FDA: PROC MIXED (‼) for ABE [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-09-17 19:11 (507 d 12:22 ago) – Posting: # 22584
Views: 1,897

Dear Mahmoud!

Dear Dr Helmut


Not a doctor. No intentions to become one. Told you that numerous times before.

❝ If SAS® is used for statistical analysis

❝ PROC MIXED should be used for fully replicated (4-way) BE studies

❝ PROC GLM should be used for partially replicated (3-way) BE studies


Since you didn’t bother to read the entire thread as suggested – and not even the subject line of my post – would you mind to digest this one?

Your quote refers to Reference-scaled Average Bioequivalence (\(\small{s_\textrm{wR}\geq 0.294}\)).
However, for (conventional, unscaled) Average Bioequivalence (\(\small{s_\textrm{wR}<0.294}\)) PROC MIXED should be used regardless the design.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
22,481 posts in 4,710 threads, 1,603 registered users;
22 visitors (0 registered, 22 guests [including 12 identified bots]).
Forum time: 06:34 CET (Europe/Vienna)

The difference between a surrogate and a true endpoint
is like the difference between a cheque and cash.
You can get the cheque earlier but then,
of course, it might bounce.    Stephen Senn

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