Download or read book Botanical Drug Products written by Jayant N. Lokhande and published by CRC Press. This book was released on 2018-11-21 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Botanical Medicines written by Dennis J. McKenna and published by Psychology Press. This book was released on 2002 with total page 1172 pages. Available in PDF, EPUB and Kindle. Book excerpt: Donated by The Australian Commercial Herb Growers Association.

Download or read book Guidance for industry written by and published by . This book was released on 2004 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Science and Regulations of Naturally Derived Complex Drugs written by Ram Sasisekharan and published by Springer. This book was released on 2019-04-23 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific topics discussed include: raw materials sourcing; manufacturing controls; characterization; identification of critical product quality components and attributes; identification of impurities, particularly as they bear on toxicity and immunogenicity; clinical trial study design considerations, and the regulatory science applications to development of such complex mixtures. Complex mixtures are challenging to characterize and analyze using standard methods. Further challenges extend throughout the product development cycle from raw material control to clinical study design. The regulatory landscape is rapidly changing as new types of complex mixtures are introduced into clinical trials and to the market (e.g., traditional Chinese medicines and medical marijuana products), while older products are facing generic competition for the first time (e.g., enoxaparin). The future outlook for complex generic drug products, as opposed to the more commonly developed targeted single agent drug products is not clear. The risks pertaining to lack of a full understanding of raw material control, process and controls in manufacture, as well as characterization of a complex mixture were seen vividly during the heparin crisis of 2008. As such powerful lessons have been learned about the regulatory science specific to complex products. The Science and Regulations of Naturally Derived Complex Drugs addresses the interests among industry, academics, and government on the issues surrounding the future development of mixtures for medicinal use.

Download or read book The Crude Botanical Drug Industry written by United States Tariff Commission and published by . This book was released on 1920 with total page 74 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Botanical Leads for Drug Discovery written by Bikarma Singh and published by Springer. This book was released on 2021-10-07 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book American Herbal Products Association s Botanical Safety Handbook Second Edition written by Zoë Gardner and published by CRC Press. This book was released on 2013-03-15 with total page 1073 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Potter s New Cyclopaedia of Botanical Drugs and Preparations written by Richard Cranfield Wren and published by C W Daniel Company. This book was released on 1975 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over 600 medicinal plants described in order that "reliable information should be available to enable dealers in these remedies to judge of their origin and quality." Intended for use of professionals and lay public. Alphabetical arrangement by common plant names. Entries include common and scientific names, synonyms, habitat, description, medicinal use, and domestic use. Miscellaneous appendixes. Drawings. Indexes of botanical names, common names, and synonyms.

Download or read book Herbal Medicine written by Iris F. F. Benzie and published by CRC Press. This book was released on 2011-03-28 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Botanical Materia Medica and Pharmacology written by Samuel Herbert Aurand and published by . This book was released on 1899 with total page 446 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Honest Drug Book Deluxe Edition written by Dominic Milton Trott and published by . This book was released on 2017-10-03 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Handbook of Preformulation written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2006-09-18 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of

Download or read book J M Nickell s Botanical Ready Reference written by James Madison Nickell and published by Franklin Classics. This book was released on 2018-10-11 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work has been selected by scholars as being culturally important and is part of the knowledge base of civilization as we know it. This work is in the public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. To ensure a quality reading experience, this work has been proofread and republished using a format that seamlessly blends the original graphical elements with text in an easy-to-read typeface. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.

Download or read book Potter s New Cyclopaedia of Botanical Drugs and Preparations written by Richard Cranfield Wren and published by C.W. Daniel Company, Limited. This book was released on 1988 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: Every plant with a known medicinal use is included.

Download or read book POTTER S New Cyclopaedia of Botanical Drugs and Preparations written by and published by . This book was released on 1975 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Toxicokinetics written by and published by . This book was released on 1995 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Botanical Medicines written by Dennis J Mckenna and published by Routledge. This book was released on 2012-11-12 with total page 1164 pages. Available in PDF, EPUB and Kindle. Book excerpt: Answer patients’questions about botanical supplements quickly and easily!This informative book is a compendium of detailed scientific research on 34 of the most popular dietary supplements used in North America and Europe. Its coverage of pharmacological studies on the main medicinal plants used in clinical practice and sold in pharmacies in the Western world is more extensive than any other publication of monographic reviews available. The way Botanical Medicines: The Desk Reference for Major Herbal Supplements, Second Edition. is organized (standardized topic formats are used in each monograph) makes it easy for you to locate relevant information quickly and to compare corresponding sections between different entries. This book is an invaluable tool for pharmacists, physicians, and other health care professionals who need detailed, scientifically accurate information on appropriate use, safety, dosages, and similar issues related to botanical dietary supplements.Each entry in Botanical Medicines: The Desk Reference for Major Herbal Supplements, Second Edition. covers botanical data (classification and nomenclature, common names, geographic occurrence, and botanical characteristics), plus: history and traditional uses chemistry therapeutic applications pre-clinical studies clinical studies recommended dosages safety profiles (including toxicology) side effects and contraindications drug interactions and special precautions safety recommendations during pregnancy and lactation This extensively referenced volume includes appendixes with information on the major provisions of DSHEA (the Dietary Supplement Health and Education Act of 1994) and on the criteria and procedures for assessing the quality of botanical products.