Bioequivalence and Bioavailability Forum • Warfarin Guidance

jag009
★★★

NJ,
2016-06-22 21:43
(2863 d 14:21 ago)

Posting: # 16444
Views: 4,406

Warfarin Guidance [Regulatives / Guidelines]

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 According to the draft guidance, we need to compute the 95% Upper Bound confidence interval base on RSABE analysis using the NTI regulatory constant and delta 0.1111.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

Helmut
★★★

Vienna, Austria,
2016-06-22 23:12
(2863 d 12:52 ago)

@ jag009
Posting: # 16445
Views: 3,838

Warfarin Guidance

Post reply

Hi John,

❝ If I read the guidance correctly then the 95% UB confidence interval should be LE to 0 then?

Nothing more. You passed the RSABE-part (continue with the #2 and #3 you mentioned).
If >0, end of story.

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jag009 ★★★ NJ, 2016-06-27 18:40 (2858 d 17:24 ago) @ Helmut Posting: # 16455 Views: 3,613	Warfarin Guidance Post reply
	Thanks Helmut.