Bioequivalence and Bioavailability Forum

Dear All,

Please any one suggest what are the main differences of Analysis for EMEA and USFDA Reference Scaled Study.

For USFDA, The 95% upper confidence bound for Square(YT -YR)-theta* within subject variability <=0
And the point estimate of the Test/Reference geometric mean ratio must fall within [0.80, 1.25]
For EMEA [U,L]= Exp[+/- k.swr] where k= 0.760,and swr = within subject variability of ln transformed of Cmax. CV % = 100*Exp(squre swr)-1 > 30% then our acceptance limit can be wide according to variability.

Is above main difference between USFDA and EMEA approach for reference scaled.

if else any other differences in approaches please suggest me. and how to do the analysis and any other criteria or any specification for regulatory also please suggest.


Thanks & Regards,
RS

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Edit: Category changed. [Helmut]