Bioequivalence and Bioavailability Forum • Usage of working standards for ANVISA studies

Debbie
★

India,
2010-03-17 14:41
(5943 d 16:42 ago)

Posting: # 4930
Views: 3,505

Usage of working standards for ANVISA studies [Bioanalytics]

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

Ramesh
☆

India,
2010-03-18 12:52
(5942 d 18:31 ago)

@ Debbie
Posting: # 4932
Views: 2,792

Usage of working standards for ANVISA studies

Post reply

❝ 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

As per my experience we should have a valid C of A of reference standards used in the BA/BE study.

In addition to this the supporting documents such as purity of the compound, charactersation of compound if any etc.

I hope this is usefull.

Regards,
Ramesh.V

—
with regards,

Ramesh