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Author

Jeffry Florian

2 papers indexed here

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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

Model‐informed drug development (MIDD) approaches are being increasingly used in neuroscience drug development programs and regulatory decision‐making. In this work, the authors summarize a select set of cases in neurology, psychiatry, addiction, anesthesia, and analgesia, where MIDD approaches were utilized to address...

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

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