Bioequivalence and Bioavailability Forum • Get v6.4

Get v6.4 [Software]

posted by Helmut – Vienna, Austria, 2017-04-26 21:16 (2936 d 13:21 ago) – Posting: # 17273
Views: 6,402

Hi Artem,

for the EMA (and agencies recommending its approach) all effects fixed.
In the Bioequivalence object > Fixed Effects > Model Specification:
sequence+subject(sequence)+period+treatment
Make sure that in Variance Structure both Random 1 and Repeated are empty.
For agencies recommending a mixed-effects model (FDA, Health Canada):
In the Bioequivalence object > Fixed Effects > Model Specification:
sequence+period+treatment
In Variance Structure Random 1: subject(sequence)

Out of the box Phoenix/WinNonlin suggests the mixed-effect model. Since it is annoying to change the specification if you have to deal mainly with the EMA’s model, there is an option since v6.4:
Edit > Preferences… > LinMixBioequivalence ☑ Default for 2x2 crossover set to all fixed effects

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Complete thread:

Anova table in Phoenix using the EMA model mittyri 2015-11-16 06:27 [Software]
- Get v6.4 Helmut 2015-11-17 15:00
  - Get v6.4 Artem Gusev 2017-04-26 17:03
    - Get v6.4Helmut 2017-04-26 19:16
      - Get v6.4 Artem Gusev 2017-04-27 09:12