Includes bibliographical references and index.

Preclinical Drug Development Planning -- Use of Project Teams in Preclinical Development -- Relationship between Animal Models and Clinical Research: Using Mucositis as a Practical Example -- Bacterial Mutation Assay -- In Vitro Mammalian Cell Mutation Assays -- In Vitro Mammalian Cytogenetic Tests -- In Vivo Genotoxicity Assays -- Repeat Dose Toxicity Studies -- Irritation and Local Tissue Tolerance Studies in Pharmaceutical Safety Assessment -- Safety Assessment Studies: Immunotoxicity -- Immunotoxicity Testing: ICH Guideline S8 and Related Aspects -- Reproductive and Developmental Toxicology -- Carcinogenicity Studies -- Toxicokinetics: An Integral Component of Preclinical Toxicity Studies -- In Vitro Toxicokinetics and Dynamics: Modeling and Interpretation of Toxicity Data -- Toxicologic Pathology -- Secondary Pharmacodynamic Studies and In Vitro Pharmacological Profiling -- Current Practices in Safety Pharmacology -- Safety Assessment of Biotechnology-Derived Therapeutics -- Preclinical Development of Protein Pharmaceuticals: An Overview -- The Pharmacogenomics of Personalized Medicine -- Genomics -- Proteomics -- Toxicogenomics in Preclinical Development -- Toxicoproteomics: Preclinical Studies -- Regulatory Considerations -- Regulatory Issues in Preclinical Safety Studies (U.S. FDA) -- Selection and Utilization of CROs for Safety Assessment -- Auditing and Inspecting Preclinical Research and Compliance with Good Laboratory Practice (GLP) -- Drug Impurities and Degradants and Their Safety Qualification -- Bridging Studies in Preclinical Pharmaceutical Safety Assessment -- Index.

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