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Hi Hötzi,
in the world of API's (and their receptors/targets) all men are not born equal. This paper might be a good illustration that one size does not necessarily fit all.
At the level of molecular pharmacology it is well illustrated by the fact that fits of effect versus concentration very often involves an empirical Hill constant that is specific to the effector at its given receptor. This is a constant that determines how steep or shallow a DRC is. By its nature it can well differ from efficacy to safety.
Fluticasone propionate or any corticosteroid for inhalation make good examples of drugs with a shallow efficacy dose-response curve, so there are almost no efficacy worries but safety is stil quite a concern.
I guess I am trying to say that yes I agree sometimes the 80.00-125.00 criterion appears too strict.
By the way, you and Ohlbe got it all wrong in your discussion of safety and benefit/risk. At EMA the decisions are not taken on basis of benefit/risk - decisions are taken only on basis of risk
in the world of API's (and their receptors/targets) all men are not born equal. This paper might be a good illustration that one size does not necessarily fit all.
At the level of molecular pharmacology it is well illustrated by the fact that fits of effect versus concentration very often involves an empirical Hill constant that is specific to the effector at its given receptor. This is a constant that determines how steep or shallow a DRC is. By its nature it can well differ from efficacy to safety.
Fluticasone propionate or any corticosteroid for inhalation make good examples of drugs with a shallow efficacy dose-response curve, so there are almost no efficacy worries but safety is stil quite a concern.
I guess I am trying to say that yes I agree sometimes the 80.00-125.00 criterion appears too strict.
By the way, you and Ohlbe got it all wrong in your discussion of safety and benefit/risk. At EMA the decisions are not taken on basis of benefit/risk - decisions are taken only on basis of risk
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
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 others Lucas 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