CAT | Regulatory issues
Nov/09
7
Regulatory perspective on potency assays
0 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
