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Volumn 1189, Issue 1-2, 2008, Pages 32-41

Risk-based approach for the transfer of quantitative methods: Bioanalytical applications

Author keywords

Analytical method transfer; Bioanalysis; Catecholamines; N Methyl laudanosine; Risk; Tolerance interval; Total error

Indexed keywords

AMINES; ELECTROCHEMISTRY; EXTRACTION; LIQUID CHROMATOGRAPHY; PLASMAS;

EID: 41949089218     PISSN: 00219673     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.chroma.2007.11.029     Document Type: Article
Times cited : (13)

References (39)
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  • 4
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    • ISO 5725 parts 1-6, Accuracy (trueness and precision) of measurement methods and results, International Organization for Standardization (ISO), Geneva, 1994.
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  • 5
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  • 6
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    • Analytical Procedure/Technology Transfer, International Society for Pharmaceutical Engineering (ISPE) Guideline, 2003, pp. 23-24.
    • Analytical Procedure/Technology Transfer, International Society for Pharmaceutical Engineering (ISPE) Guideline, 2003, pp. 23-24.
  • 12
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    • A.J. DeStefano, Issues in the Transfer of Methods to Analysts and Laboratories, AAPS Third Bioanalytical Workshop: Quantitative Bioanalytical Methods Validation and Implementation - Best Practices for Chromatographic and Ligand Binding Assays, Arlington, VA, May 1-3, 2006, http://www.aapspharmaceutica.com/meetings/meeting.asp?id=64.
    • A.J. DeStefano, Issues in the Transfer of Methods to Analysts and Laboratories, AAPS Third Bioanalytical Workshop: Quantitative Bioanalytical Methods Validation and Implementation - Best Practices for Chromatographic and Ligand Binding Assays, Arlington, VA, May 1-3, 2006, http://www.aapspharmaceutica.com/meetings/meeting.asp?id=64.
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    • B. Boulanger, W. Dewe, Ph. Hubert, B. Govaerts, C. Hammer, F. Moonen, Accuracy and Precision (Total error vs. 4/6/30), AAPS Third Bioanalytical Workshop: Quantitative Bioanalytical Methods Validation and Implementation - Best Practices for Chromatographic and Ligand Binding Assays, Arlington, VA, May 1-3, 2006, http://www.aapspharmaceutica.com/meetings/meeting.asp?id=64.
    • B. Boulanger, W. Dewe, Ph. Hubert, B. Govaerts, C. Hammer, F. Moonen, Accuracy and Precision (Total error vs. 4/6/30), AAPS Third Bioanalytical Workshop: Quantitative Bioanalytical Methods Validation and Implementation - Best Practices for Chromatographic and Ligand Binding Assays, Arlington, VA, May 1-3, 2006, http://www.aapspharmaceutica.com/meetings/meeting.asp?id=64.
  • 30
    • 41949115602 scopus 로고    scopus 로고
    • International Conference on Harmonization (ICH): Quality Risk Management Q9, Geneva, 2005, http://www.emea.eu.int/Inspections/docs/ICHQ9Step4QRM.pdf.
    • International Conference on Harmonization (ICH): Quality Risk Management Q9, Geneva, 2005, http://www.emea.eu.int/Inspections/docs/ICHQ9Step4QRM.pdf.
  • 31
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    • Process Analytical Technology (PAT), Initiative, US Food and Drugs Administration, Rockville, MD, 2004, http://www.fda.gov/cder/OPS/PAT.htm.
    • Process Analytical Technology (PAT), Initiative, US Food and Drugs Administration, Rockville, MD, 2004, http://www.fda.gov/cder/OPS/PAT.htm.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.