Bioequivalence and Bioavailability Forum • Potvin et al: effects in stage 2

Potvin et al: effects in stage 2 [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2009-10-16 15:32 (5302 d 18:27 ago) – Posting: # 4368
Views: 6,407

Dear Earlybird!

❝ we are planning a two-stage Design according Method B, Diane Potvin.

Method B = “Gürtel mit Hosenträgern”. SCNR; this is a German proverb for overweariness, which roughly translates into “waistbelt plus suspenders”.

❝ Does somebody know if the ANOVA statement has to be adapted? I.E. to add stage, stage-treatment interaction as fixed effects and subject nested within (stage × sequence) as random effect.

At least if you proceed to the second stage (see the last page of the methods-section of Potvin’s paper). Just checked it in one of my studies (Method C, which was accepted by the BfArM) – difference in the CI was 0.15% (with/without effects)… However, even if you find significant effects, no poolability criteria are to be applied anyhow.

If you have time, go and meet Diane Potvin in Ottawa.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

Two Stage Desing: ANOVA earlybird 2009-10-16 11:25
- Potvin et al: effects in stage 2Helmut 2009-10-16 13:32
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