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RegisterReplicate instead of Xover [Regulatives / Guidelines]
Helmut: I am not sure whether that general statement can be made. Have you seen any FDA documents stating their policy in such terms?
I know that if an innovator has set precedent with a BE study design for an MR formulation during their development program then a generic company will tend to do the same study. For example if the innovator has performed BE studies with a non-highly variable drug (non replicate) and determined BE then I do not know if a generic company during their program would be allowed {if they wish} to use a replicate design BE for their formulation. Or would the FDA direct then to use a non-replicate design.
My background is not in generics; it is in 505 b(2).
Angus
I know that if an innovator has set precedent with a BE study design for an MR formulation during their development program then a generic company will tend to do the same study. For example if the innovator has performed BE studies with a non-highly variable drug (non replicate) and determined BE then I do not know if a generic company during their program would be allowed {if they wish} to use a replicate design BE for their formulation. Or would the FDA direct then to use a non-replicate design.
My background is not in generics; it is in 505 b(2).
Angus
Complete thread:
- FDA: Draft guidance MPH suspension Helmut 2014-12-31 13:40
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA: Draft guidance MPH suspension AngusMcLean 2015-01-01 21:25
- Replicate instead of Xover Helmut 2015-01-01 23:07
- Replicate instead of XoverAngusMcLean 2015-01-02 00:22
- Replicate instead of Xover Helmut 2015-01-02 01:11
- Replicate instead of XoverAngusMcLean 2015-01-02 00:22
- Replicate instead of Xover Helmut 2015-01-01 23:07
- FDA: Draft guidance MPH suspension AngusMcLean 2015-01-01 21:25
Ing. Helmut Schütz