Download or read book WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems written by World Health Organization and published by . This book was released on 2004-01-01 with total page 18 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Current Challenges in Pharmacovigilance written by World Health Organization and published by . This book was released on 2001-01-01 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Evidence Based Validation of Herbal Medicine written by Pulok K. Mukherjee and published by Elsevier. This book was released on 2022-07-12 with total page 858 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Drug Safety in Developing Countries written by Yaser Mohammed Al-Worafi and published by Academic Press. This book was released on 2020-06-03 with total page 656 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Pharmacovigilance Essentials written by Mukesh Nandave and published by Springer. This book was released on 2024-01-20 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book explores the field of pharmacovigilance, its historical context, along with its critical role in ensuring the safety of medications across the world. From its foundational principles to cutting-edge advancements and future challenges, this book provides a thorough understanding of the field's intricacies. The book begins by establishing the fundamentals of pharmacovigilance, emphasizing its significance in monitoring, detecting, assessing, and preventing adverse drug reactions (ADRs) that occur during the use of medications. Delving into the history of pharmacovigilance and regulatory actions, the book traces the evolution of the field, highlighting significant milestones and the establishment of regulatory frameworks that govern medication safety. It explores the pivotal role of regulatory authorities in developing guidelines, regulations, and policies to safeguard public health. A significant aspect covered in the book is the processing of ADRs, providing insights into the steps involved in handling and evaluating ADR reports. The book also addresses specialized areas within pharmacovigilance, including vaccine safety surveillance, herbovigilance (monitoring the safety of herbal medicines), materiovigilance (monitoring the safety of medical devices), and hemovigilance (ensuring the safety of blood products). Additionally, the book explores the role of pharmacogenetics in pharmacovigilance, highlighting how genetic factors influence individual responses to medications and how this knowledge can be integrated into safety monitoring and risk assessment. This book also covers databases used in pharmacovigilance across the globe, aggregate reporting and pharmacovigilance systems in EU and non-EU countries, and the role of artificial intelligence. Finally, it emphasizes the need for continuous improvement, vigilance, and proactive measures to adapt to the changing healthcare landscape and address emerging safety concerns. The book serves as a comprehensive guide for healthcare professionals, researchers, regulators, and policymakers involved in pharmacovigilance.

Download or read book Quality Control and Standardization Of Herbals written by Dr. Dillip Kumar Jena and published by Thakur Publication Private Limited. This book was released on 2021-04-14 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Pharmacovigilance for Herbal and Traditional Medicines written by Joanne Barnes and published by Springer Nature. This book was released on 2022-08-11 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Evidence Based Validation of Traditional Medicines written by Subhash C. Mandal and published by Springer Nature. This book was released on 2021-01-18 with total page 1135 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book WHO benchmarks for the practice of Unani medicine written by and published by World Health Organization. This book was released on 2022-02-11 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt: The WHO benchmarks for the practice of Unani medicine defines the minimum requirement/criteria for establishing practice in Unani medicine in WHO Member States, by providing minimum reference standards for safety and quality of Unani medicine practice. This document provides WHO Member States with the general and minimum technical requirements for quality assurance and regulation of Unani medicine practice. It is aligned with the objectives of the WHO Traditional Medicine Strategy 2014-23, and reflects the consensus reached through established WHO processes from the community of practitioners in Unani medicine, health service providers, academics, health system managers and regulators. It provides information and describes levels of practice in Unani medicine, presents the different categories of Unani health service providers, describes the requirements for infrastructure and facilities, as well as relevant requirements and considerations in the practice of Unani health interventions, of the health products and medical devices used in Unani medicine practice, emphasizing the key elements for the safe practice of Unani medicine. It also presents the requirements and relevant considerations of regulatory, legal and ethical aspects of Unani medicine practice, and suggests the process for management of related health data.

Download or read book Poisonous Plants and Phytochemicals in Drug Discovery written by Andrew G. Mtewa and published by John Wiley & Sons. This book was released on 2020-12-22 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Key technical issues of herbal medicines with reference to interaction with other medicines written by and published by World Health Organization. This book was released on 2021-05-19 with total page 85 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book WHO Global Benchmarking Tool GBT for evaluation of national regulatory systems of medical products revision VI written by and published by World Health Organization. This book was released on 2021-05-10 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book WHO Global Report on Traditional and Complementary Medicine 2019 written by World Health Organization and published by World Health Organization. This book was released on 2019-05-16 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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).

Download or read book Cobert s Manual Of Drug Safety And Pharmacovigilance Third Edition written by Cobert Barton and published by World Scientific. This book was released on 2019-04-10 with total page 524 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies — both in the United States and around the world — and provides critical information about what to do when confronted with a drug safety problem.

Download or read book Stockley s Herbal Medicines Interactions written by Elizabeth M. Williamson and published by . This book was released on 2009 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a professional level major reference work containing information, in A-Z format, on herb-drug, herb-supplement, herb -food and herb-laboratory test interactions; all of which is data referenced. Commercial herbal medicinal products are increasingly consumed on a regular basis by people in the developed world. Often such products are taken concurrently with conventional medicines, frequently without the knowledge of health care professionals. As more evidence has become available, there has been an increasing awareness of the potential and actual problems of interactions, often dangerous, between conventional medicines and herbal medicines. This proposed new major reference brings together available data on approximately 200 of the most commonly used herbal medicines in highly structured, rigorously scientific monographs. Although our texts on herbal medicines and drug interactions include the major well-known interactions, this text is able to treat the subject in considerably more detail.

Download or read book Fingerprinting Analysis and Quality Control Methods of Herbal Medicines written by Ravindra Kumar Pandey and published by CRC Press. This book was released on 2018-07-03 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Integrating East Asian Medicine into Contemporary Healthcare E Book written by Volker Scheid and published by Elsevier Health Sciences. This book was released on 2011-10-24 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: Traditional East Asian healthcare systems have moved rapidly from the fringes of healthcare systems in the West towards the centre over the past 50 years. This change of status for traditional medicines presents their practitioners with both opportunities and challenges as the focus shifts from one of opposition towards one of integration into biomedically dominated healthcare systems. Integrating East Asian Medicine into Contemporary Healthcare examines the opportunities and challenges of integrating East Asian medicine into Western healthcare systems from an interdisciplinary perspective. Volker Scheid and Hugh MacPherson bring together contributions from acknowledged experts from a number of different disciplines - including clinical researchers, Chinese Medicine practitioners, historians, medical anthropologists, experts in the social studies of science, technology and medicine - to examine and debate the impact of the evidence-based medicine movement on the ongoing modernization of East Asian medicines. The book considers the following questions: •What are the values, goals and ethics implicit within traditional East Asian medical practices? • What claims to effectiveness and safety are made by East Asian medical practices? •What is at stake in subjecting these medical practices to biomedical models of evaluation? • What constitutes best practice? How is it to be defined and measured? • What are the ideologies and politics behind the process of integration of East Asian medical practices into modern health care systems? • What can we learn from a variety of models of integration into contemporary healthcare?