메뉴 건너뛰기




Volumn 877, Issue 23, 2009, Pages 2407-2411

Use of Total Error concept in the validation of viral activity in cell cultures

Author keywords

Accuracy; Analytical validation; Biological assay; Tolerance interval; Total Error

Indexed keywords

ACCURACY; ANALYTICAL VALIDATION; BIOLOGICAL ASSAY; TOLERANCE INTERVAL; TOTAL ERROR;

EID: 67650447427     PISSN: 15700232     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jchromb.2009.01.010     Document Type: Article
Times cited : (9)

References (20)
  • 1
    • 67650350461 scopus 로고    scopus 로고
    • International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of analytical procedures: text and methodology, Geneva, 2005.
    • International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of analytical procedures: text and methodology, Geneva, 2005.
  • 4
    • 67650413042 scopus 로고
    • Application of the statistics-accuracy (trueness and precision) of the results and methods of measurement-Part 1 to 6,
    • ISO 5725, International Organization for Standardization ISO, Geneva
    • ISO 5725, Application of the statistics-accuracy (trueness and precision) of the results and methods of measurement-Part 1 to 6, International Organization for Standardization (ISO), Geneva, 1994.
    • (1994)
  • 12
    • 67650371398 scopus 로고    scopus 로고
    • Guidance for industry: Bioanalytical method validation, US Department of Health and Human Services, US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Rockville, May 2001.
    • Guidance for industry: Bioanalytical method validation, US Department of Health and Human Services, US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Rockville, May 2001.
  • 15
    • 67650359252 scopus 로고    scopus 로고
    • International Conference on Harmonization (ICH): Quality Risk Management Q9, Geneva, 2005.
    • International Conference on Harmonization (ICH): Quality Risk Management Q9, Geneva, 2005.
  • 18
    • 0001658943 scopus 로고
    • Analytical Methods Committee
    • Analytical Methods Committee, Analyst 120 (1995) 2303.
    • (1995) Analyst , vol.120 , pp. 2303
  • 19
    • 67650411765 scopus 로고    scopus 로고
    • Eurachem/Citac guide Quantifying the uncertainty in analytical measurement, second ed., 2000.
    • Eurachem/Citac guide Quantifying the uncertainty in analytical measurement, second ed., 2000.
  • 20
    • 67650414926 scopus 로고    scopus 로고
    • CB EA-4/16, EA guidelines on the expression of uncertainty in quantitative testing, 2004, http://www.european-accreditation.org.
    • CB EA-4/16, EA guidelines on the expression of uncertainty in quantitative testing, 2004, http://www.european-accreditation.org.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.