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Bulletin de l'Academie Veterinaire de France
Volumn 161, Issue 1, 2008, Pages 61-69
Non-clinical safety in drug development
Author keywords

Drug development; Extrapolation to human; Non clinical safety; Predictability of adverse effects; Regulatory toxicology
Indexed keywords

EID: 54349115476     PISSN: 00014192     EISSN: 00341843     Source Type: Journal    
DOI: 10.4267/2042/47926     Document Type: Article
Times cited : (2)
References (7)
  • 2
    • 0032842520 scopus 로고    scopus 로고
    • Food and Drug Administration proposed testing guidelines for reproduction studies. Revision Committee. FDA Guidelines for Developmental Toxicity and Reproduction
    • Collins, T.F.X., Sprando, R.L., Shakelford, M.E., Hansen, D.K., Welsh, J.-J. 1999. Food and Drug Administration proposed testing guidelines for reproduction studies. Revision Committee. FDA Guidelines for Developmental Toxicity and Reproduction, Food and Drug Administration. Regul Toxicol Pharmacol. 30 : 29-38.
    • (1999) Food and Drug Administration. Regul Toxicol Pharmacol , vol.30 , pp. 29-38
    • Collins, T.F.X.1    Sprando, R.L.2    Shakelford, M.E.3    Hansen, D.K.4    Welsh, J.-J.5
  • 3
    • 0007292904 scopus 로고    scopus 로고
    • Safety Assessment of Pharmaceuticals
    • ed P. Williams & G. Hottendorf, pp, Elsevier, Oxford
    • Diener, R.M. 1997. Safety Assessment of Pharmaceuticals, In Comprehensive Toxicology (ed P. Williams & G. Hottendorf), pp 3-16. Elsevier, Oxford.
    • (1997) Comprehensive Toxicology , pp. 3-16
    • Diener, R.M.1
  • 4
    • 0000060569 scopus 로고    scopus 로고
    • Proposed Guidelines for Carcinogen Risk Assessment
    • EPA
    • EPA.1996. Proposed Guidelines for Carcinogen Risk Assessment. Fed Reg. 61 (85) : 17960-18010,
    • (1996) Fed Reg , vol.61 , Issue.85 , pp. 17960-18010
  • 5
    • 54349086148 scopus 로고    scopus 로고
    • FDA. 1999. Good Laboratory Practice Standards, 40 C.F.R. Part 160 ; 1999. Good Laboratory Practice Standards, 40 C.F.R. Part 792 ; 2000. Good Laboratory Practice for Nonclinical Laboratory Studies, 21 C.F.R. Part 58.
    • FDA. 1999. Good Laboratory Practice Standards, 40 C.F.R. Part 160 ; 1999. Good Laboratory Practice Standards, 40 C.F.R. Part 792 ; 2000. Good Laboratory Practice for Nonclinical Laboratory Studies, 21 C.F.R. Part 58.
  • 6
    • 0033226698 scopus 로고    scopus 로고
    • Differential alteration by thalidomide of the gluthatione content of rat vs rabbit conceptuses in vitro
    • Hansen, J.-M., Carney, E.W., Harris, C. 1999. Differential alteration by thalidomide of the gluthatione content of rat vs rabbit conceptuses in vitro. Reprod Toxicol. 13 : 547-554.
    • (1999) Reprod Toxicol , vol.13 , pp. 547-554
    • Hansen, J.-M.1    Carney, E.W.2    Harris, C.3
  • 7
    • 0028559157 scopus 로고
    • Carcinogen risk assessment : International comparison
    • Moolenaar, R.J. 1994. Carcinogen risk assessment : International comparison. Reg Tox Pharmacol.20 : 302-336.
    • (1994) Reg Tox Pharmacol , vol.20 , pp. 302-336
    • Moolenaar, R.J.1

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.