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Volumn 32, Issue 6, 1999, Pages 1067-1080

Analytical method development and validation for the academic researcher

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; ANALYTICAL PARAMETERS; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; MEDICAL RESEARCH; PRACTICE GUIDELINE; SCIENTIFIC LITERATURE; SHORT SURVEY; VALIDATION PROCESS;

EID: 0033014151     PISSN: 00032719     EISSN: None     Source Type: Journal    
DOI: 10.1080/00032719908542878     Document Type: Short Survey
Times cited : (28)

References (25)
  • 3
    • 0025025653 scopus 로고
    • Liquid chromatographic methods validation for pharmaceutical products
    • T.D. Wilson, Liquid chromatographic methods validation for pharmaceutical products. J. Pharm. Biomed. Anal., 8(5), 389 (1990).
    • (1990) J. Pharm. Biomed. Anal. , vol.8 , Issue.5 , pp. 389
    • Wilson, T.D.1
  • 4
    • 0026369122 scopus 로고
    • Calibration and validation of linearity in chromatographic biopharmaceutical analysis
    • H.T. Karnes and C. March. Calibration and validation of linearity in chromatographic biopharmaceutical analysis. J. Pharm. Biomed. Anal., 9(10-12), 911(1991).
    • (1991) J. Pharm. Biomed. Anal. , vol.9 , Issue.10-12 , pp. 911
    • Karnes, H.T.1    March, C.2
  • 5
    • 0025903573 scopus 로고
    • Validation of bioanalytical methods
    • H.T. Karnes, G. Shiu, and V.P. Shah. Validation of bioanalytical methods. Pharm. Research, 8(4), 421 (1991).
    • (1991) Pharm. Research , vol.8 , Issue.4 , pp. 421
    • Karnes, H.T.1    Shiu, G.2    Shah, V.P.3
  • 7
    • 0025678950 scopus 로고
    • A practical approach to method validation in pharmaceutical analysis
    • G.P. Carr and J.C. Wahlichs. A practical approach to method validation in pharmaceutical analysis. J. Pharm. Biomed. Anal., 8(8-12), 613 (1990).
    • (1990) J. Pharm. Biomed. Anal. , vol.8 , Issue.8-12 , pp. 613
    • Carr, G.P.1    Wahlichs, J.C.2
  • 9
    • 0026952324 scopus 로고
    • A rationale for analytical methodology development
    • guest editorial
    • I.S. Krull, J.R. Mazzeo, and C.M. Selavka. A rationale for analytical methodology development. Biomed. Chromatogr., guest editorial, 6, 259 (1992).
    • (1992) Biomed. Chromatogr. , vol.6 , pp. 259
    • Krull, I.S.1    Mazzeo, J.R.2    Selavka, C.M.3
  • 11
    • 0027300512 scopus 로고
    • Evaluation of a mixed micellar electrokinetic capillary electrophoresis method for validated pharmaceutical quality control
    • B.R. Thomas and S. Ghodbane. Evaluation of a mixed micellar electrokinetic capillary electrophoresis method for validated pharmaceutical quality control. J. Liquid Chromatogr., 16, 1983 (1993).
    • (1993) J. Liquid Chromatogr. , pp. 1983
    • Thomas, B.R.1    Ghodbane, S.2
  • 12
    • 0003992963 scopus 로고    scopus 로고
    • Capillary electrophoresis guidebook, principles, operations, and applications
    • Humana Press, Clifton, NJ
    • Capillary Electrophoresis Guidebook, Principles, Operations, and Applications, Edited by K.D. Altria, Methods in Molecular Biology, Volume 52, Humana Press, Clifton, NJ, 1996.
    • (1996) Methods in Molecular Biology , vol.52
    • Altria, K.D.1
  • 13
    • 0029954322 scopus 로고    scopus 로고
    • Validation of enantiomeric separations by micellar electrokinetic capillary chromatography using synthetic chiral surfactants
    • M. Swartz, J. Mazzeo, E. Grover, and P. Brown. Validation of enantiomeric separations by micellar electrokinetic capillary chromatography using synthetic chiral surfactants. J. Chromalogr., A, 735, 303(1996).
    • (1996) J. Chromalogr., A , vol.735 , pp. 303
    • Swartz, M.1    Mazzeo, J.2    Grover, E.3    Brown, P.4
  • 23
    • 0001390253 scopus 로고    scopus 로고
    • Validation viewpoint: Determining limits of detection and quantitation
    • I.S. Krull and M.E. Swartz. Validation Viewpoint: Determining limits of detection and quantitation. LC/GC Magazine, 16(10), 922 (1998).
    • (1998) LC/GC Magazine , vol.16 , Issue.10 , pp. 922
    • Krull, I.S.1    Swartz, M.E.2
  • 24
    • 33749289105 scopus 로고    scopus 로고
    • Validation viewpoint: Quantitation in method validation
    • I.S. Krull and M.E. Swartz. Validation Viewpoint: Quantitation in method validation. LC/GC Magazine, 16(12), 1084(1998).
    • (1998) LC/GC Magazine , vol.16 , Issue.12 , pp. 1084
    • Krull, I.S.1    Swartz, M.E.2
  • 25
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    • Validation viewpoint: System suitability samples-what they are, why they are, and what they should do?
    • in press January
    • I.S. Krull and M.E. Swartz. Validation Viewpoint: System suitability samples-what they are, why they are, and what they should do? LC/GC Magazine, in press (January, 1999).
    • (1999) LC/GC Magazine
    • Krull, I.S.1    Swartz, M.E.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.