Uncertainty quantification for complex models supporting regulatory decision making

Study identification

• EU PAS number:
  EUPAS1000000717
• Study ID:
  1000000717
• Official title and acronym:
  Uncertainty quantification for complex models supporting regulatory decision making
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Germany

  Sweden
• Study description:
  Model-informed drug development (MIDD) plays a crucial role in drug development, and evaluation by regulatory agencies. A key component of MIDD is the use of complex mechanistic models, built on an understanding of physiology, drug characteristics, and pharmacology, to make extrapolations. ; However, these models often result in inadequate assessment of uncertainty due to their complexity and the sources of parameters. ; This study aims to enhance drug development and regulatory decision-making by improving uncertainty quantification (UQ) methods for complex models. ; The primary objectives are to assess existing UQ methods, conduct simulation studies to evaluate these methods, and develop a toolkit and tutorial for applying the best methods. ; The methodology involves a comprehensive literature review to identify and summarize UQ methods, followed by simulation studies to test selected methods on use-cases such as drug-drug interactions and pediatric dosing. ; The project will culminate in the development of user-friendly tools and tutorials for implementing UQ methods. ;
• Study status:
  Ongoing

Research institutions and networks

Institutions

Uppsala University

Medical University of Vienna

Austria

University Medical Center Göttingen
Austrian Agency of Health and Food Safety

Study timelines

Date when funding contract was signed

Actual:18/04/2025

Study start date

Planned:15/05/2025

Actual:15/05/2025

Date of final study report

Planned:17/08/2026

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Unknown
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable