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Registermetformin SR steady state study (+glucose) [Design Issues]
hello sir,
i got one issue while designing BE study for metformin SR tablets. the issue is administration of 20% glucose containing water every 15 min till 4hrs after administration of dose. this is given in US draft guidlines of metformin. but when we plan a BE study for EMEA countries, is it necessary to fallow these guidlines or any specific EMEA guidlines available regarding administration of glucose solution.If we fallow US draft guidlines for EMEA BE study any problem with regulatory body?
could you share your experience in this regards
i will be thankfull to you sir,
jagan mohan k
i got one issue while designing BE study for metformin SR tablets. the issue is administration of 20% glucose containing water every 15 min till 4hrs after administration of dose. this is given in US draft guidlines of metformin. but when we plan a BE study for EMEA countries, is it necessary to fallow these guidlines or any specific EMEA guidlines available regarding administration of glucose solution.If we fallow US draft guidlines for EMEA BE study any problem with regulatory body?
could you share your experience in this regards
i will be thankfull to you sir,
jagan mohan k
Complete thread:
- metformin SR steady state study (+glucose)jagankm 2011-04-26 13:22
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- metformin SR steady state study Helmut 2011-04-26 14:17
- metformin SR steady state study jagankm 2011-04-27 05:51
- The answer is at your fingertips Helmut 2011-04-27 12:34
- metformin SR steady state study jagankm 2011-04-27 05:51
- metformin SR steady state study Helmut 2011-04-26 14:17
Ing. Helmut Schütz