메뉴 건너뛰기




Volumn 6, Issue 3, 2014, Pages 393-402

ISR: Background, evolution and implementation, with specific consideration for ligand-binding assays

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; BIOMARKER ASSAY; CHROMATOGRAPHY; EVALUATION STUDY; GOVERNMENT REGULATION; HUMAN; IMMUNOGENECITY ASSAY; ISR ANALYSIS; NONHUMAN; RECEPTOR BINDING ASSAY; REVIEW; VALIDATION STUDY;

EID: 84893410428     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.13.339     Document Type: Review
Times cited : (9)

References (44)
  • 1
    • 0026606194 scopus 로고
    • Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies
    • Shah VP, Midha KK, Dighe S et al. Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies. Pharm. Res. 9(4), 588-592 (1992
    • (1992) Pharm. Res , vol.9 , Issue.4 , pp. 588-592
    • Shah, V.P.1    Midha, K.K.2    Dighe, S.3
  • 2
    • 0034469255 scopus 로고    scopus 로고
    • Bioanalytical method validation-A revisit with a decade of progress
    • Shah VP, Midha KK, Findlay JWA et al. Bioanalytical method validation-A revisit with a decade of progress. Pharm Res. 17(12), 1551-1557 (2000
    • (2000) Pharm Res , vol.17 , Issue.12 , pp. 1551-1557
    • Shah, V.P.1    Midha, K.K.2    Findlay, J.W.A.3
  • 3
    • 0034852176 scopus 로고    scopus 로고
    • Workshop on bioanalytical methods validation for macromolecules: Summary report
    • Miller KJ, Bowsher RR, Celniker A et al. Workshop on bioanalytical methods validation for macromolecules: Summary report. Pharm. Res. 18(9), 1373-1383 (2001
    • (2001) Pharm. Res , vol.18 , Issue.9 , pp. 1373-1383
    • Miller, K.J.1    Bowsher, R.R.2    Celniker, A.3
  • 4
    • 0033989957 scopus 로고    scopus 로고
    • Validation of immunoassays for bioanalysis: A pharmaceutical industry perspective
    • Findlay JWA, Smith WC, Lee JW et al. Validation of immunoassays for bioanalysis: A pharmaceutical industry perspective. J. Pharm. Biomed. Anal. 21, 1249-1273 (2000
    • (2000) J. Pharm. Biomed. Anal , vol.21 , pp. 1249-1273
    • Findlay, J.W.A.1    Smith, W.C.2    Lee, J.W.3
  • 5
    • 0003484310 scopus 로고    scopus 로고
    • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, Center for Veterinary Medicine. US FDA, Rockville, MD, USA
    • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, Center for Veterinary Medicine. Guidance for Industry: Bioanalytical Method Validation. US FDA, Rockville, MD, USA (2001
    • (2001) Guidance for Industry: Bioanalytical Method Validation
  • 6
    • 10744230729 scopus 로고    scopus 로고
    • Recommendations for bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
    • DeSilva B, Smith W, Weiner R et al. Recommendations for 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
  • 7
    • 32544451155 scopus 로고    scopus 로고
    • Fit-for-purpose method development and validation for successful biomarker measurement
    • Lee JW, Devanarayan V, Barrett YC et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 23(2), 312-328 (2006
    • (2006) Pharm. Res , vol.23 , Issue.2 , pp. 312-328
    • Lee, J.W.1    Devanarayan, V.2    Barrett, Y.C.3
  • 8
    • 41349116947 scopus 로고    scopus 로고
    • Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products
    • Koren E, Smith HW, Shores E et al. Recommendations on risk-based strategies for detection 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.W.2    Shores, E.3
  • 9
    • 81055146012 scopus 로고    scopus 로고
    • European Medicines Agency Committee for Medicinal Products for Human Use. European Medicines Agency London, UK
    • European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on Bioanalytical Method Validation. European Medicines Agency, London, UK (2011
    • (2011) Guideline on Bioanalytical Method Validation
  • 10
    • 84875029552 scopus 로고    scopus 로고
    • The european bioanalysis forum community's evaluation, interpretation and implementation of the european medicines agency guideline on bioanalytical method validation
    • Van Amsterdam P, Companjen A, Brudny-Kloeppel M et al. The European Bioanalysis Forum community's evaluation, interpretation and implementation of the European Medicines Agency guideline on bioanalytical method validation. Bioanalysis 5(6), 645-659 (2013
    • (2013) Bioanalysis , vol.5 , Issue.6 , pp. 645-659
    • Van Amsterdam, P.1    Companjen, A.2    Brudny-Kloeppel, M.3
  • 11
    • 84859127820 scopus 로고    scopus 로고
    • Recommendations on the interpretation of the new european medicines agency guideline on bioanalytical method validation by global cro council for bioanalysis (gcc
    • Boterman M, Doig M, Breda M et al. Recommendations on the interpretation of the new European Medicines Agency guideline on bioanalytical method validation by Global CRO Council for Bioanalysis (GCC). Bioanalysis 4(6), 651-660 (2012
    • (2012) Bioanalysis , vol.4 , Issue.6 , pp. 651-660
    • Boterman, M.1    Doig, M.2    Breda, M.3
  • 12
    • 82955168442 scopus 로고    scopus 로고
    • Incurred sample reanalysis: A global transformation
    • Viswanathan CT. Incurred sample reanalysis: A global transformation. Bioanalysis 3(23), 2601-2602 (2011).
    • (2011) Bioanalysis , vol.3 , Issue.23 , pp. 2601-2602
    • Viswanathan, C.T.1
  • 13
    • 34548550429 scopus 로고    scopus 로고
    • Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays
    • Viswanathan CT, Bansal S, Booth B et al. Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays. Pharm. Res. 24(10), 1962-1973 (2007
    • (2007) Pharm. Res , vol.24 , Issue.10 , pp. 1962-1973
    • Viswanathan, C.T.1    Bansal, S.2    Booth, B.3
  • 14
    • 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
  • 15
    • 77954865192 scopus 로고    scopus 로고
    • Incurred sample reproducibility: Views and recommendations by the European Bioanalysis Forum
    • Timmerman P, Leudtke S, van Amsterdam P et al. Incurred sample reproducibility: 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    Leudtke, S.2    Van Amsterdam, P.3
  • 16
    • 79959421480 scopus 로고    scopus 로고
    • Recommendations on: Internal standard criteria, stability, incurred sample reanalysis and recent 483s by the global cro council for bioanalysis
    • Lowes S, Jersey J, Shoup R et al. Recommendations on: Internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis. Bioanalysis 3(12), 1323-1332 (2011).
    • (2011) Bioanalysis , vol.3 , Issue.12 , pp. 1323-1332
    • Lowes, S.1    Jersey, J.2    Shoup, R.3
  • 17
    • 84867355005 scopus 로고    scopus 로고
    • 2012 White paper on recent issues in bioanalysis and alignment of multiple guidelines
    • DeSilva B, Garofolo F, Rocci M et al. 2012 White paper on recent issues in bioanalysis and alignment of multiple guidelines. Bioanalysis 4(18), 2213-2226 (2012
    • (2012) Bioanalysis , vol.4 , Issue.18 , pp. 2213-2226
    • Desilva, B.1    Garofolo, F.2    Rocci, M.3
  • 18
    • 0345424863 scopus 로고    scopus 로고
    • Canadian Health Ministry. Conduct and Analysis of Bioavailability and Bioequivalence Studies-Part A: Oral Dosage Formulations Used for Systemic Effects. Minister of Health, Health Canada, Ottawa, Canada
    • Canadian Health Ministry. Guidance for Industry. Conduct and Analysis of Bioavailability and Bioequivalence Studies-Part A: Oral Dosage Formulations Used for Systemic Effects. Minister of Health, Health Canada, Ottawa, Canada (1992
    • (1992) Guidance for Industry
  • 19
    • 0345424863 scopus 로고    scopus 로고
    • Canadian Health Ministry. Conduct and Analysis of Bioavailability and Bioequivalence Studies-Part B: Oral Modified Release Formulations Used for Systemic Effects. Minister of Health, Health Canada, Ottawa, Canada
    • Canadian Health Ministry. Guidance for Industry. Conduct and Analysis of Bioavailability and Bioequivalence Studies-Part B: Oral Modified Release Formulations Used for Systemic Effects. Minister of Health, Health Canada, Ottawa, Canada (1996
    • (1996) Guidance for Industry
  • 20
    • 84893406774 scopus 로고    scopus 로고
    • Canadian Health Ministry Random Replicate Samples Minister of Health, Health Canada, Ottawa, Canada
    • Canadian Health Ministry. Notice for Industry-Removal of Requirement for 15% Random Replicate Samples. Minister of Health, Health Canada, Ottawa, Canada (2003
    • (2003) Notice for Industry-Removal of Requirement for 15%
  • 21
    • 79951747555 scopus 로고    scopus 로고
    • Building the global bioanalysis consortium-working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation
    • Van Amsterdam P, Arnold M, Bansal S et al. Building the Global Bioanalysis Consortium-working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation. Bioanalysis 2(11), 1801-1803 (2010
    • (2010) Bioanalysis , vol.2 , Issue.11 , pp. 1801-1803
    • Van Amsterdam, P.1    Arnold, M.2    Bansal, S.3
  • 22
    • 79951768879 scopus 로고    scopus 로고
    • The 2nd calibration and validation group workshop on recent issues in good laboratory practice bioanalysis
    • Savoie N, Booth BP, Bradley T et al. The 2nd Calibration and Validation Group Workshop on recent issues in Good Laboratory Practice bioanalysis. Bioanalysis 1(1), 19-30 (2009
    • (2009) Bioanalysis , vol.1 , Issue.1 , pp. 19-30
    • Savoie, N.1    Booth, B.P.2    Bradley, T.3
  • 23
    • 38849144763 scopus 로고    scopus 로고
    • Confirmatory reanalysis of incurred bioanalytical samples
    • Rocci ML Jr, Devanarayan V, Haughey DB et al. Confirmatory reanalysis of incurred bioanalytical samples. AAPS J. 9(3), E336-E343 (2007
    • (2007) AAPS J. , vol.9 , Issue.3
    • Rocci Jr., M.L.1    Devanarayan, V.2    Haughey, D.B.3
  • 25
    • 84908219488 scopus 로고
    • Statistical methods for assessing agreement between two methods of clinical measurement
    • Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet i, 307-310 (1986
    • (1986) Lancet , vol.1 , pp. 307-310
    • Bland, J.M.1    Altman, D.G.2
  • 26
    • 78751706543 scopus 로고    scopus 로고
    • Incurred sample reanalysis: Enhancing the bland-Altman approach with tolerance intervals
    • Lytle FE, Julian RK, Tabert AM. Incurred sample reanalysis: Enhancing the Bland-Altman approach with tolerance intervals. Bioanalysis 1(4), 706-714 (2009
    • (2009) Bioanalysis , vol.1 , Issue.4 , pp. 706-714
    • Lytle, F.E.1    Julian, R.K.2    Tabert, A.M.3
  • 27
    • 79952016940 scopus 로고    scopus 로고
    • Regulated bioanalysis and the desire for harmonized regulations in China
    • Tang D, Zhong D. Regulated bioanalysis and the desire for harmonized regulations in China. Bioanalysis 2(12), 1913-1919 (2010
    • (2010) Bioanalysis , vol.2 , Issue.12 , pp. 1913-1919
    • Tang, D.1    Zhong, D.2
  • 28
    • 0003484310 scopus 로고    scopus 로고
    • USDepartment of Health and Human Services, US FDA, Center for Drug Evaluation and Research, Center for Veterinary Medicine). US FDA, Rockville MD, USA
    • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, Center for Veterinary Medicine. Guidance for Industry: Bioanalytical Method Validation (DRAFT). US FDA, Rockville, MD, USA (2013
    • (2013) Guidance for Industry: Bioanalytical Method Validation (DRAFT
  • 29
    • 73349122873 scopus 로고    scopus 로고
    • Statistical considerations for assessment of bioanalytical incurred sample reproducibility
    • Hoffman D. Statistical considerations for assessment of bioanalytical incurred sample reproducibility. AAPS J. 11(3), 570-580 (2009).
    • (2009) AAPS J. , vol.11 , Issue.3 , pp. 570-580
    • Hoffman, D.1
  • 30
    • 79952016469 scopus 로고    scopus 로고
    • Identifying trends and developing solutions for incurred sample analysis failure investigations in a bioanalytical CRO
    • Meng M, Reuschel S, Bennett P. Identifying trends and developing solutions for incurred sample analysis failure investigations in a bioanalytical CRO. Bioanalysis 3(4), 449-465 (2011
    • (2011) Bioanalysis , vol.3 , Issue.4 , pp. 449-465
    • Meng, M.1    Reuschel, S.2    Bennett, P.3
  • 31
    • 80052547731 scopus 로고    scopus 로고
    • Beyond successful ISR: Case-by-case investigations for unmatched reassay results when ISR passed
    • Tan A, Gagnon-Carignan S, Lachance S et al. Beyond successful ISR: Case-by-case investigations for unmatched reassay results when ISR passed. Bioanalysis 3(9), 1031-1038 (2011
    • (2011) Bioanalysis , vol.3 , Issue.9 , pp. 1031-1038
    • Tan, A.1    Gagnon-Carignan, S.2    Lachance, S.3
  • 32
    • 80052548978 scopus 로고    scopus 로고
    • How to manage having no incurred sample reanalysis evaluation failures
    • Garofolo P, Bergeron A, Savoie N. How to manage having no incurred sample reanalysis evaluation failures. Bioanalysis 3(9), 935-938 (2011
    • (2011) Bioanalysis , vol.3 , Issue.9 , pp. 935-938
    • Garofolo, P.1    Bergeron, A.2    Savoie, N.3
  • 33
    • 80052549710 scopus 로고    scopus 로고
    • Investigation and resolution of incurred sample reanalysis failures: Two case studies
    • Rocci ML, Collins E, Wagner-Caruso KE et al. Investigation and resolution of incurred sample reanalysis failures: Two case studies. Bioanalysis 3(9), 993-1000 (2011
    • (2011) Bioanalysis , vol.3 , Issue.9 , pp. 993-1000
    • Rocci, M.L.1    Collins, E.2    Wagner-Caruso, K.E.3
  • 34
    • 80052542955 scopus 로고    scopus 로고
    • Incurred sample reanalysis (ISR): A decisive tool in bioanalytical research
    • Yadav M, Shrivastav PS. Incurred sample reanalysis (ISR): A decisive tool in bioanalytical research. Bioanalysis 3(9), 1007-1024 (2011
    • (2011) Bioanalysis , vol.3 , Issue.9 , pp. 1007-1024
    • Yadav, M.1    Shrivastav, P.S.2
  • 35
    • 57149111489 scopus 로고    scopus 로고
    • Specificity and accuracy data for ligand-binding assays for macromolecules should be interpreted with caution
    • Findlay JWA. Specificity and accuracy data for ligand-binding assays for macromolecules should be interpreted with caution. AAPS J. 10(3), 433-434 (2008
    • (2008) AAPS J. , vol.10 , Issue.3 , pp. 433-434
    • Findlay, J.W.A.1
  • 36
    • 79953072995 scopus 로고    scopus 로고
    • Specificity of bioanalytical methods for pharmacokinetic supportof biological macromolecular therapeutics is important
    • Findlay JWA. Specificity of bioanalytical methods for pharmacokinetic supportof biological macromolecular therapeutics is important. Bioanalysis 3(6), 567-569 (2011
    • (2011) Bioanalysis , vol.3 , Issue.6 , pp. 567-569
    • Findlay, J.W.A.1
  • 37
    • 79952508628 scopus 로고    scopus 로고
    • Bioanalytical method requirements and statistical considerations in incurred sample reanalysis for macromolecules
    • Thway TM, Macaraeg CR, Calamba D et al. Bioanalytical method requirements and statistical considerations in incurred sample reanalysis for macromolecules. Bioanalysis 2(9), 1587-1596 (2010
    • (2010) Bioanalysis , vol.2 , Issue.9 , pp. 1587-1596
    • Thway, T.M.1    MacAraeg, C.R.2    Calamba, D.3
  • 38
    • 79957455956 scopus 로고    scopus 로고
    • Assessment of incurred sample reanalysis for macromolecules to evaluate bioanalytical method robustness; Effects from imprecision
    • Thway TM, Eschenberg M, Calamba D et al. Assessment of incurred sample reanalysis for macromolecules to evaluate bioanalytical method robustness; effects from imprecision. AAPS J. 13(2), 291-298 (2011).
    • (2011) AAPS J. , vol.13 , Issue.2 , pp. 291-298
    • Thway, T.M.1    Eschenberg, M.2    Calamba, D.3
  • 39
    • 80052538298 scopus 로고    scopus 로고
    • Incurred sample reanalysis: Failures in macromolecule analysis-insight into possible causes
    • Sailstad JM, Salfen BE, Bowsher RR. Incurred sample reanalysis: Failures in macromolecule analysis-insight into possible causes. Bioanalysis 3(9), 1001-1006 (2011
    • (2011) Bioanalysis , vol.3 , Issue.9 , pp. 1001-1006
    • Sailstad, J.M.1    Salfen, B.E.2    Bowsher, R.R.3
  • 40
    • 85136070741 scopus 로고    scopus 로고
    • Antibody drug conjugates as cancer therapeutics
    • Trail PA. Antibody drug conjugates as cancer therapeutics. Antibodies 2, 113-129 (2013
    • (2013) Antibodies , vol.2 , pp. 113-129
    • Trail, P.A.1
  • 41
    • 84872957381 scopus 로고    scopus 로고
    • Bioanalytical assay strategies for the development of antibody-drug conjugate biotherapeutics
    • Kaur S, Xu K, Saad OM et al. Bioanalytical assay strategies for the development of antibody-drug conjugate biotherapeutics. Bioanalysis 5(2), 201-226 (2013
    • (2013) Bioanalysis , vol.5 , Issue.2 , pp. 201-226
    • Kaur, S.1    Xu, K.2    Saad, O.M.3
  • 42
    • 84877245142 scopus 로고    scopus 로고
    • Bioanalysis of antibody-drug conjugates: American association of pharmaceutical scientists antibody-drug conjugate working group position paper
    • Gorovits B, Alley SC, Bilic S et al. Bioanalysis of antibody-drug conjugates: American Association of Pharmaceutical Scientists antibody-drug conjugate working group position paper. Bioanalysis 5(9), 997-1006 (2013
    • (2013) Bioanalysis , vol.5 , Issue.9 , pp. 997-1006
    • Gorovits, B.1    Alley, S.C.2    Bilic, S.3
  • 43
    • 84890390856 scopus 로고    scopus 로고
    • 2013 White paper on recent issues in bioanalysis: Hybrid-The best of LBA & LC-MS
    • Stevenson L, Garofolo F, DeSilva B et al 2013 White paper on recent issues in bioanalysis: 'hybrid'-The best of LBA & LC-MS. Bioanalysis 5(23), 2903-2918 (2013
    • (2013) Bioanalysis , vol.5 , Issue.23 , pp. 2903-2918
    • Stevenson, L.1    Garofolo, F.2    Desilva, B.3
  • 44
    • 80052520755 scopus 로고    scopus 로고
    • Incurred sample reanalysis: It's just a matter of good scientific practice
    • Kelley M. Incurred sample reanalysis: It's just a matter of good scientific practice. Bioanalysis 3(9), 931-932 (2011
    • (2011) Bioanalysis , vol.3 , Issue.9 , pp. 931-932
    • Kelley, M.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.