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RegisterCmax of interest? [Regulatives / Guidelines]
Dear Helmut
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity. This effect is dose-related. Therefore the bioavalability in terms of total exposure (AUC) controls the effect and is consequently of much more interest than bioavailability in terms of peak exposure (tmax and Cmax). This is what the assessor had in mind (I guess). Therefore widening of acceptance range was clinically justified.
But I agree, seen under formal aspects the widening of the acceptance range should have been not possible at that time.
Kind regards
Dan
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity. This effect is dose-related. Therefore the bioavalability in terms of total exposure (AUC) controls the effect and is consequently of much more interest than bioavailability in terms of peak exposure (tmax and Cmax). This is what the assessor had in mind (I guess). Therefore widening of acceptance range was clinically justified.
But I agree, seen under formal aspects the widening of the acceptance range should have been not possible at that time.
Kind regards
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:
- Widened acceptance range w. a 2,2,2-study? ElMaestro 2011-10-09 13:44
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Widened acceptance range w. a 2,2,2-study? Helmut 2011-10-09 16:40
- Widened acceptance range w. a 2,2,2-study? Dr_Dan 2011-10-10 12:01
- Quot licet Iovi, non licet bovi Helmut 2011-10-10 12:57
- Cmax of interest?Dr_Dan 2011-10-10 16:57
- CI outside 80.00%–125.00% Helmut 2011-10-10 18:23
- CI outside 80.00%–125.00%, who cares? Dr_Dan 2011-10-11 09:54
- Common sense rulez?! Helmut 2011-10-11 16:27
- CI outside 80.00%–125.00%, who cares? Dr_Dan 2011-10-11 09:54
- CI outside 80.00%–125.00% Helmut 2011-10-10 18:23
- Cmax of interest?Dr_Dan 2011-10-10 16:57
- Quot licet Iovi, non licet bovi Helmut 2011-10-10 12:57
- Widened acceptance range w. a 2,2,2-study? Dr_Dan 2011-10-10 12:01
- Widened acceptance range w. a 2,2,2-study? Helmut 2011-10-09 16:40
Ing. Helmut Schütz