Back to the Future [Design Issues]

posted by Astea – Russia, 2016-03-29 23:57 (3240 d 01:25 ago) – Posting: # 16153
Views: 23,494

Dear Helmut!

❝ What is sufficient for them? Anything ≥80%? Smells of the end of Appendix 3 of Russia’s GLs of 2004 and 2008


You are reading my thoughts, I've just remembered that formulas, they go from russian recomendations, 2004.

[image]

      In case of disruption the assumption for mean values equality the equation could be modified like this:

[image]


By the way, there is a mistake in the first formula: comparing it with the data provided in this article (Chow S.-C., Wang H. On Sample Size Calculation in Bioequivalence Trials, Journal of Pharmacokinetics and Pharmacodynamics, Vol. 28, No. 2, 2001;12(12):1865–8. Chow S.-C., Wang H.) there should be β/2.

Funny is that there was no formal occasion to ask us to calculate it, the rest is not funny at all. :-(

So if they want aposteriory power they'll get it. I'll just take the principles, kindly presented by yicaoting  , and calculate something like winnonlin's power. Of course it would be greater (completely different sense), hoping it would be sufficient...

"Being in minority, even a minority of one, did not make you mad"

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