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Back to the forum  Query: 2017-11-22 10:23 CET (UTC+1h)
 

I've meditated hard [Two-Stage / GS Designs]

posted by ElMaestro - Denmark, 2017-11-14 12:41  - Posting: # 17979
Views: 303

Hi Hötzi,

» That’s not my point. Meditate over my example. We would initiate the second stage with 28 subjects (driven by the CV of Cmax 0.30) but should stop after the first stage for AUC (CV 0.20).

Can you reformulate?
I meditated hard and I don't see why my suggestion does not address it. It will treat AUCt as if it having a higher CV for everything except BE evaluation. It is if I get your question correctly exactly what is going on.
So perhaps I did not understand you. While I sit in Lotus position and humming gently, do you think you could somehow put other words to the part I don't get?

I could be wrong, but…


Best regards,
ElMaestro

No, I still don't believe much in the usefulness of IVIVCs for OIPs when it comes to picking candidate formulations for the next trial. This is not the same as saying I don't believe in IVIVCs.

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