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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.
A collection of test procedures for assessing the identity, purity, and content of medicinal plant materials, including determination of pesticide residues, arsenic and heavy metals. Intended to assist national laboratories engaged in drug quality control, the manual responds to the growing use of medicinal plants, the special quality problems they pose, and the corresponding need for international guidance on reliable methods for quality control. Recommended procedures - whether involving visual inspection or the use of thin-layer chromatography for the qualitative determination of impurities - should also prove useful to the pharmaceutical industry and pharmacists working with these materials.
This is the second volume in a series of monographs which are intended to promote information exchange and international harmonised standards for the quality control and use of herbal medicines. It contains scientific information on 30 selected plants, and each entry includes a pharmacopoeial summary for quality assurance purposes, information on its clinical application and sections on contraindications, pharmacology, safety issues, and dosage forms. It provides two cumulative indexes with entries in alphabetical order by plant name and according to the plant material of interest.
This volume describes the methods used in the surveillance of drinking water quality in the light of the special problems of small-community supplies, particularly in developing countries, and outlines the strategies necessary to ensure that surveillance is effective.
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.
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
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.
The Expert Committee on Specifications for Pharmaceutical Preparations works towards standards and guidelines for medicines' quality assurance. The forty-second meeting adopted 11 new monographs for inclusion in The International Pharmacopoeia (Ph. Int.) and seven related new International Chemical Reference Standards (ICRS). The specifications currently developed are internationally applicable test methodologies for antimalarial, antituberculosis, antiretroviral and specifically also medicines for children. The main principles for selection of INNs for biologicals were endorsed. In order to serve the WHO-managed Prequalification Program, two new procedures were adopted, namely on prequalification of intrauterine devices (IUDs) and of male latex condoms, together with a new guidance on the assessment of active pharmaceutical ingredients for use in medicines.--Publisher's description.