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“First-of-its-kind” PBPK Guidance Documents

On Nov 21, 2016, the European Medicines Agency (EMA) hosted a workshop to discuss its draft guideline on qualification and reporting of physiologically-based pharmacokinetic (PBPK) analysis. The “first-of-its-kind” guideline, published earlier on July 21, 2016, proposes expectations on qualifying a PBPK platform for an intended use and provides advice on reporting PBPK analyses.  Attendees from regulatory agencies, pharmaceutical companies, academic institutes, and PBPK platform developers focused their discussions primarily on impact of PBPK analyses, platform qualification, and the use of sensitivity analyses. In less than two weeks after the  workshop, on December 1, 2016, the US Food and Drug Administration (FDA) published its “first-of-its-kind” draft PBPK guidance “Physiologically-based pharmacokinetic analysis – content and format, guidance for industry”. The nearness of the publication dates can be attributed to continuing scientific dialog among regulators on the subject. We are reminded that not so long ago in 2014, there were two PBPK workshops organized by the US FDA and EMA. The progression reflects recognition and interest in the developing role of PBPK in drug discovery and development by drug regulators in the US and Europe. The community is expected to react to the publication of these two guidance documents in the months to come. On March 15, 2017, the FDA will host an advisory committee meeting to discuss the PBPK during the annual meeting of the American Society for Clinical Pharmacology and Therapeutics. These communications will help regulators to further develop regulatory guidance towards consistent and efficient assessment of PBPK analyses for intended uses.

Disclaimer: The content of this report does not reflect the views or policies of the US Food and Drug Administration (FDA) or its staff. No official support or endorsement by the FDA is intended or should be inferred.


  • 6 January 2017
  • Author: Ping Zhao, PhD
  • Number of views: 1668
  • Comments: 0
Categories: PSP
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