BE study design issue [Design Issues]

posted by Dr_Dan  – Germany, 2019-12-18 15:04 (969 d 10:56 ago) – Posting: # 20992
Views: 2,719

Hi John
if the recommended dosage regimen of the IR as per product monograph IR is to be given every 4 hrs then this means that higher doses have either a safety issue or the dose/effect relationship is in disfavor of higher doses. In this case AUC alone does not matter. Consequently, a regulatory body will reject the study
Hope this helps
KR
Dr_Dan

Kind regards and have a nice day
Dr_Dan

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