Ambroxol Sustained Release 75 mg [Design Issues]

posted by MaggieSantos – Portugal, 2016-10-28 20:16 (3024 d 12:07 ago) – Posting: # 16755
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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

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