Cmax is out of the range [Study As­sess­ment]

posted by jag009  – NJ, 2018-08-02 15:56  – Posting: # 19128
Views: 1,557

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:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,883 posts in 4,214 threads, 1,365 registered users;
online 19 (1 registered, 18 guests [including 9 identified bots]).
Forum time (Europe/Vienna): 15:24 UTC

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5