模型引导药物研发的视角。
Perspective on model-informed drug development.
机构信息
Center for Pharmacometrics and Systems Pharmacology, University of Florida College of Pharmacy, Lake Nona, FL, USA.
出版信息
CPT Pharmacometrics Syst Pharmacol. 2021 Oct;10(10):1127-1129. doi: 10.1002/psp4.12699. Epub 2021 Aug 17.
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 (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.
摘要
模型指导药物研发（MIDD）是一种旨在加速药物研发、增强监管科学并为患者带来益处的过程。定量建模和模拟——主要通过群体药代动力学（PK）、暴露-反应和基于生理学的药代动力学（PBPK）分析——是提供在各种应用中部署 MIDD 能力的技术。MIDD 在 2017 年处方药用户收费法案再授权（PDUFA VI，2018-2022）中被编纂，并设定了一个绩效目标，即到 2022 年，MIDD 试点计划每季度举行 2 到 4 次行业-美国食品和药物管理局（FDA）配对会议。
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