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Register1999 Note for Guidance? [Design Issues]
Dear Helmut
Thank you so much for your response.
As per PIL “You should take Glucophage SR with or immediately after food.” But applicant performed multiple dose study under fasting condition not under fed condition?
Regards
M
Thank you so much for your response.
As per PIL “You should take Glucophage SR with or immediately after food.” But applicant performed multiple dose study under fasting condition not under fed condition?
Regards
M
Complete thread:
- multiple dose study Mahesh M 2016-05-30 09:42
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 1999 Note for Guidance? Helmut 2016-05-30 13:37
- 1999 Note for Guidance?Mahesh M 2016-05-31 13:50
- Ask the applicant Helmut 2016-05-31 14:07
- Ask the applicant Mahesh M 2016-06-01 08:45
- Ask the applicant Helmut 2016-05-31 14:07
- 1999 Note for Guidance?Mahesh M 2016-05-31 13:50
- 1999 Note for Guidance? Helmut 2016-05-30 13:37
Ing. Helmut Schütz