EPA tasked Versar, Inc., to convene a team of five expert scientists to assist the Agency in exploring how it might improve risk assessment and toxicity testing paradigms currently in use, and ways to improve the evaluation of pharmacokinetic data in immature animals at various stages of development. A task was defined whose purpose was to develop a White Paper that would review the current state of pharmacokinetic knowledge in the animal and human perinatal population, defined as the unborn, infants and young children. Each technical expert addressed one of five different issue areas or aspects of the scope of work. This report was developed with an eye toward:
- Identifying information that would inform the development of future test guidelines and/or guidance documents related to this topic
- Identifying information or approaches that would assist EPA in improving existing noncancer risk assessment methodologies
- Exploration of Perinatal Pharmacokinetic Issues (PDF)(280 pp, 4 MB, May 10, 2001, 630-R-01-0)