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Dear PharmPK,
Can you suggest for Glimipiride which dose form bioequivalence study
submission for Brazil?
With best regards,
V.Chandra Sekhar
Head-Bioanalytical
BA/BE Division, GVK BIO
www.gvkbio.com
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Dear Chandra,
I am not sure about what exactly you want to know, but I will try to
give you some help.
According to Brazilian Regulation, bioequivalence studies shoud be
carried out with the highest concentration you want to get the
register. The highest Glimepiride concentration in Brazil is 4,0 mg
(Reference: Amaryl - Aventis, 1.0 mg, 2.0 mg and 4.0 mg tablets).
Hope this helps!
Paula
--
Paula Macedo Cerqueira, PhD
Technical Consultant
Wissen Consultores Associados
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The following message was posted to: PharmPK
In Brazil 4.0 mg tablet is the recommended strength for bio.
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