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Dear Helmut,
Thank you so much for your kind information, I go through all available metformin PAR in public domain 3 Applicant performed multiple dose study under fed condition and two under fasting condition (most recently published PAR ) That’s why I would like to discuss the same on Form. And same happened with dipyridamol XR “As per SPC it recommended under fed condition but as per available PAR applicant performed multiple dose study under fasting condition.
Regards
M
Thank you so much for your kind information, I go through all available metformin PAR in public domain 3 Applicant performed multiple dose study under fed condition and two under fasting condition (most recently published PAR ) That’s why I would like to discuss the same on Form. And same happened with dipyridamol XR “As per SPC it recommended under fed condition but as per available PAR applicant performed multiple dose study under fasting condition.
Regards
M
Complete thread:
- multiple dose study Mahesh M 2016-05-30 09:42 [Design Issues]
![[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 applicantMahesh 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