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Jeffry A. Florian

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Review Open access Sep 2026

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...

Ksenia Blinova, Kimberly Chiu, Anik Chaturbedi et al. · 0 citations
Review Open access Aug 2026

Application of Model‐Informed Approaches in Neuroscience Drug Development and Regulatory Decision‐Making

A select set of cases in neurology, psychiatry, addiction, anesthesia, and analgesia, where MIDD approaches were utilized to address critical drug development questions or fill knowledge gaps are summarized to offer insights into the utility of MIDD approaches to streamline drug development and opportunities to save co...

Michael Bewernitz, A. Nookala, Gopichand Gottipati et al. · 0 citations

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