FDA NTI BE requirement: Intra-Variability Test [Regulatives / Guidelines]

posted by jag009  – NJ, 2016-09-02 04:49 (3081 d 14:03 ago) – Posting: # 16621
Views: 3,920

Hi,
Can someone explain to me what the 2.5 cutoff for the Within subject (T/R) Variability Test is based on? I read the paper from FDA but it doesn't seem to provide a clear answer (at least to me).

Thanks
John

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