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Volumn , Issue , 2007, Pages 1-14

Quality Assurance, Quality Control and Method Validation in Chromatographic Applications

Author keywords

American Society of Clinical Pathologists (ASCP); Chemical testing in biological matrices; Control data and cumulative sum control chart; External quality assurance (EQA) of clinical laboratory methods; Internal quality assurance and control procedures; Lower limit of detection (LLOD) and lower limit of quantitation (LLOQ); Professional organizations NACB, NIST, ASCP, CLSI, IFCC and ISO; Quality assurance (QA) encompassing quality control; Quality assurance and quality control issues facing clinical laboratories

Indexed keywords


EID: 84866900875     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470023129.ch1     Document Type: Chapter
Times cited : (7)

References (19)
  • 1
    • 0003873720 scopus 로고    scopus 로고
    • Tietz Fundamentals of Clinical Chemistry
    • 5th edn. Philadelphia, PA:W. B. Saunders
    • Burtis, C. A., Ashwood, E. R. (Eds) (2001). Tietz Fundamentals of Clinical Chemistry, 5th edn. Philadelphia, PA:W. B. Saunders.
    • (2001)
    • Burtis, C.A.1    Ashwood, E.R.2
  • 2
    • 0003484310 scopus 로고    scopus 로고
    • Guidance for Industry:Bioanalytical Method Validation
    • FDA, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM)
    • FDA (2001). Guidance for Industry:Bioanalytical Method Validation. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). http://www.fda.gov/cder/guidance/4252fnl.pdf.
    • (2001)
  • 3
    • 0033374188 scopus 로고    scopus 로고
    • Introduction:strategies to set global quality specifications in laboratory medicine
    • Fraser, C. G., Kallner, A., Kenny, D., Hyltoft Petersen, P. (1999). Introduction:strategies to set global quality specifications in laboratory medicine. Scand J Clin Lab Invest, 59, 477-478.
    • (1999) Scand J Clin Lab Invest , vol.59 , pp. 477-478
    • Fraser, C.G.1    Kallner, A.2    Kenny, D.3    Hyltoft Petersen, P.4
  • 4
    • 0003681497 scopus 로고    scopus 로고
    • Quality Assurance Principles for Analytical Laboratories
    • 3rd edn. Gaithersburg, MD:AOAC International
    • Garfield, F. M., Klesta, E., Hirsch, J. (2000). Quality Assurance Principles for Analytical Laboratories, 3rd edn. Gaithersburg, MD:AOAC International.
    • (2000)
    • Garfield, F.M.1    Klesta, E.2    Hirsch, J.3
  • 6
    • 0002496324 scopus 로고    scopus 로고
    • Commonly practiced quality control and quality assurance procedures for gas chromatography/mass spectrometry analysis in forensic urine drug-testing laboratories
    • Goldberger, B. A., Huestis, M. A., Wilkins, D. G. (1997). Commonly practiced quality control and quality assurance procedures for gas chromatography/mass spectrometry analysis in forensic urine drug-testing laboratories. Forensic Sci Rev, 9, 59-80.
    • (1997) Forensic Sci Rev , vol.9 , pp. 59-80
    • Goldberger, B.A.1    Huestis, M.A.2    Wilkins, D.G.3
  • 7
    • 0033374488 scopus 로고    scopus 로고
    • Series analyses and quality specifications required for monitoring over time
    • Groth, T. (1999). Series analyses and quality specifications required for monitoring over time. Scand J Clin Lab Invest, 59, 501-508.
    • (1999) Scand J Clin Lab Invest , vol.59 , pp. 501-508
    • Groth, T.1
  • 8
    • 0036164946 scopus 로고    scopus 로고
    • Validation of qualitative chromatographic methods:strategy in antidoping control laboratories
    • Jiménez, C., Ventura, R., Segura, J. (2002). Validation of qualitative chromatographic methods:strategy in antidoping control laboratories. J Chromatogr B, 767, 341-351.
    • (2002) J Chromatogr B , vol.767 , pp. 341-351
    • Jiménez, C.1    Ventura, R.2    Segura, J.3
  • 9
    • 0033392528 scopus 로고    scopus 로고
    • The Stockholm Consensus Conference on quality specifications in laboratory medicine, 25-26 April 1999
    • Kallner, A., McQueen, M., Heuck, C. (1999). The Stockholm Consensus Conference on quality specifications in laboratory medicine, 25-26 April 1999. Scand J Clin Lab Invest, 59, 475-585.
    • (1999) Scand J Clin Lab Invest , vol.59 , pp. 475-585
    • Kallner, A.1    McQueen, M.2    Heuck, C.3
  • 10
    • 0033395235 scopus 로고    scopus 로고
    • Determination and application of desirable analytical performance goals:the ISO/TC 212 approach
    • Kaplan, L. A. (1999). Determination and application of desirable analytical performance goals:the ISO/TC 212 approach. Scand J Clin Lab Invest, 59, 479-482.
    • (1999) Scand J Clin Lab Invest , vol.59 , pp. 479-482
    • Kaplan, L.A.1
  • 11
    • 0033400846 scopus 로고    scopus 로고
    • Analytic bias specifications based on the analysis of effects on performance of medical guidelines
    • Klee, G. G., Schryver, P. G., Kisabeth, R. M. (1999). Analytic bias specifications based on the analysis of effects on performance of medical guidelines. Scand J Clin Lab Invest, 59, 509-512.
    • (1999) Scand J Clin Lab Invest , vol.59 , pp. 509-512
    • Klee, G.G.1    Schryver, P.G.2    Kisabeth, R.M.3
  • 12
    • 84860969572 scopus 로고    scopus 로고
    • Laboratory Quality Assurance System:a Manual of Quality Procedures and Forms
    • 3rd edn. Hoboken, NJ, John Wiley & Sons, Inc
    • Ratliff, T. A. (2003). Laboratory Quality Assurance System:a Manual of Quality Procedures and Forms, 3rd edn. Hoboken, NJ, John Wiley & Sons, Inc.
    • (2003)
    • Ratliff, T.A.1
  • 13
    • 2142672220 scopus 로고    scopus 로고
    • Four Centuries of Clinical Chemistry
    • Amsterdam:Gordon and Breach
    • Rosenfeld, L. (1999). Four Centuries of Clinical Chemistry. Amsterdam:Gordon and Breach.
    • (1999)
    • Rosenfeld, L.1
  • 14
    • 0026660942 scopus 로고
    • The history of proficiency testing/quality control
    • Sunderman, F. W. Sr. (1992). The history of proficiency testing/quality control. Clin Chem, 38, 1205-1209.
    • (1992) Clin Chem , vol.38 , pp. 1205-1209
    • Sunderman, F.W.S.1
  • 15
    • 82755181279 scopus 로고    scopus 로고
    • Quality assurance
    • In Encyclopedia of Forensic Sciences, J. A. Siegel, P. J. Saukko, G. C. Knupfer, G. C. (Eds). San Diego, CA:Academic Press
    • Tilstone, W. J. (2000). Quality assurance. In Encyclopedia of Forensic Sciences, J. A. Siegel, P. J. Saukko, G. C. Knupfer, G. C. (Eds). San Diego, CA:Academic Press, pp. 1307-1314.
    • (2000) , pp. 1307-1314
    • Tilstone, W.J.1
  • 16
    • 0033380048 scopus 로고    scopus 로고
    • The need for a system of quality standards for modern quality management
    • Westgard, J. O. (1999). The need for a system of quality standards for modern quality management. Scand J Clin Lab Invest, 59, 483-486.
    • (1999) Scand J Clin Lab Invest , vol.59 , pp. 483-486
    • Westgard, J.O.1
  • 17
    • 0003521027 scopus 로고
    • Cost-effective Quality Control:Managing the Quality and Productivity of Analytical Processes
    • Washington, DC:AACC Press
    • Westgard, J. O., Barry, P. L. (1986). Cost-effective Quality Control:Managing the Quality and Productivity of Analytical Processes. Washington, DC:AACC Press.
    • (1986)
    • Westgard, J.O.1    Barry, P.L.2
  • 18
    • 0019796502 scopus 로고
    • A multi-rule Shewhart chart for quality control in clinical chemistry
    • Westgard, J. O., Barry, P. L., Hunt, M. R., Groth, T. (1981). A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem, 27, 493-501.
    • (1981) Clin Chem , vol.27 , pp. 493-501
    • Westgard, J.O.1    Barry, P.L.2    Hunt, M.R.3    Groth, T.4
  • 19
    • 0032924262 scopus 로고    scopus 로고
    • Minimal standards for the performance and interpretation of toxicology tests in legal proceedings
    • Wu, A. H. B., Hill, D.W., Crouch, D., Hodnett, C. N., McCurdy, H. H. (1999). Minimal standards for the performance and interpretation of toxicology tests in legal proceedings. J Forensic Sci, 44, 516-522.
    • (1999) J Forensic Sci , vol.44 , pp. 516-522
    • Wu, A.H.B.1    Hill, D.W.2    Crouch, D.3    Hodnett, C.N.4    McCurdy, H.H.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.