Duarte Dinah M, Silva-Lima Beatriz
National Authority of Medicines and Health Products, I.P., Parque Saúde de Lisboa, Av. do Brasil 53, Lisbon, Portugal.
Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):353-8. doi: 10.1002/bdrb.20299. Epub 2011 May 18.
The need for early consideration of pediatric investigation plans (PIP) to support an indication in pediatric population has led to an increased focus on the relevance of nonclinical studies in juvenile animals (JAS). The usefulness of JAS is not yet established and a criterion for request is still a learning process.
This article compares data from JAS in all medicines approved by European centralized procedure before Pediatric Regulation (1995-2005) and data from JAS in the nonclinical information on all approved PIP (2007-2009).
Of the 226 substances licensed by centralized procedure in 10 years, 31.9% were considered for children and 31 JAS were described in 9.7%. Since 2007, of the 205 PIP decisions, 50 PIP (24.3%) have 87 JAS planned or requested. The mean number of JAS in each medicine or PIP, increased from 1.4 to 1.7 between the two periods and the juvenile rat remained as the prevalent species.
Results demonstrate that JAS planned/performed in EU environment has significantly increased.
为支持儿科人群用药适应症而尽早考虑儿科研究计划（PIP）的需求，已使人们更加关注幼年动物非临床研究（JAS）的相关性。JAS的实用性尚未确立，提出要求的标准仍在摸索之中。
本文比较了在《儿科法规》出台之前（1995 - 2005年）通过欧洲集中程序批准的所有药物的JAS数据，以及所有已批准的PIP的非临床信息中的JAS数据（2007 - 2009年）。
在10年中通过集中程序批准的226种物质中，31.9%的物质考虑用于儿童，9.7%的物质有31项JAS被描述。自2007年以来，在205项PIP决策中，50项PIP（24.3%）计划或要求进行87项JAS。两个时期内，每种药物或PIP中JAS的平均数量从1.4增加到了1.7，幼年大鼠仍然是主要的实验动物。
结果表明，在欧盟环境中计划/开展的JAS显著增加。
