Recommendations for Systematic Statistical Computation of Immunogenicity Cut Points
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmaceutical Science
Link
http://link.springer.com/article/10.1208/s12248-017-0107-3/fulltext.html
Reference40 articles.
1. Shankar G, Devanarayan V, Amaravadi L, Barrett YC, Bowsher RR, et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal. 2008;48:1267–81.
2. Shen M, Dong X, Tsong Y. Statistical evaluation of several methods for cut point determination of immunogenicity screening assay. J Biopharm Stat. 2016;25(2):269–79.
3. Su C, Zhou L, Hu Z, Weng W, Subramani J, Tadkod V, et al. Enhancing efficiency and quality of statistical estimation of immunogenicity assay cut points through standardization and automation. J Immunol Methods. 2015;425:88–96.
4. Schaarschmidt F, Hofmann M, Jaki T, Grun B, Hothorn LA. Statistical approaches for the determination of cut points in anti-drug antibody bioassays. J Immunol Methods. 2015;418:84–100.
5. Zhang J, Yu B, Zhang L, Roskos L, Richman L, Yang H. Non-normal random effects models for immunogenicity assay cut point determination. J Biopharm Stat. 2015;25(2):295–306.
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