PK modeling in BE [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2020-07-19 12:35 (26 d 15:23 ago) – Posting: # 21749
Views: 606

Hi mittyri,

» Are you referring to this one?

Nope, an even worse one. I’ll send it to you by PM.
If you have nothing better to do, watch this recording (navigate to 01:27:02 for the presentation “Improved bioequivalence assessment through model-informed and model-based strategies”) of the 2020 Generic Drug Regulatory Science Initiatives Public Workshop.

Slide 14 (left) shows the Type I Errors for the standard NCA and the model based approach. Why should be even their average in NCA >5%? Sumfink stinks here.

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