Warfarin Guidance [Regulatives / Guidelines]

posted by jag009  – NJ, 2016-06-22 21:43 (3159 d 07:46 ago) – Posting: # 16444
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Hi,

Can someone clarify something for me on FDA's Warfarin guidance? What is the first requirement for BE? According to the draft guidance, we need to compute the 95% Upper Bound confidence interval base on RSABE analysis using the NTI regulatory constant and delta 0.1111. If I read the guidance correctly then the 95% UB confidence interval should be LE to 0 then?

The 2nd (90% CI) and 3rd (T/R Within Subject SD Ratio LE 2.5) criteria are clear..

Thanks

John

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