Interpretation of guidance for clinical investigation of medicinal products in the pediatric population
10.13699/j.cnki.1001-6821.2015.24.040
- VernacularTitle:儿科人群药物临床试验技术指导原则（征求意见稿）解读（一）
- Author:
Chao ZHANG
1
;
Xiao-Ling WANG
;
Shuang MU
;
Suo-Di ZHAI
;
Zai-Ling LI
;
Ai-Lian SHAN
Author Information
1. 北京大学第三医院药剂科
- Keywords:
pediatric population;
children;
drug clinical trial;
interpre-tation
- From:
The Chinese Journal of Clinical Pharmacology
2015;(24):2496-2498
- CountryChina
- Language:Chinese
-
Abstract:
The pediatric population is different from adults in their physi-ological function and tissues structure, and therefore they should not be assumed simply as the small adults.The drug development for pediatric population is helpful to improve the health of children in the whole coun-try.However, the clinical investigation of medicinal products for adults can not apply for children and there has not available guidance for chil-dren for a while.Accordingly, Chinese Food and Drug Administration ( CFDA) issues the guidance for clinical investigation of medicinal prod-ucts in the pediatric population, which ensure the clinical trials are more scientific and ethic. This paper means to interpret the guidance and therefore to help the development of clinical trials in pediatric population.
