Biomedical Engineering Reference
In-Depth Information
51. DeSilva B, SmithW, Weiner R, KelleyM, Smolec J, Lee BM, Tacey R, Hill H, Celniker A.
Recommendations for the bioanalytical method validation of ligand-binding assays to
support pharmacokinetic assessments of macromolecules. Pharm. Res. 2003;20:1885.
52. Mires-Sluis et al. Recommendations for the design and optimization of immunoassays
used in the detection of host antibodies against biotechnology products. J. Immunol.
Methods 2004;289:1-16.
53. Gupta S, Indelicato SR, Jethwa V, Kawabata T, Kelley M, Mire-Sluis AR, Richards SM,
Rup B, Shores E, Swanson SJ, Wakshull EJ. Recommendations for the design,
optimization, and qualification of cell-based assays used for
the detection of
neutralizing antibody responses elicited to biological
therapeutics. J.
Immunol.
Methods 2007;321(1-2):1-18.
54. Cunliffe J, Derbyshire N, Keeler S, Coldwell R. An approach to the validation of flow
cytometry methods. Pharm. Res. 2009;22(12):2551-2557.
55. Clinical and Laboratory Standards Institute. Preliminary Evaluation of Quantitative
Clinical Laboratory Measurement Procedures: Approved Guideline, 3rd ed., Clinical
and Laboratory Standards Institute, Wayne, PA, CLSI document EP10-A3, 2006.
56. Shankar G, Devanarayan V, Amaravadi L, Barrett YC, Bowsher R, Finco-Kent D, Fiscella
M, Gorovits B, Kirschner S, Moxness M, Parish T, Quarmby V, Smith H, Smith W,
Zuckerman LA, Koren E. Recommendations for the validation of immunoassays used for
detection of host antibodies against biotechnology products. J. Pharm. Biomed. Anal.
2008;48:1267.
57. Reddy M, Davis C, Davis H, Pendley C, Prabhakar U. T-cell surface markers in human
peripheral whole blood using flow cytometry. In Validation of Cell-Based Assays in the
GLP Setting: A Practical Guide, John Wiley & Sons Ltd., 2008, pp.85-105.
58. Clinical and Laboratory Standards, Institute. Enumeration of Immunologically Defined
Populations by Flow Cytometry: Approved Guideline, 2nd ed., Clinical and Laboratory
Standards Institute, Wayne, PA, CLSI document H42-A2, 2007.
59. Ryan W, Warrino D. Stabilizing WBCs and immunological markers for flow cytometry.
Clin. Lab Products 2005. Available at http://www.clpmag.com/issues/articles/2005-
01_06.asp.
Search WWH ::




Custom Search