Different N's for different analytes [Regulatives / Guidelines]
Dear Dave,
I have seen such studies in the wild quite recently, targeted to EMA, where only a subgroup of subjects samples were analyzed for a second analyte.
Regulatory acceptance: Duno exactly. At least no deficiency letters w.r.t to this fact up to now. But usually only very rare feedback is given from sponsors back to CRO w.r.t. regulatory decisions.
To be on the save side consider going for a scientific advice beforehand.
I have seen such studies in the wild quite recently, targeted to EMA, where only a subgroup of subjects samples were analyzed for a second analyte.
Regulatory acceptance: Duno exactly. At least no deficiency letters w.r.t to this fact up to now. But usually only very rare feedback is given from sponsors back to CRO w.r.t. regulatory decisions.
To be on the save side consider going for a scientific advice beforehand.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- Different N's for different analytes? ddubins 2007-12-05 16:16 [Regulatives / Guidelines]
- Different N's for different analytes? Charl 2007-12-06 11:28
- Different N's for different analytes? zizou 2015-12-06 22:47
- Different N's for different analytes? nobody 2015-12-09 09:13
- Different N's for different analytesd_labes 2015-12-08 09:49