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Volumn 4, Issue 19, 2012, Pages 2357-2365

Implementation of a universal analytical method in early-stage development of human antibody therapeutics: Application to pharmacokinetic assessment for candidate selection

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY; DRUG ANTIBODY; HUMAN MONOCLONAL ANTIBODY; HYBRID PROTEIN; IMMUNOGLOBULIN FC FRAGMENT; IMMUNOGLOBULIN G; REAGENT;

EID: 84867957593     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.12.201     Document Type: Article
Times cited : (14)

References (10)
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  • 2
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  • 3
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    • Evaluation of a generic immunoassay with drug tolerance to detect immune complexes in serum samples from cynomolgus monkeys after administration of human antibodies
    • Stubenrauch K, Wessels U, Essig U, Vogel R, Schleypen J. Evaluation of a generic immunoassay with drug tolerance to detect immune complexes in serum samples from cynomolgus monkeys after administration of human antibodies. J. Pharm. Biomed. Anal. 52, 249-254 (2010).
    • (2010) J. Pharm. Biomed. Anal. , vol.52 , pp. 249-254
    • Stubenrauch, K.1    Wessels, U.2    Essig, U.3    Vogel, R.4    Schleypen, J.5
  • 4
    • 43049158163 scopus 로고    scopus 로고
    • Quantitative Determination Of Humanized Monoclonal Antibody RhuMAb2H7 In Cynomolgus Monkey Serum Using A Generic Immunoglobulin Pharmacokinetic (GRIP) Assay
    • Yang J, Ng C, Lowman H, Chestnut R et al. Quantitative determination of humanized monoclonal antibody rhuMAb2H7 in cynomolgus monkey serum using a generic immunoglobulin pharmacokinetic (GRIP) assay. J. Immunol. Methods 335, 8-20 (2008).
    • (2008) J. Immunol. Methods , vol.335 , pp. 8-20
    • Yang, J.1    Ng, C.2    Lowman, H.3    Chestnut, R.4
  • 5
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    • Evaluation of an immunoassay for human-specific quantitation of therapeutic antibodies in serum samples from non-human primates
    • Stubenrauch K, Wessels U, Lenz H. Evaluation of an immunoassay for human-specific quantitation of therapeutic antibodies in serum samples from non-human primates. J. Pharm. Biomed. Anal. 49, 1003-1008 (2009).
    • (2009) J. Pharm. Biomed. Anal. , vol.49 , pp. 1003-1008
    • Stubenrauch, K.1    Wessels, U.2    Lenz, H.3
  • 6
    • 79952529219 scopus 로고    scopus 로고
    • Application of the Gyrolab™ platform to ligand-binding assays: A user's perspective
    • Mora J, Obenauer-Kutner L, Patel V. Application of the Gyrolab™ platform to ligand-binding assays: a user's perspective. Bioanalysis 2, 1711-1715 (2010).
    • (2010) Bioanalysis , vol.2 , pp. 1711-1715
    • Mora, J.1    Obenauer-Kutner, L.2    Patel, V.3
  • 9
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    • Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macro-molecules
    • DeSilva B, Smith W, Weiner R et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macro-molecules. Pharm. Res. 20, 1885-1900 (2003).
    • (2003) Pharm. Res. , vol.20 , pp. 1885-1900
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    • Ligand-binding mass spectrometry to study bio-transformation of fusion protein drugs and guide immunoassay development: Strategic approach and application to peptibodies targeting the thrombopoietin receptor
    • Hall M, Gegg C, Walker K et al. Ligand-binding mass spectrometry to study bio-transformation of fusion protein drugs and guide immunoassay development: strategic approach and application to peptibodies targeting the thrombopoietin receptor. AAPS J. 12, 576-585 (2010).
    • (2010) AAPS J. , vol.12 , pp. 576-585
    • Hall, M.1    Gegg, C.2    Walker, K.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.