ASCPT Task Force for advancing pharmacometrics and integration into drug development

Abstract

Traditionally, medical and biostatistical experts have played a central role in ensuring validity of pharmaceutical testing. The science of pharmacometrics provides powerful approaches for supporting important drug development and regulatory decisions. Numerous case studies published by academic, industry, and US Food and Drug Administration scientists attest to the significant contribution of pharmacometrics to decision making. The economic and public health benefits of applying this discipline to clinical trials far outweigh the cost associated with its implementation. The purpose of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Task Force is to build on the momentum and accelerate dissemination of its impact and adoption into drug development. We describe briefly the contributions of pharmacometrics and the specific goals of the Task Force.