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RegisterBE study design issue [Design Issues]
Hi everyone,
Question, if one conducted a study comparing ER to an immediate release reference but not following the recommended dosage regimen of the IR. Example, as per product monograph IR is given every 4 hrs and the new ER is given every 8 hrs, but the guy designed the pk study comparing ER vs 2xIR with both give at time 0, The design is obviously wrong (due to IR dosing regimen) but would a regulatory body reject the study (assume the study pass the BE objective which is BE needed only for auc). A pivotal study not pilot.
PS, not me! Doing some due diligence..
Thx
J
Question, if one conducted a study comparing ER to an immediate release reference but not following the recommended dosage regimen of the IR. Example, as per product monograph IR is given every 4 hrs and the new ER is given every 8 hrs, but the guy designed the pk study comparing ER vs 2xIR with both give at time 0, The design is obviously wrong (due to IR dosing regimen) but would a regulatory body reject the study (assume the study pass the BE objective which is BE needed only for auc). A pivotal study not pilot.
PS, not me! Doing some due diligence..
Thx
J
Complete thread:
- BE study design issuejag009 2019-12-13 23:26
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 1×2 ≠ 2×1 Helmut 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 ≠ 2×1 Helmut 2019-12-14 00:42
Ing. Helmut Schütz