Module232025

Lack of Pharmacokinetic (PK) and Pharmacodynamic (PD) Data (2)

Innovative Tools :

In vitro – in vivo correlations (IVIVC) and PBPK/PD modeling help predict pediatric drug behavior and dosing. Need for Validation : More system data and careful evaluation of PK parameters are essential for safe drug administration in children .

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs