Comparative juvenile safety testing of new therapeutic candidates: Relevance of laboratory animal data to children

Journal of Toxicological Sciences

Volumn 34, Issue 2 SPEC. ISS., 2009, Pages

  Anderson, Tim ^a   Khan, Nasir K ^a   Tassinari, Melissa S ^a   Hurtt, Mark E ^a  

^a PFIZER INC   (United States)

Author keywords

Juvenile; Prediction; Safety

Indexed keywords

NONSTEROID ANTIINFLAMMATORY AGENT;

ATTENTION DEFICIT DISORDER; CHILD SAFETY; CLINICAL STUDY; COMPARATIVE STUDY; CONFERENCE PAPER; DRUG DESIGN; DRUG FORMULATION; DRUG LABELING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EXPERIMENTAL ANIMAL; HUMAN; JUVENILE; KIDNEY FUNCTION; LAW; NONHUMAN; ORGANOGENESIS; POSTNATAL DEVELOPMENT; RISK ASSESSMENT; TOXICOLOGY;

ANIMALIA;

EID: 67651148290     PISSN: 03881350     EISSN: 18803989     Source Type: Journal    
DOI: 10.2131/jts.34.SP209     Document Type: Conference Paper

References (27)

1. Anderson, D.H., Blanc, W.A., Crozier, D.N. and Silverman, W.A. (1956): A difference in mortality rate and incidence of kernicterus among premature infants allotted to two prophylactic antibacterial regimens. Pediatrics, 18, 614-625.
2. Anderson, J.M., Cockburn, F., Forfar, J.O., Harkness, R.A., Kelly, R.W. and Kilshaw, B. (1981): Neonatal spongioform myelinopathy after restricted application of hexachlorophane skin disinfectant. J. Clin. Pathol., 34, 25-29.
3. Beck, M.J., Padgett, E.L., Bowman, C.J., Wilson, D.T., Kaufman, L.E., Varsho, B.J., Stump, D.G., Nemec, M.D. and Holson, J.F. (2006): Nonclinical Juvenile Toxicity Testing In: Developmental and Reproductive Toxicology: A Practical Approach (Hood, R.D., ed.), pp.263-327, Taylor and Francis, Boca Raton, Fla.
4. Beckman, D.A. and Feuston, M. (2003): Landmarks in the development of the female reproductive system. Birth Defects Res. B. Dev. Reprod. Toxicol., 68, 137-143.
5. th U.S. Congress Acessed at www.fda.gov/pediatric/PL107-109.pdf
6. European Medicines Agency, Committee for Human Medicinal Products, Guideline on the Need for Nonclinical Testing in Juvenile Animals on Human Pharmaceuticals for Paediatric Indications Doc ref EMEA/CHMP/SWP/169215/2005 Accessed at www.emea.europa.eu/pdfs/human/swp/16921505en.pdf
7. Guzelian, P.S., Henry, C.J. and Olin, S.S. (1992): Similarities & Differences Between Children & Adults: Implications for Risk Assessment. ILSI Press. Washington D.C..
8. Hew, K.W. and Keller, K.A. (2003): Postnatal anatomical and functional development of the heart: a species comparison. Birth Defects Res. B. Dev. Reprod. Toxicol., 68, 309-320.
9. Holsapple, M.P., West, L.J. and Landreth, K.S. (2003): Species comparison of anatomical and functional immune system development. Birth Defects Res. B. Dev. Reprod. Toxicol., 68, 321-334.
10. Hurtt, M.E., Daston, G., Davis-Bruno, K., Feuston, M., Silva Lima, B., Makris, S., McNerney, M.E., Sandler, J.D., Whitby, K., Wier, P. and Cappon, G.D. (2004): Juvenile animal studies: testing strategies and design. Birth Defects Res. B. Dev. Reprod. Toxicol., 71, 281-288.
11. Kremer, L.C.M. and Caron, H.N. (2004): Anthracycline cardiotoxicity in children. N. Engl. J. Med., 351, 120-121.
12. Lesko, S.M. and Mitchell, A.A. (1999): The safety of acetaminophen and ibuprofen among children younger than two years old. Pediatrics, 104, e39.
13. Lovejoy, F.H.Jr. (1982): Fatal benzyl alcohol poisoning in neonatal intensive care units. A new concern for pediatricians. Am. J. Dis. Child, 136, 974-975.
14. Marty, M.S., Chapin, R.E., Parks, L.G. and Thorsrud, B.A. (2003): Development and maturation of the male reproductive system. Birth Defects Res. B. Dev. Reprod. Toxicol., 68, 125-136.
15. Milne, C.-P. (2001): White paper: the pediatric studies incentive: equal medicines for all Boston: Tufts Center for the Study of Drug Development Accessed at www.csdd.tufts.edu/-documents/www/Doc-233-7232-826.pdf
16. th U.S. Congress Accessed at www.fda.gov/cder/pediatric/S-650-PREA.pdf
17. Shah, S.S., Hall, M., Goodman, D.M., Feuer, P., Sharma, V., Fargason, C.Jr., Hyman, D., Jenkins, K., White, M.L., Levy, F.H., Levin, J.E., Bertoch, D. and Slonim, A.D. (2007): Off-label drug use in hospitalized children. Arch. Pediatr. Adolesc. Med., 161, 282-290.
18. U.S. Food and Drug Administration (2006): Guidance for Industry: Nonclinical Safety Evaluation of Pediatric Drug Products Accessed at www.fda.gov/cder/guidance/5671fnl.pdf
19. Walthall, K., Cappon, G.D., Hurtt, M.E. and Zoetis, T. (2005): Postnatal development of the gastrointestinal system: A species comparison. Birth Defects Res. B. Dev. Reprod. Toxicol., 74, 132-156.
20. Watson, R.E., DeSesso, J.M., Hurtt, M.E. and Cappon, G.D. (2006): Postnatal growth and morphological development of the brain: A species comparison. Birth Defects Res. B. Dev. Reprod. Toxicol., 77, 471-484.
21. Weiss, C.F., Glazko, A.J. and Weston, J.K. (1960): Chloramphenicol in the newborn infant: a physiological explanation of its toxicity when given in excessive doses. N. Engl. J. Med., 262, 787.
22. Wood, S.L., Beyer, B.K. and Cappon, G.D. (2003): Species comparison of postnatal CNS development: functional measures. Birth Defects Res. B. Dev. Reprod. Toxicol, 68, 391-407.
23. World Health Organization (WHO) (1986): Principles for evaluating health risks from chemicals during infancy and early childhood: the need for a special approach. International Programme on Chemical Safety, Environmental Health Criteria 59, World Health Organization, Geneva.
24. Zoetis, T. and Hurtt, M.E. (2003a): Species comparison of lung development. Birth Defects Res. B. Dev. Reprod. Toxicol., 68, 121-124.
25. Zoetis, T. and Hurtt, M.E. (2003b): Species comparison of anatomical and functional renal development. Birth Defects Res. B. Dev. Reprod. Toxicol., 68, 111-120.
26. Zoetis, T., Tassinari, M.S., Bagi, C., Walthall, K. and Hurtt, M.E. (2003): Species comparison of postnatal bone growth and development. Birth Defects Res. B. Dev. Reprod. Toxicol., 68, 86-110.
27. Zoetis, T. and Walls, I. (2003): Principles & Practices for Direct Dosing of Pre-Weaning Mammals in Toxicity Testing and Research. T. Zoetis, and I. Walls, Eds. ILSI Press, Washington, D.C..