Incorporation of Dose in statistical Model [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2012-04-07 15:07 (5198 d 07:36 ago) – Posting: # 8394
Views: 1,805

Hello Pash,

I must admit that I also find it a little weird.

The drug is dosed according to the approximate surface area. If you wish to include dose in the stats model it must be absolute dose rather than dose divided by area (expressed as mg/m2 will be the same across all subjects). Absolute dose then comes in as a covariate, I guess. But as you say, for each subject the absolute dose will be the same in both periods within any subject. So I can't imagine inclusion of dose achieves much.

I guess (and I literally mean this is a guess) that the model is:
y=intercept+Seq+Subj+Trt+Per+Dose, where the first four are fixed factors and the last one is a covariate. Or...?

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,656 posts in 4,994 threads, 1,570 registered users;
309 visitors (0 registered, 309 guests [including 18 identified bots]).
Forum time: 22:43 CEST (Europe/Vienna)

Try to learn something about everything
and everything about something.    Thomas Henry Huxley

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