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Published on: May 11, 2021
Perspective on model-informed drug development
1Center for Pharmacometrics and Systems Pharmacology, University of Florida College of Pharmacy, Lake Nona, FL, USA.
Abstract:
Model-informed drug development (MIDD) is a process intended to expedite drug development, enhance regulatory science, and produce benefits for patients. Quantitative modeling and simulation-principally by population pharmacokinetics (PK), exposure-response, and physiologically based pharmacokinetic (PBPK) analysis-is the technology that provides the capability to deploy MIDD across a range of applications. MIDD was codified in the 2017 Prescription Drug User Fee Act Reauthorization 1 (PDUFA VI, 2018-2022) and a performance goal was a MIDD pilot program to hold 2 to 4 industry-U.S. Food and Drug Administration (FDA) paired meetings quarterly through 2022.
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