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Furnishing essential data on all areas of toxicity testing, this Second Edition provides guidance on the design and evaluation of product safety studies to help ensure regulatory acceptance.nbsp; Every chapter highlights regulatory requirements specific to the United States, Europe, and Japan, and in addition to expanded information on data interpretation, hazard assessment, carcinogenicity studies, and Good Laboratory Practices, new chapters regarding safety pharmacology, juvenile studies, the health safety assessment of pharmaceuticals, and health assessment strategies in the food and cosmetic industry have been added to reflect changes to regulatory requirements.nbsp; Toxicological Testing Handbook, Second Edition is a must-have reference for individuals responsible for assuring the safety of new pharmaceutical, biotechnical, and chemical products and materials.

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• Preface(p. iii)
• Contributors(p. xi)
• 1 Regulatory Toxicology Testing: Laboratories and Good Laboratory Practices(p. 1)
• Introduction(p. 1)
• Study Monitor/Sponsor Representative and the Audit(p. 1)
• Background of the Good Laboratory Practices(p. 2)
• Conducting the Preplacement Audit(p. 3)
• Case Study of Noncompliance(p. 8)
• Conclusion(p. 12)
• References(p. 13)
• 2 Laboratory Animals and In Vitro Test Systems Used in Regulatory Toxicology(p. 15)
• Introduction(p. 15)
• Use of Animals in Toxicology Testing(p. 15)
• Common Species in Regulatory Toxicology(p. 17)
• In Vitro Test Systems in Regulatory Toxicology Testing(p. 26)
• References(p. 29)
• 3 Safety Pharmacology(p. 33)
• Background and Basic Principles(p. 33)
• Assessment of Major Organ Functions(p. 40)
• Advanced Topics(p. 59)
• Future Trends(p. 63)
• Concluding Remarks(p. 64)
• References(p. 65)
• 4 Metabolism and Toxicokinetics(p. 79)
• Introduction(p. 79)
• Study Design and Study Parameters(p. 81)
• Data Evaluation and Interpretation(p. 92)
• Current Applications(p. 102)
• References(p. 104)
• 5 Toxicologic Pathology Assessment(p. 109)
• Introduction(p. 109)
• Clinical Pathology(p. 109)
• Morphologic Pathology(p. 125)
• References(p. 130)
• 6 Acute Toxicology(p. 135)
• Acute Toxicity Studies(p. 135)
• Eye Irritation Studies(p. 139)
• Dermal Irritation Studies(p. 142)
• Testing Strategies(p. 145)
• References(p. 146)
• 7 Multidose General Toxicology Studies(p. 149)
• Introduction(p. 149)
• Study Design and Study Parameters(p. 151)
• Data Reporting, Analysis, Interpretation, and Risk Assessment(p. 163)
• Target Organs(p. 174)
• Future Trends(p. 180)
• References(p. 181)
• 8 Genetic Toxicology(p. 185)
• Introduction(p. 185)
• Bacterial Mutation Assays(p. 188)
• Mammalian Cell Mutation Assays(p. 200)
• In Vitro Chromosome Aberration Assays(p. 207)
• In Vivo Cytogenetics Assay Systems(p. 215)
• Primary DNA Damage Assays(p. 222)
• Syrian Hamster Embryo Cell Transformation Assay(p. 228)
• Single Cell Gel Electrophoresis (Comet Assay)(p. 235)
• Implication of Positive Genetox Findings(p. 236)
• References(p. 239)
• 9 Carcinogenicity Studies(p. 249)
• Introduction(p. 249)
• Traditional Study Design and Parameters Measured(p. 252)
• Data Reporting, Analysis, Interpretation, and Risk Assessment(p. 254)
• Ongoing Issues and Future Trends(p. 259)
• References(p. 259)
• 10 Juvenile Animal Toxicology Studies(p. 265)
• Introduction(p. 265)
• Study Design and Study Parameters(p. 267)
• Data Reporting, Analysis, Interpretation, and Risk Assessment(p. 286)
• Conclusion(p. 293)
• References(p. 294)
• 11 Developmental and Reproductive Toxicology(p. 305)
• Introduction(p. 305)
• Study Design and Study Parameters(p. 308)
• Data Compilation, Interpretation, and Risk Assessment(p. 321)
• Additional Parameters to Measure and Other Follow-Up Studies(p. 336)
• Conclusion(p. 339)
• Appendix Commonly Used Terms in Reproductive and Developmental Toxicity(p. 339)
• References(p. 349)
• 12 Neurotoxicology Testing(p. 357)
• Introduction: What Is Neurotoxicity?(p. 357)
• Adult Neurotoxicity Testing: Study Design(p. 360)
• Developmental Neurotoxicity Testing: Study Design(p. 366)
• Data Collection, Reporting, Evaluation, and Interpretation(p. 375)
• Conclusion(p. 385)
• References(p. 386)
• 13 Toxicological Assessment of the Immune System(p. 391)
• Introduction-Overview of the Immune System(p. 391)
• Immunosuppression, Hypersensitivity, and Autoimmunity(p. 394)
• Considerations and Approaches for Detecting Immunosuppression(p. 396)
• Dosing and Species Considerations(p. 398)
• Approaches to Evaluating Humoral Immunity(p. 398)
• Approaches to Evaluating Cellular Immunity(p. 400)
• Approaches to Evaluating Nonspecific Immunity: Macrophages, NK Cells, and Neutrophils(p. 401)
• Approaches to Evaluating Hypersensitivity Responses(p. 402)
• Developmental Immunotoxicity(p. 403)
• Immunomodulation in Human Populations(p. 404)
• Regulatory Issues in Immunotoxicology(p. 405)
• Conclusions/Further Directions(p. 410)
• References(p. 411)
• 14 Inhalation and Pulmonary Toxicity Studies(p. 417)
• Introduction(p. 417)
• Contracting an Inhalation Study(p. 418)
• Study Design(p. 421)
• The Test Substance(p. 427)
• The Test System(p. 430)
• Exposure Systems(p. 432)
• Characterizing the Effects of Exposure(p. 433)
• The Report and Data Interpretation(p. 436)
• References(p. 437)
• 15 Cancer Risk Assessment of Environmental Agents: Approaches to the Incorporation and Analysis of New Scientific Information(p. 439)
• Introduction(p. 439)
• Hazard Identification/Hazard Characterization(p. 442)
• Dose-Response Assessment/Dose-Response Characterization(p. 450)
• Emerging Directions in Exposure Assessment(p. 455)
• Risk Characterization(p. 458)
• Summary(p. 459)
• References(p. 460)
• 16 Nonclinical Safety Testing of Pharmaceuticals(p. 465)
• Introduction(p. 465)
• Direction on the Timing of Toxicology Studies in Relation to Clinical Trials(p. 466)
• Studies Needed for Most New Drug Products(p. 468)
• Carcinogenicity Testing(p. 471)
• Special Studies(p. 472)
• Studies for Previously Approved Drugs(p. 474)
• The Value of Nonclinical Testing?(p. 475)
• Summary and Future Directions(p. 476)
• References(p. 476)
• 17 Health Risk Assessment Strategies in the Food and Cosmetic Industry(p. 479)
• Introduction(p. 479)
• History(p. 479)
• International Regulations(p. 488)
• Future Trends(p. 489)
• References(p. 489)
• Index(p. 491)

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