Perspective on model‐informed drug development
Lawrence J. Lesko
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.
Topics & Concepts
Drug developmentDrugPhysiologically based pharmacokinetic modellingPerspective (graphical)Food and drug administrationPrescription drugPopulationMedical prescriptionPharmacologyBusinessMedicinePharmacokineticsProcess managementComputer scienceRisk analysis (engineering)Environmental healthArtificial intelligenceInnovative Microfluidic and Catalytic Techniques InnovationPharmacogenetics and Drug MetabolismStatistical Methods in Clinical Trials