Minimum Detection Limit
Posted: Tue Feb 27, 2007 4:00 am
by Alain
Hello does anyone have a method or procedure for calculating MDL's
Posted: Tue Feb 27, 2007 4:20 am
by tom jupille
You can find it in the USP, but I don't have the reference handy. The FDA has a "crude" way of estimating it on page 12 of their "Reviewer Guidance for Validation of Chromatographic Methods (
http://www.fda.gov/cder/guidance/cmc3.pdf )
Posted: Tue Feb 27, 2007 8:37 am
by Bruce Hamilton
If you don't have access to the USP, you can select one of the methods defined in section 6 " Detection Limit " of ICH Q2(R1) which is called " Validation of Analytical Procedures : Methodology ", and is freely available from ICH web site.
If you're not in the pharmaceutical industry, various other regulatory authorities, such as FDA, define their preferred procedures. Often the information is freely available on web sites.
Bruce Hamilton