Modern drug development problems are very complex and require integration of various scientific fields. Traditionally, statistical methods have been the primary tool for design and analysis of clinical trials. Increasingly, pharmacometric approaches using physiology-based drug and disease models are applied in this context. In this paper, we show that statistics and pharmacometrics have more in common than what keeps them apart, and collectively, the synergy from these two quantitative disciplines can provide greater advances in clinical research and development, resulting in novel and more effective medicines to patients with medical need.
Keywords: Collaboration; integration of fields; model-based adaptive optimal designs; model-informed drug development; problem solving.
© 2021 The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.