Metformin Bioequivalence Study [Design Issues]

posted by AB661 – India, 2020-08-19 09:22 (96 d 12:02 ago) – Posting: # 21888
Views: 687

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

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