Cappon Gregg D
Pfizer Global Research & Development, Groton Laboratories, Eastern Point Rd., Groton, CT 06340, USA.
Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):269-72. doi: 10.1002/bdrb.20303. Epub 2011 May 18.
The earlier inclusion of children into clinical trials has challenged toxicologists to develop nonclinical strategies to support these trials early in the drug development process, and the routine practise of global development strategies (i.e., concomitant development and filing in multiple geographical regions) adds another complication. Ideally, one would like to develop a stagey that would meet regulatory requirements from all regions. This presentation illustrated the challenges faced in developing a strategy regarding the need to perform a toxicity study in juvenile animals and the design of any necessary study that will receive global regulatory agreement.
将儿童早期纳入临床试验，这对毒理学家提出了挑战，要求他们在药物研发过程的早期就制定非临床策略来支持这些试验，而全球研发策略（即在多个地理区域同步开展研发和提交申请）的常规做法又增加了另一重复杂性。理想情况下，人们希望制定一种能满足所有地区监管要求的策略。本报告阐述了在制定有关在幼年动物中开展毒性研究的必要性以及设计任何将获得全球监管认可的必要研究的策略时所面临的挑战。
