Potencyassay.com | A blog about bioassays, immunoassays, and other potency assays

CAT | Regulatory issues

I ran across this PDF by Susan Kirchner at CDER.  It’s a nice overview of why we need run potency assays for biotherapeutics.

http://www.usp.org/pdf/EN/meetings/bioassayWorkshop/session1f.pdf

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