Group Effect in Full Replicate Design [RSABE / ABEL]

posted by GM – India, 2018-09-12 07:17 (1437 d 02:26 ago) – Posting: # 19267
Views: 6,363

Dear All,

Hope all are doing well.

We are conducting a BE study of Highly variable drug in patient population. This study will be conducted in 3 groups, which are seperated by one month from each other. There is no clarity in the guidance to check the group effect for this design.

Our doubt is, whether the group effect should be checked in the full replicate design or not?

If so, what are the fixed/random effets need to be checked in RSABE and ABE?

Kindly explain.

Best Regards,
GM

Complete thread:

UA Flag
Activity
 Admin contact
22,305 posts in 4,668 threads, 1,587 registered users;
online 10 (0 registered, 10 guests [including 3 identified bots]).
Forum time: Friday 09:44 CEST (Europe/Vienna)

Doctors are men who prescribe medicines of which they know little,
to cure diseases of which they know less,
in human beings of whom they know nothing.    Voltaire

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