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Volumn 3, Issue 1, 2011, Pages 57-66

Capsule review on bioanalytical method transfer: Opportunities and challenges for chromatographic methods

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ANALYTIC METHOD; DRUG DETERMINATION; DRUG INDUSTRY; DRUG RESEARCH; FILE TRANSFER PROTOCOL; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; INFORMATION PROCESSING; INSTRUMENT VALIDATION; INTERDISCIPLINARY COMMUNICATION; MASS SPECTROMETRY; PRACTICE GUIDELINE; QUALITY CONTROL; REVIEW; SAMPLING; SENSITIVITY AND SPECIFICITY; SYSTEMATIC ERROR;

EID: 79951933086     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.10.168     Document Type: Review
Times cited : (15)

References (12)
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    • Review of statistical methodologies used to compare (bio)assay
    • Dewe W. Review of statistical methodologies used to compare (bio)assay. J. Chromatogr. B Analyt.Technol. Biomed. Life Sci. 877, 2208-2213 (2009).
    • (2009) J. Chromatogr. B Analyt.Technol. Biomed. Life Sci. , vol.877 , pp. 2208-2213
    • Dewe, W.1
  • 5
    • 41949089218 scopus 로고    scopus 로고
    • Risk-based approach for the transfer of quantitative methods: Bioanalytical applications
    • Rozet E, Dewe W, Morello R et al. Risk-based approach for the transfer of quantitative methods: bioanalytical applications. J. Chromatogr. A 1189(1-2), 32-43 (2008).
    • (2008) J. Chromatogr. , vol.1189 A , Issue.1-2 , pp. 32-43
    • Rozet, E.1    Dewe, W.2    Morello, R.3
  • 6
    • 0036100107 scopus 로고    scopus 로고
    • Experience with a crossvalidation approach
    • Gansser D. Experience with a crossvalidation approach. Chromatographia 55, S71-S74 (2002).
    • (2002) Chromatographia , vol.55
    • Gansser, D.1
  • 7
    • 0033765733 scopus 로고    scopus 로고
    • Cross validation in bioanalysis: Why, when, and how?
    • Muirhead, Smart TS. Cross validation in bioanalysis: why, when, and how? Chromatographia 52, S72-S75 (2000).
    • (2000) Chromatographia , vol.52
    • Muirhead Smart, T.S.1
  • 8
    • 67650124266 scopus 로고    scopus 로고
    • A proposed fixed range decision criteria for transfer of bioanalytical methods
    • Shah KA, Karnes HT. A proposed fixed range decision criteria for transfer of bioanalytical methods. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 877, 2270-2274 (2009).
    • (2009) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. , vol.877 , pp. 2270-2274
    • Shah, K.A.1    Karnes, H.T.2
  • 9
    • 73349094029 scopus 로고    scopus 로고
    • A step-wise approach for transfer of immunogenicity assays during clinical drug development
    • Tartarewicz S, Moxness M, Weeraratne D et al. A step-wise approach for transfer of immunogenicity assays during clinical drug development. AAPS J. 11, 526-534 (2009).
    • (2009) AAPS J. , vol.11 , pp. 526-534
    • Tartarewicz, S.1    Moxness, M.2    Weeraratne, D.3
  • 10
    • 79951895464 scopus 로고    scopus 로고
    • Strategies for successful transfer of ligand-binding assays for successful validation and implementation in GXP environment
    • Khan MN, Findlay JW (Eds). John Wiley & Sons, Hoboken, NJ, USA
    • Klump W, Hill H. Strategies for successful transfer of ligand-binding assays for successful validation and implementation in GXP environment. In: Ligand-Binding Assays - Development, Validation and Implementation in the Drug Development Arena. Khan MN, Findlay JW (Eds). John Wiley & Sons, Hoboken, NJ, USA 265-186 (2010).
    • (2010) Ligand-Binding Assays - Development, Validation and Implementation in the Drug Development Arena , pp. 265-186
    • Klump, W.1    Hill, H.2
  • 11
    • 0003484310 scopus 로고    scopus 로고
    • US FDA US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, MD, USA compliance regulatory
    • US FDA. Guidance for industry: bioanalytical method validation. US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, MD, USA (2001). www.fda.gov/downloads/drugs/ guidance compliance regulatory information/guidance/ ucm070107.pdf
    • (2001) Guidance for Industry: Bioanalytical Method Validation


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.