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 Botanical Leads for Drug Discovery written by Bikarma Singh and published by Springer Nature. This book was released on 2020-10-05 with total page 481 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 Botanical Drugs written by Weishi Li and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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 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 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 J M Nickell s Botanical Ready Reference written by James M. Nickell and published by Forgotten Books. This book was released on 2018-08-12 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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; Giving Their Medical Properties, and All of Their Botanical, Common, Pharmacopoeal and German Common (in German) Names Am-rmomc, Am-puwcxmc. Antl-rhbuiiatic, anfl-sconntrnc. Au'n-snmc. Au'n-snsuomc. Aun-svrmu'nc. Am-vnuouovs. 8mm. Brrun. 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.

Download or read book Potter s New Cyclopaedia of Botanical Drugs and Preparations written by R. C. Wren and published by Beekman Books Incorporated. This book was released on 1988 with total page 362 pages. Available in PDF, EPUB and Kindle. Book excerpt: Every plant with a known medicinal use is included.

Download or read book J M Nickell s Botanical Ready Reference written by James Madison Nickell and published by Andesite Press. This book was released on 2015-08-09 with total page 298 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 was reproduced from the original artifact, and remains as true to the original work as possible. Therefore, you will see the original copyright references, library stamps (as most of these works have been housed in our most important libraries around the world), and other notations in the work. 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.As a reproduction of a historical artifact, this work may contain missing or blurred pages, poor pictures, errant marks, etc. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. 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 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 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 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 Botanical Dietary Supplements written by Gail B. Mahady and published by CRC Press. This book was released on 2001-06-01 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Drug Discovery Development written by Bhushan Patwardhan and published by New India Publishing. This book was released on 2007 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: While biotechnological advances, genomics and high throughput screenings or combinatorial and asymmetric syntheses are opening new opportunities in drug discovery, the industry is facing serious innovation deficit. The total number of new molecules registered per year has dropped in contrast to expected increase. Post marketing failures of blockbuster drugs have become major concerns of industries. On the other side, globally there is a major shift to sue of traditional medicine involving complementary and alternative therapies. Ethnopharmacology and traditional medicines have contributed in past significantly in the process of natural product drug discovery. There are two clear tracks where ethnopharmacology has potential to contribute in future drug research. First, as a discovery engine to provide new targets, leads, and second, use of quality assured and standardized traditional medicines. In this scenario, it is important to understand the mechanisms of drug discovery and pharmaceutical development with a focus on herbal drugs and neutraceutical. This book provides historical perspective, future prospects and significance of ethnopharmacology in drug research. It also provides important steps in botanical drug discovery and development including bioprospecting, quality control, standardization, pharmaceutics, stability, pharmacokinetics, and bioavailability with examples from ethnopharmacology and herbal medicine. One of the important feature of this book is to give an excellent insight to Good Laboratory and Good Clinical Practices along with very useful summary steps involved in filing IND or NDA of botanical products. The book also gives Regulators' perspective of validating claims and how ethnopharmacological or traditional medicines need different approach.

Download or read book FDA Approved Animal Drug Products written by and published by . This book was released on 1998 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Marijuana and Medicine written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-10 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: The medical use of marijuana is surrounded by a cloud of social, political, and religious controversy, which obscures the facts that should be considered in the debate. This book summarizes what we know about marijuana from evidence-based medicineâ€"the harm it may do and the relief it may bring to patients. The book helps the reader understand not only what science has to say about medical marijuana but also the logic behind the scientific conclusions. Marijuana and Medicine addresses the science base and the therapeutic effects of marijuana use for medical conditions such as glaucoma and multiple sclerosis. It covers marijuana's mechanism of action, acute and chronic effects on health and behavior, potential adverse effects, efficacy of different delivery systems, analysis of the data about marijuana as a gateway drug, and the prospects for developing cannabinoid drugs. The book evaluates how well marijuana meets accepted standards for medicine and considers the conclusions of other blue-ribbon panels. Full of useful facts, this volume will be important to anyone interested in informed debate about the medical use of marijuana: advocates and opponents as well as policymakers, regulators, and health care providers.