Warfarin Sodium 95% Upper bound criteria [RSABE / ABEL]

posted by Nirali  – India, 2019-01-30 15:38 (1037 d 19:41 ago) – Posting: # 19830
Views: 4,713

Dear Helmut,

I need the same guidance for Warfarin Sodium case.
If the 95% upper bound for Cmax parameter is 0.002, should we conclude this study as a bioequivalent for Cmax?

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


Regards
Nirali

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