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...
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.· Journal of clinical pharmaco...· 0 citations
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