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Quality by design - issues and challenges

  • At: 2011 FIP Congress in Hyderabad (India)
  • Type: Presentation
  • By: SAM, Tom (MSD, Oss, Netherlands)
  • Abstract:

    The application of physiologically-based pharmacokinetic (PBPK) modelling is coming of age in drug development and regulation, reflecting significant advances over the past 10 years in the predictability of key pharmacokinetic (PK) parameters from human in vitro data and the availability of dedicated software platforms and associated data bases.

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Last update 4 October 2019

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