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Dear all,
Can anybody suggest me how to calculate LOD (Limit of Detection) in Bioanalytical.
thanks in advance.
-- Regards
Kanchan Soni
Sr. Research Associate-BioAnalytical
Veeda Clinical Research
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Kanchan,
The FDA Guidance
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation /Guidances/UCM070107.pdf
defines LOD in words, but not mathematically, because, as the Guidance explains, the Lower Limit of Quantitation (LLOQ) is now used in good bioanalytical practice. You may be thinking of the estimating procedures for general analytical methods listed in section VII b, of
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation /Guidances/UCM073384.pdf
where it is stated "A signal-to-noise ratio between 3 or 2:1 is generally considered acceptable for estimating the detection limit." However, this is followed by the statement that "In cases where an estimated value for the detection limit is obtained by calculation or extrapolation, this estimate may subsequently be validated by the independent analysis of a suitable number of samples known to be near or prepared at the detection limit."
Regards, Frank Frank Bales, Ph.D.
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