Bioequivalence and Bioavailability Forum 23:11 CET

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Cmax is out of the range [Study As­sess­ment]

posted by jag009 - NJ, 2018-08-02 17:56  - Posting: # 19128
Views: 679

Hi,

» We recently conducted a BE trial. It was a classical 2-period, 2-sequence study of a drug that consists of a combination of two active substances. Unfortunately, results one of analytes, a parent drug, fell sightly outside of the 80-125% range, below 80% for Cmax. CV was below 30% and post-hoc power was less than 80% for this analyte...

Sorry, there is no way for you to argue.
John

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