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Volumn 2, Issue 9, 2010, Pages 1587-1596

Bioanalytical method requirements and statistical considerations in incurred sample reanalysis for macromolecules

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN IMMUNOGLOBULIN; IMMUNOGLOBULIN ANTIBODY; PEPTIDE ANTIBODY; RECOMBINANT PROTEIN; DRUG;

EID: 79952508628     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.10.75     Document Type: Article
Times cited : (8)

References (7)
  • 1
    • 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. Recommendataion 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
  • 2
    • 0003484310 scopus 로고    scopus 로고
    • US Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM) US Department of Health and Human Services Food and Drug Administration, USA
    • US Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). Guidance for Industry: Bioanalytical Method Validation, US Department of Health and Human Services Food and Drug Administration, USA (2001).
    • (2001) Guidance for Industry: Bioanalytical Method Validation
  • 4
    • 79953236019 scopus 로고    scopus 로고
    • Report on AAPS workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples-implication of Crystal City recommendations
    • Ray C, DeSimone D, Thway T. Report on AAPS workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples-implication of Crystal City recommendations. Ligand Binding Assay Bioanalytical Focus Group Newsletter 2(2), (2008).
    • (2008) Ligand Binding Assay Bioanalytical Focus Group Newsletter , vol.2 , pp. 2
    • Ray, C.1    Desimone, D.2    Thway, T.3
  • 5
    • 77954865192 scopus 로고    scopus 로고
    • Incurred sample reanalysis: Views and recommendations by the European Bioanalysis Forum
    • Timmerman P, Luedtke S, Amsterdam P et al. Incurred sample reanalysis: views and recommendations by the European Bioanalysis Forum. Bioanalysis 1(6), 1049-1056 (2009).
    • (2009) Bioanalysis , vol.1 , Issue.6 , pp. 1049-1056
    • Timmerman, P.1    Luedtke, S.2    Amsterdam, P.3
  • 6
    • 68249147642 scopus 로고    scopus 로고
    • Workshop report and follow-up-AAPS workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples-implications of Crystal City recommendations
    • Fast DM, Kelley M, Viswanathan CT et al. Workshop report and follow-up-AAPS workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples-implications of Crystal City recommendations. AAPS J. 11(2), 238-241 (2009).
    • (2009) AAPS J. , vol.11 , Issue.2 , pp. 238-241
    • Fast, D.M.1    Kelley, M.2    Viswanathan, C.T.3
  • 7
    • 38849144763 scopus 로고    scopus 로고
    • Confirmatory reanalysis of incurred bioanalytical samples
    • DOI 10.1208/aapsj0903040, 40
    • Rocci ML Jr, Devanarayan V, Haughey DB et al. Confrmatory reanalysis of incurred bioanalytical samples. AAPS J. 9(3), E336-E343 (2007). (Pubitemid 351816757)
    • (2007) AAPS Journal , vol.9 , Issue.3
    • Rocci Jr., M.L.1    Devanarayan, V.2    Haughey, D.B.3    Jardieu, P.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.