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

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

posted by Mahmoud – Jordan, 2021-09-17 17:24 (945 d 04:37 ago) – Posting: # 22582
Views: 2,599

❝ Please read the entire thread again. The FDA does recommend PROC MIXED for ABE in all guidances.

❝ That’s the problem.

Dear Dr Helmut

Draft Guidance on Progesterone

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

or other software accomplishes same objectives

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]

Complete thread:

Desperate reader Helmut 2021-08-27 15:51
- 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 ABEMahmoud 2021-09-17 15:24
      - FDA: PROC MIXED (‼) for ABE Helmut 2021-09-17 17:11