AB661
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India,
2020-08-19 11:22
(1728 d 17:56 ago)

Posting: # 21888
Views: 2,158
 

 Metformin Bioequivalence Study [Design Issues]

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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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