Good News, Bad News [Study As­sess­ment]

posted by Datacollector – United Kingdom, 2019-07-27 12:09  – Posting: # 20448
Views: 1,188

I was involved with a regular 2 way crossover with a non endogenous compound which is not very exotic. The good news was that the study comfortably met the usual bioequivalence criteria. The less good news was that there were significant period and sequence effects for both AUC and Cmax. We are assured we can ignore the sequence effect as the usual conditions for so doing apply. Looking at the period data (treating as two parallel studies) we find the T/R point estimator lies considerably below the acceptance range, while for period 2, it is rather higher than the BE acceptance range. This has given rise to some concern. Does the observation of the difference between periods negate the finding of equivalence? I should be grateful for any advice or suggestions. I don't have any obvious reason to suspect the design or conduct of the study.


Edit: Please follow the Forum’s Policy[Helmut]

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,892 posts in 4,215 threads, 1,364 registered users;
online 9 (0 registered, 9 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 23:43 CEST

I have no opinion about ‘incurred samples’ –
an expression which has no easily understandable
meaning for me in the English language.    Nick Holford

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