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Preclinical Evaluation of Juvenile Toxicity

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Drug Safety Evaluation

Part of the book series: Methods in Molecular Biology ((MIMB,volume 691))

Abstract

A pediatric assessment is now a required component of every New Drug Application in North America or Marketing Authorization Application in Europe, unless a waiver has been granted previously. Nonclinical juvenile toxicity studies are usually required as part of this assessment. The protocols for juvenile toxicity studies are devised in consultation with the FDA or EMEA. It is important to approach the regulatory authority well in advance in order not to delay the marketing authorization of the drug and to confirm the need or not to perform a preclinical evaluation in juvenile animals. The choice of species and the design of juvenile studies are based on a series of complex considerations, including: the therapeutic use of the drug, the age at which children will be treated, the duration of treatment, and potential age- or species-specific differences in pharmacokinetics or toxicity.

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Author information

Authors and Affiliations

  1. Ricerca Biosciences, Les Oncins, Saint-Germain sur l’Arbresle, France

    Paul C. Barrow

  2. Disposition, Safety and Animal Research, sanofi-aventis R&D, Vitry-sur-Seine, France

    Stéphane Barbellion

  3. Toxicology Consulting, Tours, France

    Jeanne Stadler

Authors
  1. Paul C. Barrow
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  2. Stéphane Barbellion
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  3. Jeanne Stadler
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Corresponding author

Correspondence to Paul C. Barrow .

Editor information

Editors and Affiliations

  1. , Toxicologie Cellulaire et Moléculaire, Sanofi-aventis, Quai Jules Guesde 13, Vitry-sur-Seine, 94400, France

    Jean-Charles Gautier

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Barrow, P.C., Barbellion, S., Stadler, J. (2011). Preclinical Evaluation of Juvenile Toxicity. In: Gautier, JC. (eds) Drug Safety Evaluation. Methods in Molecular Biology, vol 691. Humana Press. https://doi.org/10.1007/978-1-60761-849-2_2

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  • DOI: https://doi.org/10.1007/978-1-60761-849-2_2

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  • Publisher Name: Humana Press

  • Print ISBN: 978-1-60327-186-8

  • Online ISBN: 978-1-60761-849-2

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