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RegisterAmbroxol Sustained Release 75 mg [Design Issues]
Dear colleagues,
I have been asked to perform a bioequivalence study on ambroxol, sustained release formulations containing 75 mg. according to guideline a single dose fast study as well as a single dose fed may be applicable. The multiple dose study is also required due to accumulation, according to ambroxol half-life between 7 and 12 hours.
I would like to have inputs from experienced researchers in order to aware of any concerns related to this substance.
Kind Regards
I have been asked to perform a bioequivalence study on ambroxol, sustained release formulations containing 75 mg. according to guideline a single dose fast study as well as a single dose fed may be applicable. The multiple dose study is also required due to accumulation, according to ambroxol half-life between 7 and 12 hours.
I would like to have inputs from experienced researchers in order to aware of any concerns related to this substance.
Kind Regards
Complete thread:
- Ambroxol Sustained Release 75 mgMaggieSantos 2016-10-28 18:16
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Ambroxol Sustained Release 75 mg DavidManteigas 2016-11-02 10:51
Ing. Helmut Schütz