Comparative juvenile safety testing of new therapeutic candidates: Relevance of laboratory animal data to children
Author:
Affiliation:
1. Drug Safety Research and Development, Pfizer, Inc.
Publisher
Japanese Society of Toxicology
Subject
Toxicology
Link
http://www.jstage.jst.go.jp/article/jts/34/Special_/34_Special__SP209/_pdf
Reference27 articles.
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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. Best Pharmaceuticals for Children Act 2002 Pub law 107-109, 107th U.S. Congress Acessed at www.fda.gov/pediatric/PL107-109.pdf
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