From Models to Medicines: A Narrative History and Regulatory Perspective on the Translational Impact of Model‐Informed Drug Development ( MIDD )
Abstract
Model-informed drug development (MIDD) has grown from a constellation of methodological advances to a profound reorientation of how evidence is generated, evaluated, integrated, and leveraged in both drug development and regulatory decision-making. Over decades, pharmaco-statistical modeling and simulation (M&S) have moved from supplemental analyses toward shared frameworks for quantitative and mechanistic reasoning on questions as diverse as clinical trial planning, effectiveness and drug safety risk assessment, and therapeutic optimization. This perspective traces that evolution and argues that MIDD's translational promise lies not only in ever-increasing technical sophistication, but in its capacity to reshape how we talk about how medicines are developed, evaluated, and optimized for patients.
Fields of Study & Subjects
Statistical Methods in Clinical Trials
Advanced Causal Inference Techniques
Biomedical Ethics and Regulation
Publication details
- Journal / source
- Clinical and Translational Science
- Publisher
- Wiley
- Volume
- 19
- Issue
- 5
- Pages
- e70547–e70547
- Publication date
- 28 April 2026
- Language
- EN