Interpretation and Extrapolation of Reproductive Data to Establish Human Safety Standards - Khera, K.S.; Grice, H.C.; Clegg, D.J.; SpringerLink (Online service) (New York, NY : Springer New York : Imprint: Springer, 1989)
I. Introduction -- II. Terminology and Definitions -- References -- III. Teratogenicity (Embryotoxicity) Studies: Design, Conduct, and Evaluation -- 3.1. Introduction -- 3.2. Protocol -- 3.3. Conduct of the Study -- 3.4. Evaluation of Animal Data -- References -- IV. Multigeneration Studies -- 4.1. Introduction -- 4.2. Test Protocols -- 4.3. Test Material -- 4.4. Test Species -- 4.5. Route of Administration -- 4.6. Method of Administration -- 4.7. Dose Levels -- 4.8. Performance of Multigeneration Studies -- 4.9. Evaluation of Animal Data -- References -- V. Behavioral-Functional Teratology -- 5.1. Introduction -- 5.2. Review Articles -- 5.3. Methods Currently in Use or Under Development -- 5.4. Current Status of Testing Procedures and Use -- 5.4.3.1. Food and Drug Administration -- 5.4.3.2. Environmental Protection Agency -- 5.5. Discussion -- References -- VI. In Vitro Developmental Toxicity Assays -- 6.1. Introduction -- 6.2. Assay Systems Using Submammalian Species -- 6.3. Assay Systems Using Mammalian Species -- 6.4. Role of In Vitro Assays for Teratogenicity -- References -- VII. Statistical Methods for Developmental Toxicity Studies -- 7.1. Introduction -- 7.2. Comparison Between Exposed and Unexposed Groups -- 7.3. Dose-Response Models -- 7 4 Summary and Conclusions -- References -- VIII. Epidemiology -- 8.1. Introduction -- 8.2. The Conduct of Epidemiologic Studies on Human Reproduction -- 8.3. Descriptive Studies -- 8.4. Etiologic Studies -- 8.5. Characteristics of an Acceptable Human Reproduction Study -- References -- IX. Extrapolation of Reproductive Risks from Animal and Human Data -- 9.1. Introduction -- 9.2. Classification of Chemicals for In Utero Effects -- 9.3. Methods of Risk Extrapolation -- References -- X. Guidelines for Reproductive Toxicity Tests in Different Countries With a Proposal for International Harmonization -- 10.1. Introduction -- 10.2. Current Guidelines for Reproductive Toxicity Testing -- 10.3. Harmonization of Guidelines -- 10.4. Steps Toward Harmonization -- 10.5. Conclusions -- References.
Keywords: Pharmacology; Cell biology; Anthropology; Pharmacy; Pharmacology/Toxicology.; Cell Biology; Anthropology; Pharmacy