REFERENCES
- Chakraborti, S., Li, J. (2007). Confidence interval estimation of a normal percentile. American Statistician 61:331–336.
- Hoffman, D., Berger, M. (2011). Statistical considerations for calculation of immunogenicity screening assay cut points. Journal of Immunological Methods 373:200–208.
- Shankara, G., Devanarayanb, V., Amaravadic, L., Barrett, Y. C., Bowshere, R., Finco-Kentf, D., Fiscella, M., Gorovits, B., Kirschneri, S., Moxnessj, M., Parishk, T., Quarmbyl, V., Smithm, H., Smithn, W., Zuckermano, L. A., Korenp, K. (2008). Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. Journal of Pharmaceutical and Biomedical Analysis, 48:1267–1281.
- U.S. Food and Drug Administration. (2009). The Draft Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins, December 2009.
- Zhang, L., Zhang, J. J., Kubiak, R. J., Yang, H. (2013). Statistical methods and tool for cut point analysis in immunogenicity assays. Journal of Immunological Methods 389:79–87.