FDA: NTI drugs [Regulatives / Guidelines]

posted by jag009  – NJ, 2016-05-16 00:26 (3193 d 00:42 ago) – Posting: # 16312
Views: 4,229

Hi,

Can someone educate me on how FDA chose a value of 0.10 to sigma w0 as the regulatory constant for the scaled reference BE analysis for an NTI drug (see warfarin BE guidance)? I kind of understand why they chose 0.25 for sigma w0 for HVDs but I don't get the reason for NTI. According to the presntation and literature from FDA, 0.1 represents a CV of ~10% :confused:

Thanks
John

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