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

Journal of veterinary medicine . A

• Record Nr.: UNINA9910147033803321
• Pubbl/distr/stampa: [Berlin, Germany], : Blackwell Science
• ISSN: 1439-0442
• Descrizione fisica: 1 online resource
• Soggetti: Veterinary medicine; Veterinary physiology; Veterinary pathology; Médecine vétérinaire; Physiologie vétérinaire; Pathologie vétérinaire; Physiologie animale; Pathologie animale; Patologia veterinària; Veterinària; Periodicals.; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); Revistes electròniques.
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Periodico
• Note generali: Refereed/Peer-reviewed