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Volumn , Issue , 2011, Pages 233-242

Standardization and Validation of Immunoassays

Author keywords

Assay standardization and validation and immunoassay standardization and validation; Specificity cut point, percentage inhibition at or above, sample, confirmed positive; Tiered testing approach, assessment of immunogenicity of biopharmaceutical

Indexed keywords


EID: 80052700331     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781118075685.ch13     Document Type: Chapter
Times cited : (3)

References (7)
  • 1
    • 0033849494 scopus 로고    scopus 로고
    • Megakaryocyte growth and development factor (MGDF): an Mpl ligand and cytokine that regulates thrombopoiesis
    • Neumann, T.A., Foote, M. ( 2000 ). Megakaryocyte growth and development factor (MGDF): an Mpl ligand and cytokine that regulates thrombopoiesis . Cytokines Cell Mol Ther, 6, 47-56 .
    • (2000) Cytokines Cell Mol Ther , vol.6 , pp. 47-56
    • Neumann, T.A.1    Foote, M.2
  • 4
    • 58249116651 scopus 로고    scopus 로고
    • Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
    • Shankar, G ., Devanarayan, V., Amaravadi, L., et al. ( 2008 ). Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products . J Pharm Biomed Anal, 48 ( 5 ), 1267-1281 .
    • (2008) 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 non-clinical safety studies
    • Ponce, R., Abad, L., Amaravadi, L., et al. ( 2009 ). Immunogenicity of biologically-derived therapeutics : assessment and interpretation of non-clinical safety studies . Regul Toxicol Pharmacol, 54, 164-182 .
    • (2009) Regul Toxicol Pharmacol , vol.54 , pp. 164-182
    • Ponce, R.1    Abad, L.2    Amaravadi, L.3
  • 7
    • 33947397632 scopus 로고    scopus 로고
    • Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics
    • Gupta, S., Indelicato, S.R., Jethwa, V., Kawabata, T., Kelley, M., Mire-Sluis, A.R., Richards, S.M., Rup, B., Shores, E., Swanson, S.J., Wakshull, E. ( 2007 ). Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics . J Immunol Methods, 321, 1-18 .
    • (2007) J Immunol Methods , vol.321 , pp. 1-18
    • Gupta, S.1    Indelicato, S.R.2    Jethwa, V.3    Kawabata, T.4    Kelley, M.5    Mire-Sluis, A.R.6    Richards, S.M.7    Rup, B.8    Shores, E.9    Swanson, S.J.10    Wakshull, E.11


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.