nitpicking [PK / PD]

posted by ElMaestro  – Denmark, 2012-03-21 18:32 (4028 d 11:22 ago) – Posting: # 8307
Views: 6,885

Dear HS,


❝ For Cmax and AUC there’s a consensus that these metrics are lognormal.

No. There is consensus that you have to analyse the data as though they (the residuals) were normal. It does not mean it is assumed that they are. Regulators, some of them at least, know that normality sometimes really, truly isn't the case but they are willing to ignore this at the evaluation stage.


Anyways, as usual I have no qualified response to any of the core stuff you have raised in this thread. Have a good day.

Pass or fail!

Complete thread:

UA Flag
 Admin contact
22,560 posts in 4,725 threads, 1,607 registered users;
17 visitors (0 registered, 17 guests [including 4 identified bots]).
Forum time: 06:54 CEST (Europe/Vienna)

No written law has ever been more binding than
unwritten custom supported by popular opinion.    Carrie Chapman Catt

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