kumar
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2009-05-29 10:14
(6238 d 11:07 ago)

Posting: # 3786
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 BE for Metformin 1000 mg ER Tabs [Design Issues]

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I have to design the BE Studies for single dose Metformin 1000 mg Extended Release Tablets. Its in-vitro dissolution profile is: After 1 hour = 20 - 40%; after 2 hours = 35 - 55%; after 6 hours = 65 - 85% and after 10 hours NLT 85%. Can someone suggest me, at what time intervals should the plasma samples from volunteers be taken to determine drug concentration to co-relate with the in-vitro data as well as to determine AUC effectively.

Thank you and regards,

Kumar
 
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