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

CAT | Regulatory issues

Three new USP chapters on bioassays have been published on their website:

http://www.usp.org/meetings/workshops/bioassayGuidance.html

The chapters are:

  • 1032 – Design and Development of Biological Assays
  • 1033 – Biological Assay Validation
  • 1034 – Analysis of Biological Assays

If you’re in the bioassay field, these are pretty much required reading.

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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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