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

posted by d_stat – Slovenia, 2021-07-19 16:26 (92 d 06:43 ago) – Posting: # 22478
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Dear Helmut,

I have a questions regarding analysis of two-stage Potvin C data, i.e. with regard to interaction stage*formulation that mentioned here:

» 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.

Are you aware of any literature or guidance that would suggest that poolability of stages still applies even in case of significant formulation*stage interaction?

Thank you.

Regards

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