HallaGulla
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2022-05-16 19:37
(650 d 23:53 ago)

Posting: # 22992
Views: 1,211
 

 Hydrocortisone 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
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[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
methodology, conduct, analysis, and interpretation:
Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

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