Paula L. Hyland

Advances in New Approach Methodologies at FDA's Division of Applied Regulatory Science

In silico and in vitro NAMs including quantitative systems pharmacology (QSP) modeling for opioid overdose scenarios, (quantitative) structure–activity relationship ((Q)SAR) modeling for toxicity prediction and drug–drug interaction assessment, and multi‐omics approaches for pharmacodynamic biomarker discovery are desc...