Missing ambulatory samples [RSABE / ABEL]

posted by M.tareq  – 2020-04-09 15:24 (171 d 21:43 ago) – Posting: # 21325
Views: 3,412

» I like your examples! That’s an area of improvement which requires a good amount of intellectual horsepower. Not easy but the idea is to come up with rules specifying how many missings (and where) in the profile will likely lead to unreliable estimates of a given PK metric.

In one of your lectures, you mentioned comparing the two profile as is, meaning AUC0-12 to AUC0-72, but won't be comparing orange vs apples, mean, if, for example the first AUC0-12 (drug A) covers 50% of the profile while the comparator AUC0-72 (drug B) covers 80%, is this a biased comparison?

Other method that was mentioned in the forum/lectures more often; is is doing log-linear regression using the terminal part of the profile with missing points and perform extrapolation to estimate such points, but no mentioned of such methods in any of the guidelines

my question is: if comparing AUC0-t as is (missing points are ignored) without doing the extrapolation and the BE criteria not met but when doing the extrapolation the BE is achieved, how such predicament will be handled by the assessor and/or CRO ?


Complete thread:

 Admin contact
21,082 posts in 4,397 threads, 1,468 registered users;
online 7 (0 registered, 7 guests [including 4 identified bots]).
Forum time: Monday 13:07 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

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