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RegisterBioequivalence study of Sulfasalazine for Chile [Regulatives / Guidelines]
Dear All,
Please suggest the analytes to be measured and bioequivalence to be established based on, for a BE stduy of Sulfasalazine in plasma for Chile region. Considering Sulfasalazine a prodrug and having low bioavailability whether analysis of 5-aminosalicylic acid and sulphapyridine is required for establishing bioequivalence of sulfasalazine for Chile region? Whether scaling is permitted for sulfasalazine 500mg dose up to 3-4 folds.
Kind Regards,
Manoj Singh
Please suggest the analytes to be measured and bioequivalence to be established based on, for a BE stduy of Sulfasalazine in plasma for Chile region. Considering Sulfasalazine a prodrug and having low bioavailability whether analysis of 5-aminosalicylic acid and sulphapyridine is required for establishing bioequivalence of sulfasalazine for Chile region? Whether scaling is permitted for sulfasalazine 500mg dose up to 3-4 folds.
Kind Regards,
Manoj Singh
Complete thread:
- Bioequivalence study of Sulfasalazine for Chilemanojskr 2013-09-09 15:10
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Ing. Helmut Schütz