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Volumn 3, Issue 16, 2011, Pages 1799-1803

Understanding and mitigating impact of immunogenicity on pharmacokinetic assays

Author keywords

anti drug antibodies; immunogenicity; interference; pharmacodynamics; pharmacokinetic

Indexed keywords

DRUG; DRUG ANTIBODY; MONOCLONAL ANTIBODY;

EID: 80052500100     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.162     Document Type: Review
Times cited : (16)

References (4)
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    • Detection of antibodies against therapeutic proteins in the presence of residual therapeutic protein using a solid-phase extraction with acid dissociation (SPEAD) sample treatment prior to ELISA
    • DOI 10.1016/j.yrtph.2007.07.005, PII S0273230007001031
    • Smith HW, Butterfield A, Sun D. Detection of antibodies against therapeutic proteins in the presence of residual therapeutic protein using a solid-phase extraction with acid dissociation (SPEAD) sample treatment prior to ELISA. Regulatory Toxicology and Pharmacology. 49(3), 230-237 (2007). (Pubitemid 350087397)
    • (2007) Regulatory Toxicology and Pharmacology , vol.49 , Issue.3 , pp. 230-237
    • Smith, H.W.1    Butterfield, A.2    Sun, D.3
  • 2
    • 0036890997 scopus 로고    scopus 로고
    • Immune responses to therapeutic proteins in humans - Clinical significance, assessment and prediction
    • DOI 10.2174/1389201023378175
    • Koren E, Zuckerman LA, Mire-Sluis AR. Immune responses to therapeutic proteins in humans - clinical significance, assessment and prediction. Curr. Pharm. Biotechnol. 3(11). 349-360 (2002). (Pubitemid 35364009)
    • (2002) Current Pharmaceutical Biotechnology , vol.3 , Issue.4 , pp. 349-360
    • Koren, E.1    Zuckerman, L.A.2    Mire-Sluis, A.R.3
  • 3
    • 0003484310 scopus 로고    scopus 로고
    • US Department of Health and Human Services Food and Drug Administration FDA Center for Drug Evaluation and Research CDER Center for Biologics Evaluation and Research CBER
    • US Department of Health and Human Services, Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry Bioanalytical Method Validation, May 2001.
    • (2001) Guidance for Industry Bioanalytical Method Validation May
  • 4
    • 10744230729 scopus 로고    scopus 로고
    • Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
    • DOI 10.1023/B:PHAM.0000003390.51761.3d
    • DeSilva B, Smith W, Weiner R et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20(11), 1885-1900 (2003). (Pubitemid 37449466)
    • (2003) Pharmaceutical Research , vol.20 , Issue.11 , pp. 1885-1900
    • Desilva, B.1    Smith, W.2    Weiner, R.3    Kelley, M.4    Smolec, J.5    Lee, B.6    Khan, M.7    Tacey, R.8    Hill, H.9    Celniker, A.10


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.