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
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Author : World Health Organization
language : en
Publisher:
Release Date : 2004-01-01
Who Guidelines On Safety Monitoring Of Herbal Medicines In Pharmacovigilance Systems written by World Health Organization and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-01-01 with Drug monitoring categories.
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.
Pharmacovigilance For Herbal And Traditional Medicines
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Author : Joanne Barnes
language : en
Publisher: Springer Nature
Release Date : 2022-08-11
Pharmacovigilance For Herbal And Traditional Medicines written by Joanne Barnes and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-08-11 with Science categories.
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.
Evidence Based Validation Of Herbal Medicine
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Author : Pulok K. Mukherjee
language : en
Publisher: Elsevier
Release Date : 2022-07-12
Evidence Based Validation Of Herbal Medicine written by Pulok K. Mukherjee and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-07-12 with Business & Economics categories.
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
Current Challenges In Pharmacovigilance
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Author : World Health Organization
language : en
Publisher:
Release Date : 2001-01-01
Current Challenges In Pharmacovigilance written by World Health Organization and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-01-01 with Medical categories.
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 Essentials
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Author : Mukesh Nandave
language : en
Publisher: Springer Nature
Release Date :
Pharmacovigilance Essentials written by Mukesh Nandave and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.
Pharmacovigilance Essentials
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Author : Mukesh Nandave
language : en
Publisher: Springer
Release Date : 2024-01-20
Pharmacovigilance Essentials written by Mukesh Nandave and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-01-20 with Medical categories.
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.
Drug Safety In Developing Countries
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Author : Yaser Mohammed Al-Worafi
language : en
Publisher: Academic Press
Release Date : 2020-06-03
Drug Safety In Developing Countries written by Yaser Mohammed Al-Worafi and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-06-03 with Business & Economics categories.
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
Stephens Detection Of New Adverse Drug Reactions
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Author : John Talbot
language : en
Publisher: John Wiley & Sons
Release Date : 2004-11-19
Stephens Detection Of New Adverse Drug Reactions written by John Talbot and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-11-19 with Medical categories.
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
Quality Control And Standardization Of Herbals
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Author : Dr. Dillip Kumar Jena
language : en
Publisher: Thakur Publication Private Limited
Release Date : 2021-04-14
Quality Control And Standardization Of Herbals written by Dr. Dillip Kumar Jena and has been published by Thakur Publication Private Limited this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-04-14 with Education categories.
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.
Poisonous Plants And Phytochemicals In Drug Discovery
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Author : Andrew G. Mtewa
language : en
Publisher: John Wiley & Sons
Release Date : 2020-12-22
Poisonous Plants And Phytochemicals In Drug Discovery written by Andrew G. Mtewa and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-12-22 with Science categories.
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