Bioequivalence and Bioavailability Forum

jag009 ★★★ NJ, 2012-04-18 23:56 (5185 d 09:46 ago) Posting: # 8446 Views: 3,483	FDA Guidance for Relative potency within 5% [Regulatives / Guidelines] Post reply
	Hi everyone, Can someone point me to a FDA guidance which states the relative potency (Test to reference) must be within 5%? Thanks John

suds4u
☆

India,
2012-04-20 13:58
(5183 d 19:44 ago)

@ jag009
Posting: # 8449
Views: 2,610

FDA Guidance for Relative potency within 5%

Post reply

Dear John
The link is provided below
~~http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf~~.
Regards
Suds

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

Edit: Guidance removed from FDA’s website in (summer?) 2015. Latest archived copy (2015-02-16): https://web.archive.org/web/20150226060249/http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf

jag009 ★★★ NJ, 2012-04-20 23:33 (5183 d 10:09 ago) @ suds4u Posting: # 8450 Views: 2,660	FDA Guidance for Relative potency within 5% Post reply
	Thanks Suds. I found it... For some reason FDA stated "5 percent" instead of "5%" in the document... john Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

FDA Guidance for Relative potency within 5% [Regulatives / Guidelines]

FDA Guidance for Relative potency within 5%

FDA Guidance for Relative potency within 5%