Reference replicated designs [Regulatives / Guidelines]

posted by rajasekharkakarla – India, 2019-09-20 08:35 (1651 d 11:06 ago) – Posting: # 20628
Views: 1,735

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:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
72 visitors (0 registered, 72 guests [including 4 identified bots]).
Forum time: 18:42 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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