Impact of Anti-Drug Antibodies in Preclinical Pharmacokinetic Assessment
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmaceutical Science
Link
http://link.springer.com/content/pdf/10.1208/s12248-013-9484-4.pdf
Reference11 articles.
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2. Swanson SJ, Bussiere J. Immunogenicity assessment in non-clinical studies. Curr Opin Microbiol. 2012;15(3):337–47.
3. Lee J et al. Bioanalytical approaches to quantify “total” and “free” therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development. AAPS J. 2011;13(1):99–110.
4. Lee J, Ma H. Specificity and selectivity evaluations of ligand binding assay of protein therapeutics against concomitant drugs and related endogenous proteins. AAPS J. 2007;9(2):E164–70.
5. Thway TM et al. Experimental and statistical approaches in method cross-validation to support pharmacokinetic decisions. J Pharm Biomed Anal. 2009;49(3):613–8.
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