Upper bound in RSABE ≤0 [RSABE / ABEL]

Hi Nirali,

» If the 95% upper bound for Cmax parameter is 0.002, should we conclude this study as a bioequivalent for Cmax?

No, since the upper bound has to be less or equal to zero. No rounding here …

» There is no specific criteria given for 95% upper bound in the OGD of Warfarin Sodium.

≤0 is the general rule for the FDA’s RSABE.

• Endrényi L, Tóthfalusi L. Determination of Bioequivalence for Drugs with Narrow Therapeutic Index: Reduction of the Regulatory Burden. J Pharm Pharm. 2013;16(5):676–82. PMID 24393551.

Dif-tor heh smusma 🖖
Helmut Schütz

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