04221nam 2200661Ia 450 991078484260332120200520144314.01-281-23742-697866112374240-470-24905-60-470-24904-8(CKB)1000000000404577(EBL)333798(OCoLC)476138565(SSID)ssj0000226314(PQKBManifestationID)11185936(PQKBTitleCode)TC0000226314(PQKBWorkID)10233396(PQKB)11612085(MiAaPQ)EBC333798(Au-PeEL)EBL333798(CaPaEBR)ebr10226745(CaONFJC)MIL123742(PPN)243349165(EXLCZ)99100000000040457720080125d2008 uy 0engur|n|---|||||txtccrPreclinical development handbookToxicology[electronic resource] /[edited by] Shayne Cox GadHoboken, NJ Wiley-Intersciencec20081 online resource (1075 p.)Pharmaceutical Development Series ;v.4Description based upon print version of record.0-470-24846-7 Includes bibliographical references and index.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: Immunotoxicity11 Immunotoxicity Testing: ICH Guideline S8 and Related Aspects12 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 Overview21 The Pharmacogenomics of Personalized Medicine22 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; IndexA clear, straightforward resource to guide you through preclinical drug developmentFollowing 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 Pharmaceutical Development SeriesDrugsToxicologyHandbooks, manuals, etcDrugsToxicity testingHandbooks, manuals, etcDrugsToxicologyDrugsToxicity testing615.7615.7040724615.9Gad Shayne C.1948-96171MiAaPQMiAaPQMiAaPQBOOK9910784842603321Preclinical development handbook3681700UNINA