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Workshop: Physiologically Based Pharmacokinetic (PBPK) Modeling: Applications, Regulatory Perspective and Case Studies

May 12 - May 13

Pharmaceutical & Bioscience Society – International
12:00 – 6:30 PM (ET)

About the Workshop 

Model informed drug development (MIDD) is taking a central role in drug discovery and development. MIDD is an approach that integrates diverse data sources (compound information, disease mechanism and patient characteristics etc.) through a mathematical framework that can be used to quantitatively predict/extrapolate various untested scenarios with an objective of decreasing uncertainty and increasing confidence in drug development.  Physiologically based pharmacokinetic (PBPK) modeling is one such a platform that is being extensively used to predict the effects of extrinsic factors (e.g., drug-drug, drug-food interactions) and intrinsic factors (e.g., orgaBoston PBSS Workshopn impairment, disease, age) on drug exposure. This workshop aims to provide an overview on the current status of PBPK modeling and its applications to address various drug development questions and learn about regulatory perspectives.


  • Status of absorption mediated DDI prediction with PBPK modeling and regulatory guidance
  • Challenges and opportunities for prediction of CYP and transporter mediated DDIs
  • Progress made in PBPK model guided pediatric dose selection
  • New developments in prediction of pharmacokinetics in special population
  • Regulatory perspective of PBPK modeling acceptance in lieu of clinical DDI studies

Join Chief Scientific Officer, Viera Lukacova on May 13th from noon-1 PM (ET) to learn about “Challenges and opportunities for PBPK prediction of transporters mediated drug interactions.”


May 12
May 13

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