Metformin Bioequivalence Study [Design Issues]

posted by AB661 – India, 2020-08-19 07:22 (268 d 09:29 ago) – Posting: # 21888
Views: 878

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

Complete thread:

Activity
 Admin contact
21,460 posts in 4,486 threads, 1,514 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Friday 16:52 UTC (Europe/Vienna)

Art is “I”; science is “we”.    Claude Bernard

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5