Results for 'drug developement'
Nidal Al-Huniti, Yan Feng, Jingyu (Jerry) Yu, Zheng Lu, Mario Nagase, Diansong Zhou, Jennifer Sheng
Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities
tumor growth, drug developement, drug approval, TGD, MIDD, PDUFA
Model-informed drug development (MIDD) has advanced rapidly in recent years, especially in oncology. The Prescription Drug User Fee Act (PDUFA) VI includes commitments to enhance MIDD. Tumor growth dynamic (TGD) modeling is a key MIDD approach used to accelerate drug development, support new dru…
Jun 26th • 18 mins read