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Dear All,
Does any one have any information on the Bioequivalence study
requirements for Balsalazide and Olsalazine. Since these drugs belong
to class of Locally acting GI drugs, can the standard BE criteria be
applicable, like measuring the plasma concentrations of the parent
compound and the metabolites (5-ASA & N-ASA). Also kindly let me know
the FDA-OGD's stand on this.
Any information shared with me would be appreciated.
Thanks and Regards,
Dr. M. Joseph MD
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The following message was posted to: PharmPK
Dear Dr. Joseph,
There is few corrrespondence between OGD and Salix pharma regarding this
issue.
For equivalence PD is preferred than PK.
Hope this may help you.
Regards,
Dr.Bose
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