Bioequivalence and Bioavailability Forum • FA0(1) in PHX: works (& more questions)

FA0(1) in PHX: works (& more questions) [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2013-08-30 19:07 (4324 d 06:41 ago) – Posting: # 11396
Views: 9,839

Hi Linda!

❝ I was able to run both LinMix and Bioeq in Phoenix and their results matched. Also when I excluded the four subjects with incomplete data, I got:

❝ PE= 90.503 90% CI: 73.561–111.347

❝ so the same as what Detlew posted in his next post with the SAS results. I emailed you a project.

THX, confirmed. I screwed up the setup (correct BE but wrong LME) – therefore the “difference”. :crying:

So is FA0(1) the solution? Is FDA’s code – calling for FA0(2) – mandatory (aka “Holy Grail”)? As Wolfgang pointed out above in the general BE guidance FDA stated:

In the Random statement, TYPE=FA0(2) could possibly be replaced by TYPE=CSH.

As we have seen in the “nonconvergent” data sets this doesn’t help at all. “Could possibly be replaced by” FA0(1) as well?
Or abandon the partial replicate completely and opt for TRT|RTR – which seems to “work” according to Detlew’s findings?

To make a long story short: What will hurt FDA more or less likely accept?

Using the partial replicate (= guidance) and switch to FA0(1) (≠ guidance), or
Using a fully replicated 3-period design (≠ guidance) and keep FA0(2) (= guidance)?

—
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Helmut Schütz

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Complete thread:

RSAB model overspecified Wolfgang 2013-08-05 14:37 [RSABE / ABEL]
- RSAB model overspecified jag009 2013-08-05 15:35
- Proc Mixed FA0(1) for partial replicate d_labes 2013-08-05 15:59
  - Proc Mixed FA0(1) for partial replicate Wolfgang 2013-08-05 16:24
    - Proc Mixed FA0(1) for partial replicate ElMaestro 2013-08-05 17:19
      - Proc Mixed FA0(1) for partial replicate Wolfgang 2013-08-06 08:35
        
        Proc Mixed FA0(1) for partial replicate ElMaestro 2013-08-06 10:34
    - Proc Mixed FA0(1) for partial replicate d_labes 2013-08-06 10:30
      - FA0(1) for partial replicate in Phoenix Helmut 2013-08-07 15:13
        
        FA0(1) for partial replicate in SAS d_labes 2013-08-08 09:42
        FA0(1) for partial replicate in Phoenix lhughes 2013-08-30 15:17
        
        FA0(1) in PHX: works (& more questions)Helmut 2013-08-30 17:07