Role of non-clinical safety assessment in paediatric drug development

Guide to Paediatric Drug Development and Clinical Research

Volumn , Issue , 2010, Pages 138-143

  De Schaepdrijver, Luc M ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84871441717     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1159/B978-380559363-2.31558-3     Document Type: Chapter

References (22)

1. US FDA, Center for Drug Evaluation and Research: Guidance for Industry, Non-clinical Safety Evaluation of Pediatic Drug Products. Rockville, US Department of Health and Human Services, 2006.
2. European Medicines Evaluation Agency (EMA), Committee for Human Medicinal Products (CHMP): Guideline on the Need for Non-clinical Testing in Juvenile Animals on Human Pharmaceuticals for Pediatric Indications, Draft, September 2005.
3. ICH Harmonized Tripartite Guideline: Guidance on the Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3 (R2), June, 2009.
4. Buelke-Sam J: Comparative schedules of development in rats and humans: implications for developmental neurotoxicity testing. Annual Meeting of the Society of Toxicology, Salt Lake City, 2003.
5. Hew KW, Keller KA: Postnatal anatomical and functional development of the heart: a species comparison. Birth Defects Res [B] 2003;68:309-320.
6. Zoetis T, Hurtt ME: Species comparison of lung development. Birth Defects Res [B] 2003;68:121-124.
7. Zoetis T, Hurtt ME: Species comparison of anatomical and functional renal development. Birth Defects Res [B] 2003;68:111-120.
8. Wood SL, Beyer BK, Cappon GD: Species comparison of postnatal CNS development: functional measures. Birth Defects Res [B] 2003;68:391-407.
9. Watson RE, DeSesso JM, Hurtt ME, et al: Postnatal growth and morphological development of the brain: a species comparison. Birth Defects Res [B] 2006;77:471-484.
10. Holsapple MP, West LJ, Landreth KS: Species comparison of anatomical and functional immune system development. Birth Defects Res [B] 2003;68: 321-334.
11. Marty MS, Chapin RE, Parks LG, et al: Development and maturation of the male reproductive system. Birth Defects Res [B] 2003;68:125-136.
12. Beckman DA, Feuston M: Landmarks in the development of the female reproductive system. Birth Defects Res [B] 2003;68:137-143.
13. Zoetis T, Tassinari MS, Bagi C, Walthall K, et al: Species comparison of postnatal bone growth and development. Birth Defects Res [B] 2003;68:86-110.
14. Hurtt ME, Daston G, Davis-Bruno K, et al: Juvenile animal studies: testing strategy and design. Birth Defects Res [B] 2004;71:281-288.
15. De Schaepdrijver LM, Bailey GP, et al: Preclinical juvenile toxicity assessments and study designs; in Mulberg AE, Silber SS, van den Anker JN: Pediatric Drug Development: Concepts and Applications. Hoboken, Wiley, 2009.
16. Beck MJ, Padgett EL, Bowman CJ, et al: Nonclinical juvenile toxicity testing; in Hood RD (eds): Developmental and Reproductive Toxicology: A Practical Approach. Boca Raton, CRC Press, Taylor & Francis Group, 2006.
17. Freichel C, Prinssen E, Hoffmann G, Gand L, Beck M, Weiser T, Breidenbach A: Oseltamivir is devoid of specific behavioral and other central nervous system effects in juvenile rats at supratherapeutic oral doses. Int J Virol 2009;ISSN 1816-4900, 11 pp.
18. De Schaepdrijver LM, Rouan MC, Raoof A, Bailey GP, De Zwart L, Monbaliu J, Coogan TP, Lammens L, Coussement W: Real life toxicity case studies: the good, the bad and the ugly. Reprod Toxicol 2008;26:54-55.
19. De Zwart L, Scholten M, Monbaliu JG, Annaert PP, Van Houdt J, Van den Wijngaert I, De Schaepdrijver LM, Bailey GP, Coogan TP, Coussement WC, Mannens GS: The ontogeny of drug metabolizing enzymes and transporters in the rat. Reprod Toxicol 2008;26:220-230.
20. Brent RL: Utilization of juvenile animal studies to determine the human effects and risks of environmental toxicants during postnatal developmental stages. Birth Defects Res [B] 2004;71:303-320.
21. Baldrick P: Developing drugs for paediatric use: a role for juvenile animal studies? Regul Toxicol Pharmacol 2004;39:381-389.
22. Bailey GP, Dirk Marien: What have we learned from pre-clinical juvenile toxicity studies? Reprod Toxicol 2009;28:226-229.