Dose recommendations are usually established using data driven approaches, i.e., population modeling & simulation, thus requiring substantial amount of clinical data for a target population. However, the classical approaches may not work for special populations which are usually under-represented in clinical trials. These populations are frequently at risk of suboptimal treatments because conducting head-to-head clinical trials examining every possible scenario is unrealistic. For instance, population aging is a global phenomenon, and the importance of establishing optimal dosing recommendations in geriatrics is gaining more and more attention. The geriatric group is known to be highly heterogenous due to various factors, including the variability in aging rate and extent, and the high number of comorbidities and/or comedications. This complexity in the population itself leads to a restricted usability of conventional data-driven approaches for dose recommendations. In this webinar, Dr. Valvanera Vozmediano, Assistant Professor, and Chaejin Kim, PhD candidate, at the University of Florida will present a case example on the use of GastroPlus physiologically based pharmacokinetics (PBPK) modeling to generate supplementary data to inform dosing recommendations in under-represented groups in clinical trials.
Speakers: Dr. Valvanera Vozmediano, Chaejin Kim, Dan O’Connor, Jasmin Nevarez