Bioequivalence and Bioavailability Forum • EMA: all effects fixed

EMA: all effects fixed [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2013-10-08 16:08 (4236 d 11:14 ago) – Posting: # 11625
Views: 5,380

Hi RK,

❝ […] if the study is for EMEA submission, random effect will not be considered, but where as in the below given program treatment effect given as both fixed and random. what to do???

For unscaled use Proc GLM dropping the RANDOM line (I guess – don’t speak SAS). For scaling use EMA’s code in the Q&A-document. Seems that “Method A” is preferred over “Method B”.

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Complete thread:

Clarification on model statement in EMEA submission RK 2013-10-08 13:39
- EMA: all effects fixedHelmut 2013-10-08 14:08
  - EMA: all effects fixed RK 2013-10-09 06:32
    - EMA: all effects fixed - Method A! d_labes 2013-10-09 08:30
    - EMA: Method C “incompatible with CHMP GL” Helmut 2013-10-09 14:50
      - EMA: Method C “incompatible with CHMP GL” RK 2013-10-10 06:01