Nov/09
7
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
2 Comments for Regulatory perspective on potency assays
Renita | July 19, 2010 at 4:29 pm
Author comment by Dan | July 20, 2010 at 3:43 pm
Hi Renita,
Unfortunately, it looks like they took this document down from the USP website.
I wish I knew of another source, but I haven’t had any luck in finding it.
Leave a comment!
<< Potency Assays for Cell-based Therapeutic Cancer Vaccines
Is there another link to this pdf?? I would greatly appreciate if you could post the link or email me the pdf from the site you posted.
http://www.usp.org/pdf/EN/meetings/bioassayWorkshop/session1f.pdf