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RegisterFDA: NTI drugs [Regulatives / Guidelines]
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%
Thanks
John
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%
Thanks
John
Complete thread:
- FDA: NTI drugsjag009 2016-05-15 22:26 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA: NTI drugs; switching condition Helmut 2016-05-16 14:15
Ing. Helmut Schütz