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.

This book examines insights into the latest thinking and core concepts in areas of key methodological endeavor in Pharmacovigilance (PV), which strives to ever more effectively protect patients from harm caused by the medicines they need. Each book chapter tends to have a clear quantitative or clinical slant and an aim to provide an overview of methodological insights within a specific topic, while also providing a perspective on how the area is anticipated to develop in the future. Quantitative chapters focus more on statistical and epidemiological strategies and the thinking that underpins core developments in Pharmacovigilance, whereas clinical chapters focus on clinical methods for detecting hypotheses for and determining side effects of medicinal products as well as misdiagnosis pitfalls. Examples of areas of importance include signal detection, risk management, and risk benefit assessment. Vital and authoritative, Evidence-Based Pharmacovigilance: Clinical and Quantitative Aspects aims to provide readers with a sense of the advances that have occurred in pharmacovigilance methods and approaches, as well as inspiration and motivation to advance the field of pharmacovigilance with a strong sense that there is much more work to be done in ensuring the safe use of medications by patients.

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.

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

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.

Winner of American Botanical Council's 2005 James A. Duke Botanical Literature Award, the Essential Guide to Herbal Safety offers a balanced and objective perspective on the principles of herbal medicine safety as well as the complex challenges relating to self-prescribed or professionally prescribed herbal medications and supplements. With contributions from leading international practitioners and authorities, it contains comprehensive reviews, in monograph format, of the published safety data for 125 common herbs. You'll also find coverage of issues of quality, interactions, adverse reactions, toxicity, allergy, contact sensitivity, and idiosyncratic reactions. Provides the most current information on safety issues in herbal medicine. Presents authoritative and credible safety information from two experienced herbal practitioners. Combines theoretical chapters with 125 well-researched monographs, making it the most thorough and comprehensive text on the market for herbal safety in practice. Provides clear information using the most current evidence-based reviews, covering factors that influence herb safety, including the negative placebo effects (nocebo), various types of unpredictable effects, the basis for interactions between herbs and drugs, and quality issues. Uses an established grading system for assessing safety in pregnancy and lactation that is realistic and appropriate to herb use. Thoroughly critiques the dominant misinformation in the media and medical journals on herb safety issues. Contains 83 documented case studies on hepatoxicity and the effects in relation to kava. Kava safety is a hot topic. Includes two useful appendices detailing herbal references for pregnancy and lactation considerations.

A practice-oriented introduction to phytotherapy. Methodically classified by organic systems and fields of application, it offers a quick insight into dosage, form of application and effects of the most important herbal remedies. Only those herbal remedies that are of pharmacological and clinical efficiency have been considered. The authors are highly experienced in the field of postgraduate medical education and, with this work, present an indispensable reference book for the medical practice.

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.

This book highlights the medical importance of and increasing global interest in herbal medicines, herbal health products, herbal pharmaceuticals, nutraceuticals, food supplements, herbal cosmetics, etc. It also addresses various issues that are hampering the advancement of Indian herbal medicine around the globe; these include quality concerns and quality control, pharmacovigilance, scientific investigation and validation, IPR and biopiracy, and the challenge that various indigenous systems of medicine are at risk of being lost. The book also explores the role of traditional medicine in providing new functional leads and modern approaches that can offer elegant strategies for facilitating the drug discovery process. The book also provides in-depth information on various traditional medicinal systems in India and discusses their medical importance. India has a very long history of safely using many herbal drugs. Folk medicine is also a key source of medical knowledge and plays a vital role in maintaining health in rural and remote areas. Despite its importance, this form of medicine largely remains under-investigated. Out of all the traditional medicinal systems used worldwide, Indian traditional medicine holds a unique position, as it has continued to deliver healthcare throughout the Asian subcontinent since ancient times. In addition, traditional medicine has been used to derive advanced techniques and investigate many modern drugs. Given the scope of its coverage, the book offers a valuable resource for scientists and researchers exploring traditional and herbal medicine, as well as graduate students in courses on traditional medicine, herbal medicine and pharmacy.