Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission [Bioanalytics]

posted by Ohlbe – France, 2024-06-03 11:13 (401 d 03:31 ago) – Posting: # 24017
Views: 3,681

Dear Shreyas,

❝ What can be the consequences if drop out subjects due to personal reason or protocol non-compliance are been analyzed during bioanalytical stage.


The guidance says that you do not have to analyse them, not that you should not analyse them. They're just trying to spare you some time and money. If you have already spent them, well, too bad for you, but I don't see why they would care.

Regards
Ohlbe

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,687 registered users;
49 visitors (0 registered, 49 guests [including 8 identified bots]).
Forum time: 14:44 CEST (Europe/Vienna)

If I’d observed all the rules,
I’d never have got anywhere.    Marilyn Monroe

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