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目次

Preface. 1 Preclinical Drug Development Planning (Nirmala Bhogal,Robert Combes, and Michael Balls). 2 Use of Project Teams in PreclinicalDevelopment (Dorothy M. K. Keefe, Joanne M. Bowen, and Rachel J. Gibson).3 Relationship between Animal Models and Clinical Research: Using Mucositisas a Practical E xample (Rachel J. Gibson, Joanne M. Bowen, and Dorothy M. K.Keefe). 4 Bacterial Mutation Assay (Premkumar Kumpati). 5 In VitroMammalian Cell Mutation Assays (C. Anita H. Bigger, Martha M. Moore, andRobert H. Heflich). 6 In Vitro Mammalian Cytogenetic T ests (R. JulianPreston). 7 In Vivo Genotoxicity Assays (Andreas Hartmann, Krista L. Dobo,and Hans-Jorg Martus). 8 Repeat Dose Toxicity Studies (Shayne Cox Gad).9 Irritation and Local Tissue Tolerance Studies in Pharmacetical S afetyAssessment (Shayne Cox Gad). 10 Safety Assessment Studies: Immunotoxicity(Jacques Descotes). 11 Immunotoxicity Testing: ICH Guideline S8 andRelated Aspects (Hans-Gerd Pauels and John Taylor). 12 Reproductive andDevelopmental Toxicology (Ronald D. Hood and Robert M. Parker). 13Carcinogenicity Studies (Shayne Cox Gad). 14 Toxicokinetics: An IntegralComponent of Preclinical Toxicity S tudies (Sonu Sundd Singh). 15 In VitroToxicokinetics and Dynamics: Modeling and Interpretation of Toxicity Data(Arie Bruinink). 16 Toxicologic Pathology (Paul B. Tchounwou and Jose A.Centeno). 17 Secondary Pharmacodynamic Studies and In VitroPharmacological Profiling (Duncan Armstrong, Jacques Migeon, Michael G. Rolf,Joanne Bowes, Mark Crawford, and Jean-Pierre Valentin). 18 CurrentPractices in Safety Pharmacology (Alan S. Bass, Peter K. S. Siegl, Gary A.Gintant, Dennis J. Murphy, and Roger Porsolt). 19 Safety Assessment ofBiotechnology-Derived T herapeutics (Mary Ellen Cosenza). 20 PreclinicalDevelopment of Protein Pharmaceuticals: An O verview (Dipankar Das andMavanur 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 inPreclinical Development (Eric A. G. Blomme, Dimitri Semizarov, and Jeffrey F.Waring). 25 Toxicoproteomics: Preclinical Studies (B. Alex Merrick andMaribel E. Bruno). 26 Regulatory Considerations (Evan B. Siegel and DuaneB. Lakings). 27 Regulatory Issues in Preclinical Safety Studies (U.S. FDA)(Kenneth L. Hastings and William J. Brock). 28 Selection and Utilizationof CROs for Safety Assessment (Joanne R. Kopplin and Ward R. Richter). 29Auditing and Inspecting Preclinical Research and Compliance with GoodLaboratory Practice (GLP) (N. J. Dent). 30 Drug Impurities and Degradantsand Their Safety Qualification (Robin C. Guy). 31 Bridging Studies inPreclinical Pharmaceutical Safety Assessment (Shayne Cox Gad). Index.