Reproductive and developmental toxicity studies for small molecules, large molecules, biologics, and vaccines

Reproductive and developmental toxicity (DART) studies are essential to ensuring the safety of therapeutics across diverse patient populations. As drug development evolves to include small molecules, biologics, reformulations, and vaccines, DART study design and interpretation have become increasingly complex.

In this on-demand session, our experts provide practical insights into regulatory expectations (ICH, FDA, EMA, ECHA), modality-specific considerations, risk assessment strategies for clinical translation, and advanced histopathological evaluation approaches — including whole-slide imaging and AI-driven analysis.

Gain clarity on designing robust DART programs that support regulatory success and informed clinical decision-making.