Treatment effect justification [General Sta­tis­tics]

posted by ElMaestro  – Belgium?, 2020-10-07 10:19 (24 d 14:11 ago) – Posting: # 21974
Views: 413

Hi Siva Krishna,

something like this:

"The test producing a significant treatment effect is that log(y)T=log(y)R where y is the dependent variable (AUC or Cmax). This is not the hypothesis evaluated for the conclusion of bioequivalence. It is entirely expected that Test and Reference could be associated with different levels of (logarithmic) Cmax or AUC as they are truly two different formulations. What the evaluation for bioequivalence shows is that the difference in rate and extent and absorption does not differ by a clinically relevant margin, where clinical relevance is determined by the regulatory convention. Therefore the significant formulation effect does not translate, in this case, into inability to conclude bioequivalence."

Good luck.:-)

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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