Proceedings of a Workshop: US Food and Drug Administration-International Society of Pharmacometrics Model-Informed Drug Development in Oncology

摘要

The scientific and regulatory communities support the use of pharmaco-statistical models of efficacy and safety during drug development, termed "Model-Informed Drug Development (MIDD)." Under the US Food and Drug Administration (FDA) Reauthorization Act of 2017,1 the FDA will convene several workshops to identify best practices for MIDD. This summary highlights viewpoints from the first workshop, co-hosted by the FDA and International Society of Pharmacometrics (ISoP) on February 1, 2018, entitled "Model-Informed Drug Development in Oncology."