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Volumn 35, Issue 3, 2009, Pages 765-771

Performance-based monographs

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; DRUG DETERMINATION; DRUG IDENTIFICATION; DRUG IMPURITY; DRUG QUALITY; DRUG SCREENING; MEDICAL LITERATURE; PERFORMANCE BASED MONOGRAPH; QUALITATIVE ANALYSIS; QUANTITATIVE ANALYSIS; REVIEW; SCREENING TEST; UNITED STATES;

EID: 67649352683     PISSN: 03634655     EISSN: 15421945     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (12)

References (11)
  • 2
    • 84869329558 scopus 로고    scopus 로고
    • USPC, Available at:, Accessed January 13, 2009
    • USPC. Guideline for Submitting Requests for Revision to USP-NF. 2007. Available at: http://www.usp.org/USPNF/sub-mitMonograph/subCuide.html. Accessed January 13, 2009.
    • (2007) Guideline for Submitting Requests for Revision to USP-NF
  • 3
    • 67649309720 scopus 로고    scopus 로고
    • Quality by design considerations for ananlytical methods
    • Olsen BA, Gavin PF, Wozniak TJ. Quality by design considerations for ananlytical methods. AAPS Newsmagazine. 2007;10(12):16-22.
    • (2007) AAPS Newsmagazine , vol.10 , Issue.12 , pp. 16-22
    • Olsen, B.A.1    Gavin, P.F.2    Wozniak, T.J.3
  • 4
    • 67649302056 scopus 로고    scopus 로고
    • Pharmaceutical quality by design: Product and process development, understanding, and control
    • Yu LX. Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res. 2007;24(1):1-11.
    • (2007) Pharm Res , vol.24 , Issue.1 , pp. 1-11
    • Yu, L.X.1
  • 5
    • 53349098190 scopus 로고    scopus 로고
    • General Chapter on inorganic impurities: Heavy metals
    • USP Ad Hoc Advisory Panel on Inorganic Impurities and Heavy Metals
    • USP Ad Hoc Advisory Panel on Inorganic Impurities and Heavy Metals, USP Staff. General Chapter on inorganic impurities: heavy metals. Pharm Forum. 2008; 34(5): 1345-1348.
    • (2008) Pharm Forum , vol.34 , Issue.5 , pp. 1345-1348
    • Staff, U.S.P.1
  • 6
    • 67649359953 scopus 로고    scopus 로고
    • Acceptable, equivalent, or better: Approaches for alternatives to official compendial procedures
    • Hauck WW, DeStefano AJ, Cecil TL, Abernethy DR, Koch WF, Williams RL. Acceptable, equivalent, or better: approaches for alternatives to official compendial procedures. Pharm Forum. 2009;35(3):772-778.
    • (2009) Pharm Forum , vol.35 , Issue.3 , pp. 772-778
    • Hauck, W.W.1    DeStefano, A.J.2    Cecil, T.L.3    Abernethy, D.R.4    Koch, W.F.5    Williams, R.L.6
  • 7
    • 67649350950 scopus 로고    scopus 로고
    • USP 32-NF 27, Validation of Compendial Procedures (1225). Rockville, MD
    • USPC
    • USPC. USP 32-NF 27, Validation of Compendial Procedures (1225). Rockville, MD: USPC; 2009:733-737.
    • (2009) USPC , pp. 733-737
  • 10
    • 67649377711 scopus 로고    scopus 로고
    • ICH Q3A(R2). Impurities in New Drug Substances. 2002. Available at: http://www.ich.org/cache/compo/276-254-I.html. Accessed January 14, 2009.
    • ICH Q3A(R2). Impurities in New Drug Substances. 2002. Available at: http://www.ich.org/cache/compo/276-254-I.html. Accessed January 14, 2009.
  • 11
    • 67649370543 scopus 로고    scopus 로고
    • Limit of blank, limit of detection, and limit of quantitation
    • Armbruster DA, Pry T. Limit of blank, limit of detection, and limit of quantitation. Clin Biochem Rev. 2008;29 (Suppl1):S49-S52.
    • (2008) Clin Biochem Rev , vol.29 , Issue.SUPPL.1
    • Armbruster, D.A.1    Pry, T.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.