Job Kathleen M, Gamalo Margaret, Ward Robert M
1 Division of Clinical Pharmacology, Department of Pediatrics, University of Utah, Salt Lake City, UT, USA.
2 Global Statistical Sciences, Eli Lilly and Co, Indianapolis, IN, USA.
Ther Innov Regul Sci. 2019 Sep;53(5):584-589. doi: 10.1177/2168479019856572. Epub 2019 Jul 16.
Pediatric clinical trials are often requested according to specific age ranges. In the past and still today, these ages may correspond to developmental stages, such as newborn, infancy, childhood, and adolescence. Selection of ages for pediatric participation in medication studies should correspond to ages of rapid changes in pharmacokinetics and pharmacodynamics. Age-related changes in several enzymes involved in drug metabolism and glomerular filtration are described as examples of optimal ages for study of specific drugs according to their pathways of disposition.
儿科临床试验常常根据特定的年龄范围来开展。过去乃至如今，这些年龄可能对应着发育阶段，比如新生儿期、婴儿期、儿童期和青春期。选择儿科患者参与药物研究的年龄应与药代动力学和药效学快速变化的年龄相对应。文中描述了几种参与药物代谢和肾小球滤过的酶随年龄的变化情况，以此作为根据特定药物处置途径来研究其最佳年龄的示例。
