IQ Webinar - Streamlining food effect assessments via PBPK modeling
Presented by Food Effect PBPK Modeling
Sponsored by Translational and ADME Sciences Leadership Group (TALG)
• Filippos Kesisoglou, Merck, Sharp & Dohme
• Arian Emami Riedmaier, Certara
• Phil Bransford, Vertex
Although PBPK modeling has been attracting considerable attention as a tool to predict food-drug interactions, there are still considerable questions on the ability to broadly predict food effect a priori. Repeat food effect studies are very common in development, with many compounds being evaluated for food effect as early as the first-in-human (FIH) studies and then again when the late-stage formulation is developed. This is in line with current regulatory guidelines on food effect assessment recommend an early assessment of food effect to drive clinical dosing instructions as well as specifically recommend conducting a pivotal food effect study on the to-be-marketed formulation if different from that used in clinical trials. Information on such repeat food effect studies is not common in the public domain. This presentation will focus on reviewing a dataset compiled by the Food Effect PBPK IQ Working Group with studies across pharmaceutical and discuss a) how often the repeat food effect studies result in new formulation-dependent food effect findings and b) when the predictability of repeat food effect studies via PBPK modeling can be considered of higher confidence in lieu of clinical studies.
This is a public webinar. IQ membership is not required for registration.