Developmental Toxicity Risk Assessment of Pharmaceuticals: Current Use of NHP’s and Alternatives (S11-2)

This presentation will include a summary of the international regulatory guidance on the type and timing of information needed for both small molecules and biologics to support human risk evaluation on potential of adverse pregnancy outcomes of pharmaceuticals where the drug is active only in primates. Key regulatory concepts and industry working practices regarding use of NHP in developmental toxicity testing will be described and challenged using case studies of pregnant NHP studies when they were helpful versus less useful for human risk assessment. Case studies and recent reviews of alternative approaches to using the pregnant NHP to support human risk evaluation will be highlighted.