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Volumn 92, Issue 4, 2011, Pages 254-260

Juvenile animal studies and pediatric drug development: A European regulatory perspective

Author keywords

Juvenile animal studies; Medicines; Pediatric regulation; Pharmacology; Toxicology

Indexed keywords

ADOLESCENT; ANIMAL EXPERIMENT; ARTICLE; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG SAFETY; EUROPE; HUMAN; NONHUMAN; PEDIATRICS; PRIORITY JOURNAL;

EID: 80051951928     PISSN: 15429733     EISSN: 15429741     Source Type: Journal    
DOI: 10.1002/bdrb.20310     Document Type: Article
Times cited : (31)

References (9)
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    • Bailey, G.P.1    Marien, D.2
  • 2
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    • Juvenile animal studies in the development of paediatric medicines: learning with 10 years experience of centralized procedure and Paediatric Investigation Plans. Drug Information Association (DIA) 22nd Annual EuroMeeting, Mónaco, March 2010.
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    • Duarte, D.1
  • 3
    • 80051927944 scopus 로고    scopus 로고
    • The need for juvenile animal studies in paediatric drug development: experience from paediatric investigation plans. Presentation to the 37th Annual Meeting of the European Teratology Society, Arles, France.
    • Duarte D, Silva-Lima. B. 2009a. The need for juvenile animal studies in paediatric drug development: experience from paediatric investigation plans. Presentation to the 37th Annual Meeting of the European Teratology Society, Arles, France.
    • (2009)
    • Duarte, D.1    Silva-Lima, B.2
  • 4
    • 80051932151 scopus 로고    scopus 로고
    • On the need for juvenile animal studies in paediatric drugs development: Experience from Paediatric Investigation Plans. 37th Annual Meeting of the European Teratology Society, Arles, France, September 2009.
    • Duarte D, Silva-Lima B. 2009b. On the need for juvenile animal studies in paediatric drugs development: Experience from Paediatric Investigation Plans. 37th Annual Meeting of the European Teratology Society, Arles, France, September 2009.
    • (2009)
    • Duarte, D.1    Silva-Lima, B.2
  • 5
    • 80051942198 scopus 로고    scopus 로고
    • European Medicines Agency. 2008. Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications. EMEA/CHMP/SWP/169215/2005. Available at: Accessed April 28
    • European Medicines Agency. 2008. Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications. EMEA/CHMP/SWP/169215/2005. Available at: Accessed April 28, 2011).
    • (2011)
  • 6
    • 80051930617 scopus 로고    scopus 로고
    • European Medicines Agency. 2009. ICH Topic M 3 (R2) Note for guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceutical. CPMP/ICH/286/95. Available at: Accessed April 28
    • European Medicines Agency. 2009. ICH Topic M 3 (R2) Note for guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceutical. CPMP/ICH/286/95. Available at: Accessed April 28, 2011).
    • (2011)
  • 7
    • 80051925150 scopus 로고    scopus 로고
    • European Union. Regulation (EC) no 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use. Official Journal of the European Union, L 378/20.
    • European Union. 2006a. Regulation (EC) no 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use. Official Journal of the European Union, L 378/20.
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  • 8
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    • European Union. Regulation (EC) no 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union, L 378/1.
    • European Union. 2006b. Regulation (EC) no 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union, L 378/1.
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    • 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
    • Silva-Lima B, Due Theïlade-Thomsen M, 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    Due Theïlade-Thomsen, M.2    Carleer, J.3


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