Shimomura Kazuhiro
Medicinal Safety Research Laboratories, Daiichi Sankyo Co. Ltd., Fukuroi, Shizuoka, Japan.
Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):266-8. doi: 10.1002/bdrb.20300. Epub 2011 May 18.
Pharmaceuticals have been used on adults and children; however, they were previously investigated only by adult human clinical studies and adult animal nonclinical studies. The US FDA finalized the guidance of juvenile animal toxicity studies in 2006, and EMEA was finalized in 2008. At that point, juvenile animal toxicity studies were encouraged to investigate the safety of the pediatric population. In Japan, the awareness of the development of pediatric drugs is increasing, and many scientific meetings about juvenile animal studies are being held. A Japanese guideline for juvenile animal toxicity studies has been long awaited by many Japanese pharmaceutical companies because concrete directionality has not been available in Japan thus far. The Ministry of Health, Labour, and Welfare started to prepare the guideline for nonclinical safety studies in juvenile animals since October 2010. After completion of the Japanese guideline, guidelines would exist in the three regions: Japan, US, and Europe. Then, global development of pediatric pharmaceuticals would be accelerated effectively.
药品已应用于成人和儿童；然而，此前仅通过成人人体临床研究和成年动物非临床研究进行过调查。美国食品药品监督管理局（US FDA）于2006年最终确定了幼年动物毒性研究指南，欧洲药品管理局（EMEA）于2008年最终确定。彼时，鼓励进行幼年动物毒性研究以调查儿科人群的安全性。在日本，儿科药物开发的意识正在增强，并且正在举办许多关于幼年动物研究的科学会议。许多日本制药公司长期以来一直期待着日本幼年动物毒性研究指南，因为迄今为止在日本尚未有具体的指导方向。厚生劳动省自2010年10月起开始制定幼年动物非临床安全性研究指南。日本指南完成后，日本、美国和欧洲这三个地区都将有指南。届时，儿科药品的全球开发将得到有效加速。
