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Volumn 92, Issue 4, 2011, Pages 292-303

Value of juvenile animal studies

(13)  Leconte, Isabelle a,l   Bailey, Graham b   Davis Bruno, Karen c   Hew, Kok Wah d   Kim, James e   Silva Lima, Beatriz f   Liminga, Ulla g   Moffit, Jeffrey h   De Schaepdrijver, Luc b   Schmitt, Georg i   Tassinari, Melissa c   Thompson, Kary j   Hurtt, Mark k  

a SANOFI   (France)

Author keywords

Pharmaceuticals; Postnatal evaluation; Safety assessment

Indexed keywords

ANTINEOPLASTIC AGENT; ANTIRETROVIRUS AGENT; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; JANUS KINASE INHIBITOR; MONOCLONAL ANTIBODY; MU OPIATE RECEPTOR AGONIST; MUSCLE RELAXANT AGENT; SODIUM CHANNEL BLOCKING AGENT; VALPROIC ACID;

EID: 80051934019     PISSN: 15429733     EISSN: 15429741     Source Type: Journal    
DOI: 10.1002/bdrb.20331     Document Type: Review
Times cited : (21)

References (18)
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    • Bailey, G.P.1    Marien, D.2
  • 3
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    • Juvenile toxicity assessment of anidulafungin in rats: an example of navigating case-by-case study design through scientific and regulatory challenges
    • Bowman C, Chmielewski G, Lewis E, et al. 2011. Juvenile toxicity assessment of anidulafungin in rats: an example of navigating case-by-case study design through scientific and regulatory challenges. Birth Defects Res B Dev Reprod Toxicol 92:333-344.
    • (2011) Birth Defects Res B Dev Reprod Toxicol , vol.92 , pp. 333-344
    • Bowman, C.1    Chmielewski, G.2    Lewis, E.3
  • 4
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    • Development of the immune system in the cynomolgus monkey: the appropriate model in human targeted toxicology?
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    • Nonclinical support of pediatric drug development in a global context: an industry perspective
    • Cappon GD. 2011. Nonclinical support of pediatric drug development in a global context: an industry perspective. Birth Defects Res B Dev Reprod Toxicol 92:269-272.
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    • Cappon, G.D.1
  • 8
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    • Impaired reproduction in adult male, but not female, rats following juvenile treatment with the armoatase inhibitor, Exemestane
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    • Cappon GD, Chapin RE, Hurtt ME, et al. 2011. Impaired reproduction in adult male, but not female, rats following juvenile treatment with the armoatase inhibitor, Exemestane. Birth Defects Res B Dev Reprod Toxicol (in press).
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    • Cappon, G.D.1    Chapin, R.E.2    Hurtt, M.E.3
  • 9
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    • Juvenile animal studies and pediatric drug development: a European perspective
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  • 10
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    • EMEA. European Medicines Agency (EMEA), Committee for Human medicinal Products (CHMP). Guideline on the need for nonclinical testing in juvenile animals on human pharmaceuticals for paediatric indications. Available at.
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    • FDA. United States Food and Drug Administration (FDA). Guidance document. Nonclinical safety evaluation of pediatric drug products. Available at.
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    • Silva-Lima B, Theilade-Thomsen MD, Carleer J, et al. 2010. Juvenile animal studies for the development of paediatric medicines: A description and conclusions from a European Medicines Agency workshop on juvenile animal testing for nonclinical assessors. Birth Defects Res B Dev Reprod Toxicol 89:467-473.
    • (2010) Birth Defects Res B Dev Reprod Toxicol , vol.89 , pp. 467-473
    • Silva-Lima, B.1    Theilade-Thomsen, M.D.2    Carleer, J.3
  • 16
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    • Tassinari MS, Benson K, Elayan I, et al. 2011. Juvenile animal studies and pediatric drug development retrospective review: use in regulatory decisions and labeling. Birth Defects Res B Dev Reprod Toxicol (in press).
    • (2011) Birth Defects Res B Dev Reprod Toxicol
    • Tassinari, M.S.1    Benson, K.2    Elayan, I.3
  • 17
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    • Thorsrud, B.A.1    Faqi, A.S.2    Holdsworth, D.L.3    Baird, T.J.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.