Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products

Author:

Mire-Sluis Anthony R,Barrett Yu Chen,Devanarayan Viswanath,Koren Eugen,Liu Hank,Maia Mauricio,Parish Thomas,Scott George,Shankar Gopi,Shores Elizabeth,Swanson Steven J,Taniguchi Gary,Wierda Daniel,Zuckerman Linda A

Publisher

Elsevier BV

Subject

Immunology,Immunology and Allergy

Reference6 articles.

1. Statistical Method in Biological Assay;Finney,1978

2. Validation of immunoassays for bioanalysis: A pharmaceutical industry perspective;Findlay;Journal of Pharmaceutical and Biomedical Analysis,2000

3. International Committee for Harmonization. Q2A: Text on Validation of Analytical Procedures. Available at http://www.fda.gov/cder/guidance/index.htm

4. International Committee for Harmonization. Q2B: Validation of Analytical Procedures: Methodology. Available at http://www.fda.gov/cder/guidance/index.htm

5. Validation of assays for the bioanalysis of novel biomarkers;Lee,2003

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