Bioequivalence and Bioavailability Forum • 1×2 ≠ 2×1

1×2 ≠ 2×1 [Design Issues]

posted by Helmut – Vienna, Austria, 2019-12-14 00:42 (1018 d 22:18 ago) – Posting: # 20974
Views: 2,889

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.

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Complete thread:

BE study design issue jag009 2019-12-13 23:26 [Design Issues]
- 1×2 ≠ 2×1Helmut 2019-12-14 00:42
  - 1×2 ≠ 2×1 jag009 2019-12-15 19:39
    - 1×2 ≠ 2×1 ElMaestro 2019-12-15 22:02
      - x ◦ y = y ◦ x? Helmut 2019-12-16 11:00
- BE study design issue Dr_Dan 2019-12-18 15:04
  - ER vs. IR Helmut 2019-12-18 15:33
    - ER vs. IR Dr_Dan 2019-12-19 09:01