메뉴 건너뛰기




Volumn 2, Issue 12, 2010, Pages 1913-1919

Regulated bioanalysis and the desire for harmonized regulations in China

Author keywords

bioanalysis; bioanalytical method validation guidelines; global; harmonization; regulations

Indexed keywords

ACCURACY; ANALYTIC METHOD; BIOANALYSIS; CHINA; GOVERNMENT REGULATION; INTERMETHOD COMPARISON; LIMIT OF QUANTITATION; PRACTICE GUIDELINE; REVIEW; SENSITIVITY AND SPECIFICITY; STANDARDIZATION; VALIDATION PROCESS; BIOTECHNOLOGY; ECONOMICS; EDITORIAL; INTERNATIONAL COOPERATION; LEGAL ASPECT; METHODOLOGY; STANDARD;

EID: 79952016940     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.10.166     Document Type: Review
Times cited : (5)

References (11)
  • 1
    • 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 (2010).
    • (2010) Bioanalysis , vol.2 , Issue.4 , pp. 683
    • Timmerman, P.1    Lowes, S.2    Fast, D.M.3    Garofolo, F.4
  • 2
    • 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
  • 4
    • 0003484310 scopus 로고    scopus 로고
    • US FDA US Department of Health and Human Services. US FDA CDER MD, USA
    • US FDA. Guidance for industry: bioanalytical method validation. US Department of Health and Human Services. US FDA CDER, MD, USA (2001).
    • (2001) Guidance for Industry: Bioanalytical Method Validation
  • 6
    • 68249147642 scopus 로고    scopus 로고
    • Workshop report and follow-up-AAPS workshop on current topics in GLP bioana-lysis: Assay reproducibility for incurred samples-implications of Crystal City recommendations
    • Fast D, Kelley M, Viswanthan C et al. Workshop report and follow-up-AAPS workshop on current topics in GLP bioana-lysis: assay reproducibility for incurred samples-implications of Crystal City recommendations. AAPSJ. 11(2), 238-241 (2009).
    • (2009) AAPSJ , vol.11 , Issue.2 , pp. 238-241
    • Fast, D.1    Kelley, M.2    Viswanthan, C.3
  • 7
    • 79951768879 scopus 로고    scopus 로고
    • The 2nd calibration and validation group workshop on recent issues in good laboratory practice Bioanalysis
    • Savoie N, Booth BP, Garofolo F et al. The 2nd calibration and validation group workshop on recent issues in good laboratory practice Bioanalysis. Bioanalysis 1(1), 19-30 (2009).
    • (2009) Bioanalysis , vol.1 , Issue.1 , pp. 19-30
    • Savoie, N.1    Booth, B.P.2    Garofolo, F.3
  • 9
    • 79952509932 scopus 로고    scopus 로고
    • Bioanalysis in China
    • Zhong DF. Bioanalysis in China. Bioanalysis, 2(2), 153-156 (2010).
    • (2010) Bioanalysis , vol.2 , Issue.2 , pp. 153-156
    • Zhong, D.F.1
  • 10
    • 77956262888 scopus 로고    scopus 로고
    • Appendix XIX B. China Medical Science and Technology Press, Beijing, China
    • Chinese Pharmacopoeia Commission. Pharmacopoeia of the People's Republic of China (2010) Vol. II, Appendix XIX B. China Medical Science and Technology Press, Beijing, China (2010).
    • (2010) Pharmacopoeia of the People's Republic of China (2010) , vol.2
  • 11
    • 79952019611 scopus 로고    scopus 로고
    • Bioanalytical method validation: Notable points in the 2009 draft EMA guideline and differences with the 2001 US FDA Guidance
    • Smith G. Bioanalytical method validation: notable points in the 2009 draft EMA guideline and differences with the 2001 US FDA Guidance. Bioanalysis 2(5), 929-935 (2010).
    • (2009) Bioanalysis , vol.2 , Issue.5 , pp. 929-935
    • Smith, G.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.