Over the past two decades, there have been transformative changes in our approach to using modelling & simulation (M&S) to assess and manage drug–drug interactions (DDIs) involving CYP enzymes and transporters. Multidisciplinary innovations in mechanistic assessment of absorption, distribution, metabolism, and excretion (ADME) processes as well as population-based physiology have facilitated application of physiologically based pharmacokinetic (PBPK) modelling for assessment of the DDI liability of drugs in development. Indeed, M&S, specifically PBPK, has become an accepted (and encouraged) approach to inform and/or waive clinical DDI studies. In 2018, the Food and Drug Administration’s Office of Clinical Pharmacology published a commentary summarizing the application of PBPK modelling in the submissions it received between 2008 and 2017 and its impact on prescribing information. In a recent commentary, the FDA provided an update on the application of PBPK modelling in submissions received between 2018 and 2019 and highlighted a few notable examples, which will be discussed. More recently, PBPK has been applied to other scenarios involving special populations, specifically organ impairment and paediatrics. Case studies reflecting these will also be presented.
In this webinar, join our expert, Karen Rowland Yeo Ph.D, for a personalized tour of Simcyp PBPK case studies and Q&A.
Note: The session will be provided only in English.