Validation ligand binding assays

The fundamental parameters for bioanalytical validations include accuracy, precision, selectivity, sensitivity, reproducibility, stability of the drug in the matrix under study storage conditions, range, recovery, and response function (see Section 8.2.1). These parameters are also applicable to microbiological and ligand-binding assays. However, these assays possess some unique characteristics that should be considered during method validation, such as selectivity and quantification issues. 

Note that controversies over the technical and clinical validation of immunohistochemistry have not been completely resolved. Whether or not this method should completely replace biochemical ligand-binding assays remains controversial. Despite this cautionary statement, it is true that the specificity of immunohistochemistry is theoretically valid because it is based on the use of well-characterized monoclonal antibodies raised against epitopes restricted to the ERs. 

Desilva B, Smith W,Weiner R, et at. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. (2003) 20 1885-1900. 

Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, Weiner R (2007) Workshop/conference report — quantitative bioanalytical methods validation and implementation best practices for chromatographic and ligand binding assays. AAPS J 9 E30-E42... 

Viswanathan CT et al (2007) Quantitative bioanalytical methods validation and implementation best practices for chromatographic and ligand binding assays. Pharm Res 24 1962-1973... 

Ligand Binding Assays Development, Validation, and Implementation in the Drug Development Arena. Edited by Masood N. Khan and John W.A. Findlay Copyright 2010 John Wiley Sons, Inc. 

DeSilva, B., Smith, W., Wiener, R., Kelley, M., Smolec, J., Lee, B., Khan, M., Tacey, R., Hill, H., and Celniker, A. (2003) Recommendations for the bioanalytical method validation of ligand binding assays to support pharmacokinetic assessments of macro molecules. Pharmaceutical Research, 20, 1885 1900. 

Findlay, J.W.A. (2008) Some important considerations for validation of ligand binding assays. Journal of Chromatography B, 877, 2191 2197. 

Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Biotherapeutics... 

---