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Methods Mol Biol. 2017;1641:25-67. doi: 10.1007/978-1-4939-7172-5_2.

Juvenile Nonclinical Safety Studies in Support of Pediatric Drug Development.

Author information

1
Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, CH-4070, Basel, Switzerland. paul.barrow.pb1@roche.com.
2
Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, CH-4070, Basel, Switzerland.

Abstract

A pediatric assessment is now a required component of every drug marketing application in North America, Europe, and Japan, unless a waiver has been granted previously. Nonclinical juvenile toxicity studies are often required as part of this assessment. The protocols for juvenile toxicity studies are best devised in consultation with the regulatory authorities. It is important to submit the pediatric investigation plan (PIP) or pediatric study plan (PSP) early, in order not to delay the marketing authorization of the drug in adults. The choice of species and the design of juvenile toxicity studies are based on a series of complex considerations, including the therapeutic use of the drug, age at which children will be treated, duration of treatment, and potential age- or species-specific differences in efficacy, pharmacokinetics, or toxicity.

KEYWORDS:

Juvenile animals; Pediatric; Safety testing; Toxicology

PMID:
28748457
DOI:
10.1007/978-1-4939-7172-5_2
[Indexed for MEDLINE]

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