Preclinical development handbook Toxicology [[electronic resource] /] / [edited by] Shayne Cox Gad

• Record Nr.: UNINA9910784842603321
• Pubbl/distr/stampa: Hoboken, NJ, : Wiley-Interscience, c2008
• ISBN: 1-281-23742-6; 9786611237424; 0-470-24905-6; 0-470-24904-8
• Descrizione fisica: 1 online resource (1075 p.)
• Collana: Pharmaceutical Development Series ; ; v.4
• Altri autori (Persone): GadShayne C. <1948->
• Disciplina: 615.7; 615.7040724; 615.9
• Soggetti: Drugs - Toxicology; Drugs - Toxicity testing
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: 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 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 Overview; 21 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; Index
• Sommario/riassunto: A 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