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

posted by jag009 – NJ, 2016-09-02 04:49 (3226 d 13:46 ago) – Posting: # 16621
Views: 4,181

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

Complete thread:

FDA NTI BE requirement: Intra-Variability Testjag009 2016-09-02 02:49 [Regulatives / Guidelines]
- Gut feeling d_labes 2016-09-02 12:38

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