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Volumn 19, Issue 5, 1996, Pages 719-736

Chromatographic method validation: A review of current practices and procedures. I. General concepts and guidelines

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CALIBRATION; CHROMATOGRAPHY; DRUG CONTROL; DRUG DEVELOPMENT; QUANTITATIVE ASSAY; TECHNIQUE;

EID: 0029986001     PISSN: 10826076     EISSN: None     Source Type: Journal    
DOI: 10.1080/10826079608005533     Document Type: Article
Times cited : (80)

References (49)
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    • United States Pharmacopeia 23. Section 1225, "Validation of Compendial Methods." United States Pharmacopeia Convention Inc., Rockville, MD, 1995, pp. 1982-1984.
    • (1995) Validation of Compendial Methods , pp. 1982-1984
  • 3
    • 85035161932 scopus 로고
    • Guidance Notes on Applications of Product Licenses (MAL2) A20-7 and A2E-2. HMSO
    • Department of Health Medicines Act 1968, Guidance Notes on Applications of Product Licenses (MAL2) A20-7 and A2E-2. HMSO, 1987.
    • (1987) Department of Health Medicines Act 1968
  • 7
    • 0003646348 scopus 로고
    • Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, Nov
    • "Reviewer Guidance. Validation of chromatographic Methods." Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, Nov, 1994.
    • (1994) Reviewer Guidance. Validation of Chromatographic Methods
  • 8
    • 0003228192 scopus 로고
    • "International Conference on Harmonization; Guideline on Validation of Analytical Procedures: Definitions and Terminology; Availability." US Department of Health and Human Services (HHS). March 1
    • "International Conference on Harmonization; Guideline on Validation of Analytical Procedures: Definitions and Terminology; Availability." US Department of Health and Human Services (HHS). Federal Register, 60(40), 11260-11265 (March 1, 1995).
    • (1995) Federal Register , vol.60 , Issue.40 , pp. 11260-11265
  • 10
    • 85035166345 scopus 로고
    • Code of Federal Regulations (21 CFR), April 1
    • Code of Federal Regulations (21 CFR), Foods and Drugs, Parts 200 to 299, April 1, 1994.
    • (1994) Foods and Drugs , Issue.200-299 PART
  • 17
    • 3142511615 scopus 로고
    • D. R. Williams, BioPharm, 5(Nov), 34-36, 51 (1987).
    • (1987) BioPharm , vol.5 , Issue.NOV , pp. 34-36
    • Williams, D.R.1
  • 18
    • 0023244958 scopus 로고
    • A. C. Mehta, Talanta, 34, 609-613 (1987).
    • (1987) Talanta , vol.34 , pp. 609-613
    • Mehta, A.C.1
  • 30
    • 0001646014 scopus 로고
    • W. L. Paul, Pharm. Technol., 15(March), 130-160 (1991).
    • (1991) Pharm. Technol. , vol.15 , Issue.MARCH , pp. 130-160
    • Paul, W.L.1
  • 33
  • 37
    • 0000069766 scopus 로고
    • G. C. Hokanson, Pharm Tech., 18(Sept), 118-130 (1994).
    • (1994) Pharm Tech. , vol.18 , Issue.SEPT , pp. 118-130
    • Hokanson, G.C.1
  • 47
    • 3142597012 scopus 로고
    • W. Horwitz, ChemTech, 1994(March), 186-191 (1994).
    • (1994) ChemTech , vol.1994 , Issue.MARCH , pp. 186-191
    • Horwitz, W.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.