As drug development becomes increasingly complex, Model-Informed Drug Development (MIDD) has emerged as a critical strategy for optimizing clinical trial design, enhancing regulatory engagement, and accelerating development timelines. While population pharmacokinetic/pharmacodynamic (PopPK/PD) modeling is a central component of MIDD, sponsors...
Expertise: Consulting 221 results
Consulting
eTMF Site and Country Quality Reviews
Thank you for downloading our “eTMF Site and Country Quality Reviews” guide. Download the PDF here.
In vitro / in vivo correlation (IVIVC) is a scientific approach used to establish predictive relationships between laboratory-based drug release profiles (in vitro) and pharmacokinetic behavior in humans (in vivo). By linking dissolution data with plasma concentration profiles, IVIVC helps...
Consulting
Catherine Gatza, Ph.D.
Consulting
Seth DePuy, Ph.D.
Consulting
Ruth Stevens
Consulting
Stacey Ayres, Ph.D.
Consulting