Commentary on Fit-For-Purpose Models for Regulatory Applications

Model-based analyses have been applied to influence various drug development and regulatory decisions in the last 2 decades. Applied models range from empirical models to highly complex mechanistic models. Fit-for-purpose has been the principle to determine the level of model complexity. While numerous case studies have been published to highlight the impact and value of model-based analyses, more experience and lessons are being accumulated to address new challenges and create more opportunities. The inclusion of Model-Informed Drug Development in the Prescription Drug User Fee Act (PDUFA) VI represents a new landmark for the field of quantitative clinical pharmacology. (c) 2019 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.