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sasikala ☆ India, 2011-04-28 21:26 (5538 d 09:13 ago) Posting: # 6970 Views: 3,845 |
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Please suggest me on timepoints for Bioequivalence study of Metformin HCl and Glibenclamide 500 mg & 2.5 mg Tablets. Many thanks in advance. Regards, Sasikala |
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drgunasakaran1 ★★  2011-05-03 14:02 (5533 d 16:37 ago) @ sasikala Posting: # 6981 Views: 3,153 |
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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 |
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