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RegisterIV formulation [Design Issues]
Hello Helmut
Good to see you in Ljubljana. As I've said before, keep fighting the good fight!
I've been asked to design a BE study for an IV formulation. It is expected that proof of BE will be required because of differences in how the formulation has been put together compared to reference. In my view (based on NO experience!), IV administration (in this case, a 1-hour infusion) should ensure very low intra-subject CVs for Cmax and AUC because BA will be 100% in all cases. This should allow for a small study (perhaps only 12 subjects) if all the other usual assumptions apply.
Do you concur, or is there something I'm missing?
Kind regards
Andrew
Good to see you in Ljubljana. As I've said before, keep fighting the good fight!
I've been asked to design a BE study for an IV formulation. It is expected that proof of BE will be required because of differences in how the formulation has been put together compared to reference. In my view (based on NO experience!), IV administration (in this case, a 1-hour infusion) should ensure very low intra-subject CVs for Cmax and AUC because BA will be 100% in all cases. This should allow for a small study (perhaps only 12 subjects) if all the other usual assumptions apply.
Do you concur, or is there something I'm missing?
Kind regards
Andrew
Complete thread:
- IV formulationDr Andrew Leary 2010-05-21 10:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- IV formulation Helmut 2010-05-21 12:56
- IV formulation Dr Andrew Leary 2010-05-21 13:26
- IV formulation Helmut 2010-05-21 13:36
- IV formulation Dr Andrew Leary 2010-05-21 13:26
- IV formulation Helmut 2010-05-21 12:56
Ing. Helmut Schütz