内容

目次

Preface. 1 Preclinical Drug Development Planning (Nirmala Bhogal, Robert Combes, and Michael Balls). 2 Use of Project Teams in Preclinical Development (Dorothy M. K. Keefe, Joanne M. Bowen, and Rachel J. Gibson). 3 Relationship between Animal Models and Clinical Research: Using Mucositis as a Practical E xample (Rachel J. Gibson, Joanne M. Bowen, and Dorothy M. K. Keefe). 4 Bacterial Mutation Assay (Premkumar Kumpati). 5 In Vitro Mammalian Cell Mutation Assays (C. Anita H. Bigger, Martha M. Moore, and Robert H. Heflich). 6 In Vitro Mammalian Cytogenetic T ests (R. Julian Preston). 7 In Vivo Genotoxicity Assays (Andreas Hartmann, Krista L. Dobo, and Hans–Jörg Martus). 8 Repeat Dose Toxicity Studies (Shayne Cox Gad). 9 Irritation and Local Tissue Tolerance Studies in Pharmacetical S afety Assessment (Shayne Cox Gad). 10 Safety Assessment Studies: Immunotoxicity (Jacques Descotes). 11 Immunotoxicity Testing: ICH Guideline S8 and Related Aspects (Hans–Gerd Pauels and John Taylor). 12 Reproductive and Developmental Toxicology (Ronald D. Hood and Robert M. Parker). 13 Carcinogenicity Studies (Shayne Cox Gad). 14 Toxicokinetics: An Integral Component of Preclinical Toxicity S tudies (Sonu Sundd Singh). 15 In Vitro Toxicokinetics and Dynamics: Modeling and Interpretation of Toxicity Data (Arie Bruinink). 16 Toxicologic Pathology (Paul B. Tchounwou and José A. Centeno). 17 Secondary Pharmacodynamic Studies and In Vitro Pharmacological Profiling (Duncan Armstrong, Jacques Migeon, Michael G. Rolf, Joanne Bowes, Mark Crawford, and Jean–Pierre Valentin). 18 Current Practices in Safety Pharmacology (Alan S. Bass, Peter K. S. Siegl, Gary A. Gintant, Dennis J. Murphy, and Roger Porsolt). 19 Safety Assessment of Biotechnology–Derived T herapeutics (Mary Ellen Cosenza). 20 Preclinical Development of Protein Pharmaceuticals: An O verview (Dipankar Das and Mavanur R. Suresh). 21 The Pharmacogenomics of Personalized Medicine (Ronald E. Reid). 22 Genomics (Dimitri Semizarov and Eric A. G. Blomme). 23 Proteomics (Juan Casado and J. Ignacio Casal). 24 Toxicogenomics in Preclinical Development (Eric A. G. Blomme, Dimitri Semizarov, and Jeffrey F. Waring). 25 Toxicoproteomics: Preclinical Studies (B. Alex Merrick and Maribel E. Bruno). 26 Regulatory Considerations (Evan B. Siegel and Duane B. Lakings). 27 Regulatory Issues in Preclinical Safety Studies (U.S. FDA) (Kenneth L. Hastings and William J. Brock). 28 Selection and Utilization of CROs for Safety Assessment (Joanne R. Kopplin and Ward R. Richter). 29 Auditing and Inspecting Preclinical Research and Compliance with Good Laboratory Practice (GLP) (N. J. Dent). 30 Drug Impurities and Degradants and Their Safety Qualification (Robin C. Guy). 31 Bridging Studies in Preclinical Pharmaceutical Safety Assessment (Shayne Cox Gad). Index.