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Registerdifferent strength [Design Issues]
Dear Sir,
I have to perform a bioequivalence study with two strengths (120 mg and 160 mg) for a modified release formulation, which are not dose proportional. The Orange book specifies only 160 mg formulation as RLD. There is also an innovator for 120 mg, but it is not listed as RLD. In that case what shall be the reference drug for 120mg strength?
Thank you.
I have to perform a bioequivalence study with two strengths (120 mg and 160 mg) for a modified release formulation, which are not dose proportional. The Orange book specifies only 160 mg formulation as RLD. There is also an innovator for 120 mg, but it is not listed as RLD. In that case what shall be the reference drug for 120mg strength?
Thank you.
Complete thread:
- different strengthioanam 2007-03-18 00:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 'BE' to innovator's product which is not RLD Helmut 2007-03-18 13:21
Ing. Helmut Schütz