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 According to the draft guidance, we need to compute the 95% Upper Bound confidence interval base on RSABE analysis using the NTI regulatory constant and delta 0.1111.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
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 According to the draft guidance, we need to compute the 95% Upper Bound confidence interval base on RSABE analysis using the NTI regulatory constant and delta 0.1111.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
Complete thread:
- Warfarin Guidancejag009 2016-06-22 19:43 [Regulatives / Guidelines]
- Warfarin Guidance Helmut 2016-06-22 21:12
- Warfarin Guidance jag009 2016-06-27 16:40
- Warfarin Guidance Helmut 2016-06-22 21:12