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RegisterCmax is out of the range [Study Assessment]
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?
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?
Complete thread:
- Cmax is out of the rangeMikalai 2018-08-01 12:05 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bad luck Helmut 2018-08-01 13:37
- Bad luck Mikalai 2018-08-01 13:50
- Cherry-picking Helmut 2018-08-01 15:01
- Bad luck Mikalai 2018-08-01 13:50
- Cmax is out of the range jag009 2018-08-02 17:56
- Bad luck Helmut 2018-08-01 13:37
Ing. Helmut Schütz