Interpretation and Extrapolation of Reproductive Data to Establish Human Safety Standards

1. Front Matter

   Pages i-xii

   PDF

2. Introduction

   • K. S. Khera, H. C. Grice, D. J. Clegg

   Pages 1-4

3. Terminology and Definitions

   • K. S. Khera, H. C. Grice, D. J. Clegg

   Pages 5-7

4. Teratogenicity (Embryotoxicity) Studies: Design, Conduct, and Evaluation

   • K. S. Khera, H. C. Grice, D. J. Clegg

   Pages 9-20

5. Multigeneration Studies

   • K. S. Khera, H. C. Grice, D. J. Clegg

   Pages 21-40

6. Behavioral-Functional Teratology

   • K. S. Khera, H. C. Grice, D. J. Clegg

   Pages 41-58

7. In Vitro Developmental Toxicity Assays

   • K. S. Khera, H. C. Grice, D. J. Clegg

   Pages 59-68

8. Statistical Methods for Developmental Toxicity Studies

   • K. S. Khera, H. C. Grice, D. J. Clegg

   Pages 69-80

9. Epidemiology

   • K. S. Khera, H. C. Grice, D. J. Clegg

   Pages 81-90

10. Extrapolation of Reproductive Risks From Animal and Human Data

    • K. S. Khera, H. C. Grice, D. J. Clegg

    Pages 91-113

11. Guidelines for Reproductive Toxicity Tests in Different Countries With a Proposal for International Harmonization

    • K. S. Khera, H. C. Grice, D. J. Clegg

    Pages 115-133

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 together on cooperative programs to generate and disseminate scientific data. The mem­ bers and trustees of the institute believe that questions regarding health and safety are best resolved when scientists can examine and discuss issues as an independent body separate from the political pressures of individual countries and the economic concerns of individual companies. Frequently, meaningful assessment of the risk of a test substance is hindered by the inherent inconsistencies in the system. The development and refine­ ment of methods and systems to evaluate the safety of chemicals have evolved in a rapid and largely unplanned fashion. Attempts to improve the system have mainly been directed toward broad general concerns, with little attention being given to specific problems or issues. A failure to resolve these problems has frequently resulted in increased testing costs and complications in the assessment and extrapolation of the results to humans. Publicity surrounding toxicologic issues makes it difficult for governments to deal effectively with these problems. In response to these difficulties, ILSI has assembled highly qualified and renowned scientists from research institutes, universities, government, and industry with relevant scientific knowledge and expertise regarding the issues that complicate risk assessment procedures.

• CNS
• cell
• cell culture
• drug
• environment
• health effects
• human health
• human health effects
• reproduction
• research
• toxicity
• toxicity testing

• Health Protection Branch, Health and Welfare Canada, Ottawa, Canada

  K. S. Khera, D. J. Clegg

• Nepean, Canada

  H. C. Grice

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