Upper bound in RSABE ≤0 [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2019-02-02 15:15 (1998 d 00:10 ago) – Posting: # 19844
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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.
See also Jay’s post above, this thread, and a paper of the two Lász­lós.*



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