Missing ambulatory samples [RSABE / ABEL]

posted by M.tareq  – 2020-04-09 14:54 (199 d 01:32 ago) – Posting: # 21328
Views: 3,535

» 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
21,179 posts in 4,414 threads, 1,474 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Sunday 16:27 UTC (Europe/Vienna)

Mediocrity knows nothing higher than itself,
but talent instantly recognizes genius.    Arthur Conan Doyle

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