Bioequivalence and Bioavailability Forum

Hi,

Please suggest usage working standard for bioequivalence studies for ANVISA Submission.

Is this mandatory to use only compendial reference standards (Brazil/USP/EPCRS) for conducting method validation and bioequivalence studies as per the resolution 899, point no 1.4

The approch of using a working standard which was standardized against a compendial reference standard with suffient characterization data and COA is acceptable to ANVISA.

Please share any experiance with ANVISA. If acceptable what are the documents to be submitted as a part of regulatory submission.

Thanks&Regards