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Volumn 11, Issue 2, 1998, Pages 96-105

Validation of analytical methods: Review and strategy

Author keywords

[No Author keywords available]

Indexed keywords


EID: 0007433072     PISSN: 14716577     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (126)

References (22)
  • 5
    • 0344212981 scopus 로고
    • US FDA Technical Review Guide: Center for Drug Evaluation and Research (CDER), Rockvilie, Maryland, USA
    • US FDA Technical Review Guide: Validation of Chromatographic Methods, Center for Drug Evaluation and Research (CDER), Rockvilie, Maryland, USA, 1993.
    • (1993) Validation of Chromatographic Methods
  • 6
    • 0003861196 scopus 로고
    • Rockville, Maryland, USA, Center for Drug Evaluation and Research (CDER), May
    • US FDA, General Principles of Validation, Rockville, Maryland, USA, Center for Drug Evaluation and Research (CDER), May 1987.
    • (1987) General Principles of Validation
  • 7
    • 0003637741 scopus 로고
    • Rockville, Maryland, USA, Center for Drugs and Biologics Department of Health and Human Services, Feb.
    • US FDA, Guidelines for Submitting Samples and Analytical Data for Method Validation, Rockville, Maryland, USA, Center for Drugs and Biologics Department of Health and Human Services, Feb. 1987.
    • (1987) Guidelines for Submitting Samples and Analytical Data for Method Validation
  • 8
    • 84905416274 scopus 로고
    • United States Pharmacopeia XXIII, National Formulary, XVIII, Rockville, Maryland, The United States Pharmacopeial Convention Inc.
    • General Chapter 〈1225〉, Validation of Compendial Methods, United States Pharmacopeia XXIII, National Formulary, XVIII, Rockville, Maryland, The United States Pharmacopeial Convention Inc., 1995, 1610-1612.
    • (1995) Validation of Compendial Methods , pp. 1610-1612
  • 14
    • 0029111908 scopus 로고    scopus 로고
    • July/Aug.
    • B. Renger et al., J. Planar Chrom., 8, July/Aug. 1996, 269-278.
    • (1996) J. Planar Chrom. , vol.8 , pp. 269-278
    • Renger, B.1
  • 16
    • 0002274679 scopus 로고
    • Arlington, Virginia, USA, Nov.
    • AOAC Peer Verified methods Program, Manual on Policies and Procedures, Arlington, Virginia, USA, Nov. 1993.
    • (1993) Manual on Policies and Procedures
  • 18
    • 0010577066 scopus 로고    scopus 로고
    • L. Huber, LC·GC Int., 9(12), 794-799 (1996).
    • (1996) LC·GC Int. , vol.9 , Issue.12 , pp. 794-799
    • Huber, L.1
  • 21


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.