Reference replicated designs [Regulatives / Guidelines]

posted by rajasekharkakarla – India, 2019-09-20 04:35 (486 d 11:50 ago) – Posting: # 20628
Views: 1,314

Dear All,

As per FDA guidelines "We recommend that if the predose value is greater than 5 percent of Cmax, you drop the subject from all BE study evaluations".

Is it applicable for fully replicated designs also, if i got greater than 5% Cmax in period 4 whether i need to exclude the subject from entire study or can we use available data for Swr calculations if subject completed two reference treatment periods.

Thanks&Regards,
Rajasekhar

Complete thread:

Activity
 Admin contact
21,303 posts in 4,441 threads, 1,487 registered users;
online 9 (0 registered, 9 guests [including 3 identified bots]).
Forum time: Monday 16:26 UTC (Europe/Vienna)

I believe there is no philosophical high-road in science,
with epistemological signposts. No, we are in a jungle
and find our way by trial and error,
building our road behind us as we proceed.    Max Born

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5