PK modeling in BE [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2020-07-16 16:30 (29 d 09:07 ago) – Posting: # 21719
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Hi Mahmoud,

» There have been some publications: […] about using model-based approach to drive BE, though as you said it's not acceptable in BE "yet", do you think in the near future we will see model based BE studies approved by regulators?

I’m not very optimistic, esp. when dealing with missing data or – even worse – sparse sampling. Mats Karlson (quoted in your second reference) is extremely clever and France Mentré has my deepest respect when it comes to PopPK. However, last year at the 10th American Conference on Pharmacometrics (20–23 October, Orlando) she gave a presentation “Evaluation of Model Based BioEquivalence (MBBE) statistical approaches for sparse designs PK studies” with a whoopy mean (!) Type I Error of 7.6%. :-(

I hope that we can clarify things later this year.

Dif-tor heh smusma 🖖
Helmut Schütz
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