메뉴 건너뛰기




Volumn 86, Issue 2 SPEC. ISS., 2007, Pages 198-207

Risk management for analytical methods based on the total error concept: Conciliating the objectives of the pre-study and in-study validation phases

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; ARTICLE; FOOD AND DRUG ADMINISTRATION; LABORATORY; PRIORITY JOURNAL; QUALITY CONTROL; RISK MANAGEMENT; VALIDATION PROCESS;

EID: 34147101216     PISSN: 01697439     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.chemolab.2006.06.008     Document Type: Article
Times cited : (34)

References (28)
  • 1
    • 34147097593 scopus 로고    scopus 로고
    • International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures, ICH-Q2A, Geneva 1995.
  • 2
    • 34147184424 scopus 로고    scopus 로고
    • International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures: Methodology, ICH-Q2B, Geneva 1996.
  • 3
    • 0005905707 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER)
    • FDA Guidance for Industry. Bioanalytical Methods Validation (May 2001), U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER)
    • (2001) Bioanalytical Methods Validation
    • FDA Guidance for Industry1
  • 5
    • 0031762194 scopus 로고    scopus 로고
    • Conceptual and statistical issues in the validation of analytical dilution assays for pharmaceutical applications
    • Smith W.C., and Sittampalam G.S. Conceptual and statistical issues in the validation of analytical dilution assays for pharmaceutical applications. Journal of Biopharmaceutical Statistics 8 4 (1998) 509-532
    • (1998) Journal of Biopharmaceutical Statistics , vol.8 , Issue.4 , pp. 509-532
    • Smith, W.C.1    Sittampalam, G.S.2
  • 8
    • 10744230729 scopus 로고    scopus 로고
    • Recommendations for bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
    • Desilva B., Smith W., Weiner R., Kelley M., Smolec J., Lee B., Khan M., Tacey R., Hill H., and Celniker A. Recommendations for bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharmaceutical Research 20 (2003) 1885-1900
    • (2003) Pharmaceutical Research , vol.20 , pp. 1885-1900
    • Desilva, B.1    Smith, W.2    Weiner, R.3    Kelley, M.4    Smolec, J.5    Lee, B.6    Khan, M.7    Tacey, R.8    Hill, H.9    Celniker, A.10
  • 12
    • 34147115228 scopus 로고    scopus 로고
    • Conciliating objectives of analytical methods and objectives of validation: a statistical perspective
    • Philadelphia
    • Boulanger B., Dewe W., Hubert P., Rozet E., Moonen F., Govaerts B., and Maumy M. Conciliating objectives of analytical methods and objectives of validation: a statistical perspective. Inst. Validation Tech. (December 7, 2005), Philadelphia
    • (2005) Inst. Validation Tech.
    • Boulanger, B.1    Dewe, W.2    Hubert, P.3    Rozet, E.4    Moonen, F.5    Govaerts, B.6    Maumy, M.7
  • 16
    • 0042625050 scopus 로고    scopus 로고
    • An analysis of the SFSTP guide on validation of chromatographic bioanalytical methods: progresses and limitations
    • Boulanger B., Chiap P., Dewe W., Crommen J., and Hubert P. An analysis of the SFSTP guide on validation of chromatographic bioanalytical methods: progresses and limitations. Journal of Pharmaceutical and Biomedical Analysis 32 (2003) 753-765
    • (2003) Journal of Pharmaceutical and Biomedical Analysis , vol.32 , pp. 753-765
    • Boulanger, B.1    Chiap, P.2    Dewe, W.3    Crommen, J.4    Hubert, P.5
  • 17
    • 15544389000 scopus 로고    scopus 로고
    • Two-sided tolerance intervals for balanced and unbalanced random effects models
    • Hoffman D., and Kringle R. Two-sided tolerance intervals for balanced and unbalanced random effects models. Journal of Biopharmaceutical Statistics 15 2 (2005) 283-293
    • (2005) Journal of Biopharmaceutical Statistics , vol.15 , Issue.2 , pp. 283-293
    • Hoffman, D.1    Kringle, R.2
  • 18
    • 0021481069 scopus 로고
    • β-expectation and β-content tolerance limits for balanced one-way ANOVA random model
    • Mee R.W. β-expectation and β-content tolerance limits for balanced one-way ANOVA random model. Technometrics 26 3 (1984) 251-254
    • (1984) Technometrics , vol.26 , Issue.3 , pp. 251-254
    • Mee, R.W.1
  • 19
    • 30644469735 scopus 로고
    • Estimation of the percentage of a normal distribution lying outside a specified interval
    • Mee R.W. Estimation of the percentage of a normal distribution lying outside a specified interval. Communication in Statistics - Theory and Methods 17 5 (1988) 1465-1479
    • (1988) Communication in Statistics - Theory and Methods , vol.17 , Issue.5 , pp. 1465-1479
    • Mee, R.W.1
  • 22
  • 23
    • 0028197202 scopus 로고
    • An assessment of the 4-6-20 rule for acceptance of analytical runs in bioavailability, bioequivalence, and pharmacokinetic studies
    • Kringle R.O. An assessment of the 4-6-20 rule for acceptance of analytical runs in bioavailability, bioequivalence, and pharmacokinetic studies. Pharmaceutical Research 11 (1994) 556-560
    • (1994) Pharmaceutical Research , vol.11 , pp. 556-560
    • Kringle, R.O.1
  • 25


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.