Missing ambulatory samples [RSABE / ABEL]

posted by M.tareq  – 2020-04-09 16:54  – Posting: # 21328
Views: 2,121

» Well, that’s extreme. Did I really give such an example somewhere?

Think it was mentioned here: https://bebac.at/lectures/Leuven2013WS1.pdf#page=37

not specifically AUC0-12 vs AUC0-72, but AUC with with different time points

» Up to you. As long as you describe the procedure unambiguously in the SAP (which has to be accepted by the agency), fine. That’s my standard procedure for ages. No guideline is that specific.

Guess CRO should have accounted for COVID-19 impact on missingness of ambulatory samples :-D

But as always thanks alot for your prompt reply!

Stay safe and well!

Mahmoud

Complete thread:

Activity
 Admin contact
20,647 posts in 4,328 threads, 1,436 registered users;
online 27 (1 registered, 26 guests [including 16 identified bots]).
Forum time: 12:24 CEST (Europe/Vienna)

A little Learning is a dang’rous Thing;
Drink deep, or taste not the Pierian Spring:
There shallow Draughts intoxicate the Brain,
And drinking largely sobers us again.    Alexander Pope

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