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RegisterHydrocortisone BE studies for UK [Design Issues]
Dear All
It would be great if someone can put some light on dose linearity for Hydrocortisone acetate. The information available in the literature is very confusing with few suggesting it's linear between the dose up to 40mg and then few say nonlinear due to absorption and protein binding and show less than dose-proportional increase in AUC.
In case we have to plan this study for the EU/UK do we need to do a study on higher and lower strength both?
Cheers
HG
It would be great if someone can put some light on dose linearity for Hydrocortisone acetate. The information available in the literature is very confusing with few suggesting it's linear between the dose up to 40mg and then few say nonlinear due to absorption and protein binding and show less than dose-proportional increase in AUC.
In case we have to plan this study for the EU/UK do we need to do a study on higher and lower strength both?
Cheers
HG
Complete thread:
- Hydrocortisone BE studies for UKHallaGulla 2022-05-16 17:37 [Design Issues]
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Ing. Helmut Schütz