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Cmax is out of the range [Study As­sess­ment]

posted by Mikalai - Belarus, 2018-08-01 12:05  - Posting: # 19121
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Dear all,
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. Are there any ways we can defend bioequivalence without conducting another BE trail? All other analytes fell within 80-125%. Specifically, what should we put in the protocol or in a supporting letter to justify our lower border of CI around 79% for Cmax?

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