[Opinion] Should the 90% CI for GMR be required to encompass 1 [RSABE / ABEL]

posted by bebac_fan – US, 2018-03-29 16:57 (1349 d 03:41 ago) – Posting: # 18617
Views: 8,510

Dear John

» So basically he's questioning the validity of FDA's 20% window on BE then...

Actually, I am questioning the validity of FDA's Swr scaled 10% window on BE for NTID.

If a GMR of 1.1 is clinically relevant (i.e. a test should be sensitive for this), and the NTID with a Swr of .22 will pass by ABE, this is a failure IMO.

Thanks,
BF

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