Re: Validation of Analytical Procedures

["Patricia Stotland" <pstotland@celmedbio.com> (by way of PDASci-Tech Forum <moderator@pda.org>)]

Some guidance about regulators' expectations for accuracy
and precision can be found in the FDA guidance "Bioanalytical Method
Validation"
(http://www.fda.gov/cder/guidance/4252fnl.pdf)
or the ICH documents Q2B "Validation of Analytical Procedures:
Methodology" and Text on Validation of Analytical Procedures
(http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254)

P. Stotland 
pstotland@celmedbio.com