Immunogenicity to Therapeutic Proteins: Impact on PK/PD and Efficacy
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmaceutical Science
Link
http://link.springer.com/content/pdf/10.1208/s12248-012-9340-y.pdf
Reference45 articles.
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3. Dong JQ, Salinger DH, Endres CJ, Gibbs JP, Hsu CP, Stouch BJ, et al. Quantitative prediction of human pharmacokinetics for monoclonal antibodies: retrospective analysis of monkey as a single species for first-in-human prediction. Clin Pharmacokinet. 2011;50:131–42.
4. CHMP. Guideline of immunogenicity assessment of biotechnology-derived therapeutic proteins. London: EMEA Guidance Document; 2008.
5. Gupta S, Devanarayan V, Finco D, Gunn 3rd GR, Kirshner S, Richards S, et al. Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics. J Pharm Biomed Anal. 2011;55:878–88.
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