Preclinical Development Handbook : Toxicology.
Title:
Preclinical Development Handbook : Toxicology.
Author:
Gad, Shayne Cox.
ISBN:
9780470249048
Personal Author:
Edition:
1st ed.
Physical Description:
1 online resource (1075 pages)
Series:
Pharmaceutical Development Ser. ; v.4
Pharmaceutical Development Ser.
Contents:
PRECLINICAL DEVELOPMENT HANDBOOK Toxicology -- CONTRIBUTORS -- CONTENTS -- Preface -- 1 Preclinical Drug Development Planning -- 2 Use of Project Teams in Preclinical Development -- 3 Relationship between Animal Models and Clinical Research: Using Mucositis as a Practical Example -- 4 Bacterial Mutation Assay -- 5 In Vitro Mammalian Cell Mutation Assays -- 6 In Vitro Mammalian Cytogenetic Tests -- 7 In Vivo Genotoxicity Assays -- 8 Repeat Dose Toxicity Studies -- 9 Irritation and Local Tissue Tolerance Studies in Pharmacetical Safety Assessment -- 10 Safety Assessment Studies: Immunotoxicity -- 11 Immunotoxicity Testing: ICH Guideline S8 and Related Aspects -- 12 Reproductive and Developmental Toxicology -- 13 Carcinogenicity Studies -- 14 Toxicokinetics: An Integral Component of Preclinical Toxicity Studies -- 15 In Vitro Toxicokinetics and Dynamics: Modeling and Interpretation of Toxicity Data -- 16 Toxicologic Pathology -- 17 Secondary Pharmacodynamic Studies and In Vitro Pharmacological Profiling -- 18 Current Practices in Safety Pharmacology -- 19 Safety Assessment of Biotechnology-Derived Therapeutics -- 20 Preclinical Development of Protein Pharmaceuticals: An Overview -- 21 The Pharmacogenomics of Personalized Medicine -- 22 Genomics -- 23 Proteomics -- 24 Toxicogenomics in Preclinical Development -- 25 Toxicoproteomics: Preclinical Studies -- 26 Regulatory Considerations -- 27 Regulatory Issues in Preclinical Safety Studies (U.S. FDA) -- 28 Selection and Utilization of CROs for Safety Assessment -- 29 Auditing and Inspecting Preclinical Research and Compliance with Good Laboratory Practice (GLP) -- 30 Drug Impurities and Degradants and Their Safety Qualification -- 31 Bridging Studies in Preclinical Pharmaceutical Safety Assessment -- Index.
Abstract:
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, toxicity, pharmacogenomics, modeling, and regulations. This single definitive, easy-to-use resource discusses all the issues that need consideration and provides detailed instructions for current methods and techniques. Each chapter was 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, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * In vitro mammalian cytogenetics tests * Phototoxicity * Carcinogenicity studies * The pharmacogenomics of personalized medicine * Bridging studies * Toxicogenomics and toxicoproteomics 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 is a hands-on guide for 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.
Local Note:
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2017. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
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