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作者 Gad, Shayne Cox
書名 Preclinical Development Handbook : ADME and Biopharmaceutical Properties
出版項 Hoboken : John Wiley & Sons, Incorporated, 2008
國際標準書號 9780470249024 (electronic bk.)
book jacket
版本 1st ed
說明 1 online resource (1347 pages)
text txt rdacontent
computer c rdamedia
online resource cr rdacarrier
系列 Pharmaceutical Development Ser. ; v.3
Pharmaceutical Development Ser
附註 Intro -- PRECLINICAL DEVELOPMENT HANDBOOK ADME and Biopharmaceutical Properties -- CONTRIBUTORS -- CONTENTS -- Preface -- 1 Modeling and Informatics in Drug Design -- 2 Computer Techniques: Identifying Similarities Between Small Molecules -- 3 Protein-Protein Interactions -- 4 Method Development for Preclinical Bioanalytical Support -- 5 Analytical Chemistry Methods: Developments and Validation -- 6 Chemical and Physical Characterizations of Potential New Chemical Entity -- 7 Permeability Assessment -- 8 How and Where Are Drugs Absorbed? -- 9 Absorption of Drugs after Oral Administration -- 10 Distribution: Movement of Drugs through the Body -- 11 The Blood-Brain Barrier and Its Effect on Absorption and Distribution -- 12 Transporter Interactions in the ADME Pathway of Drugs -- 13 Accumulation of Drugs in Tissues -- 14 Salt and Cocrystal Form Selection -- 15 Dissolution -- 16 Stability: Physical and Chemical -- 17 Dosage Formulation -- 18 Cytochrome P450 Enzymes -- 19 Metabolism Kinetics -- 20 Drug Clearance -- 21 In Vitro Metabolism in Preclinical Drug Development -- 22 Utilization of In Vitro Cytochrome P450 Inhibition Data for Projecting Clinical Drug-Drug Interactions -- 23 In Vivo Metabolism in Preclinical Drug Development -- 24 In Vitro Evaluation of Metabolic Drug-Drug Interactions: Scientific Concepts and Practical Considerations -- 25 Mechanisms and Consequences of Drug-Drug Interactions -- 26 Species Comparison of Metabolism in Microsomes and Hepatocytes -- 27 Metabolite Profiling and Structural Identification -- 28 Linkage between Toxicology of Drugs and Metabolism -- 29 Allometric Scaling -- 30 Interrelationship between Pharmacokinetics and Metabolism -- 31 Experimental Design Considerations in Pharmacokinetic Studies -- 32 Bioavailability and Bioequivalence Studies -- 33 Mass Balance Studies -- 34 Pharmacodynamics
35 Physiologically Based Pharmacokinetic Modeling -- 36 Mathematical Modeling as a New Approach for Improving the Efficacy/Toxicity Profile of Drugs: The Thrombocytopenia Case Study -- 37 Regulatory Requirements for INDs/FIH (First in Human) Studies -- 38 Data Analysis -- Index
A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin
Description based on publisher supplied metadata and other sources
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2020. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries
鏈接 Print version: Gad, Shayne Cox Preclinical Development Handbook : ADME and Biopharmaceutical Properties Hoboken : John Wiley & Sons, Incorporated,c2008 9780470248478
主題 Pharmacokinetics -- Handbooks, manuals, etc.;Drug development -- Handbooks, manuals, etc
Electronic books
Alt Author Gad, Shayne Cox
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