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Applications of PBPK modelling for regulatory submissions: case studies involving DDIs, transporters and special populations 

Live Webinar

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.

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Bio Pic KarenYeo
Karen Rowland Yeo, PhD
Senior Vice President, Client & Regulatory Strategy
Since 2002, Karen has led projects relating to the extrapolation of in vitro data to predict in vivo pharmacokinetics in humans. This has included development and implementation of the models into the Simcyp Simulator.  Her specific research interests include physiologically based pharmacokinetic modeling and prediction of drug-drug interactions.