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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