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RegisterER vs. IR [Design Issues]
Hi Helmut
your statement only holds true in your example with different strengths. If you have only one or the highest IR strength then my statement applies. The once daily (or 8 h) dosing of the ER formulation does not have to mimicry the performance of the multiple dosing of the IR formulation if you can show that there is a well-defined therapeutic window in terms of safety and efficacy and the rate of input is known not to influence the safety and efficacy profile or the risk for tolerance development.
KR
Dan
your statement only holds true in your example with different strengths. If you have only one or the highest IR strength then my statement applies. The once daily (or 8 h) dosing of the ER formulation does not have to mimicry the performance of the multiple dosing of the IR formulation if you can show that there is a well-defined therapeutic window in terms of safety and efficacy and the rate of input is known not to influence the safety and efficacy profile or the risk for tolerance development.
KR
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- BE study design issue jag009 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
- ER vs. IR Helmut 2019-12-18 15:33
- ER vs. IRDr_Dan 2019-12-19 09:01
- ER vs. IR Helmut 2019-12-18 15:33
- 1×2 ≠ 2×1 Helmut 2019-12-14 00:42
Ing. Helmut Schütz