Bioequivalence and Bioavailability Forum • FDA: PROC MIXED (‼) for ABE

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

posted by Helmut – Vienna, Austria, 2021-09-17 19:11 (1124 d 12:17 ago) – Posting: # 22584
Views: 3,888

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!
Helmut Schütz

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

Complete thread:

Desperate reader Helmut 2021-08-27 15:51 [Regulatives / Guidelines]
- Desperate reader ElMaestro 2021-08-27 22:18
  - Misunderstanding? Helmut 2021-08-27 23:54
    - Misunderstanding? ElMaestro 2021-08-28 10:00
      - Here we are Helmut 2021-08-28 10:38
- Papers Mahmoud 2021-09-17 13:31
  - FDA: PROC MIXED (‼) for ABE Helmut 2021-09-17 15:15
    - FDA: PROC MIXED (‼) for ABE Mahmoud 2021-09-17 15:24
      - FDA: PROC MIXED (‼) for ABEHelmut 2021-09-17 17:11