References
- Bode, G., Clausing, P., Gervais, F., Loegsted, J., Luft, J., Nogues, V., Sims, J. 2010. The utility of the minipig as an animal model in regulatory toxicology. J. Pharmacol. Toxicol. Meth. 62:196–220.
- Brinks, V., Jiskoot, W., Schellekens, H. 2011. Immunogenicity of therapeutic proteins: The use of animal models. Pharm. Res. 28:2379–2385.
- Bugelski, P. J., Treacy, G. 2004. Predictive power of preclinical studies in animals for the immunogenicity of recombinant therapeutic proteins in humans.Curr. Opin. Mol. Ther. 6:10–16.
- Buttel, I. C., Chamberlain, P., Chowers, Y., Ehmann, F., Greinacher, A., Jefferis, R., Kramer, D., Kropshofer, H., Lloyd, P., Lubiniecki, A., Krause, R., Mire-Sluis, A., Platts-Mills, T., Ragheb, J. A., Reipert, B. M., Schellekens, H., Seitz, R., Stas, P., Subramanyam, M., Thorpe, R., Trouvin, J. H., Weise, M., Windisch, J., Schneider, C. K. 2011. Taking immunogenicity assessment of therapeutic proteins to the next level. Biologicals 39:100–109.
- Chirino, A. J., Ary, M. L., Marshall, S. A. 2004. Minimizing the immunogenicity of protein therapeutics. Drug Discov. Today 9:82–90.
- EMEA. 2006. Kineret: EPAR - Scientific Discussion.
- FDA. 2000. Center for drug evaluation and research and center for biologics evaluation and research. Application number 103950/0.
- FDA. 2001. Center for drug evaluation and research and center for biologics evaluation and research. Application number 103950/0; Approved labeling.
- FDA (Food and Drug Administration) Arthritis Drugs Advisory Committee. 2001. Kineret TM (anakinra) FDA Arthritis Drugs Advisory Committee Briefing Package.
- Forster, R., Ancian, P., Fredholm, M., Simianer, H., Whitelaw, B. 2010a. The minipig as a platform for new technologies in toxicology. J. Pharmacol. Toxicol. Meth. 62:227–235.
- Forster, R., Bode, G., Ellegaard, L., van der Laan, J. W. 2010b. The RETHINK project on minipigs in the toxicity testing of new medicines and chemicals: Conclusions and recommendations. J. Pharmacol. Toxicol. Meth. 62:236–242.
- Forster, R., Bode, G., Ellegaard, L., van der Laan, J. W. 2010c. The RETHINK project -minipigs as models for the toxicity testing of new medicines and chemicals: An impact assessment. J. Pharmacol. Toxicol. Meth. 62:158–159.
- Getts, D. R., Getts, M. T., McCarthy, D. P., Chastain, E. M., Miller, S. D. 2010. Have we over-estimated the benefit of human(ized) antibodies? MAbs 2:682–694.
- ICH. 2005. ICH S8. Immunotoxicity Studies for Human Pharmaceuticals.
- Kromminga, A., Schellekens, H. 2005. Antibodies against erythropoietin and other protein-based therapeutics: An overview. Ann. NY Acad. Sci. 1050:257–265.
- Penninks, A. H., van Mierlo, G. J. 2012. Immunotoxicity studies in minipigs. In: The Minipig in Biomedical Research (McAnulty, P. A., Dayan, A. D., Ganderup, N. C.Hastings, K. L., Eds.). New York: CRC Press/Taylor and Francis Group, pp. 397–414.
- Ponce, R., Abad, L., Amaravadi, L., Gelzleichter, T., Gore, E., Green, J., Gupta, S., Herzyk, D., Hurst, C., Ivens, I. A., Kawabata, T., Maier, C., Mounho, B., Rup, B., Shankar, G., Smith, H., Thomas, P., Wierda, D. 2009. Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies. Regul. Toxicol. Pharmacol. 54:164–182.
- Regulatory Affairs Canada. 2008. Product Monograph PrKineret.
- Schellekens, H. 2010. The immunogenicity of therapeutic proteins. Discov. Med. 9:560–564.
- Singh, S. K. 2011. Impact of product-related factors on immunogenicity of biotherapeutics.J. Pharm. Sci. 100:354–387.
- van der Laan, J. W., Brightwell, J., McAnulty, P., Ratky, J., Stark, C. 2010. Regulatory acceptability of the minipig in the development of pharmaceuticals, chemicals, and other products. J. Pharmacol. Toxicol. Meth. 62:184–195.
- Wierda, D., Smith, H. W., Zwickl, C. M. 2001. Immunogenicity of biopharmaceuticals in laboratory animals. Toxicology 158:71–74.
- Zuurmond, A. M., Koudijs, A., van, E. B., Doornbos, R. P., van Manen-Vernooij, B. C., Bastiaans, J. H., Penninks, A. H., van Bilsen, J. H., Cnubben, N. H., Degroot, J. 2011. Integration of efficacy, pharmacokinetic, and safety assessment of IL-1 receptor antagonist in a pre-clinical model of arthritis. Regul. Toxicol. Pharmacol. 59:461–470.