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

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

posted by Helmut – Vienna, Austria, 2021-09-17 17:15 (951 d 00:46 ago) – Posting: # 22581
Views: 2,592

Hi Mahmoud,

❝ I think that using proc mixed to fit RTR/TRR/RRT design is not suitable, because in most cases proc mixed produced Estimated G matrix is not positive definite.

❝

❝ So proc GLM recommended by FDA and Emea is more appropriate in the Semi-replicated designs

Please read the entire thread again. The FDA does recommend PROC MIXED for ABE in all guidances.
That’s the problem.

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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 ABEHelmut 2021-09-17 15:15
    - FDA: PROC MIXED (‼) for ABE Mahmoud 2021-09-17 15:24
      - FDA: PROC MIXED (‼) for ABE Helmut 2021-09-17 17:11