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Volumn 6, Issue 8, 2014, Pages 1113-1122

Measuring biotherapeutics with endogenous counterparts and pre-existing antibodies: An interferon case study

Author keywords

[No Author keywords available]

Indexed keywords

AUTOANTIBODY; BIOLOGICAL PRODUCT; DRUG ANTIBODY; INTERFERON; INTERFERON LAMBDA; UNCLASSIFIED DRUG; IL29 PROTEIN, HUMAN; INTERLEUKIN DERIVATIVE; MONOCLONAL ANTIBODY;

EID: 84901021485     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.14.37     Document Type: Article
Times cited : (7)

References (10)
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    • Findlay, J.W.A.1    Smith, W.C.2    Lee, J.W.3
  • 2
    • 10744230729 scopus 로고    scopus 로고
    • Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
    • 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
    • (2003) Pharm. Res , vol.20 , Issue.11 , pp. 1885-1900
    • DeSilva, B.1    Smith, W.2    Weiner, R.3
  • 3
    • 24044467097 scopus 로고    scopus 로고
    • Bioanalytical method validation for macromolecules in support of pharmacokinetic studies
    • Smolec J, DeSliva B, Smith W et al. Bioanalytical method validation for macromolecules in support of pharmacokinetic studies. Pharm. Res. 22(9), 1425-1431 (2005
    • (2005) Pharm. Res , vol.22 , Issue.9 , pp. 1425-1431
    • Smolec, J.1    DeSliva, B.2    Smith, W.3
  • 4
    • 34249277443 scopus 로고    scopus 로고
    • Key elements of bioanalytical method validation for macromolecules
    • Kelley M, DeSilva B. Key elements of bioanalytical method validation for macromolecules. AAPS J. 9(2), E156-E163 (2007
    • (2007) AAPS J. , vol.9 , Issue.2
    • Kelley, M.1    DeSilva, B.2
  • 5
    • 0003484310 scopus 로고    scopus 로고
    • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research. FDA, Rockville, MD, USA
    • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research. Guidance for Industry: Bioanalytical Method Validation. FDA, Rockville, MD, USA (2001
    • (2001) Guidance for Industry: Bioanalytical Method Validation
  • 6
    • 81055146012 scopus 로고    scopus 로고
    • European Medicines Agency. European Medicines Agency London UK
    • European Medicines Agency. Guideline on Bioanalytical Method Validation. European Medicines Agency, London, UK (2011
    • (2011) Guideline on Bioanalytical Method Validation
  • 8
    • 77950524946 scopus 로고    scopus 로고
    • Troubleshooting peg-hgh detection supporting pharmacokinetic evaluation in growth hormone deficient patients
    • Myler HA, McVay S, Kratzsch J. Troubleshooting PEG-hGH detection supporting pharmacokinetic evaluation in growth hormone deficient patients. J. Pharm. Toxicol. Methods 61, 92-97 (2010
    • (2010) J. Pharm. Toxicol. Methods , vol.61 , pp. 92-97
    • Myler, H.A.1    McVay, S.2    Kratzsch, J.3
  • 9
    • 79951980085 scopus 로고    scopus 로고
    • Bioanalytical approaches to quantify total and free therapeutic antibodies and their targets: Technical challenges and pk/pd applications over the course of drug development
    • Lee J, Kelley M, King L et al. Bioanalytical Approaches to quantify total and free therapeutic antibodies and their targets: Technical challenges and PK/PD applications over the course of drug development. AAPSJ. 13(1), 99-110 (2011
    • (2011) AAPSJ , vol.13 , Issue.1 , pp. 99-110
    • Lee, J.1    Kelley, M.2    King, L.3
  • 10
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    • Biotherapeutic bioanalysis: A multi-indication case study review
    • Myler H, Given A, Kolz K et al. Biotherapeutic bioanalysis: A multi-indication case study review. Bioanalysis 3(6), 623-624 (2011
    • (2011) Bioanalysis , vol.3 , Issue.6 , pp. 623-624
    • Myler, H.1    Given, A.2    Kolz, K.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.