Interpretation and Extrapolation of Reproductive Data to Establish Human Safety Standards

Interpretation and Extrapolation of Reproductive Data to Establish Human Safety Standards

Detalles Bibliográficos
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Khera, K.S. (Editor ), Grice, H.C. (Editor ), Clegg, D.J. (Editor )
Formato: eBook
Lenguaje:English
Publicado: New York, NY : Springer New York : Imprint: Springer, 1989.
Edición:1st ed. 1989.
Colección:Current Issues in Toxicology,
Materias:
Pharmacology.
Cell biology.
Anthropology.
Pharmacy.
Pharmacology/Toxicology.
Cell Biology.
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.

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