Group Effect in Full Replicate Design [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2018-09-12 13:09 (977 d 08:34 ago) – Posting: # 19276
Views: 4,938

Hi Gm,

» We don't want to take any decisions on the basis of model terms.

Very good.

» Our thought is, we need to check group effect for both ABE and RSABE also.

Again: you have to include “group” as a factor in various ways (see below).

» If this correct, how the model is to be designed for RSABE?

As I wrote above

» » Honestly, I have no clue how to modify the models given in the progesterone-guidance.

Specifically the scaling-part…
For the ABE part (if swR <0.294) like the FDA’s Model II:

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,462 posts in 4,487 threads, 1,514 registered users;
online 8 (0 registered, 8 guests [including 3 identified bots]).
Forum time: Sunday 21:44 UTC (Europe/Vienna)

Pharmacokinetics may be simply defined as
what the body does to the drug,
as opposed to pharmacodynamics, which may be defined as
what the drug does to the body.    Leslie Z. Benet

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