1×2 ≠ 2×1 [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2019-12-14 00:42  – Posting: # 20974
Views: 972

Hi John,

» The design is obviously wrong (due to IR dosing regimen) …

Yep.

» … but would a regulatory body reject the study (assume the study pass the BE objective which is BE needed only for auc).

I hope so. Imagine you have capacity-limited elimination. You would partly saturate the enzymes with the 1×2 regimen and see a higher AUC than with 2×1. Hence, the T/R-ratio will be positively biased. In an extreme case the study passes with the wrong design but would have failed with the correct one.

Cheers,
Helmut Schütz
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