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Registerserious risk to public health [RSABE / ABEL]
Dear Pash413
In the concept of bioequivalence bioavailability is taken as a surrogate parameter for safety and efficacy. If you observe zero concentrations throughout all the sampling points for test formulation in at-least one period in ~ 45 % subjects this would mean that in consequence this formulation would not be effective in a great portion of patients. The originator has demonstrated safety and efficacy in clinical trials. So your argumentation that zero concentrations throughout the all the sampling points for reference formulation in at-least one period in ~ 50 % subjects was shown and similar results were observed for this molecule in other literature too does not help.
If you claim that your formulation is as bad as the originator you have to proof that your observations are no artefact. If this is not possible you have to provide clinical data.
Kind regards
Dr_Dan
In the concept of bioequivalence bioavailability is taken as a surrogate parameter for safety and efficacy. If you observe zero concentrations throughout all the sampling points for test formulation in at-least one period in ~ 45 % subjects this would mean that in consequence this formulation would not be effective in a great portion of patients. The originator has demonstrated safety and efficacy in clinical trials. So your argumentation that zero concentrations throughout the all the sampling points for reference formulation in at-least one period in ~ 50 % subjects was shown and similar results were observed for this molecule in other literature too does not help.
If you claim that your formulation is as bad as the originator you have to proof that your observations are no artefact. If this is not possible you have to provide clinical data.
Kind regards
Dr_Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Zero concentrations – all samples – full replicate pash413 2014-04-05 14:56
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Zero concentrations – all samples – full replicate ElMaestro 2014-04-05 20:17
- Zero concentrations – all samples – full replicate luvblooms 2014-04-07 07:47
- serious risk to public healthDr_Dan 2014-04-07 08:35
- Zero concentrations – all samples – full replicate pash413 2014-04-07 08:37
- Zero concentrations – all samples – full replicate Helmut 2014-04-07 09:01
- Zero concentrations – all samples – full replicate pash413 2014-04-07 09:30
- Imputation and BE/TE ElMaestro 2014-04-07 12:14
- Zero concentrations – all samples – full replicate nobody 2014-04-07 09:31
- Zero concentrations – all samples – full replicate pash413 2014-04-07 09:30
- Zero concentrations – all samples – full replicate luvblooms 2014-04-07 11:50
- Zero concentrations – all samples – full replicate Mahesh M 2014-04-07 12:23
- Zero concentrations – all samples – full replicate jag009 2014-04-07 16:18
- Zero concentrations – all samples – full replicate jag009 2014-04-07 15:29
- Zero concentrations – all samples – full replicate Helmut 2014-04-07 09:01
- Stability ? Ohlbe 2014-04-07 18:23
- Stability ? Helmut 2014-04-07 19:39
- Stability ? pash413 2014-04-09 13:00
- Stability ? Mahesh M 2014-04-09 14:51
- Stability ? Ohlbe 2014-04-09 16:31
- Stability ? pash413 2014-04-09 13:00
- Stability ? Helmut 2014-04-07 19:39
Ing. Helmut Schütz