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Preclinical evaluation of juvenile toxicity.

Jean-Charles Gautier, Paul C Barrow, Stéphane Barbellion, and Jeanne Stadler

Methods Mol Biol (2011) PMID 20972745

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.

DOI: 10.1007/978-1-60761-849-2_2
Version: za2963e q8zae q8zbc q8zc8 q8zdd q8zea q8zf9 q8zg0

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