AB661 ☆ India, 2020-08-19 11:22 (1317 d 07:04 ago) Posting: # 21888 Views: 1,473 |
|
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 |