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Volumn 3, Issue 8, 2011, Pages 823-827

Historical perspective on the development and evolution of bioanalytical guidance and technology

Author keywords

bioanalysis; bioanalytical method validation; Crystal City bioanalysis conference; guidance; harmonization; pharmacokinteic studies; validation

Indexed keywords

ACCURACY; ANALYTIC METHOD; CONSENSUS DEVELOPMENT; PRACTICE GUIDELINE; PROCESS TECHNOLOGY; QUALITY CONTROL; REPRODUCIBILITY; REVIEW; SENSITIVITY ANALYSIS; VALIDATION PROCESS;

EID: 79955374769     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.45     Document Type: Review
Times cited : (17)

References (12)
  • 1
    • 78651388958 scopus 로고    scopus 로고
    • Regulatory observations in bioanalytical determinations
    • Viswanathan CT. Regulatory observations in bioanalytical determinations. Bioanalysis 2(7), 1325-1329 (2010).
    • (2010) Bioanalysis , vol.2 , Issue.7 , pp. 1325-1329
    • Viswanathan, C.T.1
  • 3
    • 0026606194 scopus 로고
    • Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies
    • Shah VP, Midha KK, Dighe SV et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Pharm. Res. 9(4), 588-592 (1992).
    • (1992) Pharm. Res. , vol.9 , Issue.4 , pp. 588-592
    • Shah, V.P.1    Midha, K.K.2    Dighe, S.V.3
  • 6
    • 0003484310 scopus 로고    scopus 로고
    • US FDA, US Department of Health and Human Services FDA, Center for Drug Evaluation and Research
    • US FDA. Guidance for industry: bioanalytical method validation. US Department of Health and Human Services FDA, Center for Drug Evaluation and Research (2001).
    • (2001) Guidance for Industry: Bioanalytical Method Validation
  • 9
    • 33847397009 scopus 로고    scopus 로고
    • History of bioanalytical methods validation and regulations: Evolution of a guidance document on bioanalytical methods validation
    • Article 5
    • Shah VP. History of bioanalytical methods validation and regulations: evolution of a guidance document on bioanalytical methods validation. AAPS J. 9(1) Article 5, E43-E47 (2007).
    • (2007) AAPS J. , vol.9 , Issue.1
    • Shah, V.P.1
  • 10
    • 79951743532 scopus 로고    scopus 로고
    • International harmonization of bioanalytical guidance
    • Bansal S, Arnold M, Garofolo F. International harmonization of bioanalytical guidance. Bioanalysis 2(4), 685-687 (2010).
    • (2010) Bioanalysis , vol.2 , Issue.4 , pp. 685-687
    • Bansal, S.1    Arnold, M.2    Garofolo, F.3
  • 11
    • 79951893291 scopus 로고    scopus 로고
    • Request for global harmonization of the guidance for bioanalytical method validation and sample analysis
    • Timmerman P, Lowes S, Fast DM, Garofolo F. Request for global harmonization of the guidance for bioanalytical method validation and sample analysis. Bioanalysis 2(4), 683-683 (2010).
    • (2010) Bioanalysis , vol.2 , Issue.4 , pp. 683-683
    • Timmerman, P.1    Lowes, S.2    Fast, D.M.3    Garofolo, F.4
  • 12
    • 79951747555 scopus 로고    scopus 로고
    • Building the Global Bioanalysis Consortium - Working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation
    • van Amsterdam P, Arnold M, Bansal S et al. Building the Global Bioanalysis Consortium - working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation. Bioanalysis 2(11), 1801-1803 (2010).
    • (2010) Bioanalysis , vol.2 , Issue.11 , pp. 1801-1803
    • Van Amsterdam, P.1    Arnold, M.2    Bansal, S.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.