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儿科监管举措。

Pediatric regulatory initiatives.

作者信息

Hirschfeld Steven, Saint-Raymond Agnes

机构信息

National Children's Study Eunice Kennedy Shriver, National Institute of Child Health and Human Development, Bethesda, MD 20892, USA.

出版信息

Handb Exp Pharmacol. 2011;205:245-68. doi: 10.1007/978-3-642-20195-0_12.

DOI:10.1007/978-3-642-20195-0_12
PMID:21882115
Abstract

A series of government actions have evolved since the 1990s to facilitate the development of medicinal products for pediatric use using a combination of incentives and mandates. The initiatives have been successful in stimulating activity and interest in products developed for pediatric use. The initiatives continue to evolve as experience accumulates and regulatory agencies develop robust cooperative programs. A multidimensional program is necessary to achieve the necessary goal of aligning pediatric therapeutics with adult therapeutics and providing children the most favorable opportunity to benefit and minimize risk to vulnerable populations.

摘要

自20世纪90年代以来,一系列政府行动不断发展,通过激励措施和指令相结合的方式,促进儿科用药产品的开发。这些举措成功地激发了人们对儿科用药产品开发的积极性和兴趣。随着经验的积累以及监管机构制定强有力的合作项目,这些举措也在不断演变。为了实现儿科治疗与成人治疗接轨这一必要目标,并为儿童提供最有利的机会以从中受益并将对弱势群体的风险降至最低,需要一个多维度的项目。

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