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Volumn 32, Issue , 2005, Pages 241-260

Validation of Chromatographic Methods of Analysis

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Indexed keywords


EID: 33748793902     PISSN: 10756280     EISSN: None     Source Type: Book Series    
DOI: 10.1016/S0099-5428(05)32009-0     Document Type: Review
Times cited : (71)

References (48)
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    • The United States Pharmacopoeia 28, United States Pharmacopoeial Convention, Rockville, MD
    • The United States Pharmacopoeia 28, United States Pharmacopoeial Convention, Rockville, MD (2004) 2748-2751
    • (2004) , pp. 2748-2751
  • 4
    • 33750907032 scopus 로고    scopus 로고
    • Development and validation of automated methods
    • Chan C.C., Lam H., Lee Y.C., and Zhang X.-U. (Eds), Wiley-Interscience, Hoboken, NJ
    • Incledon C., and Lam H. Development and validation of automated methods. In: Chan C.C., Lam H., Lee Y.C., and Zhang X.-U. (Eds). Analytical Method Validation and Instrument Performance Verification (2004), Wiley-Interscience, Hoboken, NJ 67-84
    • (2004) Analytical Method Validation and Instrument Performance Verification , pp. 67-84
    • Incledon, C.1    Lam, H.2
  • 7
    • 0345424863 scopus 로고    scopus 로고
    • CDER
    • CDER. Guidance for Industry (1/2/2004). http://www.fda.gov/cder/gidance/2396dtf.htm
    • (2004) Guidance for Industry
  • 13
    • 33750923772 scopus 로고    scopus 로고
    • Peak purity determination with a diode array detector
    • Marcel-Dekker, Inc.
    • Papadoyannis I.N., and Gika H.G. Peak purity determination with a diode array detector. Encyclopedia of Chromatography (2003), Marcel-Dekker, Inc., online http://www.dekker.com.
    • (2003) Encyclopedia of Chromatography
    • Papadoyannis, I.N.1    Gika, H.G.2
  • 18
    • 33746840672 scopus 로고    scopus 로고
    • Bioanalytical method validation
    • Chan C.C., Lam H., Lee Y.C., and Zhang X.-U. (Eds), Wiley-Interscience, Hoboken, NJ
    • Garofolo F. Bioanalytical method validation. In: Chan C.C., Lam H., Lee Y.C., and Zhang X.-U. (Eds). Analytical Method Validation and Instrument Performance Verification (2004), Wiley-Interscience, Hoboken, NJ 105-138
    • (2004) Analytical Method Validation and Instrument Performance Verification , pp. 105-138
    • Garofolo, F.1
  • 26
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    • Potency method validation
    • Chan C.C., Lam H., Lee Y.C., and Zhang X.-U. (Eds), Wiley-Interscience, Hoboken, NJ
    • Chan C.C. Potency method validation. In: Chan C.C., Lam H., Lee Y.C., and Zhang X.-U. (Eds). Analytical Method Validation and Instrument Performance Verification (2004), Wiley-Interscience, Hoboken, NJ 11-26
    • (2004) Analytical Method Validation and Instrument Performance Verification , pp. 11-26
    • Chan, C.C.1
  • 27
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    • US Department of Health Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine
    • Guidance for Industry, Bioanalytical method validation (2001), US Department of Health Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine
    • (2001) Guidance for Industry, Bioanalytical method validation
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    • 37049076739 scopus 로고
    • Uses (proper and improper) of correlation coefficient
    • Analytical Method Committee
    • Analytical Method Committee,. Uses (proper and improper) of correlation coefficient. Analyst 113 (1988) 1469-1471
    • (1988) Analyst , vol.113 , pp. 1469-1471
  • 37
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    • Guidance for Industry, US Department of Health Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine
    • Guidance for Industry. Q2B Validation of Analytical Procedures: Methodology (2001), US Department of Health Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine
    • (2001) Q2B Validation of Analytical Procedures: Methodology
  • 40
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    • Validation of TLC Analyses
    • Cazes J. (Ed), Marcel-Dekker Inc.
    • Indrayanto G., and Yuwono M. Validation of TLC Analyses. In: Cazes J. (Ed). Encyclopedia of Chromatography (2003), Marcel-Dekker Inc., online http://www.dekker.com.
    • (2003) Encyclopedia of Chromatography
    • Indrayanto, G.1    Yuwono, M.2
  • 45
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    • Overview of pharmaceutical product development and its associated quality system
    • Chan C.C., Lam H., Lee Y.C., and Zhang X.-U. (Eds), Wiley-Interscience, Hoboken, NJ
    • Chan C.C., and Jensen E. Overview of pharmaceutical product development and its associated quality system. In: Chan C.C., Lam H., Lee Y.C., and Zhang X.-U. (Eds). Analytical Method Validation and Instrument Performance Verification (2004), Wiley-Interscience, Hoboken, NJ 1-10
    • (2004) Analytical Method Validation and Instrument Performance Verification , pp. 1-10
    • Chan, C.C.1    Jensen, E.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.