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May 15, 2019
  |  Presentation

Advancing current PBPK model applications to support internal development and regulatory decisions

Take home messages:
• Number of applications received by the U.S. FDA including PBPK models is exponentially rising since 2008
• The U.S. FDA is an advocate of the PBPK approach to waive some clinical trials
• The U.S. FDA is investing time and money to improve the confidence level for PBPK model

European Federation for Exploratory Medicines Development in Lyon, France May 15-17, 2019

By Maxime Le Merdy

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