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Register3-arm bio study [Design Issues]
Hello Everyone...
Can anyone through some light on the below issue please?
I am currently running a DCP procedure (1 RMS, 5 X CMS’s) for an X product in EU to secure MA for four different strengths (2.5mg, 5mg, 7.5mg and 10mg). Reference product is only available for higher strength so I applied higher strength application as 10.1 and other 3 strengths application as hybrid . WHO guidelines and available literature suggested that bio study is not required so I went a head and submitted application without a bio study. Now authorities requested us to do a bio study on higher and lower strength citing it’s non-linearity, variable absorption and also because of its AUC (it increases with less than proportional with increasing dose.)
My question is whether a three arm bio study (2.5mg x 4 vs 10mg (Test) vs 10mg (Ref) is acceptable on the above case and whether authorities allow to use two reference products (RMP & ERP) on the same DCP procedure?
Can anyone through some light on the below issue please?
I am currently running a DCP procedure (1 RMS, 5 X CMS’s) for an X product in EU to secure MA for four different strengths (2.5mg, 5mg, 7.5mg and 10mg). Reference product is only available for higher strength so I applied higher strength application as 10.1 and other 3 strengths application as hybrid . WHO guidelines and available literature suggested that bio study is not required so I went a head and submitted application without a bio study. Now authorities requested us to do a bio study on higher and lower strength citing it’s non-linearity, variable absorption and also because of its AUC (it increases with less than proportional with increasing dose.)
My question is whether a three arm bio study (2.5mg x 4 vs 10mg (Test) vs 10mg (Ref) is acceptable on the above case and whether authorities allow to use two reference products (RMP & ERP) on the same DCP procedure?
Complete thread:
- 3-arm bio studyrocky 2013-06-19 19:59
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 3-arm bio study ElMaestro 2013-06-20 09:24
- 3-arm bio study Dr_Dan 2013-06-20 09:30
- 3-arm bio study Nicolaj 2013-06-21 13:27
Ing. Helmut Schütz