Concurrent Use of Behavioral/Functional Testing in Existing Reproductive and Developmental Toxicity Screens: Practical Considerations

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Abstract
Behavioral/functional testing is a required segment of reproductive/developmental toxicity safety evaluations of pharmaceuticals to be marketed in the United Kingdom and Japan. Should the current momentum for mandating behavioral teratology testing continue, these evaluations may become required components of reproductive/developmental toxicity safety evaluations submitted to regulatory agencies of the United States. The selection of appropriate behavioral tests and the practical application of these tests in existing safety evaluations present an array of problems. Although there is a vast number of different types of behavioral tests, the specific methodologies of many of the tests are incompatible with standard endpoints of existing reproductive/developmental toxicity protocols. There are multiple inherent methodological and practical problems associated with the incorporation of behavioral tests into currently existing safety evaluations designed for regulatory review. These problems include relative time and cost effectiveness, interlaboratory and intralaboratory variability, test validity, and the interpretation of data.