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支持儿科药物研发的青少年非临床安全性研究。

Juvenile Nonclinical Safety Studies in Support of Pediatric Drug Development.

作者信息

Barrow Paul C, Schmitt Georg

机构信息

Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, CH-4070, Basel, Switzerland.

出版信息

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

DOI:10.1007/978-1-4939-7172-5_2
PMID:28748457
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.

摘要

在北美、欧洲和日本,除非此前已获批豁免,否则儿科评估如今是每份药品上市申请的必要组成部分。非临床幼年毒性研究通常是该评估的一部分。幼年毒性研究方案最好在与监管机构协商后制定。尽早提交儿科研究计划(PIP)或儿科研究方案(PSP)很重要,以免延误该药物在成人中的上市许可。物种的选择和幼年毒性研究的设计基于一系列复杂的考量因素,包括药物的治疗用途、儿童接受治疗的年龄、治疗持续时间,以及疗效、药代动力学或毒性方面潜在的年龄或物种特异性差异。

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