Analytical Considerations for Immunoassays for Macromolecules
作者： Marian Kelley , Binodh DeSilva
DOI: 10.1002/9780470571224.PSE307
关键词: Analyte 、 Guidance documents 、 Partial validation 、 Antigen binding 、 Total error 、 Biological fluids 、 Chromatography 、 Macromolecule 、 Chemistry 、 Sample collection
摘要: Current guidance documents for the assessment of analytes and their metabolites in biological fluids are focused on quantification small molecules using chromatographic mass spectrometry platforms. These guidelines come short immunoassays that confer practicality specificity associated with antibody binding from fluids. This article focuses analytical considerations macromolecules, such as parameters, partial validation, method transfer, cross-validation, total error, documentation. Keywords: immunoassays; macromolecules; reagents; selectivity; sample collection
sci-hub.st 参考文章(8)
Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Conference report. European Journal of Drug Metabolism and Pharmacokinetics. ,vol. 16, pp. 249- ,(1991) , 10.1007/BF03189968
Vinod P Shah, Kamal K Midha, John WA Findlay, Howard M Hill, James D Hulse, Iain J McGilveray, Gordon McKay, Krys J Miller, Rabindra N Patnaik, Mark L Powell, Alfred Tonelli, CT Viswanathan, Avraham Yacobi, Bioanalytical method validation--a revisit with a decade of progress. Pharmaceutical Research. ,vol. 17, pp. 1551- 1557 ,(2000) , 10.1023/A:1007669411738
Vinod P. Shah, Kamal K. Midha, Shrikant Dighe, Iain J. McGilveray, Jerome P. Skelly, Avraham Yacobi, Thomas Layloff, C.T. Viswanathan, C. Edgar Cook, R.D. Mcdowall, Kenneth A. Pittman, Sidney Spector, Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies Journal of Pharmaceutical Sciences. ,vol. 81, pp. 309- 312 ,(1992) , 10.1002/JPS.2600810324
Christa. Hartmann, Johanna. Smeyers-Verbeke, Wim. Penninckx, Yvan. Vander Heyden, Pieter. Vankeerberghen, Desire L. Massart, Reappraisal of hypothesis testing for method validation : detection of systematic error by comparing the means of two methods or of two laboratories Analytical Chemistry. ,vol. 67, pp. 4491- 4499 ,(1995) , 10.1021/AC00120A011
J.W.A. Findlay, W.C. Smith, J.W. Lee, G.D. Nordblom, I. Das, B.S. DeSilva, M.N. Khan, R.R. Bowsher, Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. Journal of Pharmaceutical and Biomedical Analysis. ,vol. 21, pp. 1249- 1273 ,(2000) , 10.1016/S0731-7085(99)00244-7
Robert W. Mee, β-Expectation and β-Content Tolerance Limits for Balanced One-Way ANOVA Random Model Technometrics. ,vol. 26, pp. 251- 254 ,(1984) , 10.1080/00401706.1984.10487962
Binodh DeSilva, Wendell Smith, Russell Weiner, Marian Kelley, JoMarie Smolec, Ben Lee, Masood Khan, Richard Tacey, Howard Hill, Abbie Celniker, Recommendations for the Bioanalytical Method Validation of Ligand-binding Assays to Support Pharmacokinetic Assessments of Macromolecules Pharmaceutical Research. ,vol. 20, pp. 1885- 1900 ,(2003) , 10.1023/B:PHAM.0000003390.51761.3D
Vinod P. Shah, Kamal K. Midha, Shrikant Dighe, Iain J. McGilveray, Jerome P. Skelly, Avraham Yacobi, Thomas Layloff, C. T. Viswanathan, C. Edgar Cook, R. D. McDowall, Kenneth A. Pittman, Sidney Spector, Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies Journal of AOAC International. ,vol. 75, pp. 588- 592 ,(1992) , 10.1023/A:1015829422034