anky1212
☆    

India,
2019-02-21 04:05

Posting: # 19951
Views: 775
 

 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
Activity
 Admin contact
20,801 posts in 4,354 threads, 1,446 registered users;
online 12 (0 registered, 12 guests [including 8 identified bots]).
Forum time: 14:46 UTC (Europe/Vienna)

If a man will begin with certainties, he will end in doubts;
but if he will be content to begin with doubts,
he will end in certainties.    Francis Bacon

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