Who Guidelines On Safety Monitoring Of Herbal Medicines In Pharmacovigilance Systems
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WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems by World Health Organization Pdf
Safety is a fundamental principle in the privision of herbal medicines and herbal products for health care and a critical component of quality control. These guidelines provide practical technical guidance for monitoring the safety of herbal medicines with pharmacovigilance systems.
Evidence-Based Validation of Herbal Medicine by Pulok K. Mukherjee Pdf
Evidence-Based Validation of Herbal Medicines: Translational Research on Botanicals brings together current thinking and practice in the characterization and validation of natural products. The book describes different approaches and techniques for evaluating the quality, safety and efficacy of herbal medicine, particularly methods to assess their activity and understand compounds responsible and their probable underlying mechanisms of action. This book brings together the views, expertise and experiences of scientific experts in the field of medicinal plant research, hence it will be useful for researcher who want to know more about the natural lead with their validation and also useful to exploit traditional medicines. Includes state-of-the-art methods for detecting, isolating and performing structure elucidation by degradation and spectroscopic techniques Highlights the trends in validation and value addition of herbal medicine with different scientific approaches used in therapeutics Contains several all-new chapters on topics such as traditional-medicine-inspired drug development to treat emerging viral diseases, medicinal plants in antimicrobial resistance, TLC bio profiling, botanicals as medicinal foods, bioprospecting and bioassay-guided isolation of medicinal plants, immunomodulators from medicinal plants, and more
World Health Organization,Council for International Organizations of Medical Sciences,Cioms
Author : World Health Organization,Council for International Organizations of Medical Sciences,Cioms Publisher : Unknown Page : 381 pages File Size : 51,7 Mb Release : 2001-01-01 Category : Medical ISBN : 9290360747
Current Challenges in Pharmacovigilance by World Health Organization,Council for International Organizations of Medical Sciences,Cioms Pdf
In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
Pharmacovigilance for Herbal and Traditional Medicines by Joanne Barnes Pdf
This remarkable new book is the first text dedicated to the topic of pharmacovigilance for herbal and traditional medicines. Taking a truly global perspective, this volume draws together contributions from a diverse group of experts, writing on current knowledge and practices in pharmacovigilance for herbal and traditional medicines, and on advances and innovation in monitoring the safety of this unique and complex category of products and preparations. In part one, the book discusses the current status of pharmacovigilance for herbal and traditional medicines, including the importance of natural products chemistry to harms, and its relevance in considering how pharmacovigilance for these products could be undertaken. Several other chapters discuss methodological approaches and ongoing challenges in pharmacovigilance for herbal and traditional medicines, including issues relating to nomenclature, coding and classification, and the nuances involved in causality assessment. Part two of the book focusses on pharmacovigilance for herbal and traditional medicines around the world, with chapters from authors in several different countries representing diverse historical, ethnic, cultural, social and political contexts. These chapters provide deeper insights and perspectives into spontaneous reporting for herbal and traditional medicines in those countries, and in the context of the local use, practice and regulatory landscape for these products. Part two also provides an overview and new analysis of international case safety reports for herbal medicines held in VigiBase (the World Health Organization's global database of individual case safety reports, maintained by the Uppsala Monitoring Centre). This book is aimed at pharmacists, doctors, nurses and other health professionals, herbal-medicine practitioners and organisations, herbal medicine and pharmaceutical industry personnel, pharmacovigilance specialists, medicines’ regulators, health and social science researchers and academics, pharmacovigilance and health professional students, and students of herbal and traditional medicine, throughout the world. It is an extremely valuable resource for all individuals whose work touches the intersection between herbal medicines and pharmacovigilance, and it provides both an introduction to the topic and a deeper, comprehensive, contemporary account of the topic.
Drug Safety in Developing Countries by Yaser Mohammed Al-Worafi Pdf
Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues Describes current achievements of drug safety practice in developing countries Addresses the challenges of drug safety in developing countries Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety
Quality Control and Standardization Of Herbals by Dr. Dillip Kumar Jena,Dr. Pankaj Pradhan Pdf
Purchase the e-Book version of ‘Quality Control and Standardization of Herbals’ for B.Pharm 8th Semester, meticulously aligned with the PCI Syllabus. Published by Thakur Publication, this digital edition offers a comprehensive exploration of advanced instrumentation techniques at your fingertips. Upgrade your learning experience with the convenience and portability of an e-Book. Dive into the world of cutting-edge pharmaceutical instrumentation with ease. Get your copy today and embark on a journey of enhanced understanding.
Stephens' Detection of New Adverse Drug Reactions by John Talbot,Patrick Waller Pdf
A key text for all those involved in pharmacovigilance. Detection of new adverse drug reactions is fundamental to the protection of patients from harm that may occur as a result of medication. This book explores the methods used to investigate new adverse drug reactions, discussing all elements from the scientific background and animal toxicology through to worldwide regulatory and ethical issues. Stephens' Detection of New Adverse Drug Reactions provides comprehensive and up-to-date coverage of material fundamentally important to all those active in the field, whether they work in the pharmaceutical industry, drug regulatory authorities or in academia. The fifth edition of this classic reference work includes new chapters on: vaccine safety surveillance managing drug safety issues with marketed products operational aspects of drug safety function safety of biotechnology products future of pharmacovigilance Reviews of previous editions: "This book surpasses all its educational aims. Not only is the subject matter covered comprehensively but the material is presented in a very user-friendly manner. The editors have succeeded in producing a highly-specific, definitive reference book which doubles as a most enjoyable read." —Commended by the 1999 BMA Medical Book Competition "For anyone entering the field of adverse reaction monitoring one could not wish for a better primer" —International Journal of Risk and Safety in Medicine
Evidence Based Validation of Traditional Medicines by Subhash C. Mandal,Raja Chakraborty,Saikat Sen Pdf
The demand for traditional medicines, herbal health products, herbal pharmaceuticals, nutraceuticals, food supplements and herbal cosmetics etc. is increasing globally due to the growing recognition of these products as mainly non-toxic, having lesser side effects, better compatibility with physiological flora, and availability at affordable prices. In the last century, medical science has made incredible advances all over the globe. In spite of global reorganization and a very sound history of traditional uses, the promotion of traditional medicine faces a number of challenges around the globe, primarily in developed nations. Regulation and safety is the high concern for the promotion of traditional medicine. Quality issues and quality control, pharmacogivilane, scientific investigation and validation, intellectual property rights, and biopiracy are some key issues that restrain the advancement of traditional medicine around the globe. This book contains diverse and unique chapters, explaining in detail various subsections like phytomolecule, drug discovery and modern techniques, standardization and validation of traditional medicine, and medicinal plants, safety and regulatory issue of traditional medicine, pharmaceutical excipients from nature, plants for future. The contents of the book will be useful for the academicians, researchers and people working in the area of traditional medicine.
Author : World Health Organization Publisher : World Health Organization Page : 146 pages File Size : 55,9 Mb Release : 2009 Category : Medical ISBN : 9789241547949
A Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines by World Health Organization Pdf
"This is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programmes. A number of WHO publications are available that provide a background to pharmacovigilance and, as far as possible, that material will not be repeated here."--Publisher's description.
Poisonous Plants and Phytochemicals in Drug Discovery by Andrew G. Mtewa,Chukwuebuka Egbuna,G. M. Narasimha Rao Pdf
Focusing on phytochemicals and their potential for drug discovery, this book offers a comprehensive resource on poisonous plants and their applications in chemistry and in pharmacology. Provides a comprehensive resource on phytotoxins, covering historical perspectives, modern applications, and their potential in drug discovery Covers the mechanisms, benefits, risks and management protocols of phytotoxins in a scientific laboratory and the usefulness in drug discovery Presents chapters in a carefully designed, clear order, making it an ideal resource for the academic researcher or the industry professional at any stage in their career
Fingerprinting Analysis and Quality Control Methods of Herbal Medicines by Ravindra Kumar Pandey,Shiv Shankar Shukla,Amber Vyas,Vishal Jain,Parag Jain,Shailendra Saraf Pdf
Due to the increase in the consumption of herbal medicine, there is a need to know which scientifically based methods are appropriate for assessing the quality of herbal medicines. Fingerprinting has emerged as a suitable technique for quality estimation. Chemical markers are used for evaluation of herbal medicines. Identification and quantification of these chemical markers are crucial for quality control of herbal medicines. This book provides updated knowledge on methodology, quality assessment, toxicity analysis and medicinal values of natural compounds.
Key technical issues of herbal medicines with reference to interaction with other medicines by Anonim Pdf
This document provides information on the critical technical issues related to interactions between herbal medicines and other medicines for health-care professionals, regulators, researchers, pharmacovigilance centres, manufacturers and consumers. The intention of this document is to provide as much concise information as possible, and to give direction and guidance on capitalizing resources to support informed decision-making and maximize the safe concurrent use of herbal medicines and other medicines. The concepts of beneficial and harmful herb-drug interaction (HDI)s are introduced, with documented examples from the published literature. Types of HDI and their mechanisms are outlined, and the relevance of in vitro, general screening and in vivo tests is included. Challenges faced in evaluating and monitoring HDIs, data collection, assessment and dissemination of information are briefly discussed. The education and training of health professionals and consumers are addressed, together with potential research strategies for further investigation of the mechanisms, incidence, monitoring and management of HDIs.
Author : World Health Organization Publisher : World Health Organization Page : 228 pages File Size : 47,5 Mb Release : 2019-05-16 Category : Business & Economics ISBN : 9789241515436
WHO Global Report on Traditional and Complementary Medicine 2019 by World Health Organization Pdf
This report is structured in five parts: national framework for traditional and complementary medicine (T&CM); product regulation; practices and practitioners; the challenges faced by countries; and finally the country profiles. Apart from the section on practices and practitioners the report is consistent with the format of the report of the first global survey in order to provide a useful comparison. The section on practices and practitioners which covers providers education and health insurance is a new section incorporated to reflect the emerging trends in T&CM and to gather new information regarding these topics at a national level. All new information received has been incorporated into individual country profiles and data graphs. The report captures the three phases of progress made by Member States; that is before and after the first WHO Traditional Medicine Strategy (1999?2005) from the first global survey to the second global survey (2005?2012) and from the second survey to the most recent timeline (2012?2018).
Organización Mundial de la Salud,World Health Organization,WHO
Author : Organización Mundial de la Salud,World Health Organization,WHO Publisher : World Health Organization Page : 81 pages File Size : 51,5 Mb Release : 2003-12-16 Category : Business & Economics ISBN : 9789241546270
WHO Guidelines on Good Agricultural and Collection Practices [GACP] for Medicinal Plants by Organización Mundial de la Salud,World Health Organization,WHO Pdf
Medicinal plant materials are supplied through collection from wild populations and cultivation. Under the overall context of quality assurance and control of herbal medicines WHO developed the Guidelines on good agricultural and collection practices (GACP) for medicinal plants providing general technical guidance on obtaining medicinal plant materials of good quality for the sustainable production of herbal products classified as medicines. These guidelines are also related to WHO's work on the protection of medicinal plants aiming promotion of sustainable use and cultivation of medicinal plants. The main objectives of these guidelines are to: (1) contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve the quality safety and efficacy of finished herbal products; (2) guide the formulation of national and/or regional GACP guidelines and GACP monographs for medicinal plants and related standard operating procedures; and (3) encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general. These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations. Good agricultural and collection practices for medicinal plants are the first step in quality assurance on which the safety and efficacy of herbal medicinal products directly depend. These practices also play an important role in protection natural resources of medicinal plants for sustainable use.
Francesco Capasso,Timothy S. Gaginella,Giuliano Grandolini,Angelo A. Izzo
Author : Francesco Capasso,Timothy S. Gaginella,Giuliano Grandolini,Angelo A. Izzo Publisher : Springer Science & Business Media Page : 424 pages File Size : 44,9 Mb Release : 2012-12-06 Category : Medical ISBN : 9783642555282
Phytotherapy by Francesco Capasso,Timothy S. Gaginella,Giuliano Grandolini,Angelo A. Izzo Pdf
This richly illustrated reference guide treats the subject of herbal medicines in an integrated fashion with reference to pharmacognosy, pharmacology and toxicology. It will help to enable internists, phytotherapists, physicians, healthcare practitioners as well as students to understand why, when and how herbal medicines can be used in the treatment of diseases. A great deal of pathology and therapeutic information is also included. Numerous tables as well as figures clarify complex mechanisms and other information. The most important medicinal plants and drugs are illustrated with exceptional color plates.