Modeling and Simulation at the Interface of Nonclinical and Early Clinical Drug Development

Abstract

The role of modeling and simulation (M&S) in early drug development was discussed in a break out session of the European Medicines Agency/European Federation of Pharmaceutical Industries and Associations (EMA/EFPIA) M&S workshop held in December 2011 in London, UK. The discussions were focused on two themes: (i) M&S in nonclinical and early clinical drug development and (ii) M&S for first-in-human (FIH) dose selection. Illustrative case studies were presented and links are listed in Table 1. Common objectives and next steps were identified, discussed, and agreed.