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Nov/09

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Regulatory perspective on potency assays

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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2 Comments for Regulatory perspective on potency assays

Renita | July 19, 2010 at 4:29 pm

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

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.

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