Bioequivalence and Bioavailability Forum • Metformin HCl and Glibenclamide 500 mg & 2.5 mg Tablets

Metformin HCl and Glibenclamide 500 mg & 2.5 mg Tablets [Regulatives / Guidelines]

posted by drgunasakaran1 – 2011-05-03 14:02 (5537 d 15:36 ago) – Posting: # 6981
Views: 3,162

Dear Ms.Sasikala,

You may follow the below sampling time points for Fasting and Fed study for FDA submission.

Time points for Fasting study
00.00, 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 02.75, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.25, 07.50, 07.75, 08.00, 10.00, 12.00, 16.00, 20.00, 24.00, 30.00, 36.00, 42.00 and 48.00

Time points for Fed study

00.00, 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 02.75, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 10.00, 12.00, 16.00, 20.00, 24.00, 30.00, 36.00, 42.00 and 48.00

Regards,
Dr.S.Gunasakaran, MD

—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

Complete thread:

Metformin HCl and Glibenclamide 500 mg & 2.5 mg Tablets sasikala 2011-04-28 19:26
- Metformin HCl and Glibenclamide 500 mg & 2.5 mg Tabletsdrgunasakaran1 2011-05-03 12:02