Log in
RegisterKinetica [Software]
Hi all,
"BSWP response to letter received from Dr Fuglsang regarding Kinetica software used in BE studies (EMA/1085 07/2015). The CHMP discussed the BSWP response and concluded that no medically relevant impact could be observed following the assessed studies. The Committee agreed that a response to CMDh should be drafted by BSWP as well as a response letter to Dr Fuglsang."
I tried to read the sentence a few times but I am not convinced I understand what they are actually saying. If I get it right there is no problem. I can live with that as I am not on a personal crusade against anything or anyone. Haha I am just a scientist and not even a good one at that.
Most of us have been involved in handling of narrowly failing drugs. The acceptance range 80.00%-125.00% is very strictly enforced. Two decimals. And that's it.
I am under the impression that the error introduced by Kinetica on the PE can be somewhat higher than that zero tolerance regulators enforce. Is that not a little strange? Perhaps I should just put this entire story into the odd sock drawer and consider it another curiosum which I can't fathom much like Conchita Wurst, the Danish soccer championsship in 1992, or the reason why anyone would wish to put raisins or cornflakes inside RitterSport?
Edit: Category changed. [Helmut]
"BSWP response to letter received from Dr Fuglsang regarding Kinetica software used in BE studies (EMA/1085 07/2015). The CHMP discussed the BSWP response and concluded that no medically relevant impact could be observed following the assessed studies. The Committee agreed that a response to CMDh should be drafted by BSWP as well as a response letter to Dr Fuglsang."
I tried to read the sentence a few times but I am not convinced I understand what they are actually saying. If I get it right there is no problem. I can live with that as I am not on a personal crusade against anything or anyone. Haha I am just a scientist and not even a good one at that.
Most of us have been involved in handling of narrowly failing drugs. The acceptance range 80.00%-125.00% is very strictly enforced. Two decimals. And that's it.
I am under the impression that the error introduced by Kinetica on the PE can be somewhat higher than that zero tolerance regulators enforce. Is that not a little strange? Perhaps I should just put this entire story into the odd sock drawer and consider it another curiosum which I can't fathom much like Conchita Wurst, the Danish soccer championsship in 1992, or the reason why anyone would wish to put raisins or cornflakes inside RitterSport?
Edit: Category changed. [Helmut]
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- KineticaElMaestro 2015-06-03 17:57 [Software]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
Ing. Helmut Schütz