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Register1×2 ≠ 2×1 [Design Issues]
posted by Helmut 
– 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.
» 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
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Cheers,
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- BE study design issue jag009 2019-12-13 23:26 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- 1×2 ≠ 2×1 ElMaestro 2019-12-15 22:02
- 1×2 ≠ 2×1 jag009 2019-12-15 19:39
- BE study design issue Dr_Dan 2019-12-18 15:04
- 1×2 ≠ 2×1Helmut 2019-12-14 00:42
Ing. Helmut Schütz