Bioequivalence and Bioavailability Forum

Cmax is out of the range [Study Assessment]

posted by jag009 – NJ, 2018-08-02 19:56 (2092 d 06:34 ago) – Posting: # 19128
Views: 4,030

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

Complete thread:

Cmax is out of the range Mikalai 2018-08-01 12:05
- Bad luck Helmut 2018-08-01 13:37
  - Bad luck Mikalai 2018-08-01 13:50
    - Cherry-picking Helmut 2018-08-01 15:01
- Cmax is out of the rangejag009 2018-08-02 17:56

Cmax is out of the range [Study As­sess­ment]

Complete thread:

Cmax is out of the range [Study Assessment]