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RegisterMetformin Bioequivalence Study [Design Issues]
Dear Colleagues,
I need your advice please for Metformin Oral Solution. As per Orange book it have AB TE code.
Should BE required to support ANDA application?
Metformin has non-linear pharmacokinetics. There No OGD BE guidance for this product . Whether BE study should be conducted with 500 dose or 1000 mg dose.
I would be grateful if someone could guide me.
With regards
AB
I need your advice please for Metformin Oral Solution. As per Orange book it have AB TE code.
Should BE required to support ANDA application?
Metformin has non-linear pharmacokinetics. There No OGD BE guidance for this product . Whether BE study should be conducted with 500 dose or 1000 mg dose.
I would be grateful if someone could guide me.
With regards
AB
Complete thread:
- Metformin Bioequivalence StudyAB661 2020-08-19 09:22 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
Ing. Helmut Schütz