Missing ambulatory samples [RSABE / ABEL]

posted by M.tareq  – 2020-04-09 16:54 (122 d 17:13 ago) – Posting: # 21328
Views: 2,902

» 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
20,991 posts in 4,375 threads, 1,460 registered users;
online 12 (0 registered, 12 guests [including 10 identified bots]).
Forum time: Monday 10:08 CEST (Europe/Vienna)

[Those] who have an excessive faith in their theories or in their
ideas are not only poorly disposed to make discoveries, but they
also make very poor observations.    Claude Bernard

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