메뉴 건너뛰기




Volumn 54, Issue , 2015, Pages 167-173

Prediction of clinical risks by analysis of preclinical and clinical adverse events

Author keywords

Adverse events; Animal human concordance; Bayesian; Drug risk; Likelihood ratio; Translational medicine

Indexed keywords

CELL DEATH; COMMERCE; DIAGNOSIS; DRUG PRODUCTS; FORECASTING; RISK ASSESSMENT; RISK PERCEPTION; SAFETY ENGINEERING;

EID: 84927927473     PISSN: 15320464     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jbi.2015.02.008     Document Type: Article
Times cited : (27)

References (26)
  • 1
    • 84927914699 scopus 로고    scopus 로고
    • Guidance for industry nonclinical safety evaluation of drug or biologic combinations. United States Food Drug Adm; .
    • Guidance for industry nonclinical safety evaluation of drug or biologic combinations. United States Food Drug Adm; 2006, . http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0004-gdl0002.pdf.
    • (2006)
  • 2
    • 84927927955 scopus 로고
    • Eyelash-dye (Lash-Lure) dermatitis with conjunctivitis
    • Jamieson R.C. Eyelash-dye (Lash-Lure) dermatitis with conjunctivitis. J Am Med Assoc 1933, 20:1560.
    • (1933) J Am Med Assoc , vol.20 , pp. 1560
    • Jamieson, R.C.1
  • 3
    • 0029644362 scopus 로고
    • Federal food, drug and cosmetic act
    • Wax P.M. Federal food, drug and cosmetic act. Ann Intern Med 1938, 122(1995):456-461. 10.1097/00043764-199607000-00005.
    • (1938) Ann Intern Med , vol.122 , Issue.1995 , pp. 456-461
    • Wax, P.M.1
  • 4
    • 73849164353 scopus 로고
    • A study of the German outbreak of phocomelia
    • Taussig H.B. A study of the German outbreak of phocomelia. J Am Med Assoc 1962, 180:1106-1114. 10.1001/jama.1962.03050260028005.
    • (1962) J Am Med Assoc , vol.180 , pp. 1106-1114
    • Taussig, H.B.1
  • 7
    • 0016821405 scopus 로고
    • Quantitative prediction of drug toxicity in humans from toxicology in small and large animals
    • Goldsmith M.A., Slavik M., Carter S.K. Quantitative prediction of drug toxicity in humans from toxicology in small and large animals. Cancer Res 1975, 35:1354-1364.
    • (1975) Cancer Res , vol.35 , pp. 1354-1364
    • Goldsmith, M.A.1    Slavik, M.2    Carter, S.K.3
  • 8
    • 0018013604 scopus 로고
    • Drug safety tests and subsequent clinical experience
    • Fletcher A.P. Drug safety tests and subsequent clinical experience. J R Soc Med 1978, 71:693-696.
    • (1978) J R Soc Med , vol.71 , pp. 693-696
    • Fletcher, A.P.1
  • 10
    • 33846677129 scopus 로고    scopus 로고
    • Comparison of treatment effects between animal experiments and clinical trials: systematic review
    • Perel P., Roberts I., Sena E., Wheble P., Briscoe C., Sandercock P., et al. Comparison of treatment effects between animal experiments and clinical trials: systematic review. BMJ 2007, 334:197. 10.1136/bmj.39048.407928.BE.
    • (2007) BMJ , vol.334 , pp. 197
    • Perel, P.1    Roberts, I.2    Sena, E.3    Wheble, P.4    Briscoe, C.5    Sandercock, P.6
  • 11
    • 35348954386 scopus 로고    scopus 로고
    • The translation of drug efficacy from in vivo models to human disease with special reference to experimental autoimmune encephalomyelitis and multiple sclerosis
    • Bolton C. The translation of drug efficacy from in vivo models to human disease with special reference to experimental autoimmune encephalomyelitis and multiple sclerosis. Inflammopharmacology 2007, 15:183-187. 10.1007/s10787-007-1607-z.
    • (2007) Inflammopharmacology , vol.15 , pp. 183-187
    • Bolton, C.1
  • 12
    • 0025946166 scopus 로고
    • Predictive value of animal studies in toxicology
    • Zbinden G. Predictive value of animal studies in toxicology. Regul Toxicol Pharmacol 1991, 14:167-177. 10.1016/0273-2300(91)90004-F.
    • (1991) Regul Toxicol Pharmacol , vol.14 , pp. 167-177
    • Zbinden, G.1
  • 13
    • 0001936586 scopus 로고
    • Clinical toxicity-could it have been predicted?
    • Lumley CE, Walker S, editors. Animal toxicity studies: their relevance for man. Quay, Lancaster
    • Heywood R. Clinical toxicity-could it have been predicted? post-marketing experience. In: Lumley CE, Walker S, editors. Animal toxicity studies: their relevance for man. Quay, Lancaster; 1990. p. 57-67.
    • (1990) post-marketing experience , pp. 57-67
    • Heywood, R.1
  • 15
    • 36448954646 scopus 로고    scopus 로고
    • Are animal models as good as we think?
    • Wall R.J., Shani M. Are animal models as good as we think?. Theriogenology 2008, 69:2-9. 10.1016/j.theriogenology.2007.09.030.
    • (2008) Theriogenology , vol.69 , pp. 2-9
    • Wall, R.J.1    Shani, M.2
  • 16
    • 57349180719 scopus 로고    scopus 로고
    • Integrated decision-tree testing strategies for mutagenicity and carcinogenicity with respect to the requirements of the EU REACH legislation
    • Combes R., Grindon C., Cronin M.T.D., Roberts D.W., Garrod J.F. Integrated decision-tree testing strategies for mutagenicity and carcinogenicity with respect to the requirements of the EU REACH legislation. ATLA Altern Lab Anim 2008, 36:43-63.
    • (2008) ATLA Altern Lab Anim , vol.36 , pp. 43-63
    • Combes, R.1    Grindon, C.2    Cronin, M.T.D.3    Roberts, D.W.4    Garrod, J.F.5
  • 17
    • 84927931739 scopus 로고    scopus 로고
    • Pharmapendium. Reed Elsevier Properties SA. .
    • Pharmapendium. Reed Elsevier Properties SA; 2014. . https://pharmapendium.com.
    • (2014)
  • 18
    • 0032991290 scopus 로고    scopus 로고
    • The medical dictionary for regulatory activities (MedDRA)
    • Brown E.G., Wood L., Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf 1999, 20:109-117. 10.2165/00002018-199920020-00002.
    • (1999) Drug Saf , vol.20 , pp. 109-117
    • Brown, E.G.1    Wood, L.2    Wood, S.3
  • 19
    • 84927934293 scopus 로고    scopus 로고
    • Mosby's Drug Consult 13th ed. Mosby, St. Louis, MO; .
    • Mosby's Drug Consult 13th ed. Mosby, St. Louis, MO; 2003.
    • (2003)
  • 20
    • 0003845352 scopus 로고
    • Elsevier Science Publishers BV, Amsterdam, Amsterdam
    • Dukes M.N.G. Meyler's side effects of drugs 1992, Elsevier Science Publishers BV, Amsterdam, Amsterdam. 12th ed.
    • (1992) Meyler's side effects of drugs
    • Dukes, M.N.G.1
  • 21
    • 17844402965 scopus 로고    scopus 로고
    • Refining clinical diagnosis with likelihood ratios
    • Grimes D.A., Schulz K.F. Refining clinical diagnosis with likelihood ratios. Lancet 2005, 365:1500-1505. 10.1016/S0140-6736(05)66422-7.
    • (2005) Lancet , vol.365 , pp. 1500-1505
    • Grimes, D.A.1    Schulz, K.F.2
  • 22
    • 0035380779 scopus 로고    scopus 로고
    • Evaluation of a clinical test. II: Assessment of validity
    • Chien P.F.W., Khan K.S. Evaluation of a clinical test. II: Assessment of validity. Br J Obstet Gynaecol 2001, 108:568-572. 10.1016/S0306-5456(00)00128-5.
    • (2001) Br J Obstet Gynaecol , vol.108 , pp. 568-572
    • Chien, P.F.W.1    Khan, K.S.2
  • 24
    • 48449090595 scopus 로고    scopus 로고
    • Drug withdrawals because of adverse effects
    • Aronson J.K. Drug withdrawals because of adverse effects. Side Eff Drugs Annu 2008, 30. 10.1016/S0378-6080(08)00064-0.
    • (2008) Side Eff Drugs Annu , vol.30
    • Aronson, J.K.1
  • 25
    • 50149112857 scopus 로고    scopus 로고
    • The QT syndromes: long and short
    • Morita H., Wu J., Zipes D.P. The QT syndromes: long and short. Lancet 2008, 372:750-763. 10.1016/S0140-6736(08)61307-0.
    • (2008) Lancet , vol.372 , pp. 750-763
    • Morita, H.1    Wu, J.2    Zipes, D.P.3
  • 26
    • 13444302921 scopus 로고    scopus 로고
    • Do preclinical testing strategies help predict human hepatotoxic potentials?
    • Peters T.S. Do preclinical testing strategies help predict human hepatotoxic potentials?. Toxicol Pathol 2005, 33:146-154. 10.1080/01926230590522121.
    • (2005) Toxicol Pathol , vol.33 , pp. 146-154
    • Peters, T.S.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.