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Volumn 2, Issue SUPPL. 3, 2010, Pages 18-22

Validation of analytical methods - Strategies & importance

Author keywords

Accuracy; Analysis; Precision; Validation

Indexed keywords

ACCURACY; ANALYTIC METHOD; PARAMETER; REVIEW; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS;

EID: 77957551491     PISSN: None     EISSN: 09751491     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (96)

References (19)
  • 1
    • 77957603426 scopus 로고
    • US EPA, Guidance for methods development and methods validation for the Resource Conservation and Recovery Act (RCRA) Program, Washington
    • US EPA, Guidance for methods development and methods validation for the Resource Conservation and Recovery Act (RCRA) Program, Washington; 1995.
    • (1995)
  • 2
    • 0024511806 scopus 로고
    • Selection of HPLC methods in pharmaceutical analysis-III method validation
    • Szepesi MG, Mihalyfi K. Selection of HPLC methods in pharmaceutical analysis-III method validation. J Chromatogr 1989; 464: 265-78.
    • (1989) J Chromatogr , vol.464 , pp. 265-278
    • Szepesi, M.G.1    Mihalyfi, K.2
  • 4
    • 0000069766 scopus 로고
    • A life cycle approach to the validation of analytical methods during pharmaceutical product development, part I: The initial validation process
    • Hokanson GC. A life cycle approach to the validation of analytical methods during pharmaceutical product development, part I: The initial validation process. Pharm Tech. 1994; 118-30.
    • (1994) Pharm Tech , pp. 118-130
    • Hokanson, G.C.1
  • 5
    • 0011236397 scopus 로고
    • Hokanson, A life cycle approach to the validation of analytical methods during pharmaceutical product development, part II: Changes and the need for additional validation
    • Hokanson GC. Hokanson, A life cycle approach to the validation of analytical methods during pharmaceutical product development, part II: Changes and the need for additional validation. Pharm Tech. 1994; 92-100.
    • (1994) Pharm Tech , pp. 92-100
    • Hokanson, G.C.1
  • 6
    • 0001229909 scopus 로고    scopus 로고
    • A practical guide to analytical method validation
    • Green JM. A practical guide to analytical method validation. Anal Chem News Features. 1996; 305-9.
    • (1996) Anal Chem News Features , pp. 305-309
    • Green, J.M.1
  • 7
    • 0029111908 scopus 로고
    • Validation of analytical procedures in pharmaceutical analytical chemistry: HPTLC assay of theophylline in an effervescent tablet
    • Renger B, Jehle H, Fischer M, Funk W. Validation of analytical procedures in pharmaceutical analytical chemistry: HPTLC assay of theophylline in an effervescent tablet. J Planar Chrom.1995; 8: 269-78.
    • (1995) J Planar Chrom , vol.8 , pp. 269-278
    • Renger, B.1    Jehle, H.2    Fischer, M.3    Funk, W.4
  • 9
    • 77957608303 scopus 로고
    • AOAC Peer Verified methods Program, Manual on policies and procedures, Arlington, VA
    • AOAC Peer Verified methods Program, Manual on policies and procedures, Arlington, VA; 1993.
    • (1993)
  • 10
    • 0030176354 scopus 로고    scopus 로고
    • Selectivity or specificity? Validation of analytical methods from the perspective of an analytical chemist in the pharmaceutical industry
    • Vessman J. Selectivity or specificity? Validation of analytical methods from the perspective of an analytical chemist in the pharmaceutical industry. J Pharm Biomed Analy. 1996; 14: 867-69.
    • (1996) J Pharm Biomed Analy , vol.14 , pp. 867-869
    • Vessman, J.1
  • 11
    • 30344469192 scopus 로고    scopus 로고
    • Validation of computerized analytical systems, Part 3: Installation and operational qualification
    • Huber L. Validation of computerized analytical systems, Part 3: Installation and operational qualification. LC-GC Magazine. 1996; 14: 806-12.
    • (1996) LC-GC Magazine , vol.14 , pp. 806-812
    • Huber, L.1
  • 13
    • 77957580189 scopus 로고
    • EURACHEM Guidance Document No. 1/WELAC Guidance Document No. WGD: Accreditation for chemical laboratories: Guidance on the interpretation of the EN 45000 series of standards and ISO/IEC Guide 25
    • EURACHEM Guidance Document No. 1/WELAC Guidance Document No. WGD 2: Accreditation for chemical laboratories: Guidance on the interpretation of the EN 45000 series of standards and ISO/IEC Guide 25, 1993.
    • (1993) , vol.2
  • 14
    • 77957608613 scopus 로고    scopus 로고
    • General Chapter, Validation of compendial methods, United States Pharmacopeia, 26th Revision, National Formulary, 21st Edition, Rockville, MD, The United States Pharmacopeial Convention, Inc
    • General Chapter, Validation of compendial methods, United States Pharmacopeia, 26th Revision, National Formulary, 21st Edition, Rockville, MD, The United States Pharmacopeial Convention, Inc, 2440; 2003.
    • (2003) , vol.2440
  • 15
    • 77957578081 scopus 로고
    • International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures, ICH-Q2A, Geneva
    • International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures, ICH-Q2A, Geneva; 1995.
    • (1995)
  • 16
    • 77957597219 scopus 로고    scopus 로고
    • International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures: Methodology, ICH-Q2B, Geneva
    • International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures: Methodology, ICH-Q2B, Geneva; 1996.
    • (1996)
  • 17
    • 77957560933 scopus 로고
    • US FDA Technical Review Guide: Validation of Chromatographic Methods, Center for Drug Evaluation and Research (CDER), Rockville, MD
    • US FDA Technical Review Guide: Validation of Chromatographic Methods, Center for Drug Evaluation and Research (CDER), Rockville, MD; 1993.
    • (1993)
  • 18
    • 77957604738 scopus 로고
    • US FDA, General principles of validation, Rockville, MD, Center for Drug Evaluation and Research (CDER
    • US FDA, General principles of validation, Rockville, MD, Center for Drug Evaluation and Research (CDER); 1987.
    • (1987)
  • 19
    • 77957563013 scopus 로고
    • US FDA, Guidelines for submitting samples and analytical data for method validation, Rockville, MD, Center for Drugs and Biologics Department of Health and Human Services
    • US FDA, Guidelines for submitting samples and analytical data for method validation, Rockville, MD, Center for Drugs and Biologics Department of Health and Human Services; 1987.
    • (1987)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.