Mitigation of Pre-existing Antibodies to a Biotherapeutic in Non-clinical Species When Establishing Anti-drug Antibody Assay Cutpoint
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmaceutical Science
Link
http://link.springer.com/content/pdf/10.1208/s12248-016-0011-2.pdf
Reference13 articles.
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2. Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B, et al. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J Immunol Methods. 2008;333(1–2):1–9.
3. Jani D, Marsden R, Mikulskis A, Gleason C, Klem T, Krinos Fiorotti C, et al. Recommendations for the development and validation of confirmatory anti-drug antibody assays. Bioanalysis. 2015;7(13):1619–31.
4. Hoffman D, Berger M. Statistical considerations for calculation of immunogenicity screening assay cut points. J Immunol Methods. 2011;373(1–2):200–8.
5. Jaki T, Lawo JP, Wolfsegger MJ, Singer J, Allacher P, Horling F. A formal comparison of different methods for establishing cut points to distinguish positive and negative samples in immunoassays. J Pharm Biomed Anal. 2011;55(5):1148–56.
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