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Author

Mehul Mehta

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Review Sep 2026

Four decades of History & Evolution of Clinical Pharmacology at US Food and Drug Administration (FDA)– Part I: Product Quality

The Office of Clinical Pharmacology (OCP) is a part of the Center for Drug Evaluation and Research (CDER) at the FDA. OCP probably comprises the largest group of scientists with expertise in, and involved with, the evaluation of all aspects of clinical pharmacology in new drug development, approval, and lifecycle manag...

Mehul U. Mehta · 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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