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Hi everybody!
I would love to see studies showing that the 80-125% and also Reference-scaling are actually good. I'm not an expert in physiology, and maybe that's the problem, but I think that this is a very strong statement when you say that some drugs does not show difference in efficacy/safety when the 80-125% criteria is applied. Even worst may be for HVDPs. It is scientifically proved that higher the CV wider is the therapeutic index? Do all drugs, regardless of class or indication, have similar PBPK/PD relation?
❝ Maybe. The origin of these limits lies in the dark ages.
❝ • Reference-scaling for HVDPs is dependent on the CVWR estimated in particular studies. That’s completely different from the “one size fits all” 80/125-concept. Sooner or later we will have generics of HVDPs on the market which were approved according to different rules.
I would love to see studies showing that the 80-125% and also Reference-scaling are actually good. I'm not an expert in physiology, and maybe that's the problem, but I think that this is a very strong statement when you say that some drugs does not show difference in efficacy/safety when the 80-125% criteria is applied. Even worst may be for HVDPs. It is scientifically proved that higher the CV wider is the therapeutic index? Do all drugs, regardless of class or indication, have similar PBPK/PD relation?
Complete thread:
- Article: BE-criteria too strict sometimes? Helmut 2014-09-23 12:39 [BE/BA News]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Article: BE-criteria too strict sometimes? Ohlbe 2014-09-23 22:20
- Risk assessment Helmut 2014-09-24 03:34
- Risk assessment Ohlbe 2014-09-24 10:22
- Risk assessment nobody 2014-09-30 17:59
- Risk assessment Helmut 2014-10-01 13:02
- Risk assessment nobody 2014-10-01 13:32
- Risk assessment Helmut 2014-10-01 13:02
- Risk assessment nobody 2014-09-30 17:59
- Risk assessment Ohlbe 2014-09-24 10:22
- Risk assessment Helmut 2014-09-24 03:34
- Are all men born equal? ElMaestro 2014-09-24 11:20
- Article: BE-criteria too strict sometimes? felipeberlinski 2014-09-24 18:47
- Some animals are more equal than others Helmut 2014-09-24 19:14
- Some animals are more equal than others nobody 2014-09-24 20:32
- Some animals are more equal than othersLucas 2014-10-14 17:02
- Some animals are more equal than others Helmut 2014-10-14 21:15
- Some animals are more equal than others Lucas 2014-10-14 22:25
- Some animals are more equal than others Helmut 2014-10-15 03:20
- Some animals are more equal than others Lucas 2014-10-14 22:25
- Some animals are more equal than others Helmut 2014-10-14 21:15
- Article: BE-criteria too strict sometimes? Ohlbe 2014-09-23 22:20
Ing. Helmut Schütz