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Approaches to Address the Regulatory Requirements for System Qualification of the Simcyp Simulator

Live webinar

Physiologically-based pharmacokinetic (PBPK) modeling is being increasingly used in drug development to avoid unnecessary clinical drug–drug interaction (DDI) studies and inform drug labels.

Thus, regulatory agencies are recommending more rigorous demonstration of the prediction accuracy of PBPK platforms in their intended use. 

During the webinar, we will present a framework for qualification of the Simcyp Simulator with respect to competitive and mechanism-based CYP-mediated DDIs involving inhibition that was published recently (click on link below for our recent publication).

We will also discuss our strategy and ongoing qualification efforts for other key areas.    

Prediction of CYP‐mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator – Kilford – – CPT: Pharmacometrics & Systems Pharmacology – Wiley Online Library

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Speakers
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.
Certara Oliver H
Oliver Hatley
Senior Research Scientist
Oliver Hatley is a Senior Research Scientist who has been working at Certara since 2013. He obtained his PhD investigating in vitro-in vivo extrapolation of intestinal metabolism from the Centre for Applied Pharmacokinetic Research (CAPKR) at the University of Manchester. Oliver is part of the translational sciences in DMPK group within Simcyp and has lead development of the esterase organ and blood in vitro-in vivo scaling strategies. He is also involved in the development of special populations within the Simcyp Population-based Simulator.
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