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Immunochemistry Resources |
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Relevant Literature References and Guidances |
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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: E30-E42. |
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Gupta S, Indelicato SR, Jethwa V, Kawabata T, Kelley M, Mire-Sluis AR, Richards SM, Rup B, Shores E, Swanson SJ, and Wakshull E. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. Journal of Immunological Methods, 2007, 321:1-18. |
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Smolec J, DeSilva B, Smith W, Weiner R, Kelly M, Lee B, Khan M, Tacey R, Hill H, Celniker A, Shah V, Bowsher R, Mire-Sluis A, Findlay JW, Saltarelli M, Quarmby V, Lansky D, Dillard R, Ullmann M, Keller S, Karnes HT. Bioanalytical method validation for macromolecules in support of pharmacokinetic studies. Pharmaceutical Research, 2005, 22:1425-31. |
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Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, Parish T, Scott G, Shankar G, Shores E, Swanson SJ, Taniguchi G, Wierda D, Zuckerman LA. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. Journal of Immunological Methods, 2004, 289:1-16. |
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DeSilva B, Smith W, Weiner R, Kelley M, Smolec JM, Lee B, Khan M, Tacey R, Hill H, and Celniker A. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharmaceutical Research, 2003, 20:1885-1900. |
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Food and Drug Administration. Guidance for Industry: Bioanalytical Method Validation. Rockville, MD: US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, 2001. |
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