Life is good [🇷 for BE/BA]

posted by ElMaestro  – Denmark, 2018-01-30 19:23 (2365 d 19:35 ago) – Posting: # 18305
Views: 13,528

Hi all,

well, pooling is good for many things. Not very good for others.

Consider also the issue with scaling in BE. We operate on basis of a variance of lnR-lnR, so to say. Not a variance of lnR-lnT or lnT-lnT. But why? - bear in mind that differences in lnT and lnR is accounted for by the fixed effect. It is because the within variance may be heavily formulation dependent. Keep this in mind when you pool different studies. You are potentially throwing a lot of variance of lnT-lnR into the pot from all sorts of different processes and formulations and batches.

To me common sense is not pooling variances from different trials. But at least trying to check fi you can relate to the published cases and picking the one you think matches your own conditions best. Yes, the amount of detail may not be enormous in a PAR. Annoying but just a fact of life. The amount of info that you do not have in a set of PARs is scientifically not compensated by pooling of variances.

Pass or fail!

Complete thread:

UA Flag
 Admin contact
23,117 posts in 4,859 threads, 1,647 registered users;
33 visitors (0 registered, 33 guests [including 6 identified bots]).
Forum time: 15:59 CEST (Europe/Vienna)

You can’t really say “similar” if it’s the same again you want.
“Similar” means something different.    Anthony Burgess

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