Missing ambulatory samples [RSABE / ABEL]

posted by M.tareq  – 2020-04-09 15:24 (194 d 10:18 ago) – Posting: # 21325
Views: 3,520

» 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 ?

Mahmoud

Complete thread:

Activity
 Admin contact
21,170 posts in 4,411 threads, 1,474 registered users;
online 5 (0 registered, 5 guests [including 5 identified bots]).
Forum time: Wednesday 01:42 CEST (Europe/Vienna)

But it is in matters beyond the limits of mere rule
that the skill of the analyst is evinced.
He makes in silence a host of observations and inferences…    Edgar Allan Poe

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