Bioequivalence and Bioavailability Forum

Dear Gstat,

Please clarify, for reference Scale Design in USFDA submission :

Our BE criteria: Upper bound of 95% CI of (µT-µR)2 – θ σ2wr <= 0

Where θ = scaled average BE limit and θ = (ln Δ)2/ σ2wo Where σwo = 0.25

is that correct or not.

Thanks & Regards,
RS

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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]