ELISA Validation

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Nardine's picture
ELISA Validation

Hii all,
Does anyone have a protocol for immunoassays validation as I can't find clear guidelines for this??
or at least if anybody can provide me with any guidelines for the validation of immunoassays.

thank you

bobhardcastle's picture
The crystal city white paper

The crystal city white paper is probably your best bet for quantitative pharmacokinetic assay, Gene Lee et al is probably the best for biomarker validation, and Shanka et al is the best for qualitative ADA validations.

FDA Guidance

Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, Weiner R. Workshop/Conference Report—Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays. AAPS Journal.2007;9(1):E30–E42. doi: 10.1208/aapsj0901004

Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement, Lee et al, Research paper, Pharmaceutical Research (# 2006).

Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products, Shanka et al, Journal of Pharmaceutical and Biomedical Analysis 48 (2008) 1267–1281.