Group Effect in Full Replicate Design [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2018-09-12 15:09  – Posting: # 19276
Views: 1,487

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:

Cheers,
Helmut Schütz
[image]

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

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,405 posts in 4,122 threads, 1,323 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 04:34 CEST

[Those] who have an excessive faith in their theories or in their
ideas are not only poorly disposed to make discoveries, but they
also make very poor observations.    Claude Bernard

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5