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Author: Jayant N. Lokhande
Publisher: CRC Press
ISBN: 1315352281
Category : Health & Fitness
Languages : en
Pages : 199
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Book Description
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.
Author: Jayant N. Lokhande
Publisher: CRC Press
ISBN: 1315352281
Category : Health & Fitness
Languages : en
Pages : 199
Get Book Here
Book Description
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.
Author: Dennis J. McKenna
Publisher: Psychology Press
ISBN: 9780789012661
Category : Gardening
Languages : en
Pages : 1172
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Book Description
Donated by The Australian Commercial Herb Growers Association.
Author: Bikarma Singh
Publisher: Springer Nature
ISBN: 9811559171
Category : Medical
Languages : en
Pages : 481
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Book Description
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.
Author: Zoë Gardner
Publisher: CRC Press
ISBN: 1466516941
Category : Health & Fitness
Languages : en
Pages : 1073
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Book Description
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.
Author: Jayant N. Lokhande
Publisher: CRC Press
ISBN: 1498740065
Category : Health & Fitness
Languages : en
Pages : 295
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Book Description
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
Author: Valdir Cechinel-Filho
Publisher: John Wiley & Sons
ISBN: 1118259920
Category : Science
Languages : en
Pages : 600
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Book Description
An in-depth exploration of the applications of plant bioactive metabolites in drug research and development Highlighting the complexity and applications of plant bioactive metabolites in organic and medicinal chemistry, Plant Bioactives and Drug Discovery: Principles, Practice, and Perspectives provides an in-depth overview of the ways in which plants can inform drug research and development. An edited volume featuring multidisciplinary international contributions from acclaimed scientists researching bioactive natural products, the book provides an incisive overview of one of the most important topics in pharmaceutical studies today. With coverage of strategic methods of natural compound isolation, structural manipulation, natural products in clinical trials, quality control, and more, and featuring case studies on medicinal plants, the book serves as a definitive guide to the field of plant biodiversity as it relates to medicine. In addition, chapters on using natural products as drugs that target specific disease areas, including neurological disorders, inflammation, infectious diseases, and cancer, illustrate the myriad possibilities for therapeutic applications. Wide ranging and comprehensive, Plant Bioactives and Drug Discovery also includes important information on marketing, regulations, intellectual property rights, and academic-industry collaboration as they relate to plant-based drug research, making it an essential resource for advanced students and academic and industry professionals working in biochemical, pharmaceutical, and related fields.
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 24
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Book Description
Author: Gail B. Mahady
Publisher: CRC Press
ISBN: 9789026518553
Category : Science
Languages : en
Pages : 288
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Book Description
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.
Author:
Publisher:
ISBN:
Category : Veterinary drugs
Languages : en
Pages : 144
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Book Description
Author: Ali S. Faqi
Publisher: Elsevier
ISBN: 0323984622
Category : Medical
Languages : en
Pages : 1074
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Book Description
A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. - Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy - Includes the latest international guidelines for nonclinical toxicology in both small and large molecules - Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology
