Bioequivalence and Bioavailability Forum • Papers

Papers [Regulatives / Guidelines]

posted by Mahmoud – Jordan, 2021-09-17 15:31 (948 d 18:16 ago) – Posting: # 22580
Views: 2,545

Dear all

Dr Anders Fuglsang discussed in his paper

Mitigation of the convergence issues associated with semi-replicated bioequivalence data. Pharmaceutical Statistics. 2021;1–3
used the proc mixed in RTR/TRR/RRT design in ABE

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

M.Youseef

Edit: Post moved. [Helmut]

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
- PapersMahmoud 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 ABE Helmut 2021-09-17 17:11