Interpretation and Extrapolation of Reproductive Data to Establish Human Safety Standards
Autor Corporativo: | |
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Otros Autores: | , , |
Formato: | eBook |
Lenguaje: | English |
Publicado: |
New York, NY :
Springer New York : Imprint: Springer,
1989.
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Edición: | 1st ed. 1989. |
Colección: | Current Issues in Toxicology,
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Materias: | |
Acceso en línea: | https://doi.org/10.1007/978-1-4684-6379-8 |
Tabla de Contenidos:
- 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.