메뉴 건너뛰기




Volumn 88, Issue 2, 2010, Pages 260-262

A Systematic approach to preclinical and clinical safety biomarker qualification incorporating bradford hill's principles of causality association

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER;

EID: 77954887461     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2010.77     Document Type: Short Survey
Times cited : (10)

References (15)
  • 1
    • 77952133994 scopus 로고    scopus 로고
    • Towards consensus practices to qualify safety biomarkers for use in early drug development
    • Sistare, F.D. et al. towards consensus practices to qualify safety biomarkers for use in early drug development. Nat. Biotechnol. 28, 446-454 (2010).
    • (2010) Nat. Biotechnol. , vol.28 , pp. 446-454
    • Sistare, F.D.1
  • 3
    • 77954888549 scopus 로고    scopus 로고
    • Gaps for qualifying biomarker candidates of drug induced liver injury
    • in press
    • Ozer, J.S. et al. gaps for qualifying biomarker candidates of drug induced liver injury. Biomark. Med., in press.
    • Biomark. Med.
    • Ozer, J.S.1
  • 4
    • 77952138048 scopus 로고    scopus 로고
    • Renal biomarker qualifcation submission: A dialog between the FDA/EMEA and PstC
    • Dieterle, F. et al. Renal biomarker qualifcation submission: a dialog between the FDA/EMEA and PstC. Nat. Biotechnol. 28, 455-462 (2010).
    • (2010) Nat. Biotechnol. , vol.28 , pp. 455-462
    • Dieterle, F.1
  • 5
    • 38349144995 scopus 로고    scopus 로고
    • A prototypical process for creating evidentiary standards for biomarkers and diagnostics
    • Altar, C.A. et al. A prototypical process for creating evidentiary standards for biomarkers and diagnostics. Clin. Pharmacol. Ther. 83, 368-371 (2008).
    • (2008) Clin. Pharmacol. Ther. , vol.83 , pp. 368-371
    • Altar, C.A.1
  • 6
    • 31844443695 scopus 로고
    • The environment and disease: Association or causation?
    • Bradford-Hill, A. the environment and disease: association or causation? Proc. R. Soc. Med. 58, 295-300 (1965).
    • (1965) Proc. R. Soc. Med. , vol.58 , pp. 295-300
    • Bradford-Hill, A.1
  • 8
    • 9644264494 scopus 로고    scopus 로고
    • Estimation of diagnostic-test sensitivity and specifcity through Bayesian modelling
    • Branscum, A.J., gardner, I.A., & Johnson, W.O. Estimation of diagnostic-test sensitivity and specifcity through Bayesian modelling. Prev. Vet. Med. 68, 145-163 (2005).
    • (2005) Prev. Vet. Med. , vol.68 , pp. 145-163
    • Branscum, A.J.1    Gardner, I.A.2    Johnson, W.O.3
  • 9
    • 0034732928 scopus 로고    scopus 로고
    • Estimation of sensitivity and specifcity of diagnostic tests and disease prevalence when the true disease state is unknown
    • Enøe, C., georgiadis, M.P. & Johnson, W.O. Estimation of sensitivity and specifcity of diagnostic tests and disease prevalence when the true disease state is unknown. Prev. Vet. Med. 45, 61-81 (2000).
    • (2000) Prev. Vet. Med. , vol.45 , pp. 61-81
    • Enøe, C.1    Georgiadis, M.P.2    Johnson, W.O.3
  • 11
    • 77952228263 scopus 로고    scopus 로고
    • A panel of urinary biomarkers to monitor reversibility of renal injury and a serum marker with improved potential to assess renal function
    • Ozer, J.S. et al. A panel of urinary biomarkers to monitor reversibility of renal injury and a serum marker with improved potential to assess renal function. Nat. Biotechnol. 28, 486-494 (2010).
    • (2010) Nat. Biotechnol. , vol.28 , pp. 486-494
    • Ozer, J.S.1
  • 12
    • 28444443001 scopus 로고    scopus 로고
    • The Bradford Hill considerations on causality: A counterfactual perspective
    • Höfer, M. the Bradford Hill considerations on causality: a counterfactual perspective. Emerg. Themes Epidemiol. 2, 11 (2005).
    • (2005) Emerg. Themes Epidemiol. , vol.2 , pp. 11
    • Höfer, M.1
  • 13
    • 67649635807 scopus 로고    scopus 로고
    • Renal and retinal efects of enalapril and losartan in type 1 diabetes
    • Mauer, M. et al. Renal and retinal efects of enalapril and losartan in type 1 diabetes. N. Engl. J. Med. 361, 40-51 (2009)
    • (2009) N. Engl. J. Med. , vol.361 , pp. 40-51
    • Mauer, M.1
  • 14
    • 0025809884 scopus 로고
    • What is a cause and how do we know one? A grammar for pragmatic epidemiology
    • Susser, M. What is a cause and how do we know one? A grammar for pragmatic epidemiology. Am. J. Epidemiol. 133, 635-648 (1991).
    • (1991) Am. J. Epidemiol. , vol.133 , pp. 635-648
    • Susser, M.1
  • 15
    • 0004292914 scopus 로고    scopus 로고
    • 2nd edn. (Lippincott Williams & Wilkins, Philadelphia, PA
    • Rothman, K.J. & greenland, S. Modern Epidemiology 2nd edn. p. 27 (Lippincott Williams & Wilkins, Philadelphia, PA, 1998).
    • (1998) Modern Epidemiology , pp. 27
    • Rothman, K.J.1    Greenland, S.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.