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Registergender specific generics? [Surveys]
Dear Dan,
Well, that can't be ruled out but you make a good case why it isn't.
I do not have an explanation. I am thinking into coating or other excipients but have not heard of any such things having gender specificity.
In principle a story like this deserves publication, but I would not be surprised if originator companies would use it against the generic industry in an attempt to make life difficult.
Another thing: Sometimes males and females are separated (dosing, sleeping, meals etc) at CROs. Do you know if this was the case in your studies? I think I would look into this aspect; after all, subtle differences in habits and the fact that BE studies are open-label could play a role, although I will not speculate into exactly how this might be with the present knowledge.
And oh please, include me on the recipient list for the data
❝ Is this just a statistical artefact?
Well, that can't be ruled out but you make a good case why it isn't.
❝ Looking forward to your reply
I do not have an explanation. I am thinking into coating or other excipients but have not heard of any such things having gender specificity.
In principle a story like this deserves publication, but I would not be surprised if originator companies would use it against the generic industry in an attempt to make life difficult.
Another thing: Sometimes males and females are separated (dosing, sleeping, meals etc) at CROs. Do you know if this was the case in your studies? I think I would look into this aspect; after all, subtle differences in habits and the fact that BE studies are open-label could play a role, although I will not speculate into exactly how this might be with the present knowledge.
And oh please, include me on the recipient list for the data
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- gender specific generics? Dr_Dan 2011-02-17 10:34
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- gender specific generics? ElMaestro 2011-02-17 13:54
- gender specific generics? Dr_Dan 2011-02-17 15:09
- gender specific generics? ElMaestro 2011-02-17 15:44
- gender specific generics? Dr_Dan 2011-03-11 15:24
- gender specific generics? Helmut 2011-03-11 15:32
- gender specific generics?ElMaestro 2011-03-11 16:37
- gender specific generics? Dr_Dan 2011-03-14 09:20
- Formulation-by-gender interaction? d_labes 2011-03-14 08:32
- gender specific generics? Dr_Dan 2011-03-11 15:24
- gender specific generics? ElMaestro 2011-02-17 15:44
- gender specific generics? Dr_Dan 2011-02-17 15:09
- gender specific generics? ElMaestro 2011-02-17 13:54
Ing. Helmut Schütz