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