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.
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.
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.
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
This is the full colour coffee table edition of The Honest Drug Book, with dimensions of 8.5" x 11" (21.59 x 27.94 cm). Produced to do justice to the hundreds of photographs, it also allows a more leisurely perusal of the contents. The Honest Drug Book presents the hidden truth about a topic which touches the lives of almost everyone. It cuts through the blustering rhetoric of the war on drugs, and documents the facts about the subject in general, and about the individual drugs specifically. This is a journey through 140 psychoactives, both chemical and botanical, each of which was personally tested and used by the author. For every drug, it lists the fundamental and sometimes life-critical information, including the anticipated onset, the common threshold doses, and the expected period of efficacy. It also describes the subjective experience: what the drug was actually like at each stage of the duration. These 'trip reports' are vital, as they help to identify pitfalls and specific risks for each substance. Often, this is achieved in a humorous and anecdotal manner, which is occasionally accentuated by the fact that the author had to travel the world to undertake the experiments lawfully. In addition to these often rich and lengthy reports, the book is crammed with data and general information, inclusive of legal briefings, relative harm tables, addiction and overdose advice, detailed reference material, and even a drug dictionary. Of critical importance is the first section, as it introduces the basics of harm reduction, in the form of a 10 step procedure to help mitigate risk. The same section explains core safety issues, such as how to test and identify a drug, and how to properly establish a dose. The book itself is lavishly illustrated with hundreds of photographs, including of the drugs themselves. The images in the botanical section also encompass some of the indigenous settings encountered on the journey. The full gamut of psychoactive chemicals and botanicals is covered. The well known include: LSD, heroin, cannabis, mephedrone, kratom, cocaine, 2C-B, DMT, yopo, methamphetamine, salvia divinorum, ketamine, ayahuasca and MDMA. The lesser known include: betel nut, 4-ho-met, changa, TPA, 4F-MPH, ephenidine, ololiuqui, cebil seeds, mapacho, MNA, celastrus paniculatus, yohimbe, and MEAI. The scope also extends beyond the most common categories of hallucinogens, stimulants, depressants, cannabinoids and opioids. Included, for example, are nootropics (smart drugs) and oneirogenics (lucid and vivid dream herbs). Another dimension, which is covered largely in the final section, is that of politics and the war on drugs. This is confronted head-on, with a statement of intent which is crystal clear: "People are dying because of ignorance. They are dying because unremitting propaganda is denying them essential safety information. They are dying because legislators and the media are censoring the science, and are ruthlessly pushing an ideological agenda instead. They are dying because the first casualty of war is truth, and the war on drugs is no different. This book is a step to counter this harrowing and destructive situation." Emphasised and underpinned throughout is personal safety and risk mitigation. This is the first and last message, and guides the entire narrative. This is a book that won't only fascinate and inform: it will save lives.
This volume provides reviews and details of the quality, safety and efficacy for some of the top-selling botanicals worldwide, including black cohosh, chamomile, comfrey, echinacea, garlic, ginkgo, ginseng, kava, milk thistle, St John's wort and valerian. The work was written based on a systematic review of the scientific literature from 1975-2000.;Each review includes a brief introduction, a section on quality including a definition of the crude drug, geographical distribution, and a listing of the major chemical constituents. The safety and efficacy sections summarize the medical uses, pharmacology, contraindications, warnings, precautions, adverse reactions, dose and dosage forms. The safety and efficacy sections were written for a busy health-care professional, and should enable one to ascertain which clinical uses are supported by clinical data, without having to read through all the pharmacology. Each chapter is fully referenced, enabling the reader to access further information when necessary.
Plant Drug Analysis has proven an invaluable and unique aid for all those involved with drug production and analysis, including pharmacists, chemical and pharmaceutical researchers and technicians, drug importers and exporters, governmental chemical control agencies, and health authorities. From the reviews of the German Edition: "The reviewer would like to recommend this excellent book to all chromatographers, as he considers it highly relevant to the solution of numerous problems. Its main purpose is the demonstration of thin-layer chromatograms of the usual commercial drugs as an aid in testing for identity and purity. ... 165 colour plates, each showing 6 chromatograms and all of superb quality photographs ..." (Journal of Chromatography)
