rajasekharkakarla
☆    

India,
2019-09-20 08:35
(1677 d 03:32 ago)

Posting: # 20628
Views: 1,784
 

 Reference replicated designs [Regulatives / Guidelines]

Post reply
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
 
UA Flag
Activity
 Admin contact
22,990 posts in 4,826 threads, 1,664 registered users;
63 visitors (0 registered, 63 guests [including 4 identified bots]).
Forum time: 12:08 CEST (Europe/Vienna)

If you don’t like something change it;
if you can’t change it, change the way you think about it.    Mary Engelbreit

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