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.
Nov/09
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Regulatory perspective on potency assays
2 Comments | Posted by Dan in References, 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
