Interpretation and Extrapolation of Reproductive Data to Establish Human Safety Standards
The International Life Sciences Institute (!LSI) is a scientific foundation that addresses critical health and safety issues of national and international con cern. ILSI promotes international cooperation by providing the mechanism for scientists from government, industry, and universities to work...
| Other Authors: | , , |
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| Format: | eBook |
| Language: | English |
| Published: |
New York, NY
Springer New York
1989, 1989
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| Edition: | 1st ed. 1989 |
| Series: | Current Issues in Toxicology
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| Subjects: | |
| Online Access: | |
| Collection: | Springer Book Archives -2004 - Collection details see MPG.ReNa |
Table of Contents:
- 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
- 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
- 10.3. Harmonization of Guidelines
- 10.4. Steps Toward Harmonization
- 10.5. Conclusions
- References