Cmax is out of the range [Study Assessment]
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?