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Volumn 3, Issue 23, 2011, Pages 2627-2636

Proposal for a new protein therapeutic immunogenicity titer assay cutpoint

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; ANTIBODY TITER; ARTICLE; CONTROLLED STUDY; IMMUNOASSAY; IMMUNOGENICITY; INTERMETHOD COMPARISON; PLOTS AND CURVES; REFERENCE VALUE; SCREENING TEST; STATISTICAL ANALYSIS;

EID: 82955239926     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.273     Document Type: Article
Times cited : (3)

References (9)
  • 2
    • 16844367771 scopus 로고    scopus 로고
    • A risk-based approach to immunogenicity concerns of therapeutic protein products
    • Parts 1-3 Nov Dec 2004 Jan
    • Rosenberg AS, Worobec A. A risk-based approach to immunogenicity concerns of therapeutic protein products. BioPharm. Int. Parts 1-3, Nov, Dec 2004, Jan 2005.
    • (2005) BioPharm.Int
    • Rosenberg, A.S.1    Worobec, A.2
  • 4
    • 41349116947 scopus 로고    scopus 로고
    • Recommendations on risk-based strategies for detecion and characterization of antibodies against biotechnology products
    • Koren E, Smith H, Shores E et al. Recommendations on risk-based strategies for detecion and characterization of antibodies against biotechnology products. J. Immunol. Methods 333(1-2), 1-9 (2008).
    • (2008) J. Immunol. Methods , vol.333 , Issue.1-2 , pp. 1-9
    • Koren, E.1    Smith, H.2    Shores, E.3
  • 5
    • 58249116651 scopus 로고    scopus 로고
    • Recommendations for the validation of immunoassays used for the detection of host antibodies against biotechnology products
    • Shankar G, Devanarayan V, Amaravadi L et al. Recommendations for the validation of immunoassays used for the detection of host antibodies against biotechnology products. J. Pharm. Biomed. Anal. 48(5), 1267-1281 (2009).
    • (2009) J. Pharm. Biomed. Anal. , vol.48 , Issue.5 , pp. 1267-1281
    • Shankar, G.1    Devanarayan, V.2    Amaravadi, L.3
  • 6
    • 67349241946 scopus 로고    scopus 로고
    • Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies
    • Ponce R, Abad L, Amaravadi L et al. Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies. Regul. Toxicol. Pharmacol. 54(2), 164-182 (2009).
    • (2009) Regul. Toxicol. Pharmacol. , vol.54 , Issue.2 , pp. 164-182
    • Ponce, R.1    Abad, L.2    Amaravadi, L.3
  • 7
    • 82955168670 scopus 로고    scopus 로고
    • EMA. Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins (EMEA/CHMP/BMWP/14327/2006), effective April
    • EMA. Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins (EMEA/CHMP/BMWP/14327/2006), effective April 2008.
    • (2008)
  • 9
    • 77958509120 scopus 로고    scopus 로고
    • A novel homogenous biotin-digoxigenin based assay for the detection of human anti-therapeutic antibodies in autoimmune serum
    • Qiu ZJ, Ying Y, Fox M et al. A novel homogenous biotin-digoxigenin based assay for the detection of human anti-therapeutic antibodies in autoimmune serum. J. Immunol. Methods 362(1-2), 101-111 (2010).
    • (2010) J. Immunol. Methods , vol.362 , Issue.1-2 , pp. 101-111
    • Qiu, Z.J.1    Ying, Y.2    Fox, M.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.