Health Canada Study reports [Regulatives / Guidelines]

posted by anky1212 – India, 2019-02-21 05:05  – Posting: # 19951
Views: 203

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

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,280 posts in 4,099 threads, 1,315 registered users;
online 8 (2 registered, 6 guests [including 6 identified bots]).

It’s easy to lie with statistics;
it is easier to lie without them.    Frederick Mosteller

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5