up a system of requirements, rewards and incentives, together with horizontal measures, to ensure that medicinal products are researched, developed and authorised to meet the therapeutic needs of children. The Regulation is addressed to: 1. The pharmaceutical industry by setting out the legal framework for receiving rewards and incentives by conducting clinical trials in the paediatric population. 2. The Member States to set out to support research into, and the development and availability of, medicinal products for paediatric use. 3. The Community as funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate. The legal framework for conducting clinical trials, including children/minors, is set up in Directive 2001/20/EC, the Clinical Trials Directive (CTD, for the European Union (EU. The CTD establishes specific provisions regarding conduct of

  1. 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


    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.

  2. [Vigilance for veterinary medicinal products: declarations of adverse reactions in the year 2009]. (United States)

    Müntener, C R; Bruckner, L; Stürer, A; Althaus, F R; Caduff-Janosa, P


    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.

  3. EU decision-making for marketing authorization of advanced therapy medicinal products: a case study. (United States)

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


    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.

  4. Revision of the ICH guideline on detection of toxicity to reproduction for medicinal products: SWOT analysis. (United States)

    Barrow, Paul


    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.

  5. Do ultra-orphan medicinal products warrant ultra-high prices? A review

    Directory of Open Access Journals (Sweden)

    Picavet E


    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

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

    Directory of Open Access Journals (Sweden)

    Camila Leal-Lopes


    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.


    Directory of Open Access Journals (Sweden)

    Shibabrata Pattanayak


    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

  8. [European Union regulatory and quality requirements for botanical drugs and their implications for Chinese herbal medicinal products development]. (United States)

    Zhu, You-Ping


    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.

  9. Scientific Production of Research Fellows at the Zagreb University School of Medicine, Croatia (United States)

    Polašek, Ozren; Kolčić, Ivana; Buneta, Zoran; Čikeš, Nada; Pećina, Marko


    Aim To evaluate scientific production among research fellows employed at the Zagreb University School of Medicine and identify factors associated with their scientific output. Method We conducted a survey among research fellows and their mentors during June 2005. The main outcome measure was publication success, defined for each fellow as publishing at least 0.5 articles per employment year in journals indexed in the Current Contents bibliographic database. Bivariate methods and binary logistic regression were used in data analysis. Results A total of 117 fellows (response rate 95%) and 83 mentors (100%) were surveyed. The highest scientific production was recorded among research fellows employed in public health departments (median 3.0 articles, interquartile range 4.0), compared with those from pre-clinical (median 0.0, interquartile range 2.0) and clinical departments (median 1.0, interquartile range 2.0) (Kruskal-Wallis, P = 0.003). A total of 36 (29%) research fellows published at least 0.5 articles per employment year and were considered successful. Three variables were associated with fellows’ publication success: mentor’s scientific production (odds ratio [OR], 3.14; 95% confidence interval [CI], 1.31-7.53), positive mentor’s assessment (OR, 3.15; 95% CI, 1.10-9.05), and fellows’ undergraduate publication in journals indexed in the Current Contents bibliographic database (OR, 4.05; 95% CI, 1.07-15.34). Conclusion Undergraduate publication could be used as one of the main criteria in selecting research fellows. One of the crucial factors in a fellow’s scientific production and career advancement is mentor’s input, which is why research fellows would benefit most from working with scientifically productive mentors. PMID:17042070

  10. Clinical evidence for orphan medicinal products-a cause for concern? (United States)

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


    The difficulties associated with organising clinical studies for orphan medicinal products (OMPs) are plentiful. Recent debate on the long-term effectiveness of some OMPs, led us to question whether the initial standards for clinical evidence for OMPs, set by the European Medicines Agency (EMA) at the time of marketing authorization, are too low. Therefore, the aim of this study was to quantitatively evaluate the characteristics and quality of clinical evidence that is presented for OMPs to obtain marketing authorization in Europe, using the new and validated COMPASS tool. We quantitatively assessed the characteristics and quality of clinical evidence of the pivotal studies of 64 OMPs as described in the European Public Assessment Report and/or the Scientific Discussion document prepared by the Committee for Human Medicinal Products of the EMA. The 64 OMPs were altogether authorized for 78 orphan indications, for which 117 studies were identified as 'pivotal' or 'main' studies. In approximately two thirds of the studies, the allocation was randomized (64.8%) and a control arm was used (68.5%). Half of the studies applied some type of blinding. Only a minority (26.9%) of the studies included a Quality-of-Life (QoL) related endpoint, of which a third claim an improvement in QoL. Upon analyzing the quality of reporting, we found that some aspects (i.e. the endpoints, the sampling criteria, and the interventions) are well described, whereas other items (i.e. a description of the patients and of potential biases) are not reported for all studies. In conclusion, the pivotal studies that are the basis for marketing authorization of OMPs are a cause for concern, as they exhibit methodological flaws i.e. the lack of QoL-related endpoints as outcome, lack of blinding in the study design and the use of surrogate endpoints. Additionally, there are shortcomings in the reporting of those studies that complicate the interpretation. A more demanding regulatory process for OMPs is

  11. Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation (United States)

    Arguello, Blanca; Salgado, Teresa M; Fernandez-Llimos, Fernando


    Aims To assess the completeness and applicability of information for the use of medicines in pregnancy and lactation contained in European Summaries of Product Characteristics (SmPCs). Methods SmPCs available on the EMA website in April 2011 were retrieved, and information on the use of medicines during pregnancy and lactation was analyzed. A form was designed to extract information regarding drug concentrations crossing the placenta, excretion of the drug in milk, the existence of pre-clinical and clinical studies and clinical experience describing the use of the medicine in pregnancy and lactation, medicine effects on human fertility, medicines use in women of child-bearing potential and specific recommendations for use during pregnancy and breastfeeding. SmPCs were classified as containing ‘conclusive’ or ‘ambiguous’ information depending on whether (or not) they provided clear instructions regarding medicine use in pregnancy and lactation. Results Of the 534 SmPCs, 89.3% did not mention whether the drug crossed the placenta, 67.6% indicated that there was no clinical experience during pregnancy and in 61.4% it was unknown whether the medicine was excreted in human milk. Recommendations for medicine use during pregnancy and breastfeeding were ambiguous in 57.0% and 16.5% of the SmPCs, respectively, and medicine use was restricted in over 90% SmPCs for both pregnancy and breastfeeding, despite no information supporting these restrictions being reported. The time elapsed since a SmPCs first approval was not associated with an increase in information quality. Conclusions Important information deficits on the use of medicines during pregnancy and breastfeeding were found in European SmPCs. PMID:25224071

  12. Computer aided design of medicinal products based on interactive chemical/herbal ingredients - An R&D approach (United States)

    Siontorou, Christina G.


    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.

  13. Development of a productive research culture in emergency medicine: Report of the outcomes of a research forum. (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


    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.

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


    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.

  15. Optimization of ethanol production from garcinia cambogia residues and the effects of its medicinal component on production yield

    International Nuclear Information System (INIS)

    Ma, H.; Zhang, F.


    Garcinia cambogia, a Chinese herbal medicine, was popular due to its effect for weight loss. The main medical component inside was determined to be hydroxycitric acid (HCA). To realize the resource technology of garcinia cambogia residue, Optimum ethanol production from residues was investigated, and the effects of remaining HCA on the ethanol yield were investigated. A Plackett-Burman experimental design was used to screen the significance of several influencing factors, and cellulase, yeast extract, and KH2PO4 were observed to exert important effects. The optimum ethanol fermentation conditions were determined through an orthogonal design to include a cellulase concentration of 100 U/g, a yeast extract concentration of 15 g/L, and a KH2PO4 concentration of 1.0 g/L. The ethanol concentration obtained under optimal conditions was 4.0 g/L. The remained HCA in the residues showed minimal influences on ethanol fermentation and could even increase ethanol yield at low concentrations. (author)

  16. Analytical similarity assessment of rituximab biosimilar CT-P10 to reference medicinal product. (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


    CT-P10 (Truxima™) was recently approved as the world's first rituximab biosimilar product in the European Union (EU) and South Korea. To demonstrate biosimilarity of CT-P10 with the reference medicinal product (RMP), extensive 3-way similarity assessment has been conducted between CT-P10, EU-Rituximab and US-Rituximab, focusing on the physicochemical and biological quality attributes. A multitude of state-of-the-art analyses revealed that CT-P10 has identical primary and higher order structures compared to the original product. Purity/impurity profiles of CT-P10 measured by the levels of aggregates, fragments, non-glycosylated form and process-related impurities were also found to be comparable with those of RMPs. In terms of the post-translational modification, CT-P10 contains slightly less N-terminal pyro-glutamate variant, which has been known not to affect product efficacy or safety. Oligosaccharide profiling has revealed that, although CT-P10 contains the same conserved glycan species and relative proportion with the RMPs, the content of total afucosylated glycan in CT-P10 was slightly higher than in EU- or US-Rituximab. Nevertheless, the effect of the observed level of afucosylation in CT-P10 drug product on Fc receptor binding affinity or antibody-dependent cell-mediated cytotoxicity was found to be negligible based on the spiking study with highly afucosylated sample. Arrays of biological assays representative of known and putative mechanisms of action for rituximab have shown that biological activities of CT-P10 are within the quality range of RMPs. Recent results of clinical studies have further confirmed that the CT-P10 exhibits equivalent clinical efficacy and safety profiles compared to EU- and US-Rituximab. The current 3-way similarity assessment together with clinical study results confidently demonstrate that CT-P10 is highly similar with EU- and US-Rituximab in terms of physicochemical properties, biological activities, efficacy, and safety for

  17. Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture

    Directory of Open Access Journals (Sweden)

    Bate R


    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

  18. The use of terrestrial and aquatic microcosms and mesocosms for the ecological risk assessment of veterinary medicinal products

    NARCIS (Netherlands)

    Brink, van den P.J.; Tarzona, J.V.; Solomon, K.R.; Knacker, T.; Brink, van den N.W.; Brock, T.C.M.; Hoogland, J.P.


    In this paper, we investigate the applicability of experimental model ecosystems (microcosms and mesocosms) for the ecological risk assessment of veterinary medicinal products (VMPs). VMPs are used in large quantities, but the assessment of associated risks to the environment is limited, although

  19. Conservation and sustainable use of medicinal and aromatic products in North America: Are there really lessons to be learned? (United States)

    A. L. Hammett; James L. Chamberlain


    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...

  20. Optimization, validation and application of UV-Vis spectrophotometric-colorimetric methods for determination of trimethoprim in different medicinal products

    Directory of Open Access Journals (Sweden)

    Goran Stojković


    Full Text Available Two simple, sensitive, selective, precise, and accurate methods for determination of trimethoprim in different sulfonamide formulations intended for use in human and veterinary medicine were optimized and validated. The methods are based on the trimethoprim reaction with bromcresol green (BCG and 2,4-dinitro-1-fluorobenzene (DNFB. As extraction solvents we used 10 % N,N-dimethylacetamide in methanol and acetone for both methods, respectively. The colored products are quantified applying visible spectrophotometry at their corresponding absorption maxima. The methods were validated for linearity, sensitivity, accuracy, and precision. We tested the method applicability on four different medicinal products in tablet and powder forms containing sulfametrole and sulfamethoxazole in combination with trimethoprim. The results revealed that both methods are equally accurate with recoveries within the range 95-105 %. The obtained between-day precision for both methods, when applied on four different medicinal products, was within in the range 1.08-3.20 %. By applying the F-statistical test (P<0.05, it was concluded that for three medicinal products tested both methods are applicable with statistically insignificant difference in precision. The optimized and validated BCG and DNFB methods could find application in routine quality control of trimethoprim in various formulation forms, at different concentration levels, and in combination with different sulfonamides.

  1. [Analysis on influential factors in China's exports of primary and semi-finished products of traditional Chinese medicine to ASEAN]. (United States)

    Qian, Yun-Xu; Yang, Yue; Zhao, Wei; Bi, Kai-Shun


    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.

  2. Use of medicines and other products for therapeutic purposes among children in Brazil. (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


    To assess the prevalence of the use of medicines and other products for therapeutic purposes in the Brazilian pediatric population and test whether demographic, socioeconomic and health factors are associated with use. A cross-sectional population-based study (National Survey on Access, Use and Promotion of Rational Use of Medicines - PNAUM), including 7,528 children aged 12 or younger, living in urban areas in Brazil. Medicine use to treat chronic or acute diseases was reported by the primary caregiver present at the household interview. Associations between independent variables and medicine use were investigated by Poisson regression. The overall prevalence of medicine use was 30.7% (95%CI 28.3-33.1). The prevalence of medicine use for chronic diseases was 5.6% (95%CI 4.7-6.7) and for acute conditions, 27.1% (95%CI 24.8-29.4). The factors significantly associated with overall use were five years old or under, living in the Northeast region, having health insurance and using health services in the last 12 months (emergency visits and hospitalizations). The following were associated with drug use for chronic diseases: age ≥ 2 years, Southeast and South regions, and use of health services. For drug use in treating acute conditions, the following associated factors were identified: ≤ 5 years, North, Northeast or Midwest regions, health insurance, and one or more emergency visits. The most commonly used drugs among children under two years of age were paracetamol, ascorbic acid, and dipyrone; for children aged two years or over they were dipyrone, paracetamol, and amoxicillin. The use of medicine by children is considerable, especially in treating acute medical conditions. Children using drugs for chronic diseases have a different demographic profile from those using drugs for acute conditions in relation to gender, age, and geographic region. Estimar a prevalência de uso de medicamentos e outros produtos com finalidade terapêutica na população pedi

  3. Preliminary investigation of the possibility for implementation of modified pharmacopoeial HPLC methods for quality control of metronidazole and ciprofloxacin in medicinal products used in veterinary medicine

    Directory of Open Access Journals (Sweden)

    Marjan Piponski


    Full Text Available Quality control of veterinary medicine products containing two different frequently used antibiotics metronidazole and ciprofloxacin hydrochloride, was considered and performed, using modified pharmacopoeial HPLC methods. Three different HPLC systems were used: Varian ProStar, Perkin Elmer Series and UPLC Shimadzu Prominence XR. The chromatographic columns used were LiChropher RP Select B 75 mm x 4 mm with 5 μm particles and Discovery C18 100 mm x 4,6 mm with 5 μm particles. Chromatographic methods used for both analytes were compendial, with minor modifications made for experimental purposes. Minor modifications of the pharmacopoeia prescribed chromatographic conditions, in both cases, led to better chromatographic parameters, good resolution and shorter analysis times. Optimized methods can be used for: determination of metronidazole in gel formulation, for its simultaneous quantification with preservatives present in the formulation and even for identification and quantification of its specified impurity, 2-methyl-5-nitroimidazole; determination of ciprofloxacin hydrochloride in film coated tablets and eye drops and identification and quantification of its specified impurities. These slightly modified and optimized pharmacopoeial methods for quality control of metronidazole and ciprofloxacin dosage forms used in veterinary medicine can be successfully applied in laboratories for quality control of veterinary medicines.

  4. Using SSR-HRM to Identify Closely Related Species in Herbal Medicine Products: A Case Study on Licorice. (United States)

    Li, Jingjian; Xiong, Chao; He, Xia; Lu, Zhaocen; Zhang, Xin; Chen, Xiaoyang; Sun, Wei


    Traditional herbal medicines have played important roles in the ways of life of people around the world since ancient times. Despite the advanced medical technology of the modern world, herbal medicines are still used as popular alternatives to synthetic drugs. Due to the increasing demand for herbal medicines, plant species identification has become an important tool to prevent substitution and adulteration. Here we propose a method for biological assessment of the quality of prescribed species in the Chinese Pharmacopoeia by use of high resolution melting (HRM) analysis of microsatellite loci. We tested this method on licorice, a traditional herbal medicine with a long history. Results showed that nine simple sequence repeat (SSR) markers produced distinct melting curve profiles for the five licorice species investigated using HRM analysis. These results were validated by capillary electrophoresis. We applied this protocol to commercially available licorice products, thus enabling the consistent identification of 11 labels with non-declared Glycyrrhiza species. This novel strategy may thus facilitate DNA barcoding as a method of identification of closely related species in herbal medicine products. Based on this study, a brief operating procedure for using the SSR-HRM protocol for herbal authentication is provided.

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

    Directory of Open Access Journals (Sweden)

    Anastasia-Varvara Ferlemi


    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.

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

    International Nuclear Information System (INIS)

    Srivastava, S.C.


    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.

  7. Hurdles in clinical implementation of academic advanced therapy medicinal products: A national evaluation. (United States)

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


    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.

  8. [Practical Use Evaluation of Aluminum Packaging for Medicinal Products Based on Universal Design]. (United States)

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


    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.

  9. 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.


    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.

  10. 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.


    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

  11. Legal requirements for the quality of herbal substances and herbal preparations for the manufacturing of herbal medicinal products in the European union. (United States)

    Vlietinck, Arnold; Pieters, Luc; Apers, Sandra


    In the European Union (EU) herbal medicinal products have become increasingly important. This is, for instance, underlined by the recent introduction of a simplified procedure in the Member States of the EU allowing the registration of herbal medicinal products which fulfill the criteria of a traditional herbal medicinal product, i.e., sufficient evidence of its medicinal use throughout a period of at least 30 years for products in the EU and at least 15 years within the EU and 15 years elsewhere for products outside the EU. With regard to the manufacturing of these products and their quality, applications of traditional herbal medicinal products have to fulfil the same requirements as applications for a marketing authorization. The quality of herbal substances as well as herbal preparations will be determined by the availability of modern science-based public monographs in the European Pharmacopoeia and their equivalents developed by the pharmaceutical industry. The standards put forward in these monographs must allow us not only to define the quality of these products, but also to eliminate dangerous counterfeit, substandard, adulterated and contaminated (traditional) herbal medicinal products. The usefulness of these monographs to implement the criteria on quality and specifications put forward for these products in the different guidelines of the European Medicines Agency (EMEA) is discussed.

  12. Production of gel 99mTc generators for Nuclear Medicine at the Nuclear Power Institute of China, Chengdu

    International Nuclear Information System (INIS)

    Boyd, R.E.


    The development and testing of the gel-type 99m Tc generator technology has been going on for several years at the Nuclear Power Institute of China. This generator type has already been licensed by the Ministry of Health. With the co-operation of the IAEA, under Model Project CPR/2/006,it is intended to upgrade and optimise the existing facility for large scale production and continue to improve the generator performance in terms of quality and reliability of its use in nuclear medicine. The expert mission objective was to carry out final laboratory tests to assess the performance of the gel- type 99m Tc, locally produced, as well as to assess the suitability of the corresponding 99m Tc eluate for nuclear medicine studies. In particular, the expert tested the suitability of the 99m Tc for the labelling of sensitive biomolecules and its general performance in a nuclear medicine service

  13. 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


    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.

  14. Medicinal plants and finished marketed herbal products used in the treatment of malaria in the Ashanti region, Ghana. (United States)

    Komlaga, Gustav; Agyare, Christian; Dickson, Rita Akosua; Mensah, Merlin Lincoln Kwao; Annan, Kofi; Loiseau, Philippe M; Champy, Pierre


    Ethnobotanical survey was performed to document medicinal plants employed in the management of malaria in the Bosomtwe and Sekyere East Districts of the Ashanti Region (Ghana), in comparison with the plant ingredients in herbal antimalarial remedies registered by the Ghana Food and Drug Administration. Two hundred and three (203) herbalists from 33 communities within the two districts were interviewed on medicinal plants they use to manage malaria. A literature search was made to determine already documented plants. In addition, 23 finished marketed herbal products indicated for the management of malaria were identified and their labels examined to find out which of the plants mentioned in our survey were listed as ingredients and whether these products are in anyway regulated. Ninety-eight (98) species of plants were cited for the management of malaria. In comparison with literature citations, 12 (12.2%) species were reported for the management of malaria for the first time and 20 (20.4%) others for the first time in Ghana. Twenty-three (23) finished marketed herbal antimalarial products examined contained aerial or underground parts of 29 of the plants cited in our survey as ingredients. Twenty-two (22) of these products have been registered by the Ghana Food and Drugs Authority, four (4) of which were included in the recommended herbal medicine list for treating malaria in Ghana. This study provides new additions to the inventory of medicinal plants used for the management of malaria and reports the commercial availability and regulation of finished marketed labelled herbal products intended for the treatment of malaria in Ghana. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.


    Directory of Open Access Journals (Sweden)

    E. I. Tarlovskaya


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

  16. Current advanced therapy cell-based medicinal products for type-1-diabetes treatment. (United States)

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


    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

  17. Conformity of package inserts information to regulatory requirements among selected branded and generic medicinal products circulating on the East African market. (United States)

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


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

  18. 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 ...

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


    M. Bozorgi; G.R. Amin; S.N. Ostad; N. Samadi; E. Nazem; M. Shekarchi


    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...

  20. [The Herceptin® case : A case of falsification of medicinal products to a greater extent]. (United States)

    Streit, Renz


    Falsified medicines are a raising problem for the German drug market. The complex distribution channels across the European market facilitates the introduction of falsified and stolen medicines into the legal supply chain and may pose a risk for patients. The "Herceptin® case" from 2014 of falsified medicines of Italian origin demonstrates how complex distribution systems have been misused by criminal organizations in order to introduce stolen and thus falsified medicines via the parallel trade into the market, and which measures the authorities and the parallel-traders in the national and European network have taken to ensure patient safety. Falsified medicines will continue to be a problem in the future, so new monitoring systems have to be established and effectively used for prevention. The introduction of the EU-wide serialisation system in February 2019 is therefore intended to identify falsified drugs and to prevent the further trade as well as the expenditure to the patient. Furthermore, the maintenance and intensification of the cooperation between all EU authorities involved remains indispensable to close gateways in the distribution system for falsified medicines and to minimise the risk to the population.

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

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


    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.

  2. Medicinal claims

    NARCIS (Netherlands)

    Meulen, van der Bernd


    Under EU medicinal law, substances presented as having properties for treating or preventing disease are medicinal products by virtue of their presentation. EU food law prohibits attributing to any food the property of preventing, treating or curing a disease. However, if certain conditions are

  3. Relating mentor type and mentoring behaviors to academic medicine faculty satisfaction and productivity at one medical school. (United States)

    Shollen, S Lynn; Bland, Carole J; Center, Bruce A; Finstad, Deborah A; Taylor, Anne L


    To examine relationships among having formal and informal mentors, mentoring behaviors, and satisfaction and productivity for academic medicine faculty. In 2005, the authors surveyed full-time faculty at the University of Minnesota Medical School to assess their perceptions of variables associated with job satisfaction and productivity. This analysis focused on perceptions of mentoring as related to satisfaction with current position and productivity (articles published in peer-reviewed journals [article production] and role as a primary investigator [PI] or a co-PI on a grant/contract). Of 615 faculty, 354 (58%) responded. Satisfied faculty were not necessarily productive, and vice versa. Outcomes differed somewhat for mentor types: Informal mentoring was more important for satisfaction, and formal mentoring was more important for productivity. Regardless of mentor type, the 14 mentoring behaviors examined related more to satisfaction than productivity. Only one behavior-serves as a role model-was significantly, positively related to article production. Although participants reported that formal and informal mentors performed the same mentoring behaviors, mentees were more satisfied or productive when some behaviors were performed by formal mentors. The results emphasize the importance of having both formal and informal mentors who perform mentoring behaviors associated with satisfaction and productivity. The results provide a preliminary indication that mentor types and specific mentoring behaviors may have different effects on satisfaction and productivity. Despite the differences found for some behaviors, it seems that it is more essential that mentoring behaviors be performed by any mentor than by a specific type of mentor.

  4. Analysis of an Adulterated Herbal Medicinal Product Using Ultra-Performance Liquid Chromatography Coupled with QTOF Mass Spectrometry

    Directory of Open Access Journals (Sweden)

    Kate Yu


    Full Text Available The reports of severe adverse effects and fatalities associated with herbal medicinal products adulterated with synthetic compounds have raised global concerns. The objective of this study is to analyze one commercial herbal medicinal product suspected to be adulterated with synthetic drugs in order to identify potential adulterants, to verify if the product contained the herbs listed as ingredients in label claim and to determine quality consistency among different batches of the product. Analyses of suspected product obtained from seven different batches were performed using ultra performance liquid chromatography coupled to quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF-MS with multiple data processing tools and multivariate analyses. In addition, 23 individual powdered herbs (12 as per label claim and 11 suspected herbs, 11 marker compounds of the labeled herbs and five suspected synthetic drugs as adulterants were also concurrently analyzed to have clear understanding of product composition. Based on our analysis, the major ingredients of studied product were found to be 5 synthetic compounds: caffeine, chlorphenamine, piroxicam, betamethasone and oxethazaine. Three of them have been found to exceed their recommended doses. From the herbal composition analysis, GanCao (Glycyrrhizae radix et rhizoma was found to be the main ingredient, which is not among the claimed 12 herbs that were supposed to be in the product. Other herbs detected as minor ingredients were MuGua (Chaenomelis fructus, DangGui (Angelicae sinensis radix, and HuangQi (Astragali radix, which are among the 12 herbs that were supposed to be in the product. Based on our results we demonstrated that UPLC-QTOF MS is an effective and versatile tool for the analysis of herbal medicinal products. It is highly desirable to have a streamlined process with automatic workflow and fit-for-purpose database to increase efficiency and productivity of sample analysis. Results of

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


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


    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: ...

  6. 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


    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.

  7. Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2001 - February 2002 : report

    Directory of Open Access Journals (Sweden)

    V. Naidoo


    Full Text Available An overview of reports of suspected adverse drug reactions received by the Veterinary Pharmacovigilance and Medicines Information Centre during the period March 2001 to February 2002 is given. A total of 77 reports were received. The majority of reports involved suspected adverse reactions that occurred in dogs and cats. Most products implicated in the reports were Stock Remedies. The products were predominantly administered either by veterinarians or trained paraveterinary professionals. Although the majority of reports were received from veterinary pharmaceutical companies, the proportion of reports received directly from veterinarians increased compared with previous years.


    International Nuclear Information System (INIS)



    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

  9. 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.


    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)

  10. [Correlation research of photosynthetic characteristics and medicinal materials production with 4 Uncariae Cum Uncis]. (United States)

    Luo, Min; Song, Zhi-Qin; Yang, Ping-Fei; Liu, Hai; Yang, Zai-Gang; Wu, Ming-Kai


    Using four Uncariae Cum Uncis materials including Uncaria sinensis (HGT), U. hirsutea (MGT), Jianhe U. rhynchophylla (JHGT) and U. rhynchophylla(GT) as the research objects, the correlations between medicinal materials' yield and photosynthetic ecophysiology-factors in the plant exuberant growth period were studied. Results showed that the Uncaria plants net photosynthetic rate (Pn) changed by unimodal curve. There was not "midday depression" phenomenon. There was a different relationship among the photosynthetic ecophysiology-factors and between photosynthetic ecophysiology-factors and medicinal materials' yield. Pn,Tl,Gs had a significant correlation with medicinal materials' yield(M)and were the most important factors of growth. Copyright© by the Chinese Pharmaceutical Association.

  11. Adulteration of proprietary Chinese medicines and health products with undeclared drugs: experience of a tertiary toxicology laboratory in Hong Kong. (United States)

    Ching, Chor Kwan; Chen, Sammy Pak Lam; Lee, Hencher Han Chih; Lam, Ying Hoo; Ng, Sau Wah; Chen, Mo Lung; Tang, Magdalene Huen Yin; Chan, Suzanne Suk San; Ng, Candy Wai Yan; Cheung, Jana Wing Lan; Chan, Tina Yee Ching; Lau, Nike Kwai Cheung; Chong, Yeow Kuan; Mak, Tony Wing Lai


    Proprietary Chinese medicines (pCMs) and health products, generally believed to be natural and safe, are gaining popularity worldwide. However, the safety of pCMs and health products has been severely compromised by the practice of adulteration. The current study aimed to examine the problem of adulteration of pCMs and health products in Hong Kong. The present study was conducted in a tertiary referral clinical toxicology laboratory in Hong Kong. All cases involving the use of pCMs or health products, which were subsequently confirmed to contain undeclared adulterants, from 2005 to 2015 were reviewed retrospectively. A total of 404 cases involving the use of 487 adulterated pCMs or health products with a total of 1234 adulterants were identified. The adulterants consisted of approved drugs, banned drugs, drug analogues and animal thyroid tissue. The six most common categories of adulterants detected were nonsteroidal anti-inflammatory drugs (17.7%), anorectics (15.3%), corticosteroids (13.8%), diuretics and laxatives (11.4%), oral antidiabetic agents (10.0%) and erectile dysfunction drugs (6.0%). Sibutramine was the most common adulterant (n = 155). The reported sources of these illicit products included over-the-counter drug stores, the internet and Chinese medicine practitioners. A significant proportion of patients (65.1%) had adverse effects attributable to these illicit products, including 14 severe and two fatal cases. Psychosis, iatrogenic Cushing syndrome and hypoglycaemia were the three most frequently encountered adverse effects. Adulteration of pCMs and health products with undeclared drugs poses severe health hazards. Public education and effective regulatory measures are essential to address the problem. © 2017 The British Pharmacological Society.

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

    NARCIS (Netherlands)

    Krystek, Petra; Ritsema, Rob


    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

  13. 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

  14. 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


    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.

  15. 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


    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.

  16. Concise Review: Bone Marrow Mononuclear Cells for the Treatment of Ischemic Syndromes: Medicinal Product or Cell Transplantation? (United States)

    Rico, Laura; Herrera, Concha


    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

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


    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.

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

    Wittstock, Marcus; Paeschke, Norbert


    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.

  19. Development of indigenous technology at CNEN in the fields of nuclear medicine, nuclear detectors, instrumentation, radioisotope production and application of nuclear techniques

    International Nuclear Information System (INIS)

    Mafra, O.


    The main objectives of the program developed at CNEN in the field of nuclear medicine, nuclear detectors, instrumentation, radioisotope production and application of nuclear technique are described. (E.G.) [pt

  20. Improvement of Nutritional and Bioactive Compound Production by Lion's Mane Medicinal Mushroom, Hericium erinaceus (Agaricomycetes), by Spraying Growth Regulators. (United States)

    Vi, Minhthuan; Yang, Xueqin; Zeng, Xianlu; Chen, Rui'an; Guo, Liqiong; Lin, Junfang; He, Qianyun; Zheng, Qianwang; Wei, Tao


    Hericium erinaceus is a popular culinary and medicinal mushroom in China because of its broad beneficial effects. In this study we evaluated the effects of stimulation with 7 growth regulators at 5 different concentrations on improving the production of nutritional and bioactive compounds by H. erinaceus. Results showed that among all the tested regulators, gibberellic acid (GA) increased protein content (165%), free amino acids (100%), polysaccharides (108%), and polyphenols (26%). Spraying nephthyl acetic acid increased polysaccharides and triterpenoids to 4.37 and 17.27 g/100 g, respectively. Spraying chitosan significantly increased polyphenols by 42%. The addition of triacontanol, indole acetic acid, and 2,4-dichlorophenoxyacetic acid improved the production of proteins, free amino acids, polysaccharides, and polyphenols, but not to the extent that GA did. These results indicate that adding certain growth regulators can effectively improve the production of nutritional and bioactive compounds in H. erinaceus.

  1. [Study on botanical pesticides and its application in production of traditional Chinese medicine]. (United States)

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


    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.

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


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


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

  3. 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.


    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

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

    Directory of Open Access Journals (Sweden)

    Leandro Ortigoza Martins


    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.

  5. Stakeholders' perspectives on the regulation and integration of complementary and alternative medicine products in Lebanon: a qualitative study (United States)


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

  6. Inhibitory effect on nitric oxide production and free radical scavenging activity of Thai medicinal plants in osteoarthritic knee treatment. (United States)

    Anuthakoengkun, Areeya; Itharat, Arunporn


    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.

  7. Pharmacological study on traditional Chinese medicine and natural product in China

    Institute of Scientific and Technical Information of China (English)

    Yong-xiang ZHANG


    China is abundant in natural medicinal resources. Natural medicine (NP), especially traditional Chinese medicine (TCM), have been widely employed in prevention and treatment of diseases in China for thousands of years, which make a great contribution to health care of Chinese people and the prosperity of the Chinese nation. TCM is the excellence culture inheritance of China and a medicine system with long history, tradition and unique theory and technique. Prescriptions or formula are the main form of TCM and the compatibility and composition of them are made up following the theory of TCM among which the theory of compatibility is the essential part. Clinical application and modern pharmacological study both demonstrated that TCM prescription possesses unique effect in comparison with chemical drugs. However, the pharmacological study of TCM prescription is very difficult due to multiple herbs which contain complicated chemical components in the prescription. So, the key point for the pharmacological study of TCM prescription is to elucidate its integrative effect and the mechanism of action. In recent years, great advances have been achieved in the research on TCM prescription and modern study of TCM prescription, including pharmacological and chemical studies, has becoming a hot research field in China. The pharmacological studies of TCM and NP are conducted with different ways and methods including holistic approaches in various experimental model animals and in vitro experiments in tissue, organ and cell models. In addition, a lot of new technics and methods such as″ omics″ technologies were employed in the molecular level studies, for example, researches on the mechanism of action of TCM and NP. In addition, a lot of new drugs have been developed from TCM prescriptions in China. The classical preparations of TCM, including decoction, pill, powder, ointment and pellet, etc, are prepared with traditional methods. While, the new preparations are similar to

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

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


    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.

  9. Two approaches to incorporate clinical data uncertainty into multiple criteria decision analysis for benefit-risk assessment of medicinal products. (United States)

    Wen, Shihua; Zhang, Lanju; Yang, Bo


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

  10. Active compounds in Chinese herbs and medicinal animal products which promote blood circulation via inhibition of Na+, K+-ATPase. (United States)

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


    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.

  11. Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2004 - February 2006 : report

    Directory of Open Access Journals (Sweden)

    V. Naidoo


    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 2004 to February 2006 is presented. A total of 21 reports was received in the 2-year period, continuing the decline in the number of reports to a lower figure than in any previous year. This is surprising considering the legal obligation of the veterinary professionals to report all adverse drug reactions. Once again the majority of reports involved suspected adverse reactions that occurred in dogs and cats. Most of the products implicated were stock remedies. Veterinarians predominantly administered these products.

  12. [Peruvian scientific production in medicine and collaboration networks, analysis of the Science Citation Index 2000-2009]. (United States)

    Huamaní, Charles; Mayta-Tristán, Percy


    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.

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

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

    International Nuclear Information System (INIS)

    Beddoes, J.M.


    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)

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

    DEFF Research Database (Denmark)

    Schulman, S; Angerås, U; Bergqvist, D


    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......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...... 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...

  16. 99Mo production for using in the nuclear medicine in 99mTc generators

    International Nuclear Information System (INIS)

    Kurenkov, N.V.; Chuvilin, D.Yu.


    The review of methods and advanced technologies for obtaining 99 Mo in nuclear reactors is presented. The 99 Mo isotope is used for preparing the 99m Tc generators, widely applied in nuclear medicine. The reactor method for obtaining 99 Mo is based on the 98 Mo(n, γ) 99 Mo radiation capture reaction and 235 U fission reaction under the effect of the 235 U (n, f) 99 Mo reaction. The results of studies on obtaining 99 Mo on the charged particles accelerators, mainly, on the proton beam and under the effect of photonuclear reaction is also described. The data on the 99 Mo real consumption and forecast for its application in different regions of the world from 1994 up to 2006 are presented [ru

  17. Carbazole Scaffold in Medicinal Chemistry and Natural Products: A Review from 2010-2015. (United States)

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


    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.

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


    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.

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

    Directory of Open Access Journals (Sweden)

    M. Bozorgi


    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.

  20. Metabolic engineering approaches for production of biochemicals in food and medicinal plants. (United States)

    Wilson, Sarah A; Roberts, Susan C


    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.

  1. The Prevalance of Herbal Product Use as a Alternative Medicine Among Cancer Patients in Turkey

    Directory of Open Access Journals (Sweden)

    Nilufer Avci


    Full Text Available Aim: We investigated the prevalance of herbal product use in cancer patients who were followed up and treated at our center. Material and Method: A total of 271 patients were enrolled in this study. Patients asked to complete a questionnaire form and the stage of the patients and the treatment given were recorded following the delivery of the questionnaire form by the investigator. Results: Herbal products were used by 97 (35.7% of 271 patients who completed the questionaire. The most common herbal products used alone or in combination were urtica urens, ginger, bee pollen, green tea. The highest use rate was observed in patients between the age of 40 and 49 (54%, p=0.099. The rate also was found to increase in in paralel to the increased level of income i.e 32% in patients with a lower income level, 35% patients with a moderate income level, and 44% in patients with a high income level (p=0.386. As the education level increased, the rate of use of herbal products also increased (p=0.023. Discussion: The use of herbal products is rather prevalent among cancer patients. There is a need to increase the awareness of the physicians regarding herbal products and educate the population as a whole.

  2. 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


    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......, they are not necessarily available to the patient. This is due to the fact that decisions about the price and the reimbursement of these (very expensive) products are made at the national level. This article draws up a framework for distributing limited health resources where medicinal products for rare diseases (orphan...... medicine) are concerned. The provision in the Patients’ Rights Directive (Dir. 2011/27/EU) on cooperation in health care among the Member States is discussed through the lens of ‘solidarity’ (understood as mutual cooperation) in order to align and remedy the deficits in the system and guarantee the patient...

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

    Marion, H


    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.

  4. 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.


    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

  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

    NARCIS (Netherlands)

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


    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

  6. Contact dermatitis as an adverse reaction to some topically used European herbal medicinal products - part 2: Echinacea purpurea-Lavandula angustifolia. (United States)

    Gangemi, Sebastiano; Minciullo, Paola L; Miroddi, Marco; Chinou, Ioanna; Calapai, Gioacchino; Schmidt, Richard J


    This review focuses on contact dermatitis as an adverse effect of a selection of topically used herbal medicinal products for which the European Medicines Agency has completed an evaluation up to the end of November 2013 and for which a Community herbal monograph has been produced. Part 2: Echinacea purpurea Moench-Lavandula angustifolia Mill. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

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


    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.

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

    Directory of Open Access Journals (Sweden)

    V. H. Sunitha.


    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.

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

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


    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.

  10. 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.


    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

  11. The Role of Biotechnology for Conservation and Biologically Active Substances Production of Rhodiola rosea: Endangered Medicinal Species (United States)

    Tasheva, Krasimira; Kosturkova, Georgina


    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. PMID:22666097

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

    DEFF Research Database (Denmark)

    Bruun, Johan Musaeus

    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. In the pres......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....... 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...... 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...

  13. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. (United States)

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


    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.

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

    Directory of Open Access Journals (Sweden)

    Ietidal E. Mohamed


    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.

  15. Regulatory/Scientific Supports for Micro-, Small-, and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA. (United States)

    Kondo, Hideyuki; Shibatsuji, Masayoshi; Yasuda, Naoyuki


    Micro-, small-, and medium-sized enterprises (SMEs) have been considered as key players who can bring innovative medicinal products and/or technologies into the field. However, they may need much regulatory/scientific supports to provide their products, technologies, or services to the market in a timely way. Both the Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA), regulatory authorities for medicinal products in Japan and the EU, respectively, have prepared supportive measures for SMEs from the early phase of product/technology development to the postmarketing phase. With respect to supports for SMEs, both agencies have provided similar SME-specific supportive activities, including routine administrative assistance, consultations about product development strategy from an early phase, as well as specific regulatory/scientific issues and fee incentives. In addition, there is a system to register SME status in the EU, which can be a tool for regulators to know how much potential SME-driven activities have and with whom they should communicate to provide necessary supports. Furthermore, as new technologies and novel products from SMEs are not limited to the region where they are developed, close communication about these topics between the PMDA and the EMA will contribute to advancing patients' access to necessary medicinal products.

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

    Directory of Open Access Journals (Sweden)

    Gisela Sjøgaard


    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.

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


    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.

  18. [Requirements for long-term follow-up on efficacy and safety of advanced therapy medicinal products. Risk management and traceability]. (United States)

    Klug, B; Reinhardt, J; Schröder, C


    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.

  19. Biotechnological production and applications of Cordyceps militaris, a valued traditional Chinese medicine. (United States)

    Cui, Jian Dong


    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.

  20. Heat and light stresses affect metabolite production in the fruit body of the medicinal mushroom Cordyceps militaris. (United States)

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


    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 fruit body of C. militaris and contribute to further elucidation of the effects of abiotic stress on metabolite accumulation in fungi.

  1. Visualization of evidence-based medicine domain knowledge: production and citation of Cochrane systematic reviews. (United States)

    Shen, Jiantong; Li, Youping; Clarke, Mike; Du, Liang; Wang, Li; Zhong, Dake


    To evaluate the production and utilization of Cochrane systematic reviews (CSRs) and to analyze its influential factors, so as to improve the capacity of translating CSRs into practice. All CSRs and protocols were retrieved from the Cochrane Library (Issue 2, 2011) and citation data were retrieved from SCI database. Citation analysis was used to analyze the situation of CSRs production and utilization. CSR publication had grown from an annual average of 32 to 718 documents. Only one developing country was among the ten countries with the largest amount of publications. High-income countries accounted for 83% of CSR publications and 90.8% of cited counts. A total 34.7% of CSRs had a cited count of 0, whereas only 0.9% had been cited more than 50 times. Highly cited CSRs were published in England, Australia, Canada, USA and other high-income countries. The countries with a Cochrane center or a Cochrane methodology group had a greater capability of CSRs production and citing than others. The CSRs addressing the topics of diseases were more than those targeted at public health issues. There was a big gap in citations of different interventions even on the same topic. The capability of CSR production and utilization grew rapidly, but varied among countries and institutions, which was affected by several factors such as the capability of research, resources and the applicability of evidence. It is important to improve evidence translation through educating, training and prioritizing the problems based on real demands of end users. © 2013 Wiley Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

  2. The feminisation of Canadian medicine and its impact upon doctor productivity. (United States)

    Weizblit, Nataly; Noble, Jason; Baerlocher, Mark Otto


    We examined the differences in work patterns between female and male doctors in Canada to gain insight into the effect of an increased number of female doctors on overall doctor productivity. Data on the practice profiles of female and male doctors across Canada were extracted from the 2007 National Physician Survey. A doctor productivity measure, 'work hours per week per population' (WHPWPP), was created, based on the number of weekly doctor hours spent providing direct patient care per 100,000 citizens. The predicted WHPWPP was calculated for a hypothetical time-point when the female and male doctor populations reach equilibrium. The differences in current and predicted WHPWPP were then analysed. Female medical students currently (2007) outnumber male medical students (at 57.8% of the medical student population). The percentage of practising doctors who are women is highest in the fields of paediatrics, obstetrics and gynaecology, psychiatry and family practice. Female doctors work an average of 47.5 hours per week (giving 30.0 hours of direct patient care), compared with 53.8 hours worked by male doctors (35.0 hours of direct patient care) (P work less on call hours per week and see fewer patients while on-call. Female doctors are also more likely to take parental leave or a leave of absence (P work patterns described in the present study persist, an overall decrease in doctor productivity is to be anticipated.

  3. Enhancing Tissue Engineering and Regenerative Medicine Product Commercialization: The Role of Science in Regulatory Decision-Making for the TE/RM Product Development. (United States)

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


    TERMIS-AM Industry Committee (TERMIS-AM/IC), in collaboration with the TERMIS-Europe (EU)/IC, conducted a symposium involving the European Medicines Agency and the U.S. Food and Drug Administration (FDA) toward building an understanding of the rational basis for regulatory decision-making and providing a framework for decisions made during the evaluation of safety and efficacy of TE/RM technologies. This symposium was held in August 2012 during the TERMIS-WC in Vienna, Austria. Emerging from this international initiative by the European Union and the United States, representatives from the respective agencies demonstrated that there are ongoing interagency efforts for developing common national practices toward harmonization of regulatory requirements for the TE/RM products. To extend a broad-based understanding of the role of science in regulatory decision-making, TERMIS-AM/IC, in cooperation with the FDA, organized a symposium at the 2014 TERMIS-AM Annual Meeting, which was held in Washington, DC. This event provided insights from leaders in the FDA and TERMIS on the current status of regulatory approaches for the approved TE/RM products, the use of science in making regulatory decisions, and TE/RM technologies that are in the development pipeline to address unmet medical needs. A far-ranging discussion with FDA representatives, industrialists, physicians, regenerative medicine biologists, and tissue engineers considered the gaps in today's scientific and regulatory understanding of TE/RM technologies. The identified gaps represent significant opportunities to advance TE/RM technologies toward commercialization.


    Directory of Open Access Journals (Sweden)

    Danny Soetrisnanto


    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

  5. The potential of three different PCR-related approaches for the authentication of mixtures of herbal substances and finished herbal medicinal products. (United States)

    Doganay-Knapp, Kirsten; Orland, Annika; König, Gabriele M; Knöss, Werner


    Herbal substances and preparations thereof play an important role in healthcare systems worldwide. Due to the variety of these products regarding origin, composition and processing procedures, appropriate methodologies for quality assessment need to be considered. A majority of herbal substances is administered as multicomponent mixtures, especially in the field of Traditional Chinese Medicine and ayurvedic medicine, but also in finished medicinal products. Quality assessment of complex mixtures of herbal substances with conventional methods is challenging. Thus, emphasis of the present work was directed on the development of complementary methods to elucidate the composition of mixtures of herbal substances and finished herbal medicinal products. An indispensable prerequisite for the safe and effective use of herbal medicines is the unequivocal authentication of the medicinal plants used therein. In this context, we investigated the potential of three different PCR-related methods in the characterization and authentication of herbal substances. A multiplex PCR assay and a quantitative PCR (qPCR) assay were established to analyze defined mixtures of the herbal substances Quercus cortex, Juglandis folium, Aristolochiae herba, Matricariae flos and Salviae miltiorrhizae radix et rhizoma and a finished herbal medicinal product. Furthermore, a standard cloning approach using universal primers targeting the ITS region was established in order to allow the investigation of herbal mixtures with unknown content. The cloning approach had some limitations regarding the detection/recovery of the components in defined mixtures of herbal substances, but the complementary use of two sets of universal primer pairs increased the detection of components out of the mixture. While the multiplex PCR did not retrace all components in the defined mixtures of herbal substances, the established qPCR resulted in simultaneous and specific detection of the five target sequences in all defined

  6. 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). (United States)

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


    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).

  7. Investigating the Impact of Herbal Medicines Marketing Mix and Physicians' Product Involvement on Prescription of these Drugs


    Bahram Ranjbarian; Ali Kazemi; Samira Shokrollahi


    Although the main side effects of chemical medicines have been discovered, the level of using herbal medicines is still low in Iran. Today prescribing herbal medicines along with chemical ones have different kinds of advantages including: increased health rate in society and developed job opportunities in the fields of agriculture, medicine industry and all of related processes. In our country there are few researches in which the important factors influencing the prescription of herbal medic...

  8. Use of natural products for oral hygiene maintenance: revisiting traditional medicine. (United States)

    Gupta, Pankaj; Shetty, Heeresh


    The use of traditional means of oral hygiene maintenance has a long-recorded history, with widespread usage in rural areas of Africa, South America and the Indian subcontinent till date. Though dental healthcare professionals and the general population, especially in the urban areas can have the temptation of out-rightly rejecting them as ineffective, the usage of these natural products is based on time-tested scientific principles. The present article provides an overview of the major traditional practices of oral hygiene maintenance and how they compare against the modern-day armamentarium of oral hygiene maintenance.

  9. Radiation applications in industry and medicine: DAE fostering availability, quality and safety of products and service

    International Nuclear Information System (INIS)

    Ramamoorthy, N.


    Nuclear and radiation applications play a significant role in aiding industrial process management, food security and safety, health care practices, manufacturing and value-addition to certain materials, treating pollutants/waste, etc. Most of these applications have contributed to improving the quality of life and industrial efficiency. India is among the large-scale producers cum users of radioisotope products and radiation technology applications over the past nearly five decades, thanks to the Department of Atomic Energy (DAE) and its various units pioneering the development and deployment of the above-mentioned applications in our country

  10. Exploring Consumer and Patient Knowledge, Behavior, and Attitude Toward Medicinal and Lifestyle Products Purchased From the Internet: A Web-Based Survey. (United States)

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


    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

  11. Exploring Consumer and Patient Knowledge, Behavior, and Attitude Toward Medicinal and Lifestyle Products Purchased From the Internet: A Web-Based Survey (United States)

    Thomas, Jordan


    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

  12. Gamma irradiation of medicinally important plants and the enhancement of secondary metabolite production. (United States)

    Vardhan, P Vivek; Shukla, Lata I


    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

  13. 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. (United States)

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


    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.

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

    Directory of Open Access Journals (Sweden)

    Ioana Valentina Tihulca


    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.

  15. Authenticity analyses of Phyllanthus amarus using barcoding coupled with HRM analysis to control its quality for medicinal plant product. (United States)

    Buddhachat, Kittisak; Osathanunkul, Maslin; Madesis, Panagiotis; Chomdej, Siriwadee; Ongchai, Siriwan


    The Phyllanthus genus, a plant used in traditional Thai medicine, has according to several pharmacopeias hepatoprotective properties. Not only is the anatomical morphology of these species relatively similar but they also share the Thai common names Look-Tai-Bai (ลูกใต้ใบ) and Yah-Tai-Bai (หญ้าใต้ใบ), which might cause confusion for laypersons. This study attempted to develop a method for accurate identification of Phyllanthus species, especially Phyllanthus amarus, and to detect contaminants in P. amarus products by using DNA barcoding coupled with high resolution melting (HRM) analysis (bar-HRM). Two plastid loci (rbcL and trnL) were chosen for DNA barcoding to generate a suitable primer for distinguishing Phyllanthus species by HRM analysis. The five species of Phyllanthus were subjected to amplification for testing the specificity and discrimination power of the designed primers derived from rbcL and trnL regions. Sensitivity of the method (DNA barcoding conjugated with HRM) to detect adulterant in P. amarus samples was evaluated. The commercial P. amarus products obtained from a local market were authenticated. The primer pair derived from trnL DNA barcoding (PhylltrnL) had more specificity and power of discrimination for Phyllanthus species than that derived from rbcL DNA barcoding (PhyllrbcL). The result showed that Tm of P. amarus, Phyllanthus urinaria, Phyllanthus debilis, Phyllanthus airy-shawii, and Phyllanthus virgatus was 74.3±0.08, 73.04±0.07, 73.36±0.05, 72.21±0.06, 72.77±0.15°C, respectively. This method proved to be a very sensitive tool that can be used for rapid detection of contamination as low as 1% of other Phyllanthus species in P. amarus admixtures. All commercial products of P. amarus obtained from a local market in Thailand were found to contain pure raw materials of P. amarus without any substitution or contamination. Our results indicated that the use of DNA barcoding coupled with HRM was an

  16. Bibliometric Analysis of Traditional Chinese Medicine Scientific Production between 1982 and 2016 Indexed in PubMed. (United States)

    Consentino, Ricardo; Santos, Maria João; Matos, Luís Carlos; Machado, Jorge Pereira


    Background: Traditional Chinese medicine (TCM) may be understood as a system of sensations and findings designed to establish the functional vegetative state of the body. This state may be treated by several therapeutic methods such as acupuncture, Chinese pharmacotherapy, dietetics, Tuina , and Qigong . Nowadays, as a result of several evidence-based reported beneficial effects over specific pathological conditions, there is an increasing tendency to integrate some of these practices in Western medicine. The main goal of this study was to perform a bibliometric analysis of TCM scientific production between 1982 and 2016 indexed in PubMed, by analyzing several parameters including time and location distribution, publication quality, experimental design, and treatment methods. Methods: The methodology was based on the quantitative inventory of published scientific research indexed in PubMed medical subject headings (MeSH), sorted within the broad term “Traditional Chinese Medicine” and integrating the following criteria as limit filters: “Species: Humans”, “Article Type: Clinical Trial”. In addition, the articles’ triage was ruled by temporal limitations set between 1945 and 2016. Results: The overall analysis of data allowed observation of an average annual growth of approximately 33%, with a productive peak of 122 articles in 2007. The scientific production was distributed in 27 countries, led by China (76.1%), followed by the United States of America (3.0%) and South Korea (2.1%). A significant amount of references were published in Chinese journals: more than 50%; however, these journals had a low impact factor. The most cited treatments in the keywords section of the articles were phytotherapy (55%) and acupuncture (40%). Conclusion: The increasing demand for TCM seems to be due to factors such as lower side effects and greater efficacy in some patients not responding well to conventional therapy. As a result, a considerable amount of TCM science

  17. Disposal of agro-industrial by-products by organic cultivation of the culinary and medicinal mushroom Hypsizygus marmoreus. (United States)

    Akavia, E; Beharav, A; Wasser, S P; Nevo, E


    Organic mushroom cultivation is one of the fastest growing segments of agriculture. At the core of the organic philosophy lies a ban on the use of synthetic fertilizers, pesticides and herbicides, in addition to such tenets as animal welfare, energy efficiency, and social justice. Hypsizygus marmoreus (HM) is a highly praised cultivated culinary and medicinal mushroom. The objective of this paper was to assess the suitability of different spawn media and then the potential of various cultivation substrates to support HM mushroom production compatible with organic standards. This objective was met through the setup of a low-cost cultivation infrastructure. First, seven types of spawn media were tested; then we tested 24 substrates made from organic by-products for their biological efficiency (BE) with strain HM 830, using the liquid inoculation method. The best substrate in terms of BE was corn cob with bran and olive press cake, with a BE of 85.6%. The BE of the same composition but without olive press cake was only 67.5%. The next best substrates were cotton straw combinations with a BE of 31.5-53%. The spent mushroom substrate provides a good method for the disposal of solid waste. The guidance provided in this research complies with organic mushroom cultivation standards and can be used to produce certified organic mushrooms. In addition, it allows responsible and beneficial disposal of a large amount of solid agro-industrial waste.

  18. Increased production of azadirachtin from an improved method of androgenic cultures of a medicinal tree Azadirachta indica A. Juss. (United States)

    Srivastava, Priyanka; Chaturvedi, Rakhi


    Present report is the first direct evidence of azadirachtin production in androgenic haploid cultures of Azadirachta indica, a woody medicinal tree. Anther cultures at early-late-uninucleate stage of microspores were established on MS medium with BAP (5 μM), 2,4-D (1 μM) and NAA (1 μM) containing 12% sucrose. The calli, induced, were further multiplied on 2,4-D and Kinetin media. Shoots, differentiated on BAP (2.2 μM) + NAA (0.05 μM) medium, were elongated on MS + BAP (0.5 μM) and multiplied on MS + BAP (1 μM) + CH (250 mg/l). Thereafter, the shoots were rooted on ¼ MS + IBA (0.5 μM). Cytological analysis of the calli and regenerants have confirmed their haploid status with the chromosome number as 2n = x = 12. The haploid cell lines and leaves from in vitro grown plantlets were analyzed for azadirachtin by RP-HPLC and mass spectroscopy. Maximum azadirachtin (728.41 μg/g DW) was detected in calli supporting best shoot proliferation while least (49 μg/g DW) was observed in an undifferentiated line from maintenance medium. This study has brought us a step closer to develop genetically pure lines that could serve as new and attractive alternative ways of homogeneous controlled production of high value compounds, round the year, independent of geographical and climatic barrier.

  19. 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


    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.

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


    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.

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

    International Nuclear Information System (INIS)

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


    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

  2. Culinary-Medicinal Mushroom Products as a Potential Source of Vitamin D. (United States)

    Bernas, Emilia; Jaworska, Grażyna


    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.

  3. 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.


    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

  4. Towards toxicokinetic modelling of aluminium exposure from adjuvants in medicinal products. (United States)

    Weisser, Karin; Stübler, Sabine; Matheis, Walter; Huisinga, Wilhelm


    As a potentially toxic agent on nervous system and bone, the safety of aluminium exposure from adjuvants in vaccines and subcutaneous immune therapy (SCIT) products has to be continuously re-evaluated, especially regarding concomitant administrations. For this purpose, knowledge on absorption and disposition of aluminium in plasma and tissues is essential. Pharmacokinetic data after vaccination in humans, however, are not available, and for methodological and ethical reasons difficult to obtain. To overcome these limitations, we discuss the possibility of an in vitro-in silico approach combining a toxicokinetic model for aluminium disposition with biorelevant kinetic absorption parameters from adjuvants. We critically review available kinetic aluminium-26 data for model building and, on the basis of a reparameterized toxicokinetic model (Nolte et al., 2001), we identify main modelling gaps. The potential of in vitro dissolution experiments for the prediction of intramuscular absorption kinetics of aluminium after vaccination is explored. It becomes apparent that there is need for detailed in vitro dissolution and in vivo absorption data to establish an in vitro-in vivo correlation (IVIVC) for aluminium adjuvants. We conclude that a combination of new experimental data and further refinement of the Nolte model has the potential to fill a gap in aluminium risk assessment. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Nuclear Medicine (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 ...

  6. 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


    Full Text Available AccessMedicine ( 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.

  7. 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


    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.

  8. The use of community herbal monographs to facilitate registrations and authorisations of herbal medicinal products in the European Union 2004-2012. (United States)

    Peschel, Wieland


    The provisions for the simplified registration of traditional herbal medicinal products in the European Union were introduced by Directive 2004/24/EC amending Directive 2001/83/EC (Chapter 2a) in 2004. Since implementation in the European member states until December 2012 a total of 1015 registrations (traditional use) and 514 authorisations (well-established use) have been granted for products containing substances/ preparations from about 200 different herbal drugs. The overall number of received applications with more than one third still under assessment suggests a further increase for the next years. This review summarises the main features of registered and authorised herbal medicinal products in the EU and evaluates available data against provisions of Directive 2004/24/EC and European standards established by the Committee on Herbal Medicinal Products at the European Medicines Agency. The supportive function of Community herbal monographs is described as regards availability and their use in national procedures, which is complemented by an analysis of specific future challenges from experiences made with the implementation of Directive 2004/24/EC so far. Copyright © 2014. Published by Elsevier Ireland Ltd.

  9. 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


    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.

  10. Commentary: considerations for using the 'Trials within Cohorts' design in a clinical trial of an investigational medicinal product. (United States)

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


    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.

  11. HTA programme response to the challenges of dealing with orphan medicinal products: Process evaluation in selected European countries. (United States)

    Nicod, Elena; Annemans, Lieven; Bucsics, Anna; Lee, Anne; Upadhyaya, Sheela; Facey, Karen


    Challenges commonly encountered in HTA of orphan medicinal products (OMPs) were identified in Advance-HTA. Since then, new initiatives have been developed to specifically address issues related to HTA of OMPs. This study aimed to understand why these new HTA initiatives in England, Scotland and at European-level were established and whether they resolve the challenges of OMPs. The work of Advance-HTA was updated with a literature review and a conceptual framework of clinical, regulatory and economic challenges for OMPs was developed. The new HTA programmes were critiqued against the conceptual framework and outstanding challenges identified. The new programmes in England and Scotland recognise the challenges identified in demonstrating the value of ultra-OMPs (and OMPs) and that they require a different process to standard HTA approaches. Wider considerations of disease and treatment experiences from a multi-stakeholder standpoint are needed, combined with other measures to deal with uncertainty (e.g. managed entry agreements). While approaches to assessing this new view of value of OMPs, extending beyond cost/QALY frameworks, differ, their criteria are similar. These are complemented by a European initiative that fosters multi-stakeholder dialogue and consensus about value determinants throughout the life-cycle of an OMP. New HTA programmes specific to OMPs have been developed but questions remain about whether they sufficiently capture value and manage uncertainty in clinical practice. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  12. Determination of the Marker Diarylheptanoid Phytoestrogens in Curcuma comosa Rhizomes and Selected Herbal Medicinal Products by HPLC-DAD. (United States)

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


    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.

  13. Production of biomass and polysaccharides of Lingzhi or Reishi medicinal mushroom, Ganoderma lucidum (W.Curt. :Fr.) P. Karst. (higher Basidiomycetes), by submerged cultivation. (United States)

    Habijanic, Jozica; Berovic, Marin; Boh, Bojana; Wraber, Branka; Petravic-Tominac, Vlatka


    Submerged batch and repeated fed-batch cultivation techniques were used for mycelia cultivation and polysaccharide production of the Lingzhi or Reishi medicinal mushroom Ganoderma lucidum. Although most publications use various Asiatic G. lucidum strains, the growth of the strain Ga.l 4 (Biotechnical Faculty Strain Collection, Ljubljana, Slovenia), originally isolated from the Slovenian forest, is much faster. The results between the batch and repeated fed-batch cultivation are compared with the polysaccharide production in batch cultivation. From the aspect of biomass production, the best results were obtained in repeated fed-batch after 44 days, where 12.4 g/L of dry fungal biomass was obtained.

  14. The European Medicines Agency review of Tegafur/Gimeracil/Oteracil (Teysuno™) for the treatment of advanced gastric cancer when given in combination with cisplatin: summary of the Scientific Assessment of the Committee for medicinal products for human use (CHMP). (United States)

    Matt, Petra; van Zwieten-Boot, Barbara; Calvo Rojas, Gonzalo; Ter Hofstede, Hadewych; Garcia-Carbonero, Rocio; Camarero, Jorge; Abadie, Eric; Pignatti, Francesco


    The product Teysuno™ (S-1) contains tegafur, a prodrug of 5-fluorouracil (5-FU), and two modulators of 5-FU metabolism, gimeracil and oteracil. The main clinical study in this application was a randomized controlled study comparing S-1 plus cisplatin with 5-FU plus cisplatin. In this study, median overall survival times of 8.6 months and 7.9 months for S-1 plus cisplatin and 5-FU plus cisplatin, respectively, were observed (hazard ratio, 0.92; 95% confidence interval, 0.80-1.05). The Committee for Medicinal Products for Human Use of the European Medicines Agency concluded that S-1 in combination with cisplatin (75 mg/m²) was noninferior to 5-FU plus cisplatin (100 mg/m²) in patients with advanced gastric cancer and adopted a positive opinion recommending the marketing authorization for this product for the treatment of advanced gastric cancer when given in combination with cisplatin. The recommended dose of S-1 is 25 mg/m² (expressed as tegafur content) twice a day, for 21 consecutive days followed by 7 days rest (one treatment cycle), in combination with 75 mg/m² cisplatin i.v. administered on day 1. This treatment cycle is repeated every 4 weeks. The most common side effects reported in the pivotal study were anemia, neutropenia, vomiting, diarrhea, abdominal pain, weight decrease, anorexia, and fatigue. The objective of this paper is to summarize the scientific review of the application leading to approval in the EU. The full scientific assessment report and the summary of product characteristics are available on the European Medicines Agency website (

  15. 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

  16. 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 ...

  17. 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


    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.

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

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


    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.

  19. 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". (United States)

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


    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.

  20. [Strategic considerations on the design and choice of animal models for non-clinical investigations of cell-based medicinal products]. (United States)

    Lehmann, Jörg; Schulz, Ronny M; Sanzenbacher, Ralf


    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

  1. Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union. (United States)

    Jokura, Yoji; Yano, Kazuo; Yamato, Masayuki


    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. Copyright © 2017 The Authors. Tissue

  2. Integrative Medicine in Preventive Medicine Education (United States)

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


    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

  3. Aligning clinical compensation with clinical productivity: design and implementation of the financial value unit (FVU) system in an academic department of internal medicine. (United States)

    Stites, Steven; Steffen, Patrick; Turner, Scott; Pingleton, Susan


    A new metric was developed and implemented at the University of Kansas School of Medicine Department of Internal Medicine, the financial value unit (FVU). This metric analyzes faculty clinical compensation compared with clinical work productivity as a transparent means to decrease the physician compensation variability and compensate faculty equitably for clinical work.The FVU is the ratio of individual faculty clinical compensation compared with their total work relative value units (wRVUs) generated divided by Medical Group Management Association (MGMA) salary to wRVUs of a similar MGMA physician.The closer the FVU ratio is to 1.0, the closer clinical compensation is to that of an MGMA physician with similar clinical productivity. Using FVU metrics to calculate a faculty salary gap compared with MGMA median salary and wRVU productivity, a divisional production payment was established annually.From FY 2006 to FY 2011, both total faculty numbers and overall clinical activity increased. With the implementation of the FVU, both clinical productivity and compensation increased while, at the same time, physician retention rates remained high. Variability in physician compensation decreased. Dramatic clinical growth was associated with the alignment of clinical work and clinical compensation in a transparent and equable process.

  4. 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


    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...... acidosis and imbalanced energy supply, respectively. Calving interval was used as an indicator for fertility. Milk recording data and treatment data were retrospectively collected for a one year period before and after the first farm visit. Focus areas of animal health and welfare plans were either...

  5. Hurdles in tissue engineering/regenerative medicine product commercialization: a pilot survey of governmental funding agencies and the financial industry. (United States)

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


    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

  6. Imaging and development of medicines

    International Nuclear Information System (INIS)

    Syrota, A.


    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.)

  7. A review of the cultivation and processing of cannabis (Cannabis sativa L.) for production of prescription medicines in the UK. (United States)

    Potter, David J


    The quality demands of the pharmaceutical industry require prescription medicines to be consistent in their active ingredient content. Achieving this, using raw cannabis as a feedstock, is especially challenging. The plant material is extremely inhomogeneous, and the ratios of active ingredients are affected by a range of factors. These include the genetics of the plant, the growing and storage conditions, the state of maturity at harvest, and the methods used to process and formulate the material. The reasons for this variability are described, with particular emphasis on the botanical considerations. To produce the complex botanical medicine Sativex®, which contains the cannabinoids Δ(9)-tetrahydrocannabinol (THC) and cannabidiol (CBD) and a range of other ingredients, GW Pharmaceuticals had to manage these variables. This medicine, for the treatment of spasticity due to multiple sclerosis, is the first cannabis-based medicine to be approved in the UK. The company's methodology for producing this and other chemotypes is described. Copyright © 2013 John Wiley & Sons, Ltd.

  8. Aerospace Medicine (United States)

    Michaud, Vince


    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.

  9. Traditional Chinese Nootropic Medicine Radix Polygalae and Its Active Constituent Onjisaponin B Reduce β-Amyloid Production and Improve Cognitive Impairments. (United States)

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


    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.

  10. Nuclear medicine

    International Nuclear Information System (INIS)

    Casier, Ph.; Lepage, B.


    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)

  11. Medicines from Marine Invertebrates (United States)

    Davies-Coleman, Mike


    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.…

  12. Nuclear energy and medicine

    International Nuclear Information System (INIS)


    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

  13. Kitchen chemistry: A scoping review of the diversionary use of pharmaceuticals for non-medicinal use and home production of drug solutions. (United States)

    Van Hout, Marie Claire


    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.

  14. 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


    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.

  15. Modern science for better quality control of medicinal products "Towards global harmonization of 3Rs in biologicals": The report of an EPAA workshop. (United States)

    Schutte, Katrin; Szczepanska, Anna; Halder, Marlies; Cussler, Klaus; Sauer, Ursula G; Stirling, Catrina; Uhlrich, Sylvie; Wilk-Zasadna, Iwona; John, David; Bopst, Martin; Garbe, Joerg; Glansbeek, Harrie L; Levis, Robin; Serreyn, Pieter-Jan; Smith, Dean; Stickings, Paul


    This article summarizes the outcome of an international workshop organized by the European Partnership for Alternative Approaches to Animal Testing (EPAA) on Modern science for better quality control of medicinal products: Towards global harmonization of 3Rs in biologicals. As regards the safety testing of biologicals, the workshop participants agreed to actively encourage the deletion of abnormal toxicity tests and target animal batch safety tests from all relevant legal requirements and guidance documents (country-specific guidelines, pharmacopoeia monographs, WHO recommendations). To facilitate the global regulatory acceptance of non-animal methods for the potency testing of, e.g., human diphtheria and tetanus vaccines and veterinary swine erysipelas vaccines, international convergence on the scientific principles of the use of appropriately validated in vitro assays for replacing in vivo methods was identified as an overarching goal. The establishment of scientific requirements for new assays was recognized as a further means to unify regulatory approaches in different jurisdictions. It was recommended to include key regulators and manufacturers early in the corresponding discussions. Manufacturers and responsible expert groups, e.g. at the European Directorate for the Quality of Medicines and Health Care of the Council of Europe or the European Medicines Agency, were invited to consider leadership for international collaboration. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  16. Giving Voice to the Medically Under-Served: A Qualitative Co-Production Approach to Explore Patient Medicine Experiences and Improve Services to Marginalized Communities. (United States)

    Latif, Asam; Tariq, Sana; Abbasi, Nasa; Mandane, Baguiasri


    With an aging population, the appropriate, effective and safe use of medicines is a global health priority. However, "'medically under-served" patients continue to experience significant inequalities around access to healthcare services. This study forms part of a wider project to co-develop and evaluate a digital educational intervention for community pharmacy. The aim of this paper is to explore the medicine needs of patients from marginalized communities and suggest practical way on how services could be better tailored to their requirements. Following ethical approval, qualitative data was gathered from: (1) workshops with patients and professionals ( n = 57 attendees); and (2) qualitative semi-structured interviews (10 patients and 10 pharmacists). Our findings revealed that patients from marginalized communities reported poor management of their medical conditions and significant problems with adherence to prescribed medicines. Their experience of pharmacy services was found to be variable with many experiencing discrimination or disadvantage as a result of their status. This study highlights the plight of medically under-served communities and the need for policy makers to tailor services to an individual's needs and circumstances. Furthermore, patients and professionals can work in collaboration using a co-production approach to develop educational interventions for pharmacy service improvements.

  17. Nuclear medicine

    International Nuclear Information System (INIS)

    Lentle, B.C.


    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

  18. 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. (United States)

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


    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

  19. Inhibition of TNF-α production in LPS-activated THP-1 monocytic cells by the crude extracts of seven Bhutanese medicinal plants. (United States)

    Wangchuk, Phurpa; Keller, Paul A; Pyne, Stephen G; Taweechotipatr, Malai


    Seven studied medicinal plants; Aconitum laciniatum, Ajania nubigena, Codonopsis bhutanica, Corydalis crispa, Corydalis dubia, Meconopsis simplicifolia and Pleurospermum amabile, are currently used in the Bhutanese Traditional Medicine (BTM) for the management of different types of disorders including the diseases that bore relevance to various inflammatory conditions. This study aimed to evaluate the inhibition of TNF-α production in LPS-activated THP-1 monocytic cells by the crude extracts of seven selected Bhutanese medicinal plants. It is expected to; (a) generate a scientific basis for their use in the BTM and (b) form a basis for prioritization of the seven plants for further phytochemical and anti-inflammatory studies. Seven plants were selected using an ethno-directed bio-rational approach and their crude extracts were prepared using four different solvents (methanol, hexane, dichloromethane and chloroform). The TNF-α inhibitory activity of these extracts was determined by cytokine-specific sandwich quantitative enzyme-linked immunosorbent assays (ELISAs). The results were quantified statistically and the statistical significance were evaluated by GraphPad Prism version 5.01 using Student's t-test with one-tailed distribution. A p-value ≤0.05 was considered statistically significant. Of the seven plants studied, the crude extracts of six of them inhibited the production of pro-inflammatory cytokine, TNF-α in LPS-activated THP-1 monocytic cells. Amongst the six plants, Corydalis crispa gave the best inhibitory activity followed by Pleurospermum amabile, Ajania nubigena, Corydalis dubia, Meconopsis simplicifolia and Codonopsis bhutanica. Of the 13 extracts that exhibited statistically significant TNF-α inhibitory activity (p<0.05; p<0.01), five of them showed very strong inhibition when compared to the DMSO control and RPMI media. Six medicinal plants studied here showed promising TNF-α inhibitory activity. These findings rationalize the traditional

  20. Heart failure - medicines (United States)

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

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

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


    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).

  2. Formulation of an aloe-based product according to Iranian traditional medicine and development of its analysis method. (United States)

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


    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.

  3. Veterinary medicinal products for the bees - the current situation and future strategies - an important topic discussed at European level

    Directory of Open Access Journals (Sweden)

    Alina Karina Draghici,


    Full Text Available To analyze the current situation and future issues relating to health and treatment options bees, bee breeders in Europe, agencies and drug manufacturers in Europe have held several meetings. One of thesetook place last year in December at the EMEA (European Medicines Agency in London, United Kingdom. The purpose of this meeting was to consider the current situation of pathology in bees to identify the most common diseases found in this species, identification and lack of treatment options for some diseases, and identifying solutions to improve the situation.

  4. 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

  5. De Novo Deep Transcriptome Analysis of Medicinal Plants for Gene Discovery in Biosynthesis of Plant Natural Products. (United States)

    Han, R; Rai, A; Nakamura, M; Suzuki, H; Takahashi, H; Yamazaki, M; Saito, K


    Study on transcriptome, the entire pool of transcripts in an organism or single cells at certain physiological or pathological stage, is indispensable in unraveling the connection and regulation between DNA and protein. Before the advent of deep sequencing, microarray was the main approach to handle transcripts. Despite obvious shortcomings, including limited dynamic range and difficulties to compare the results from distinct experiments, microarray was widely applied. During the past decade, next-generation sequencing (NGS) has revolutionized our understanding of genomics in a fast, high-throughput, cost-effective, and tractable manner. By adopting NGS, efficiency and fruitful outcomes concerning the efforts to elucidate genes responsible for producing active compounds in medicinal plants were profoundly enhanced. The whole process involves steps, from the plant material sampling, to cDNA library preparation, to deep sequencing, and then bioinformatics takes over to assemble enormous-yet fragmentary-data from which to comb and extract information. The unprecedentedly rapid development of such technologies provides so many choices to facilitate the task, which can cause confusion when choosing the suitable methodology for specific purposes. Here, we review the general approaches for deep transcriptome analysis and then focus on their application in discovering biosynthetic pathways of medicinal plants that produce important secondary metabolites. © 2016 Elsevier Inc. All rights reserved.

  6. 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


    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.

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

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


    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).

  8. Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133+ Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy (United States)

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


    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

  9. The assessment and appraisal of regenerative medicines and cell therapy products: an exploration of methods for review, economic evaluation and appraisal. (United States)

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


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

  10. Medicinal cannabis. (United States)

    Murnion, Bridin


    A number of therapeutic uses of cannabis and its derivatives have been postulated from preclinical investigations. Possible clinical indications include spasticity and pain in multiple sclerosis, cancer-associated nausea and vomiting, cancer pain and HIV neuropathy. However, evidence is limited, may reflect subjective rather than objective outcomes, and is not conclusive. Controversies lie in how to produce, supply and administer cannabinoid products. Introduction of cannabinoids therapeutically should be supported by a regulatory and educational framework that minimises the risk of harm to patients and the community. The Regulator of Medicinal Cannabis Bill 2014 is under consideration in Australia to address this. Nabiximols is the only cannabinoid on the Australian Register of Therapeutic Goods at present, although cannabidiol has been recommended for inclusion in Schedule 4.

  11. Effect of Cold Stress on Fruiting Body Production by Medicinal Basidiomycetes in Submerged and Solid-phase Culture

    Directory of Open Access Journals (Sweden)

    E.P. Vetchinkina


    Full Text Available The ability of the medicinal xylotrophic basidiomycetes Lentinus edodes, Pleurotus ostreatus, Ganoderma lucidum and Grifola frondosa to produce typical and atypical fruiting bodies with viable basidiospores in submerged and solid-phase culture under stationary conditions in a beer wort-containing medium under cold stress was shown. The examined mushrooms, when not exposed to temperature stress, did not form fruiting bodies. In solid-phase culture in an agarized medium after cold treatment, the basidiome formation period was shortened by 1.5–2 times. Furthermore, the use of a mycelium subjected to temperature stress for inoculation induced and accelerated the formation of fruiting bodies on an industrial wood substrate, which is of great biotechnological importance.

  12. Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs. (United States)

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


    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

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


    ..., and the FDA Orphan Products Grant program to participants representing pharmaceutical, biotechnology... treatment of a rare disease or condition in order to discuss the processes for putting together an...

  14. Critical care medicine as a distinct product line with substantial financial profitability: the role of business planning. (United States)

    Bekes, Carolyn E; Dellinger, R Phillip; Brooks, Daniel; Edmondson, Robert; Olivia, Christopher T; Parrillo, Joseph E


    As academic health centers face increasing financial pressures, they have adopted a more businesslike approach to planning, particularly for discrete "product" or clinical service lines. Since critical care typically has been viewed as a service provided by a hospital, and not a product line, business plans have not historically been developed to expand and promote critical care. The major focus when examining the finances of critical care has been cost reduction, not business development. We hypothesized that a critical care business plan can be developed and analyzed like other more typical product lines and that such a critical care product line can be profitable for an institution. In-depth analysis of critical care including business planning for critical care services. Regional academic health center in southern New Jersey. None. As part of an overall business planning process directed by the Board of Trustees, the critical care product line was identified by isolating revenue, expenses, and profitability associated with critical care patients. We were able to identify the major sources ("value chain") of critical care patients: the emergency room, patients who are admitted for other problems but spend time in a critical care unit, and patients transferred to our intensive care units from other hospitals. The greatest opportunity to expand the product line comes from increasing the referrals from other hospitals. A methodology was developed to identify the revenue and expenses associated with critical care, based on the analysis of past experience. With this model, we were able to demonstrate a positive contribution margin of dollar 7 million per year related to patients transferred to the institution primarily for critical care services. This can be seen as the profit related to the product line segment of critical care. There was an additional positive contribution margin of dollar 5.8 million attributed to the critical care portion of the hospital stay of

  15. Diabetes Medicines (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 ...

  16. Herbal Medicine (United States)

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

  17. An approach to optimize the batch mixing process for improving the quality consistency of the products made from traditional Chinese medicines* (United States)

    Yan, Bin-jun; Qu, Hai-bin


    The efficacy of traditional Chinese medicine (TCM) is based on the combined effects of its constituents. Variation in chemical composition between batches of TCM has always been the deterring factor in achieving consistency in efficacy. The batch mixing process can significantly reduce the batch-to-batch quality variation in TCM extracts by mixing them in a well-designed proportion. However, reducing the quality variation without sacrificing too much of the production efficiency is one of the challenges. Accordingly, an innovative and practical batch mixing method aimed at providing acceptable efficiency for industrial production of TCM products is proposed in this work, which uses a minimum number of batches of extracts to meet the content limits. The important factors affecting the utilization ratio of the extracts (URE) were studied by simulations. The results have shown that URE was affected by the correlation between the contents of constituents, and URE decreased with the increase in the number of targets and the relative standard deviations of the contents. URE could be increased by increasing the number of storage tanks. The results have provided a reference for designing the batch mixing process. The proposed method has possible application value in reducing the quality variation in TCM and providing acceptable production efficiency simultaneously. PMID:24190450

  18. An approach to optimize the batch mixing process for improving the quality consistency of the products made from traditional Chinese medicines. (United States)

    Yan, Bin-jun; Qu, Hai-bin


    The efficacy of traditional Chinese medicine (TCM) is based on the combined effects of its constituents. Variation in chemical composition between batches of TCM has always been the deterring factor in achieving consistency in efficacy. The batch mixing process can significantly reduce the batch-to-batch quality variation in TCM extracts by mixing them in a well-designed proportion. However, reducing the quality variation without sacrificing too much of the production efficiency is one of the challenges. Accordingly, an innovative and practical batch mixing method aimed at providing acceptable efficiency for industrial production of TCM products is proposed in this work, which uses a minimum number of batches of extracts to meet the content limits. The important factors affecting the utilization ratio of the extracts (URE) were studied by simulations. The results have shown that URE was affected by the correlation between the contents of constituents, and URE decreased with the increase in the number of targets and the relative standard deviations of the contents. URE could be increased by increasing the number of storage tanks. The results have provided a reference for designing the batch mixing process. The proposed method has possible application value in reducing the quality variation in TCM and providing acceptable production efficiency simultaneously.

  19. Folk Medicine (United States)

    ... lead’s effects on health. How to tell if herbal medicines or folk medicines contain lead You only can ... as high as 90%. Ghasard, an Indian folk medicine, has also been found to contain lead. It is a brown powder used as a tonic. Ba-baw-san is a Chinese herbal remedy that contains lead. It is used to ...

  20. Non-Timber Forest Products Marketing Systems and Market Players in Southwest Virginia: A Case Study of Craft, Medicinal and Herbal, Specialty Wood, and Edible Forest Products


    Greene, Sarah Marsden


    Non-timber forest products (NTFPs) are important in rural southwest Virginia as a source of household sustenance and supplemental income. The trade in NTFPs from this region is centuries old and now helps supply growing worldwide demands. Although marketing is a vital part of optimizing the value of these products, it has been ignored in rural natural resource development. This research analyzes marketing systems for selected NTFPs in southwest Virginia by describing marketing chains, inter...


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


    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

  2. Experimental plant for investigation of the possibility of production of medicine intended isotopes on the basis of linear accelerator

    International Nuclear Information System (INIS)

    Avagyan, R.H.; Avetisyan, A.E.; Kerobyan, I.A.; Taroyan, S.P.; Mirzoyan, R.M.; Sargsyan, R.Ts.; Galumyan, S.A.; Yeganov, V.S.; Oganesyan, A.A.; Vartanyan, H.S.; Gavalyan, V.B.; Nikogosyan, V.Ts.; Ayrapetyan, V.S.; Babayan, A.Z.; Matosyan, A.A.; Jamkochyan, S.V.; Dallakyan, R.K.; Danagulyan, A.S.; Bunyatov, K.S.


    A method of 99 mT c production by irradiation of molybdenum using high-intensity Bremsstrahlung photons from the electron beam of linear electron accelerator LUE50 of the A.I.Alikhanian National Science Laboratory (former Yerevan Physics Institute) is described. The experimental layout for 99 mT c production technology development has been designed and constructed. An upgrade of the linear electron accelerator was carried out to increase the electron beam intensity and spatial density. A system of computer-based remote control of the accelerator and experimental layout has been built up. Preliminary experimental investigations of 99 mT c production methods have been preformed and the qualitative and quantitative results of these studies are presented

  3. Considering context in academic medicine: differences in demographic and professional characteristics and in research productivity and advancement metrics across seven clinical departments. (United States)

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


    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 advancement across 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.

  4. 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


    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...

  5. 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)


    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.

  6. Modeling below-ground biomass to improve sustainable management of Actaea racemosa, a globally important medicinal forest product (United States)

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


    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...

  7. Extracts of Canadian first nations medicinal plants, used as natural products, inhibit neisseria gonorrhoeae isolates with different antibiotic resistance profiles. (United States)

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


    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.

  8. 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


    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.

  9. Use Medicines Safely (United States)

    ... Prescription Medicines 1 of 7 sections The Basics: Prescription Medicines There are different types of medicine. The 2 ... medicine are prescription and over-the-counter (OTC). Prescription medicines Prescription medicines are medicines you can get only ...

  10. Production of /sup 77/Br for nuclear medicine using the CV-28 cyclotron of Instituto de Engenharia Nuclear (RJ, Brazil)

    Energy Technology Data Exchange (ETDEWEB)

    Bastos, M A.V.; Silva, A.G. da [Instituto de Engenharia Nuclear, Rio de Janeiro (Brazil); Newton, W A [Manchester Univ. (UK)


    The reaction /sup 75/As (..cap alpha..,2n)/sup 77/Br with 28 MeV alpha particles is used to obtain /sup 77/Br with the CV-28 cyclotron of Instituto de Engenharia Nuclear (Rio de Janeiro, Brazil). A production method has been developed, using 200 mg of arsenium metal, electroplated on platinum. These targets can withstand 25 beams for several hours, yielding 0.29 mCi/ h. The /sup 77/Br which is separated by coprecipitation with AgCl, is recovered as NaBr with yields better than 98%. Measures have been taken to obtain a product which is pure, sterile and carrier-free.

  11. 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


    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.

  12. Radioisotopes in nuclear medicine

    International Nuclear Information System (INIS)

    Samuel, A.M.


    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

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

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


    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.

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

    Institute of Scientific and Technical Information of China (English)

    Gisela Sjøgaard; Jeanette Reffstrup Christensen; Just Bendix Justesen; Mike Murray; Tina Dalager; Gitte Hansen Fredslund; Karen Søgaard


    Background: Physical activity (PA) includes muscle activity during exercise, manual work, and leisure time activities including sport. Conflicting results exist regarding health effects of PA that may deteriorate with manual work and elite sports, but improve when performed in moderation in accordance with international guidelines and may additionally enhance well-being and productivity. Methods: In Denmark 15 randomized controlled trials have been conducted, introducing exercise at the workplace enrolling>3500 workers. The interventions lasted from 10 to 52 weeks and offered~1 h weekly supervised exercise during working hours according to the concept of intelligent physical exercise training (IPET) that is based on evidenced sports sciences training principles and tailored to work exposure, employee health status, and physical capacity. Questionnaire surveys and health checks including blood and muscle sampling were performed at baseline and follow-up. The job groups included: office and computer workers, dentists, industrial technicians, cleaning personnel, health care workers, construction workers, and fighter/helicopter pilots. Results: In all job groups significant improvements were documented regarding health outcomes. These were job group specific:neck pain was reduced among office and computer workers, dentists, industrial laboratory technicians, health care workers as well as fighter pilots. Cardio-respiratory fitness—a health risk indicator for cardio-metabolic diseases—was improved among office and computer workers, health care workers, and construction workers. Additionally, other improvements were evidenced such as increased muscle strength and balance control. Importantly, productivity increased with improved muscle strength and decreased body mass index. 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

  15. Nuclear medicine

    Energy Technology Data Exchange (ETDEWEB)

    Sharma, S M [Bhabha Atomic Research Centre, Bombay (India). Radiation Medicine Centre


    The article deals with the growth of nuclear medicine in India. Radiopharmaceuticals both in elemental form and radiolabelled compounds became commercially available in India in 1961. Objectives and educational efforts of the Radiation Medicine Centre setup in Bombay are mentioned. In vivo tests of nuclear medicine such as imaging procedures, dynamic studies, dilution studies, thyroid function studies, renal function studies, linear function studies, blood flow, and absorption studies are reported. Techniques of radioimmunoassay are also mentioned.

  16. Effects of medium components and culture conditions on mycelial biomass and the production of bioactive ingredients in submerged culture of Xylaria nigripes (Ascomycetes), a Chinese medicinal fungus. (United States)

    Chen, Jian-Zhi; Lo, Hui-Chen; Lin, Fang-Yi; Chang, Shih-Liang; Hsieh, Changwei; Liang, Zeng-Chin; Ho, Wai-Jane; Hsu, Tai-Hao


    The optimal culture conditions were investigated to maximize the production of mycelial biomass and bioactive ingredients in submerged cultivation of Xylaria nigripes, a Chinese medicinal fungus. The one-factor-at-a-time method was used to explore the effects of medium components, including carbon, nitrogen, mineral sources, and initial pH of the medium and environmental factors, such as culture temperature and rotation speed, on mycelial growth and production of bioactive ingredients. The results indicated that the optimal culture temperature and rotation speed were 25°C and 100 rpm in a medium with 20 g fructose, 6 g yeast extract, and 2 g magnesiun sulfate heptahydrate as carbon, nitrogen, and mineral sources, respectively, in 1 L distilled water with an initial medium pH of 5.5. With optimal medium components and conditions of cultivation, the maximal production of mycelial biomass was 6.64 ± 0.88 g/L, with maximal production of bioactive ingredients such as extracellular polysaccharides (2.36 ± 0.18 mg/mL), intracellular polysaccharides (2.38 ± 0.07 mg/g), adenosine (43.27 ± 2.37 mg/g), total polyphenols (36.57 ± 1.36 mg/g), and triterpenoids (31.29 ± 1.17 mg/g) in a shake flask culture. These results suggest that different bioactive ingredients including intracellular polysaccharides, adenosine, total polyphenols and triterpenoids in mycelia and extracellular polysaccharides in broth can be obtained from one simple medium for submerged cultivation of X. nigripes.

  17. Nuclear medicine

    International Nuclear Information System (INIS)



    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

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


    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

  19. Production of ajmalicine and ajmaline in hairy root cultures of Rauvolfia micrantha Hook f., a rare and endemic medicinal plant. (United States)

    Sudha, C G; Obul Reddy, B; Ravishankar, G A; Seeni, S


    Hairy roots of Rauvolfia micrantha were induced from hypocotyl explants of 2-3 weeks old aseptic seedlings using Agrobacterium rhizogenes ATCC 15834. Hairy roots grown in half-strength Murashige & Skoog (MS) medium with 0.2 mg indole 3-butyric acid l-1 and 0.1 mg alpha-naphthaleneacetic acid l-1 produced more ajmaline (0.01 mg g-1 dry wt) and ajmalicine (0.006 mg g-1 dry wt) than roots grown in auxin-free medium. Ajmaline (0.003 mg g-1 dry wt) and ajmalicine (0.0007 mg g-1 dry wt) were also produced in normal root cultures. This is the first report of production of ajmaline and ajmalicine in hairy root cultures of Rauvolfia micrantha.

  20. Medicine organizer (United States)

    Martins, Ricardo; Belchior, Ismael


    In the last year of secondary school, students studying physics and chemistry are incentivized to do a project where they must put in practice their improvement of scientific knowledge and skills, like observation of phenomena and analysis of data with scientific knowledge. In this project a group of students, tutored by the teacher, wanted to build an instrument that helps people to take their medical drugs at the right time. This instrument must have some compartments with an alarm and an LED light where the people can put their medical drugs. The instrument must be easily programed using an android program that also registers if the medicine has been taken. The students needed to simulate the hardware and software, draw the electronic system and build the final product. At the end of the school year, a public oral presentation was prepared by each group of students and presented to the school community. They are also encouraged to participate in national and international scientific shows and competitions.

  1. Arbuscular mycorrhizal fungi are an alternative to the application of chemical fertilizer in the production of the medicinal and aromatic plant Coriandrum sativum L. (United States)

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


    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.

  2. A Brief Account of the Discovery of the Fetal/Placental Unit for Estrogen Production in Equine and Human Pregnancies: Relation to Human Medicine. (United States)

    Raeside, James I


    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.

  3. 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


    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.

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

    Institute of Scientific and Technical Information of China (English)

    Marwa Chraibi; Abdellah Farah; Sara Lebrazi; Oumaima El Amine; Mohammed Iraqui Houssaini; Kawtar Fikri-Benbrahim


    Objective: To evaluate the susceptibility of Mycobacterium aurum and Mycobacterium smegmatis in vitro to the essential oils obtained from two medicinal plants: Thymus satureioides(T. satureioides) and Mentha pulegium(M. pulegium), and to study their chemical composition.Methods: The aerial parts of T. satureioides and M. pulegium(leaves and stems) were hydro-distillated using a Clevenger-type apparatus and essential oils were analyzed and identified by gas chromatography-mass spectrometry. Antimycobacterial screening of essential oils was performed on the basis of the inhibition zone diameter by disc diffusion method against two mycobacterial strains whereas the minimal inhibitory concentration and minimal bactericidal concentration were determined by using the micro-dilution method.Results: Chemical analysis of their aerial part’s essential oils gave as major compounds,borneol(34.26%), carvacrol(31.21%) and thymol(3.71%) for T. satureioides and R(+)-pulegone(75.48%), carvone(6.66%) and dihydrocarvone(4.64%) for M. pulegium.Thereafter their antimycobacterial effect evaluation, using the micro-dilution method,indicated that minimal inhibitory concentration values of T. satureioides essential oil ranged from 0.062% to 0.015%(v/v) and from 0.125% to 0.031%(v/v) for M. pulegium respectively against Mycobacterium aurum and Mycobacterium smegmatis.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.

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

    Institute of Scientific and Technical Information of China (English)

    Marwa Chraibi; Abdellah Farah; Sara Lebrazi; Oumaima El Amine; Mohammed Iraqui Houssaini; Kawtar Fikri-Benbrahim


    Objective: To evaluate the susceptibility of Mycobacterium aurum and Mycobacterium smegmatis in vitro to the essential oils obtained from two medicinal plants: Thymus satureioides (T. satureioides) and Mentha pulegium (M. pulegium), and to study their chemical composition. Methods: The aerial parts of T. satureioides and M. pulegium (leaves and stems) were hydro-distillated using a Clevenger-type apparatus and essential oils were analyzed and identified by gas chromatography-mass spectrometry. Antimycobacterial screening of essential oils was performed on the basis of the inhibition zone diameter by disc diffusion method against two mycobacterial strains whereas the minimal inhibitory concentration and minimal bactericidal concentration were determined by using the micro-dilution method. Results: Chemical analysis of their aerial part's essential oils gave as major compounds, borneol (34.26%), carvacrol (31.21%) and thymol (3.71%) for T. satureioides and R(+)-pulegone (75.48%), carvone (6.66%) and dihydrocarvone (4.64%) for M. pulegium. Thereafter their antimycobacterial effect evaluation, using the micro-dilution method, indicated that minimal inhibitory concentration values of T. satureioides essential oil ranged from 0.062%to 0.015%(v/v) and from 0.125%to 0.031%(v/v) for M. pulegium respectively against Mycobacterium aurum and Mycobacterium smegmatis. 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.

  6. Medicinal cannabis in oncology. (United States)

    Engels, Frederike K; de Jong, Floris A; Mathijssen, Ron H J; Erkens, Joëlle A; Herings, Ron M; Verweij, Jaap


    In The Netherlands, since September 2003, a legal medicinal cannabis product, constituting the whole range of cannabinoids, is available for clinical research, drug development strategies, and on prescription for patients. To date, this policy, initiated by the Dutch Government, has not yet led to the desired outcome; the amount of initiated clinical research is less than expected and only a minority of patients resorts to the legal product. This review aims to discuss the background for the introduction of legal medicinal cannabis in The Netherlands, the past years of Dutch clinical experience in oncology practice, possible reasons underlying the current outcome, and future perspectives.

  7. 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


    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

  8. Vulnerable Medicine (United States)

    Bochner, Arthur P.


    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…

  9. [Evolutionary medicine]. (United States)

    Wjst, M


    Evolutionary medicine allows new insights into long standing medical problems. Are we "really stoneagers on the fast lane"? This insight might have enormous consequences and will allow new answers that could never been provided by traditional anthropology. Only now this is made possible using data from molecular medicine and systems biology. Thereby evolutionary medicine takes a leap from a merely theoretical discipline to practical fields - reproductive, nutritional and preventive medicine, as well as microbiology, immunology and psychiatry. Evolutionary medicine is not another "just so story" but a serious candidate for the medical curriculum providing a universal understanding of health and disease based on our biological origin. © Georg Thieme Verlag KG Stuttgart · New York.

  10. Genetic transformation of the endangered Tibetan medicinal plant Przewalskia tangutica Maxim and alkaloid production profiling revealed by HPLC. (United States)

    Lei, Tianxiang; Wang, Huan; Li, Songling; Shen, Jianwei; Chen, Shilong; Cai, Xiaojian; Zhou, Dangwei


    To achieve a high yield of tropane alkaloids (TA) and exploit the alpine plant sustainably, an optimized protocol for induction and establishment of hairy roots culture of Prezwalskia tangutica Maxim was developed through selection of appropriate Agrobacterium strain and the explant type. The hypocotyl is more readily facile to induce the HR than the cotyledon is when infected with the three different agrobacterium strains. MUS440 has an efficiency (of up to 20%), whereas the ATCC10060 (A4) can induce HR on both types of explants with the highest frequency (33.33%), root length (21.17 ± 2.84 cm), and root number (10.83 ± 1.43) per explant than the other strains. The highest HR production resulted from using hypocotyl as explants. Independent transformed HR was able to grow vigorously and to propagate on a no-hormone 1/2MS liquid medium. The presence of pRi rol B gene in transformation of HR was confirmed by PCR amplification. In the liquid medium, the HR growth curve appeared to be "S" shaped, and ADB had increased to 4.633 g/l. Moreover, HPLC analysis showed that HR lines have an extraordinary ability to produce atropine (229.88 mg/100 g), anisodine (4.09 mg/100 g), anisodamine (12.85 mg/100 g), and scopolamine (10.69 mg/100 g), which were all more significant than the control roots. In conclusion, our study optimized the culture condition and established a feasible genetics reactor for P. tangutica green exploration and biological study in the alpine region.

  11. Shiitake Medicinal Mushroom, Lentinus edodes (Higher Basidiomycetes) Productivity and Lignocellulolytic Enzyme Profiles during Wheat Straw and Tree Leaf Bioconversion. (United States)

    Elisashvili, Vladimir; Kachlishvili, Eva; Asatiani, Mikheil D


    Two commercial strains of Lentinus edodes have been comparatively evaluated for their productivity and lignocellulolytic enzyme profiles in mushroom cultivation using wheat straw or tree leaves as the growth substrates. Both substrates are profitable for recycling into shiitake fruit bodies. L. edodes 3715 gave the lowest yield of mushroom during tree leaves bioconversion with the biological efficiency (BE) 74.8% while the L. edodes 3721 BE achieved 83.4%. Cultivation of shiitake on wheat straw, especially in the presence of additional nitrogen source, increased the L. edodes 3721 BE to 92-95.3% owing to the high hydrolases activity and favorable conditions. Despite the quantitative variations, each strain of L. edodes had a similar pattern for secreting enzymes into the wheat straw and tree leaves. The mushrooms laccase and MnP activities were high during substrate colonization and declined rapidly during primordia appearance and fruit body development. While oxidase activity decreased, during the same period cellulases and xylanase activity raised sharply. Both cellulase and xylanase activity peaked at the mature fruit body stage. When mushrooms again shifted to the vegetative growth, oxidase activity gradually increased, whereas the hydrolases activity dropped rapidly. The MnP, CMCase, and FP activities of L. edodes 3721 during cultivation on wheat straw were higher than those during mushroom growth on tree leaves whereas the laccase activity was rather higher in fermentation of tree leaves. Enrichment of wheat straw with an additional nitrogen source rather favored to laccase, MnP, and FPA secretion during the vegetative stage of the L. edodes 3721 growth.

  12. Marketing herbal medicines. (United States)

    Lazarus, M


    HIV-positive support groups, together with hospital pharmacists in Thailand are fighting the high cost and lack of access to pharmaceuticals by producing and distributing herbal medicines. In Theung district, Chiang Rai province, members of the local support group for people with HIV produce their own, low-cost, herbal medicines. Although the herbal medicines they produce do not provide a cure for HIV/AIDS, they do offer relief for some of the symptoms of opportunistic infections. The herbs are prepared by the group members under the supervision of the pharmacy department at the district hospital. Local people judge their effectiveness by hearing testimonials from people who have witnessed improvement in symptoms. In response to the popularity and effectiveness of herbal medicines, the Ministry of Public Health has approved plans to sell products derived from local herbs in the pharmacies of government hospitals.

  13. Occupational medicine and toxicology

    Directory of Open Access Journals (Sweden)

    Fischer Axel


    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.

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

    Directory of Open Access Journals (Sweden)

    Bianca Maria Poli


    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.

  15. Nuclear medicine

    International Nuclear Information System (INIS)

    Kand, Purushottam


    Nuclear medicine is a specialized area of radiology that uses very small amounts of radioactive materials to examine organ function and structure. Nuclear medicine is older than CT, ultrasound and MRI. It was first used in patients over 60-70 years ago. Today it is an established medical specialty and offers procedures that are essential in many medical specialities like nephrology, pediatrics, cardiology, psychiatry, endocrinology and oncology. Nuclear medicine refers to medicine (a pharmaceutical) that is attached to a small quantity of radioactive material (a radioisotope). This combination is called a radiopharmaceutical. There are many radiopharmaceuticals like DTPA, DMSA, HIDA, MIBI and MDP available to study different parts of the body like kidneys, heart and bones etc. Nuclear medicine uses radiation coming from inside a patient's body where as conventional radiology exposes patients to radiation from outside the body. Thus nuclear imaging study is a physiological imaging, whereas diagnostic radiology is anatomical imaging. It combines many different disciplines like chemistry, physics mathematics, computer technology, and medicine. It helps in diagnosis and to treat abnormalities very early in the progression of a disease. The information provides a quick and accurate diagnosis of wide range of conditions and diseases in a person of any age. These tests are painless and most scans expose patients to only minimal and safe amounts of radiation. The amount of radiation received from a nuclear medicine procedure is comparable to, or often many times less than, that of a diagnostic X-ray. Nuclear medicine provides an effective means of examining whether some tissues/organs are functioning properly. Therapy using nuclear medicine in an effective, safe and relatively inexpensive way of controlling and in some cases eliminating, conditions such as overactive thyroid, thyroid cancer and arthritis. Nuclear medicine imaging is unique because it provides doctors with

  16. Traditional, complementary, and alternative medicine: Focusing on research into traditional Tibetan medicine in China. (United States)

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


    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.

  17. A ten-year audit of traditional Chinese medicine and other natural product research published in the Chinese Medical Journal (2000-2009)

    Institute of Scientific and Technical Information of China (English)

    Richard A. Collins


    Background Clinical research encompasses a wide variety of disciplines. Traditional Chinese medicine (TCM) and natural product research have made great contributions to preventing and treating illness. The number and content of original research reports evaluating TCM and natural products have not previously been described. Information in this area will identify areas of relative strength and weakness in terms of knowledge gaps with respect to clinical conditions and natural product remedies.Methods Original research reports (i.e. original articles, brief reports, and research letters) published in the Chinese Medical Journal (CMJ) from January 2000 to December 2009 evaluating TCM and other natural products were reviewed.The United Kingdom Clinical Research Collaboration (UK-CRC) Health Research Classification System was used to analyze the type of health research conducted. Further analysis on the major illnesses addressed and the major herbal components utilized was conducted.Results One hundred and seventeen original research reports involving TCM or other natural products were identified,comprising 3.82% of the CMJ output in the period covered by this study. Of the different materia medica described in these reports, 74.4% were derived exclusively from plant material, 10.3% from animals, 3.4% from fungi, 1.7% from minerals, and 10.3% were of mixed (plant / animal / fungal / mineral) composition. Twelve herbs were investigated exclusively or were constituents of 66/87 (75.9%) of the plant-based materia medica investigated. Panax ginseng was the most commonly investigated herb or constituent (14/87, 16.1%), followed by Astragalus membranaceus (9/87, 10.3%),Coptis chinensis/Berberis spp. (7/87, 8.0%) and Rheum spp. (7/87, 8.0%). Four UK-CRC health categories accounted for the majority of TCM and other natural product research (cancer, 20.9%; cardiovascular, 19.2%; oral/gastrointestinal,9.8%; and inflammatory/immune, 9.0%). The most common research activity was

  18. Fostering efficacy and toxicity evaluation of traditional Chinese medicine and natural products: Chick embryo as a high throughput model bridging in vitro and in vivo studies. (United States)

    Wu, Tong; Yu, Gui-Yuan; Xiao, Jia; Yan, Chang; Kurihara, Hiroshi; Li, Yi-Fang; So, Kwok-Fai; He, Rong-Rong


    Efficacy and safety assessments are essential thresholds for drug candidates from preclinical to clinical research. Conventional mammalian in vivo models cannot offer rapid pharmacological and toxicological screening, whereas cell-based or cell-free in vitro systems often lead to inaccurate results because of the lack of physiological environment. Within the avian species, gallus gallus is the first bird to have its genome sequencing. Meantime, chick embryo is an easily operating, relatively transparent and extensively accessible model, whose physiological and pathological alterations can be visualized by egg candler, staining and image technologies. These features facilitate chick embryo as a high-throughput screening platform bridging in vivo and in vitro gaps in the pharmaceutical research. Due to the complicated ingredients and multiple-targets natures of traditional Chinese medicine (TCM), testing the efficacy and safety of TCM by in vitro methods are laborious and inaccurate, while testing in mammalian models consume massive cost and time. As such, the productive living organism chick embryo serves as an ideal biological system for pharmacodynamics studies of TCM. Herein, we comprehensively update recent progresses on the specialty of chick embryo in evaluation of efficacy and toxicity of drugs, with special concerns of TCM. Copyright © 2018 Elsevier Ltd. All rights reserved.

  19. [Analysis of the decision to buy medicine in light of the existence of generic products: a study in the city of Belo Horizonte, Brazil]. (United States)

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


    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.

  20. Complementary medicines (herbal and nutritional products) in the treatment of Attention Deficit Hyperactivity Disorder (ADHD): a systematic review of the evidence. (United States)

    Sarris, Jerome; Kean, James; Schweitzer, Isaac; Lake, James


    Complementary and Alternative Medicines (CAMs) are frequently given to children and adolescents for reputed benefits in the treatment of hyperkinetic and concentration disorders such as Attention Deficit Hyperactivity Disorder (ADHD). In such vulnerable populations high quality evidence is required to support such claims. The aim of the paper is to assess the current evidence of herbal and nutritional interventions for ADHD using a systematic search of clinical trials meeting an acceptable standard of evidence. PubMed, PsycINFO, Cochrane Library and CINAHL were searched up to May 26th, 2011 for randomised, controlled clinical trials using CAM products as interventions to treat ADHD. A quality analysis using a purpose-designed scale, and an estimation of effect sizes (Cohen's d) where data were available, were also calculated. The review revealed that 16 studies met inclusion criteria, with predominant evidentiary support found for zinc, iron, Pinus marinus (French maritime pine bark), and a Chinese herbal formula (Ningdong); and mixed (mainly inconclusive) evidence for omega-3, and l-acetyl carnitine. Current data suggest that Ginkgo biloba (ginkgo), and Hypercium perforatum (St. John's wort) are ineffective in treating ADHD. The research suggests only some CAMs may be beneficial in ADHD, thus clinicians need to be aware of the current evidence. Promising candidates for future research include Bacopa monniera (brahmi) and Piper methysticum (kava), providing potential efficacy in improving attentional and hyperkinetic disorders via a combination of cognitive enhancing and sedative effects. Copyright © 2011 Elsevier Ltd. All rights reserved.

  1. 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


    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.

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


    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.

  3. Current Over-the-Counter Medicine Label: Take a Look (United States)

    ... This is to help protect consumers against possible criminal tampering. Drug products with tamper-evident packaging have ... Medicines Medicines in My Home (MIMH) Choosing the right over-the-counter medicine (OTCs) The Over-the- ...

  4. Ayurvedic Medicine (United States)

    ... to the biologic humors of the ancient Greek system. Using these concepts, Ayurvedic physicians prescribe individualized treatments, including compounds of herbs or proprietary ingredients, and diet, exercise, and lifestyle recommendations. The majority of India’s population uses Ayurvedic medicine ...

  5. COPD Medicine (United States)

    ... Education & Training Home Treatment & Programs Medications COPD Medications COPD Medications Make an Appointment Ask a Question Refer ... control the symptoms of chronic obstructive pulmonary disease (COPD). Most people with COPD take long-acting medicine ...

  6. Nuclear medicine

    International Nuclear Information System (INIS)

    Blanquet, Paul; Blanc, Daniel.


    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

  7. Nuclear medicine

    International Nuclear Information System (INIS)

    Chamberlain, M.J.


    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'

  8. Personalized Regenerative Medicine

    Directory of Open Access Journals (Sweden)

    Babak Arjmand


    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.

  9. [Falsified medicines in parallel trade]. (United States)

    Muckenfuß, Heide


    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.

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

  11. Travel medicine (United States)

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


    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

  12. Mesopotamian medicine. (United States)

    Retief, F P; Cilliers, L


    Although the Mesopotamian civilisation is as old as that of Egypt and might even have predated it, we know much less about Mesopotamian medicine, mainly because the cuneiform source material is less well researched. Medical healers existed from the middle of the 3rd millennium. In line with the strong theocratic state culture, healers were closely integrated with the powerful priestly fraternity, and were essentially of three main kinds: barû (seers) who were experts in divination, âshipu (exorcists), and asû (healing priests) who tended directly to the sick. All illness was accepted as sent by gods, demons and other evil spirits, either as retribution for sins or as malevolent visitations. Treatment revolved around identification of the offending supernatural power, appeasement of the angry gods, for example by offering amulets or incantations, exorcism of evil spirits, as well as a measure of empirical therapy aimed against certain recognised symptom complexes. Medical practice was rigidly codified, starting with Hammurabi's Code in the 18th century BC and persisting to the late 1st millennium BC. Works like the so-called Diagnostic Handbook, the Assyrian Herbal and Prescription Texts describe the rationale of Mesopotamian medicine, based predominantly on supernatural concepts, although rudimentary traces of empirical medicine are discernible. There is evidence that Egyptian medicine might have been influenced by Mesopotamian practices, but Greek rational medicine as it evolved in the 5th/4th centuries BC almost certainly had no significant Mesopotamian roots.

  13. Spotlight on medicinal chemistry education. (United States)

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


    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.

  14. Medicines by Design (United States)

    ... Home > Science Education > Medicines By Design Medicines By Design Spotlight Nature's Medicine Cabinet A Medicine's Life Inside ... hunt for drugs of the future. Medicines By Design in PDF | E-PUB Tell Us What You ...

  15. 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 ...

  16. 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 ...

  17. General Nuclear Medicine (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 ...

  18. Children's (Pediatric) Nuclear Medicine (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 ...

  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 ... 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 ...

  1. In silico modeling on ADME properties of natural products: Classification models for blood-brain barrier permeability, its application to traditional Chinese medicine and in vitro experimental validation. (United States)

    Zhang, Xiuqing; Liu, Ting; Fan, Xiaohui; Ai, Ni


    In silico modeling of blood-brain barrier (BBB) permeability plays an important role in early discovery of central nervous system (CNS) drugs due to its high-throughput and cost-effectiveness. Natural products (NP) have demonstrated considerable therapeutic efficacy against several CNS diseases. However, BBB permeation property of NP is scarcely evaluated both experimentally and computationally. It is well accepted that significant difference in chemical spaces exists between NP and synthetic drugs, which calls into doubt on suitability of available synthetic chemical based BBB permeability models for the evaluation of NP. Herein poor discriminative performance on BBB permeability of NP are first confirmed using internal constructed and previously published drug-derived computational models, which warrants the need for NP-oriented modeling. Then a quantitative structure-property relationship (QSPR) study on a NP dataset was carried out using four different machine learning methods including support vector machine, random forest, Naïve Bayes and probabilistic neural network with 67 selected features. The final consensus model was obtained with approximate 90% overall accuracy for the cross-validation study, which is further taken to predict passive BBB permeability of a large dataset consisting of over 10,000 compounds from traditional Chinese medicine (TCM). For 32 selected TCM molecules, their predicted BBB permeability were evaluated by in vitro parallel artificial membrane permeability assay and overall accuracy for in vitro experimental validation is around 81%. Interestingly, our in silico model successfully predicted different BBB permeation potentials of parent molecules and their known in vivo metabolites. Finally, we found that the lipophilicity, the number of hydrogen bonds and molecular polarity were important molecular determinants for BBB permeability of NP. Our results suggest that the consensus model proposed in current work is a reliable tool for

  2. [Medicinal cannabis]. (United States)

    Van der Meersch, H; Verschuere, A P; Bottriaux, F


    Pharmaceutical grade cannabis is available to Dutch patients from public pharmacies in the Netherlands. The first part of this paper reviews the pharmaceutical and pharmacological properties of medicinal cannabis. Detailed information about its composition and quality, potential applications, methods of administration, adverse reactions, drug interactions and safety during pregnancy or breastfeeding are given. The second part deals with the legal aspects of dispensing medicinal cannabis through pharmacies in view of the Belgian and Dutch legislation. The last part discusses the present Belgian regulation about the possession of cannabis.

  3. Nuclear medicine

    International Nuclear Information System (INIS)

    Reichelt, H.G.


    Nuclear medicine as a complex diagnostical method is used mainly to detect functional organic disorders, to locate disorders and for radioimmunologic assays (RIA) in vitro. In surgery, its indication range comprises the thyroid (in vivo and in vitro), liver and bile ducts, skeletal and joint diseases, disorders of the cerebro-spinal liquor system and the urologic disorders. In the early detection of tumors, the search for metastases and tumor after-care, scintiscanning and the tumor marcher method (CEA) can be of great practical advantage, but the value of myocardial sciritiscanning in cardiac respectively coronary disorders is restricted. The paper is also concerned with the radiation doses in nuclear medicine. (orig.) [de

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

  5. Technetium in chemistry and nuclear medicine

    International Nuclear Information System (INIS)

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


    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

  6. Mountain medicin

    DEFF Research Database (Denmark)

    Bay, Bjørn; Hjuler, Kasper Fjellhaugen


    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...

  7. Personalized medicine

    DEFF Research Database (Denmark)

    Bendtzen, Klaus


    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...

  8. Predictive medicine

    NARCIS (Netherlands)

    Boenink, Marianne; ten Have, Henk


    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

  9. Medicinal Mushrooms

    NARCIS (Netherlands)

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


    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. (United States)

    Phillipson, J. David


    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. 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. (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


    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.

  12. Essentials of nuclear medicine physics and instrumentation

    CERN Document Server

    Powsner, Rachel A; Powsner, Edward R


    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

  13. Reconciling uncertainty of costs and outcomes with the need for access to orphan medicinal products: a comparative study of managed entry agreements across seven European countries. (United States)

    Morel, Thomas; Arickx, Francis; Befrits, Gustaf; Siviero, Paolo; van der Meijden, Caroline; Xoxi, Entela; Simoens, Steven


    National payers across Europe have been increasingly looking into innovative reimbursement approaches - called managed entry agreements (MEAs) - to balance the need to provide rapid access to potentially beneficial orphan medicinal products (OMPs) with the requirements to circumscribe uncertainty, obtain best value for money or to ensure affordability. This study aimed to identify, describe and classify MEAs applied to OMPs by national payers and to analyse their practice in Europe. To identify and describe MEAs, national health technology assessments and reimbursement decisions on OMPs across seven European countries were reviewed and their main characteristics extracted. To fill data gaps and validate the accuracy of the extraction, collaboration was sought from national payers. To classify MEAs, a bespoke taxonomy was implemented. Identified MEAs were analysed and compared by focusing on five key themes, namely by describing the MEAs in relation to: drug targets and therapeutic classes, geographical spread, type of MEA applied, declared rationale for setting-up of MEAs, and evolution over time. 42 MEAs for 26 OMPs, implemented between 2006 and 2012 and representing a variety of MEA designs, were identified. Italy was the country with the highest number of schemes (n=15), followed by the Netherlands (n=10), England and Wales (n=8), Sweden (n=5) and Belgium (n=4). No MEA was identified for France and Germany due to data unavailability. Antineoplastic agents were the primary targets of MEAs. 55% of the identified MEAs were performance-based risk-sharing arrangements; the other 45% were financial-based. Nine of these 26 OMPs were subject to MEAs in two or three different countries, resulting in 24 MEAs. 60% of identified MEAs focused on conditions whose prevalence is less than 1 per 10,000. This study confirmed that a variety of MEAs were increasingly used by European payers to manage aspects of uncertainty associated with the introduction of OMPs in the healthcare

  14. [Nanotechnology future of medicine]. (United States)

    Terlega, Katarzyna; Latocha, Małgorzata


    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.

  15. Environmental medicine

    International Nuclear Information System (INIS)

    Steneberg, A.


    '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

  16. [Medicine after Galen]. (United States)

    Mazzini, Innocenzo


    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.

  17. Nuclear medicine

    International Nuclear Information System (INIS)

    Sibille, L.; Nalda, E.; Collombier, L.; Kotzki, P.O.; Boudousq, V.


    Nuclear medicine is a medical specialty using the properties of radioactivity. Radioactive markers associated with vectors are used as a tracer or radiopharmaceutical for diagnostic purposes and/or therapy. Since its birth more than half a century ago, it has become essential in the care of many patients, particularly in oncology. After some definitions, this paper presents the main nuclear techniques - imaging for diagnostic, radiopharmaceuticals as therapeutic agents, intra-operative detection, technique of radioimmunoassay - and the future of this field. (authors)

  18. Transfusion Medicine

    Directory of Open Access Journals (Sweden)

    Smit Sibinga CT


    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.



    Srinivasan, T. M.


    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...

  20. Transfusion medicine

    International Nuclear Information System (INIS)

    Murawski, K.; Peetoom, F.


    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

  1. Medicinal Herbs Affecting Gray Hair in Iranian Traditional Medicine. (United States)

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


    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.

  2. First principles of Hamiltonian medicine. (United States)

    Crespi, Bernard; Foster, Kevin; Úbeda, Francisco


    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.

  3. African palm ethno-medicine

    DEFF Research Database (Denmark)

    Gruca, Marta; Blach-Overgaard, Anne; Balslev, Henrik


    -medicinal data on African palms, and investigate patterns of palm uses in traditional medicine; and highlight possible under-investigated areas. Materials and methods References were found through bibliographic searches using several sources including PubMed, Embase, and Google Scholar and search engines...... in traditional medicine, with most of the uses related to fruit (and palm oil), root, seed and leaf. Palms were used in traditional medicine mostly without being mixed with other plants, and less commonly in mixtures, sometimes in mixture with products of animal origin. Future ethno-botanical surveys should...... were able to demonstrate the value of palms in traditional medicine, and provide recommendations for the areas that should be targeted in future ethno-botanical surveys....

  4. A Supramolecular Approach to Medicinal Chemistry: Medicine Beyond the Molecule (United States)

    Smith, David K.


    This article focuses on the essential roles played by intermolecular forces in mediating the interactions between chemical molecules and biological systems. Intermolecular forces constitute a key topic in chemistry programs, yet can sometimes seem disconnected from real-life applications. However, by taking a "supramolecular" view of medicinal chemistry and focusing on interactions between molecules, it is possible to come to a deeper understanding of recent developments in medicine. This allows us to gain a real insight into the interface between biology and chemistry—an interdisciplinary area that is crucial for the development of modern medicinal products. This article emphasizes a conceptual view of medicinal chemistry, which has important implications for the future, as the supramolecular approach to medicinal-chemistry products outlined here is rapidly allowing nanotechnology to converge with medicine. In particular, this article discusses recent developments including the rational design of drugs such as Relenza and Tamiflu, the mode of action of vancomycin, and the mechanism by which bacteria develop resistance, drug delivery using cyclodextrins, and the importance of supramolecular chemistry in understanding protein aggregation diseases such as Alzheimer's and Creutzfield Jacob. The article also indicates how taking a supramolecular approach will enable the development of new nanoscale medicines.

  5. Complementary and Alternative Medicine (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 ...

  6. [Intensive medicine in Spain]. (United States)


    Intensive care medicine is a medical specialty that was officially established in our country in 1978, with a 5-year training program including two years of common core training followed by three years of specific training in an intensive care unit accredited for training. During this 32-year period, intensive care medicine has carried out an intense and varied activity, which has allowed its positioning as an attractive and with future specialty in the hospital setting. This document summarizes the history of the specialty, its current situation, the key role played in the programs of organ donation and transplantation of the National Transplant Organization (after more than 20 years of mutual collaboration), its training activities with the development of the National Plan of Cardiopulmonary Resuscitation, with a trajectory of more than 25 years, its interest in providing care based on quality and safety programs for the severely ill patient. It also describes the development of reference registries due to the need for reliable data on the care process for the most prevalent diseases, such as ischemic heart disease or ICU-acquired infections, based on long-term experience (more than 15 years), which results in the availability of epidemiological information and characteristics of care that may affect the practical patient's care. Moreover, features of its scientific society (SEMICYUC) are reported, an organization that agglutinates the interests of more than 280 ICUs and more than 2700 intensivists, with reference to the journal Medicina Intensiva, the official journal of the society and the Panamerican and Iberian Federation of Critical Medicine and Intensive Care Societies. Medicina Intensiva is indexed in the Thompson Reuters products of Science Citation Index Expanded (Scisearch(®)) and Journal Citation Reports, Science Edition. The important contribution of the Spanish intensive care medicine to the scientific community is also analyzed, and in relation to

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

    Berhan, Yifru


    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

  8. [The role of German official medicines control laboratories in combating counterfeit medicines]. (United States)

    Wiegard, Andrea; Heuermann, Matthias


    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.

  9. Nuclear medicine

    International Nuclear Information System (INIS)

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


    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

  10. 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.


    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

  11. 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....

  12. Nuclear Medicine Engineering

    International Nuclear Information System (INIS)

    Mateescu, Gheorghe; Craciunescu, Teddy


    'An image is more valuable than a thousand words' - this is the thought that underlies the authors' vision about the field of nuclear medicine. The monograph starts with a review of some theoretical and engineering notions that grounds the field of nuclear medicine: nuclear radiation, interaction of radiation with matter, radiation detection and measurement, numerical analysis. Products and methods needed for the implementation of diagnostic and research procedures in nuclear medicine are presented: radioisotopes and radiopharmaceuticals, equipment for in-vitro (radioimmunoassay, liquid scintillation counting) and in-vivo investigations (thyroid uptake, renography, dynamic studies, imaging). A special attention is focused on medical imaging theory and practice as a source of clinical information (morphological and functional). The large variety of parameters, components, biological structures and specific properties of live matter determines the practical use of three-dimensional tomographic techniques based on diverse physical principles: single-photon emission, positron emission, X-rays transmission, nuclear magnetic resonance, ultrasounds transmission and reflection, electrical impedance measurement. The fundamental reconstruction algorithms i.e., algorithms based on the projection theorem and Fourier filtering, algebraic reconstruction techniques and the algorithms based on statistical principles: maximum entropy, maximum likelihood, Monte Carlo algorithms, are depicted in details. A method based on the use of the measured point spread function is suggested. Some classical but often used techniques like linear scintigraphy and Anger gamma camera imaging are also presented together with some image enhancement techniques like Wiener filtering and blind deconvolution. The topic of the book is illustrated with some clinical samples obtained with nuclear medicine devices developed in the Nuclear Medicine Laboratory of the National Institute of Nuclear Physics and

  13. Integrative Medicine in Preventive Medicine Education


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


    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 esta...

  14. Interpretive Medicine (United States)

    Reeve, Joanne


    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

  15. Narrativ medicin

    DEFF Research Database (Denmark)

    Hvas, Lotte; Getz, Linn


    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?...

  16. World Health Organization Ranking of Antimicrobials According to Their Importance in Human Medicine: A Critical Step for Developing Risk Management Strategies for the Use of Antimicrobials in Food Production Animals

    DEFF Research Database (Denmark)

    Collignon, P.; Powers, J. H.; Chiller, T. M.


    stakeholders can use this ranking when developing risk management strategies for the use of antimicrobials in food production animals. The ranking allows stakeholders to focus risk management efforts on drugs used in food animals that are the most important to human medicine and, thus, need to be addressed......The use of antimicrobials in food animals creates an important source of antimicrobial-resistant bacteria that can spread to humans through the food supply. Improved management of the use of antimicrobials in food animals, particularly reducing the usage of those that are "critically important...

  17. 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. (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


    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

  18. Nuclear power in human medicine

    International Nuclear Information System (INIS)

    Kuczera, Bernhard


    The public widely associate nuclear power with the megawatt dimensions of nuclear power plants in which nuclear power is released and used for electricity production. While this use of nuclear power for electricity generation is rejected by part of the population adopting the polemic attitude of ''opting out of nuclear,'' the application of nuclear power in medicine is generally accepted. The appreciative, positive term used in this case is nuclear medicine. Both areas, nuclear medicine and environmentally friendly nuclear electricity production, can be traced back to one common origin, i.e. the ''Atoms for Peace'' speech by U.S. President Eisenhower to the U.N. Plenary Assembly on December 8, 1953. The methods of examination and treatment in nuclear medicine are illustrated in a few examples from the perspective of a nuclear engineer. Nuclear medicine is a medical discipline dealing with the use of radionuclides in humans for medical purposes. This is based on 2 principles, namely that the human organism is unable to distinguish among different isotopes in metabolic processes, and the radioactive substances are employed in amounts so small that metabolic processes will not be influenced. As in classical medicine, the application of these principles serves two complementary purposes: diagnosis and therapy. (orig.)

  19. Medicine safety and children (United States)

    ... it is candy. What to Do If Your Child Takes Medicine If you think your child has taken medicine, call the poison control center ... blood pressure monitored. Preventing Medicine Mistakes When giving medicine to your young child, follow these safety tips: Use medicine made only ...

  20. The regulation of herbal medicines in Australia

    International Nuclear Information System (INIS)

    Briggs, David R.


    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

  1. [Arsenic - Poison or medicine?]. (United States)

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


    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.

  2. Research medicine

    International Nuclear Information System (INIS)



    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

  3. Optimization of the Production of Extracellular Polysaccharide from the Shiitake Medicinal Mushroom Lentinus edodes (Agaricomycetes) Using Mutation and a Genetic Algorithm-Coupled Artificial Neural Network (GA-ANN). (United States)

    Adeeyo, Adeyemi Ojutalayo; Lateef, Agbaje; Gueguim-Kana, Evariste Bosco


    Exopolysaccharide (EPS) production by a strain of Lentinus edodes was studied via the effects of treatments with ultraviolet (UV) irradiation and acridine orange. Furthermore, optimization of EPS production was studied using a genetic algorithm coupled with an artificial neural network in submerged fermentation. Exposure to irradiation and acridine orange resulted in improved EPS production (2.783 and 5.548 g/L, respectively) when compared with the wild strain (1.044 g/L), whereas optimization led to improved productivity (23.21 g/L). The EPS produced by various strains also demonstrated good DPPH scavenging activities of 45.40-88.90%, and also inhibited the growth of Escherichia coli and Klebsiella pneumoniae. This study shows that multistep optimization schemes involving physical-chemical mutation and media optimization can be an attractive strategy for improving the yield of bioactives from medicinal mushrooms. To the best of our knowledge, this report presents the first reference of a multistep approach to optimizing EPS production in L. edodes.

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

    Directory of Open Access Journals (Sweden)

    Gabriela Ulloa-Urizar


    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.

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

  6. Cough & Cold Medicine Abuse (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 ...

  7. Complementary and Integrative Medicine (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 ...

  8. Depression - stopping your medicines (United States)

    ... this page: // 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 ...

  9. Cold medicines and children (United States)

    ... ingredient. Avoid giving more than one OTC cold medicine to your child. It may cause an overdose with severe side ... the dosage instructions strictly while giving an OTC medicine to your child. When giving OTC cold medicines to your child: ...

  10. Traveling Safely with Medicines (United States)

    ... Medications Safely My Medicine List How to Administer Traveling Safely with Medicines Planes, trains, cars – even boats ... your trip, ask your pharmacist about how to travel safely with your medicines. Make sure that you ...

  11. Metabolomics in transfusion medicine. (United States)

    Nemkov, Travis; Hansen, Kirk C; Dumont, Larry J; D'Alessandro, Angelo


    Biochemical investigations on the regulatory mechanisms of red blood cell (RBC) and platelet (PLT) metabolism have fostered a century of advances in the field of transfusion medicine. Owing to these advances, storage of RBCs and PLT concentrates has become a lifesaving practice in clinical and military settings. There, however, remains room for improvement, especially with regard to the introduction of novel storage and/or rejuvenation solutions, alternative cell processing strategies (e.g., pathogen inactivation technologies), and quality testing (e.g., evaluation of novel containers with alternative plasticizers). Recent advancements in mass spectrometry-based metabolomics and systems biology, the bioinformatics integration of omics data, promise to speed up the design and testing of innovative storage strategies developed to improve the quality, safety, and effectiveness of blood products. Here we review the currently available metabolomics technologies and briefly describe the routine workflow for transfusion medicine-relevant studies. The goal is to provide transfusion medicine experts with adequate tools to navigate through the otherwise overwhelming amount of metabolomics data burgeoning in the field during the past few years. Descriptive metabolomics data have represented the first step omics researchers have taken into the field of transfusion medicine. However, to up the ante, clinical and omics experts will need to merge their expertise to investigate correlative and mechanistic relationships among metabolic variables and transfusion-relevant variables, such as 24-hour in vivo recovery for transfused RBCs. Integration with systems biology models will potentially allow for in silico prediction of metabolic phenotypes, thus streamlining the design and testing of alternative storage strategies and/or solutions. © 2015 AABB.

  12. Medicines, excipients and dietary intolerances. (United States)


    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

  13. Obstetric medicine

    Directory of Open Access Journals (Sweden)

    L. Balbi


    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.

  14. Medicines for sleep (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 ...

  15. [Nitrous oxide production by the German Armed Forces in the 20th century : History of medicine and pharmacy in the Armed Forces]. (United States)

    Kronabel, D B J


    The nitrous oxide production unit of the German Armed Forces was a worldwide unique facility which was only employed in the former main medical depot at Euskirchen (nitrous oxide: medical gas which is now obsolete). The last unit was phased out in 2002 and brought to the main medical depot at Blankenburg. Unfortunately the unit is now no longer in the depot and seems to have disappeared. This article describes the nitrous oxide production process and the use of the production unit which was designed by the Socsil company of Switzerland.

  16. 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


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


    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 (1954–201...

  17. A pluralist challenge to "integrative medicine": Feyerabend and Popper on the cognitive value of alternative medicine. (United States)

    Kidd, Ian James


    This paper is a critique of 'integrative medicine' as an ideal of medical progress on the grounds that it fails to realise the cognitive value of alternative medicine. After a brief account of the cognitive value of alternative medicine, I outline the form of 'integrative medicine' defended by the late Stephen Straus, former director of the US National Centre for Complementary and Alternative Medicine. Straus' account is then considered in the light of Zuzana Parusnikova's recent criticism of 'integrative medicine' and her distinction between 'cognitive' and 'opportunistic' engagement with alternative medicine. Parusnikova warns that the medical establishment is guilty of 'dogmatism' and proposes that one can usefully invoke Karl Popper's 'critical rationalism' as an antidote. Using the example of Straus, I argue that an appeal to Popper is insufficient, on the grounds that 'integrative medicine' can class as a form of cognitively-productive, critical engagement. I suggest that Parusnikova's appeal to Popper should be augmented with Paul Feyerabend's emphasis upon the role of 'radical alternatives' in maximising criticism. 'Integrative medicine' fails to maximise criticism because it 'translates' alternative medicine into the theories and terminology of allopathic medicine and so erodes its capacity to provide cognitively-valuable 'radical alternatives'. These claims are then illustrated with a discussion of 'traditional' and 'medical' acupuncture. I conclude that 'integrative medicine' fails to exploit the cognitive value of alternative medicine and so should be rejected as an ideal of medical progress. Copyright © 2013 Elsevier Ltd. All rights reserved.

  18. Researching the life stages of medicines: Introduction

    NARCIS (Netherlands)

    van der Geest, S.; Chamberlain, K.


    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,

  19. 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


    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.

  20. Folk Medicine, Folk Healing

    Directory of Open Access Journals (Sweden)

    Mustafa SEVER


    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

  1. Regenerative Medicine Build-Out (United States)

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


    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

  2. Regenerative Medicine Build-Out. (United States)

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


    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

  3. Links between nuclear medicine and radiopharmacy

    International Nuclear Information System (INIS)

    Pelegrin, M.; Francois-Joubert, A.; Chassel, M.L.; Desruet, M.D.; Bolot, C.; Lao, S.


    Radiopharmaceuticals are nowadays under the responsibility of the radio-pharmacist because of their medicinal product status. Radiopharmacy belongs to the hospital pharmacy department, nevertheless, interactions with nuclear medicine department are important: rooms are included or located near nuclear medicine departments in order to respect radiation protection rules, more over staff, a part of the material and some activities are shared between the two departments. Consequently, it seems essential to formalize links between the radiopharmacy and the nuclear medicine department, setting the goals to avoid conflicts and to ensure patients' security. Modalities chosen for this formalization will depend on the establishment's organization. (authors)

  4. Correcting India’s Chronic Shortage of Drug Inspectors to Ensure the Production and Distribution of Safe, High-Quality Medicines (United States)

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


    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

  5. 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


    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%.

  6. 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))


    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.

  7. Risk attitudes and personality traits predict perceptions of benefits and risks for medicinal products: a field study of European medical assessors. (United States)

    Beyer, Andrea R; Fasolo, Barbara; de Graeff, P A; Hillege, H L


    Risk attitudes and personality traits are known predictors of decision making among laypersons, but very little is known of their influence among experts participating in organizational decision making. Seventy-five European medical assessors were assessed in a field study using the Domain Specific Risk Taking scale and the Big Five Inventory scale. Assessors rated the risks and benefits for a mock "clinical dossier" specific to their area of expertise, and ordinal regression models were used to assess the odds of risk attitude or personality traits in predicting either the benefit or the risk ratings. An increase in the "conscientiousness" score predicted an increase in the perception of the drug's benefit, and male assessors gave higher scores for the drug's benefit ratings than did female assessors. Extraverted assessors saw fewer risks, and assessors with a perceived neutral-averse or averse risk profile saw greater risks. Medical assessors perceive the benefits and risks of medicines via a complex interplay of the medical situation, their personality traits and even their gender. Further research in this area is needed to determine how these potential biases are managed within the regulatory setting. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  8. Ethnozoological study of traditional medicinal appreciation of animals and their products among the indigenous people of Metema Woreda, North-Western Ethiopia. (United States)

    Kendie, Fasil Adugna; Mekuriaw, Sileshi Andualem; Dagnew, Melkamu Andargie


    Using animals for different purposes goes back to the dawn of mankind. Animals served as a source of food, medicine, and clothing for humans and provided other services. This study was designed to undertake a cross-sectional ethnozoological field survey among the residents of Metema Woreda from November 2015 to May 2016. Data were collected through studied questionnaires, interviews, and focus group discussions with 36 purposively selected respondents. Ethnozoological data were collected of the local name of the animals, part of the animal used, mode of preparation and administration, and of additional information deemed useful. A total of 51 animal species were identified to treat around 36 different ailments. Of the animals used therapeutically, 27 species were mammals, 9 were birds, 7 arthropods, 6 reptiles, and 1 species each represented fish and annelids. Furthermore, the honey of the bee Apis mellifera was used to relieve many ailments and scored the highest fidelity value (n = 35.97%). The snake (Naja naja) and the teeth of crocodiles (Crocodylus spp.) had the lowest fidelity value (n = 2.56%). The results show that there is a wealth of ethnozoological knowledge to be documented which could be of use in developing new drugs. Hence, it is hoped that the information contained in this paper will be useful in future ethnozoological, ethnopharmacological, and conservation-related research of the region.


    NARCIS (Netherlands)



    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

  10. Medicinal Properties of Clinacanthus nutans: A review

    African Journals Online (AJOL)

    (DOAJ), African Journal Online, Bioline International, Open-J-Gate and Pharmacy Abstracts. INTRODUCTION. Complementary and alternative medicine (CAM) .... with apigenin backbone were found in the green ..... products A.D. 2006.

  11. Introductory physics of nuclear medicine

    International Nuclear Information System (INIS)

    Chandra, R.


    This presentation is primarily addressed to resident physicians in nuclear medicine, as well as residents in radiology, pathology, and internal medicine. Topics covered include: basic review; nuclides and radioactive processes; radioactivity-law of decay, half-life, and statistics; production of radionuclides; radiopharmaceuticals; interaction of high-energy radiation with matter; radiation dosimetry; detection of high-energy radiation; in-vitro radiation detection; in-vivo radiation detection using external detectors; detectability or final contrast in a scan; resolution and sensitivity of a scanner; special techniques and instruments; therapeutic uses of radionuclides; biological effects of radiation; and safe handling of radionuclides

  12. 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)


    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)

  13. Neutron use in nuclear medicine

    International Nuclear Information System (INIS)

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


    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)

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

    Virt, G


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

  15. Correlation of different spectral lights with biomass accumulation and production of antioxidant secondary metabolites in callus cultures of medicinally important Prunella vulgaris L. (United States)

    Fazal, Hina; Abbasi, Bilal Haider; Ahmad, Nisar; Ali, Syed Shujait; Akbar, Fazal; Kanwal, Farina


    Light is one of the key elicitors that directly fluctuates plant developmental processes and biosynthesis of secondary metabolites. In this study, the effects of various spectral lights on biomass accumulation and production of antioxidant secondary metabolites in callus cultures of Prunella vulgaris were investigated. Among different spectral lights, green light induced the maximum callogenic response (95%). Enhanced fresh biomass accumulation was observed in log phases on day-35, when callus cultures were exposed to yellow and violet lights. Yellow light induced maximum biomass accumulation (3.67g/100ml) from leaf explants as compared to control (1.27g/100ml). In contrast, violet lights enhanced biomass accumulation (3.49g/100ml) from petiole explant. Maximum total phenolics content (TPC; 23.9mg/g-DW) and total flavonoids content (TFC; 1.65mg/g-DW) were observed when cultures were grown under blue lights. In contrast, green and yellow lights enhanced total phenolics production (TPP; 112.52g/100ml) and total flavonoids production (TFP; 9.64g/100ml) as compared to control. The calli grown under green, red and blue lights enhanced DPPH-free radical scavenging activity (DFRSA; 91.3%, 93.1% and 93%) than control (56.44%) respectively. The DFRSA was correlated either with TPC and TFC or TPP and TFP. Furthermore, yellow lights enhanced superoxide dismutase (SOD), peroxidase (POD) and protease activities, however, the content of total protein (CTP) was higher in control cultures (186μg BSAE/mg FW) as compared to spectral lights. These results suggest that the exposure of callus cultures to various spectral lights have shown a key role in biomass accumulation and production of antioxidant secondary metabolites. Copyright © 2016 Elsevier B.V. All rights reserved.

  16. 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


    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.

  17. Nutrient Optimization Using Response Surface Methodology for Simultaneous Biomass and Bioactive Compound Production by Lion's Mane Medicinal Mushroom, Hericium erinaceus (Agaricomycetes). (United States)

    Ofosu, Fred K; Yu, Xiaobin; Wang, Qiang; Li, Hanguang


    Due to the unpleasant side effects of long-term use of commercially available drugs, the discovery and development of natural therapeutic agents to prevent life-debilitating diseases is urgently needed. In the present study, the optimization of medium composition for maximum mycelial biomass and bioactive compounds production by Hericium erinaceus was studied using response surface methodology based on a central composite design. Under the optimal conditions and at a pH of 5.41 ± 0.28, the maximum mycelial biomass and exopolysaccharide production reached 25.0 ± 1.38 g/L and 1.73 ± 0.06 g/L, respectively, compared with 22.65 ± 0.10 g/L and 1.56 ± 0.23 g/L in the basal medium, after 7 days of cultivation. Furthermore, we report for the first time the production of adenosine, both intra- and extracellularly in submerged cultures of H. erinaceus. Although most of the adenosine detected existed in the culture medium, the highest intracellular and extracellular adenosine concentrations of 150.84 ± 1.87 mg/L and 142.48 ± 3.78 mg/L were achieved after 7 and 6 days of cultivation, respectively.

  18. Radiation physics for nuclear medicine

    CERN Document Server

    Hoeschen, Christoph


    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.

  19. Retailing policies for generic medicines. (United States)

    Narciso, Susana


    As there is general disagreement about the way generic medicines should be commercialized, two retailing policies are analyzed, taking into account their effects on the welfare of patients, government, pharmacies and physicians. In the first policy scenario, pharmacies are allowed to substitute generic medicines for branded ones, while in the second, substitution is forbidden. In both cases a pharmacies association is allowed to have a share in the production of generic medicines. The model predicts that under some conditions patients may prefer substitution by pharmacies but when doctors' decisions are binding, they are never "excessively bad". However, the policy choice belongs to the government, which prefers to allow for substitution more often than patients would like.

  20. Artemisinin, a miracle of traditional Chinese medicine.