ORGANIC CHEMISTRY OF DRUG DEGRADATION DRUG DISCOVERY

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Organic Chemistry Of Drug Degradation

Author : Min Li
ISBN : 9781782625636
Genre : Medical
File Size : 30.48 MB
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The vast majority of drugs are organic molecular entities. A clear understanding of the organic chemistry of drug degradation is essential to maintaining the stability, efficacy, and safety of a drug product throughout its shelf-life. During analytical method development, stability testing, and pharmaceutical manufacturing troubleshooting activities, one of the frequently occurring and usually challenging events would be the identification of drug degradants and understanding of drug degradation mechanisms and pathways. This book is written by a veteran of the pharmaceutical industry who has first-hand experience in drug design and development, drug degradation mechanism studies, analytical development, and manufacturing process troubleshooting and improvement. The author discusses various degradation pathways with an emphasis on the mechanisms of the underlying organic chemistry, which should aid greatly in the efforts of degradant identification, formulation development, analytical development, and manufacturing process improvement. Organic reactions that are significant in drug degradation will first be reviewed and then illustrated by examples of drug degradation reported in the literature. The author brings the book to a close with a final chapter dedicated to the strategy for rapid elucidation of drug degradants with regard to the current regulatory requirements and guidelines. One chapter that should be given special attention is Chapter 3, Oxidative Degradation. Oxidative degradation is one of the most common degradation pathways but perhaps the most complex one. This chapter employs more than sixty drug degradation case studies with in-depth discussion in regard to their unique degradation pathways. With the increasing regulatory requirements on the quality and safety of pharmaceutical products, in particular with regard to drug impurities and degradants, the book will be an invaluable resource for pharmaceutical and analytical scientists who engage in formulation development, analytical development, stability studies, degradant identification, and support of manufacturing process improvement. In addition, it will also be helpful to scientists engaged in drug discovery and development as well as in drug metabolism studies.
Category: Medical

Kinase Drug Discovery

Author : Richard A. Ward
ISBN : 9781788010832
Genre :
File Size : 75.86 MB
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Kinase inhibition remains an area of significant interest, and growing importance, across academia and the pharmaceutical industry. There are now many marketed drugs that target kinases and a significant number of compounds are currently in various stages of clinical development. This book is a forward-looking analysis of a number of key areas for kinase inhibition in the coming years.
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Green Chemistry Strategies For Drug Discovery

Author : Emily A. Peterson
ISBN : 9781782622659
Genre : Medical
File Size : 46.42 MB
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The incorporation of Green Chemistry is a relatively new phenomenon in the drug discovery discipline, since the scale that chemists operate on in drug discovery is smaller than those of process and manufacturing chemistry. The necessary metrics are more difficult to obtain in drug discovery due to the diversity of reactions conducted. However, pharmaceutical companies are realizing that incorporation of green chemistry techniques at earlier stages of drug development can speed the development of a drug candidate. Written by experts who have pioneered green chemistry efforts within their own institutions, this book provides a practical guide for both academic and industrial labs wanting to know where to start with introducing greener approaches for greatest return on investment. The Editors have taken a comprehensive approach to the topic, covering the entire drug discovery process from molecule conception, through synthesis, formulation and toxicology with specific examples and case studies where green chemistry strategies have been implemented. Emerging techniques for performing greener drug discovery chemistry are addressed as well as cutting-edge topics like biologics discovery and continuous processing. Moreover, important surrounding issues such as intellectual property are included. This book serves as a practical guide for both academic and industrial chemists who work across the breadth of the drug discovery discipline. Ultimately, readers will learn how to incorporate green chemistry strategies into their everyday workflow without slowing down their science.
Category: Medical

Pharmaceutical Stress Testing

Author : Steven W. Baertschi
ISBN : 9781439801802
Genre : Medical
File Size : 82.73 MB
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The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability into the physical aspects of stress testing, and incorporates the concept of Quality by Design into the stress testing construct / framework. It has been revised and expanded to include chapters on large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years. Key features include: A renowned Editorial team and contributions from all major drug companies, reflecting a wealth of experience. 10 new chapters, including Stress Testing and its relationship to the assessment of potential genotoxic degradants, combination drug therapies, proteins, oligonucleotides, physical changes and alternative dosage forms such as liposomal formulations Updated methodologies for predicting drug stability and degradation pathways Best practice models to follow An expanded Frequently Asked Questions section This is an essential reference book for Pharmaceutical Scientists and those working in Quality Assurance and Drug Development (analytical sciences, formulations, chemical process, project management).
Category: Medical

Anti Angiogenesis Drug Discovery And Development

Author : Atta-ur- Rahman
ISBN : 9781608051625
Genre : Medical
File Size : 42.23 MB
Format : PDF
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The inhibition of angiogenesis is an effective mechanism of slowing down tumor growth and malignancies. the process of induction or pro-angiogenesis is highly desirable for the treatment of cardiovascular diseases, wound healing disorders, etc. Efforts to understand the molecular basis, both for inhibition and induction, have yielded fascinating results. Anti-angiogenesis Drug Discovery and Development provides an excellent compilation of well-written reviews on various aspects of the anti-angiogenesis process. These reviews have been contributed by leading practitioners in drug discovery science and highlight the major developments in this exciting field in the last two decades. the feast of these reader-friendly reviews on topics of great scientific importance - many of which are considered significant medical breakthroughs, makes this book excellent reading both for the novice as well as for expert medicinal chemists and clinicians.
Category: Medical

Natural Product Chemistry For Drug Discovery

Author : Antony D. Buss
ISBN : 9780854041930
Genre : Medical
File Size : 60.64 MB
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This up-to-date summary of natural product chemistry in drug discovery will appeal to scientists, professionals, postgraduates and industrial chemists.
Category: Medical

Drug Discovery From Nature

Author : S. Grabley
ISBN : 3540648445
Genre : Medical
File Size : 50.45 MB
Format : PDF
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This book is unique in covering the present status and future potential of natural products in drug discovery. It provides readers with recent information regarding the impact on drug discovery, development and strategies, technical and automation aspects, and methods based on biochemistry as well as molecular biology, highlighting compounds from natural sources. Special emphasis is placed on the various strategies to gain access to natural compounds and combinatorial approaches by making use of both synthetic and biological methods.
Category: Medical

Handbook Of Modern Pharmaceutical Analysis

Author : Satinder Ahuja
ISBN : 0120455552
Genre : Medical
File Size : 74.25 MB
Format : PDF, ePub
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This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories. No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.
Category: Medical

Photostability Of Drugs And Drug Formulations Second Edition

Author : Hanne Hjorth Tonnesen
ISBN : 1420023594
Genre : Medical
File Size : 26.51 MB
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Providing the guidance needed for formulation, handling, and quality control of photolabile drugs, Photostability of Drugs and Drug Formulations, Second Edition explores the significance of new information on drug photoreactivity in a pharmaceutical context. Completely revised and updated, with chapter authors drawn from an international panel of experts, the book supplies the background necessary for planning standardized photochemical stability studies as a part of drug development and formulation work. It contains comprehensive coverage of the physical and chemical aspects of drug photoreactivity, formulation, stability testing, and drug design/discovery in one resource. The contents have been reorganized to focus on the standardization of photostability testing of drug substances and products, in vitro photoreactivity screening of drugs, and various aspects of the formulation of photoreactive substances. The information on in vitro screening of drug photoreactivity is of great relevance for scientists who are developing and validating a set of testing protocols to address photosafety. Discussing kinetic and chemical aspects of drug photodecomposition as well as the practical problems frequently encountered in photochemical stability testing, this book helps you design a test protocol and interpret the results. Features Assists non-experts in this field design a test protocol and interpret the results Covers in vitro and in vivo aspects of interactions between drugs and light Explores the kinetic and chemical aspects of drug photodecomposition Discusses the problems frequently encountered in photochemical stability testing Provides guidance on how to address photosafety assessments and labeling requirements of potentially photoreactive drugs Highlights the practical implications of drug photodecomposition from a pharmaceutical viewpoint Offers specific guidance in photostability testing and screening of drug photoreactivity
Category: Medical

Handbook Of Isolation And Characterization Of Impurities In Pharmaceuticals

Author : Satinder Ahuja
ISBN : 012044982X
Genre : Medical
File Size : 37.88 MB
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The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product. This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements. It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization. - Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.
Category: Medical