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Botanicals, which have been part of human food and medicine for thousands of years, are perceived as being safer than synthetic pharmaceuticals. The global botanical drug market was expected to reach $26.6 billion by 2017. In terms of FDA regulations, botanical drugs are no different from non-botanical products, having to meet the safety and effectiveness standards of a new drug in accordance. This book comprises a complete start-to-end process from drug-idea conception, to drug development process. Key Features: Provides a complete compendium for botanical drug products Describes what BDP is and how it differs from Pharma, Biopharma, and Nutraceuticals Compiles all critical regulatory steps in a variety of countries Discusses clinical trial management for BDP development and how it differs from conventional chemical-based drugs and biopharmaceutics
Active botanical ingredients are a prime requirement for herbal formulations and discovering a drug is all about integration of science disciplines. In recent decades there has been a growing interest in treating wounds and diseases using traditional remedies based on local herbs, combined with chemical advances. Although this has led to the development of new bioactive ingredients from plants, there has been little success in terms of clinical trials and post-marketing studies to comply with FDA guidelines. Plants have been used as a source of medicine throughout history and continue to serve as the basis for many pharmaceuticals used today. However, despite the modern pharmaceutical industry being founded on botanical medicine, synthetic approaches to drug discovery have now become standard. Science-driven translational discovery and botanical development has created a new reality, leading to enormous changes in strategies, technologies and the disciplines involved, which have been embraced by the pharmaceutical and biotech industries. This book gathers scientific expertise and traditional knowledge to promote the discovery and development of new formulations and drugs based on active ingredients and to provide guidance on taking these to clinical trials. It discusses major topics, such as how the phytochemical composition of many plants has changed over time due to factors like cultivation, which can have both positive and negative effects on the levels of bioactive compounds. It also explores the importance of plants as a valuable source of therapeutic compounds as a result of their vast biosynthetic capacity, and classifies them according to their intended use, safety and regulatory status. Further, the book offers insights into the regulatory aspects of botanical products, which is an important issue when considering standardization and quality assessment, and also examines the commercial aspects of plant-derived medications and their proven role in the treatment of chronic diseases such as heart disease, high blood pressure, pain, asthma, and other associated conditions. Given its scope, this book is a valuable tool for botanists, natural product chemists, pharmacologists and microbiologists involved in the study of phytochemicals for drug discovery.
Herbal medicines have a long history of practice and hold great promise for treating human diseases. However, the traditional formula suffers many limitations that impede the fulfillment of their potential. There is, thus, a great need to transform traditional herbal medicines into Food and Drug Administration (FDA) approved modern botanical drugs. The current regulation of herbal medicines in the United States fails to provide sufficient incentives for the American drug industry to develop botanical drugs from herbal medicines. To provide such an incentive, this paper argues that the FDA should take into account the unique history and characteristics of herbal medicines, and adopt a special approval guideline for botanical drugs developed from these medicines. Such a guideline will facilitate the mainstreaming of herbal medicines in the United States, and at the same time alleviate the production crisis facing the American pharmaceutical industry. The paper then evaluates the recent FDA's Draft Guidance for Botanical Drug Products for its incentive effects on the industry and makes specific recommendations for the final version of the Guidance.
Access to accurate, evidence-based, and clinically relevant information is essential to anyone who uses or recommends herbal products. With input from some of the most respected experts in herbal and integrative medicine, this completely revised edition of the American Herbal Products Association’s Botanical Safety Handbook reviews both traditional knowledge and contemporary research on herbs to provide an authoritative resource on botanical safety. The book covers more than 500 species of herbs and provides a holistic understanding of safety through data compiled from clinical trials, pharmacological and toxicological studies, medical case reports, and historical texts. For each species, a brief safety summary is provided for quick reference, along with a detailed review of the literature. Easily understood classification systems are used to indicate the safety of each listed species and the potential for the species to interact with drugs. Enhancements to the Second Edition include: Classification of each herb with both a safety rating and a drug interaction rating More references listed for each individual herb, vetted for accuracy Specific information on adverse events reported in clinical trials or case reports Safety-related pharmacology and pharmacokinetics of each herb, including drug interactions Additional information on the use of herbs by pregnant or lactating women Toxicological studies and data on toxic compounds Representing the core of the botanical trade and comprising the finest growers, processors, manufacturers, and marketers of herbal products, the mission of the AHPA is to promote the responsible commerce of herbal products. The American Herbal Products Association Botanical Safety Handbook, Second Edition ensures that this vision is attained. The book will be a valuable reference for product manufacturers, healthcare practitioners, regulatory agencies, researchers, and consumers of herbal products.
The global popularity of herbal supplements and the promise they hold in treating various disease states has caused an unprecedented interest in understanding the molecular basis of the biological activity of traditional remedies. Herbal Medicine: Biomolecular and Clinical Aspects focuses on presenting current scientific evidence of biomolecular ef
Excerpt from J. M. Nickell's Botanical Ready Reference: Especially Designed for Druggists and Physicians; Containing All of the Botanical Drugs Known Up to the Present Time A medicine which claims the property of causing abortion. Substances which possess a sourish taste. Hot, biting. Irritating. Relieving or arresting glandular pain. Preventing the bad effects of inwardly. Producing a salutary change Without perceptible evacuation. Relievmg pain, or causing it to cease. A remedy which expels worms. Gently laxative, without purging. Medicine believed capable of exciting the venereal appetite. Odoriferous, stimulant, spicy. Having the property of constrmging the organic texture. A substance capable of blunting the venereal appetite. Opaplosed to biliousness acting on the l e. A remedy for vomiting. Opposed to epilepsy A remedy for hysteria. Preventing the formation of calculi in the urinary organs. Arresting morbid periodical movemen Opposed to in ammation. Relieving or curing rr eumatism. Curing or preventing scurvy. Opposed to putrefaction. Relieving or preventing spasm. Opposed to or curing venereal diseases Used against bites of insects, snakes, etc Healing or $00thing to in amed parts. Havinga tonic effect. Expelung wind from the bowels. [els. Increasing evacuations from the bow The property of burning or disorgan izin g animal substance. Relating to diseases of the head. Increasmg the ow of bile. Improving the savor of food, as salt, pepper, salad, etc. A warm stomachic; exciting the heart. Used for improving the complexion. Causing irritation in one part to relieve pain in another part. Soothing, mucilaginous, ammation. 'removing obstructions; aperient in a l general sense. Purifying the blood. [ulceis. Drying the moisture of wounds and Cleansmg to wounds, boils or ulcers. Producing insensible perspiration. Dispelling or resolving tumors. [urine. Increasing the secretion and ow of Removing super uous hair. Detergent. Powerfully cathartic; Producing or causing vomiting. Promoting menstruation. Softening to in amed parts; soothing. Eatable as food. A substance which, applied to a living part, causes an eschar. Relating to eruption or skin diseases. About the Publisher Forgotten Books publishes hundreds of thousands of rare and classic books. Find more at www.forgottenbooks.com This book is a reproduction of an important historical work. Forgotten Books uses state-of-the-art technology to digitally reconstruct the work, preserving the original format whilst repairing imperfections present in the aged copy. In rare cases, an imperfection in the original, such as a blemish or missing page, may be replicated in our edition. We do, however, repair the vast majority of imperfections successfully; any imperfections that remain are intentionally left to preserve the state of such historical works."