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Volumn , Issue , 2003, Pages 507-524

Validation of analytical methods and processes

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[No Author keywords available]

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EID: 84875140216     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter
Times cited : (15)

References (27)
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    • International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use. Validation of Analytical Procedures: Definitions and Terminology. ICH-Q2A, Geneva (1995); (CPMP/ICH/381/95), Internet: ttp://www.fda.gov/cder/guidance/ichq2a.pdf.
    • (1995) Validation of Analytical Procedures: Definitions and Terminology
  • 4
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    • International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use
    • ICH-Q2B, Geneva, (CPMP/ICH/281/95), Internet
    • 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); (CPMP/ICH/281/95), Internet: http://www.nihs.go.jp/drug/validation/q2bwww.html.
    • (1996) Validation of Analytical Procedures: Methodology
  • 6
    • 39349089831 scopus 로고
    • Rockville, MD: Center for Drug Evaluation and Research (CDER
    • U.S. Food and Drug Administration. Technical Review Guide: Validation of Chromatographic Methods.Rockville, MD: Center for Drug Evaluation and Research (CDER) (1993).
    • (1993) Technical Review Guide: Validation of Chromatographic Methods
  • 7
    • 0003861196 scopus 로고
    • Rockville, MD: Center for Drug Evaluation and Research (CDER), May
    • U.S. Food and Drug Administration. General Principles of Validation. Rockville, MD: Center for Drug Evaluation and Research (CDER), (May 1987).
    • (1987) General Principles of Validation
  • 8
    • 0003637741 scopus 로고
    • Rockville, MD: Center for Drugs and Biologics Department of Health and Human Services, Feb
    • U.S. Food and Drug Administration. Guidelines for Submitting Samples and Analytical Data for Method Validation. Rockville, MD: Center for Drugs and Biologics Department of Health and Human Services (Feb. 1987).
    • (1987) Guidelines for Submitting Samples and Analytical Data for Method Validation
  • 11
    • 0026336726 scopus 로고
    • Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies
    • (1991) and Pharm Res 9:588-592 (1992)
    • Shah, P. et al. Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies. Eur J Drug Metab Pharmaco 16(4): 249-255 (1989) (1991) and Pharm Res 9:588-592 (1992).
    • (1989) Eur J Drug Metab Pharmaco , vol.16 , Issue.4 , pp. 249-255
    • Shah, P.1
  • 12
    • 85056918184 scopus 로고
    • General Chapter <1225>: Validation of compendial methods
    • National Formulary, XVIII. Rockville, MD: U.S. Pharmacopeial Convention
    • General Chapter <1225>: Validation of compendial methods. United States Pharmacopeia XXIII, National Formulary, XVIII. Rockville, MD: U.S. Pharmacopeial Convention, pp. 1710-1612 (1995).
    • (1995) United States Pharmacopeia XXIII , pp. 1612-1710
  • 13
    • 0003875690 scopus 로고    scopus 로고
    • Feb, Eurachem Secretariat, PO Box 46, Teddington, Middlesex, TW11 ONH, UK
    • Eurachem. The fitness for Purpose of Analytical Methods (Feb. 1998): available from the Eurachem Secretariat, PO Box 46, Teddington, Middlesex, TW11 ONH, UK.
    • (1998) The Fitness for Purpose of Analytical Methods
  • 14
    • 0000069766 scopus 로고
    • Life cycle approach to the validation of analytical methods during pharmaceutical product development, part I: The initial validation process
    • Sept
    • Hokanson, G. C. A life cycle approach to the validation of analytical methods during pharmaceutical product development, part I: The initial validation process. Pharm Tech 118-130(Sept. 1994).
    • (1994) Pharm Tech , pp. 118-130
    • Hokanson, G.1
  • 15
    • 0011236397 scopus 로고
    • Life cycle approach to the validation of analytical methods during pharmaceutical product development, part II: Changes and the need for additional validation
    • Oct
    • Hokanson, G. C. 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 92-100(Oct. 1994).
    • (1994) Pharm Tech , pp. 92-100
    • Hokanson, G.1
  • 16
    • 0001229909 scopus 로고    scopus 로고
    • A practical guide to analytical method validation
    • May 1
    • Green, J. M. A practical guide to analytical method validation. Anal Chem News Feat 305A/309A(May 1, 1996).
    • (1996) Anal Chem News Feat 305A/309A
    • Green, J.M.1
  • 17
    • 0029111908 scopus 로고
    • Validation of analytical procedures in pharmaceutical analytical chemistry: HPTLC assay of theophylline in an effervescent tablet
    • July/Aug
    • Renger, B., Jehle, H., Fischer, M., and Funk, W. Validation of analytical procedures in pharmaceutical analytical chemistry: HPTLC assay of theophylline in an effervescent tablet. J Planar Chrom 8: 269-278 (July/Aug. 1995).
    • (1995) J Planar Chrom , vol.8 , pp. 269-278
    • Renger, B.1    Jehle, H.2    Fischer, M.3    Funk, W.4
  • 20
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    • Validation of HPLC methods
    • March
    • Huber, L. Validation of HPLC methods. BioPharm 12:64/66(March 1999).
    • (1999) Biopharm , vol.12 , Issue.64-66
    • Huber, L.1
  • 24
    • 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. L. Selectivity or specificity? Validation of analytical methods from the perspective of an analytical chemist in the pharmaceutical industry. J Pharm Bio-med Anal 14:867/869(1996).
    • (1996) J Pharm Bio-Med Anal , vol.14 , Issue.867-869
    • Vessman, J.L.1
  • 25
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    • Waldbronn, Germany: Agilent Technologies, publ. number
    • Huber, L. Applications of Diode-Array Detection in HPLC. Waldbronn, Germany: Agilent Technologies (1989), publ. number 12-5953-2330.
    • (1989) Applications of Diode-Array Detection in HPLC , vol.12 , pp. 2330-5953
    • Huber, L.1
  • 26
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    • Assessment of peak homogeneity in HPLC by computer-aided photodiode-array detection
    • Marr, D., Horvath, P., Clark, B. J., Fell, A. F. Assessment of peak homogeneity in HPLC by computer-aided photodiode-array detection, Anal Proceed 23:254-257(1986).
    • (1986) Anal Proceed , vol.23 , pp. 254-257
    • Marr, D.1    Horvath, P.2    Clark, B.J.3    Fell, A.F.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.