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Volumn 13, Issue 12, 2001, Pages 72-73+76

Analytical method validation: Similarities and differences in ICH/FDA/USP

Author keywords

[No Author keywords available]

Indexed keywords

DRUG; ETHYL PARABEN; TAMOXIFEN;

EID: 0035211875     PISSN: 01646826     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (3)

References (14)
  • 2
    • 0026437190 scopus 로고
    • FDA's policy statement for the development of new stereoisomeric drugs
    • (1992) Chirality , vol.4 , pp. 338-340
  • 4
    • 0025753113 scopus 로고
    • Method development and selectivity control for small molecule pharmaceutical separations by CE
    • (1991) J. Liq. Chrom. , vol.14 , pp. 923-938
    • Swartz, M.E.1
  • 5
    • 0029954322 scopus 로고    scopus 로고
    • Validation of enantiomeric separations by micellar electrokinetic capillary chromatography using synthetic chiral surfactants
    • (1996) J. Chrom. A , vol.735 , pp. 303-310
    • Swartz, M.E.1
  • 9
    • 0006911849 scopus 로고
    • (US Pharmacopeia Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852, USA)
    • (1995) US Pharmacopeia 23
  • 10
    • 0001588435 scopus 로고
    • Selection and validation of legal reference methods of analysis for pharmaceutical products in the United States
    • (1992) Pharm. Technol. , vol.16 , Issue.9 , pp. 122-132
    • Layloff, T.1    Motise, P.2
  • 11
    • 0003228192 scopus 로고
    • Draft guideline on validation of analytical procedures: Definitions and terminology
    • (1995) Federal Register , vol.60 , pp. 11260-11262
  • 13


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.