메뉴 건너뛰기




Volumn 2, Issue 4, 2010, Pages 689-691

Towards harmonized regulations for bioanalysis: Moving forward!

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; BIOANALYSIS; EDITORIAL; FOOD AND DRUG ADMINISTRATION; PRACTICE GUIDELINE; STANDARDIZATION; SYMPOSIUM; VALIDATION PROCESS; CHEMICAL ANALYSIS; HUMAN; METHODOLOGY; SOCIAL CONTROL; STANDARD;

EID: 79951747139     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.10.37     Document Type: Editorial
Times cited : (18)

References (13)
  • 1
    • 33847184252 scopus 로고    scopus 로고
    • Bioanalytical method validation and implementation: Best practices for chromatographic and ligand binding assays
    • Viswanathan CT, Bansal S, Booth B et al. Bioanalytical method validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 9(1), E30-E38 (2007).
    • (2007) AAPS J. , vol.9 , Issue.1
    • Viswanathan, C.T.1    Bansal, S.2    Booth, B.3
  • 2
    • 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 D, Kelley M, Viswanathan C 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.1    Kelley, M.2    Viswanathan, C.3
  • 3
    • 79951768879 scopus 로고    scopus 로고
    • The 2nd Calibration and Validation Group Workshop on recent issues in good laboratory practice bioanalysis
    • Savoie N, Booth BP, Garofolo F 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    Garofolo, F.3
  • 4
    • 77954865192 scopus 로고    scopus 로고
    • Incurred sample reproducibility: Views and recommendations by the European Bioanalysis Forum
    • Timmerman P, Luedtke S, van Amsterdam P, Brudny-Kloeppel M, Lausecker B. 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    Luedtke, S.2    Van Amsterdam, P.3    Brudny-Kloeppel, M.4    Lausecker, B.5
  • 5
    • 79951769600 scopus 로고    scopus 로고
    • White Paper on recent issues in regulated bioanalysis from the 3rd calibration and validation group workshop
    • Savoie N, Garofolo F, van Amsterdam P et al. White Paper on recent issues in regulated bioanalysis from the 3rd calibration and validation group workshop. Bioanalysis 2(1), 53-68 (2010).
    • (2010) Bioanalysis , vol.2 , Issue.1 , pp. 53-68
    • Savoie, N.1    Garofolo, F.2    Van Amsterdam, P.3
  • 7
    • 79952472083 scopus 로고    scopus 로고
    • The broadening scope of validation: Towards best practices in the world of bioanalysis
    • Abbott R. The broadening scope of validation: towards best practices in the world of bioanalysis. Bioanalysis 2(4), 703-708 (2010).
    • (2010) Bioanalysis , vol.2 , Issue.4 , pp. 703-708
    • Abbott, R.1
  • 8
    • 79951893291 scopus 로고    scopus 로고
    • Request for global harmonization of the guidance for bioanalytical method validation and sample analysis
    • Timmerman P, Lowes S, Fast DM, Garofolo F. Request for global harmonization of the guidance for bioanalytical method validation and sample analysis. Bioanalysis 2(4), 683 (2010).
    • (2010) Bioanalysis , vol.2 , Issue.4 , pp. 683
    • Timmerman, P.1    Lowes, S.2    Fast, D.M.3    Garofolo, F.4
  • 9
    • 0026606194 scopus 로고
    • Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies
    • Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Pharm. Res. 9, 588-592 (1992).
    • (1992) Pharm. Res. , vol.9 , pp. 588-592
    • Shah, V.P.1    Midha, K.K.2    Dighe, S.3    McGilveray, I.J.4    Skelly, J.P.5
  • 12
    • 0003484310 scopus 로고    scopus 로고
    • US FDA Rockville MD USA: US Department of Health and Human Services FDA Center for Drug Evaluation and Research
    • US FDA. Guidance for Industry: Bioanalytical Method Validation. Rockville, MD, USA: US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, 2001 www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf
    • (2001) Guidance for Industry: Bioanalytical Method Validation
  • 13
    • 79953285058 scopus 로고    scopus 로고
    • European Medicines Agency draft guideline on validation of bioanalytical methods
    • European Medicines Agency draft guideline on validation of bioanalytical methods. EMA/CHMP/EWP/192217/2009 www.ema.europa.eu/pdfs/human/ ewp/19221709en.pdf
    • (2009) EMA/CHMP/EWP/192217


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.