anky1212
☆    

India,
2019-02-21 06:05
(1863 d 10:35 ago)

Posting: # 19951
Views: 1,224
 

 Health Canada Study reports [Regulatives / Guidelines]

Dear All,

As per Health canada guidance document, "To avoid study bias, comparative bioavailability studies should be conducted in such a way that the subjects are not aware of which product (test or reference) is being administered. Furthermore, the persons checking for adverse reactions and those conducting the bioanalysis of samples should not know the treatment sequence."

In this case, if adverse events is ongoing, analysis both analytical and statistical phase completed, shall we submit treatment or code in study report?

Upto which phase guidance is applicable?

After completion of statistical phase if adverse event is still ongoing, still we need to follow guidance?

Thanks
Ankur Patel
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
117 visitors (0 registered, 117 guests [including 3 identified bots]).
Forum time: 16:40 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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