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Registerlong half-life and large variability [Regulatives / Guidelines]
Hi All!
I believe there are few MR drug with high variability and still USFDA recommends partial or fully replicate design. Mesalamine PSG or
Mesalamine PSG for 800 mg strength
Considering the Mechanism of Action, PK variability, non-Linearity- the study and formultion could indeed be challenging.
Regards,
Dshah
I believe there are few MR drug with high variability and still USFDA recommends partial or fully replicate design. Mesalamine PSG or
Mesalamine PSG for 800 mg strength
Considering the Mechanism of Action, PK variability, non-Linearity- the study and formultion could indeed be challenging.
Regards,
Dshah
Complete thread:
- long half-life and large variability martin 2020-07-29 16:57 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- long half-life and large variability ElMaestro 2020-07-29 21:24
- long half-life and large variability martin 2020-07-29 22:49
- long half-life and large variability ElMaestro 2020-07-30 08:17
- long half-life and large variabilitydshah 2020-08-10 06:18
- long half-life and large variability ElMaestro 2020-07-30 08:17
- long half-life and large variability martin 2020-07-29 22:49
- long half-life and large variability Achievwin 2020-08-12 15:22
- long half-life and large variability Helmut 2020-08-12 15:53
- long half-life and large variability ElMaestro 2020-07-29 21:24
Ing. Helmut Schütz