Interpretation of guidance for clinical investigation of medicinal products in the pediatric population
10.13699/j.cnki.1001-6821.2015.24.041
- VernacularTitle:儿科人群药物临床试验技术指导原则（征求意见稿）解读（二）
- 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;
interpretation
- From:
The Chinese Journal of Clinical Pharmacology
2015;(24):2499-2501
- CountryChina
- Language:Chinese
-
Abstract:
The pediatric population is different from adults in their dis-ease types and medication use in clinics.The drug clinic trial in pediatric population provides reliable clinic data for new drug development and medication use, and is helpful to promote the health of children.Howev-er, considering the specificity of children, it is changeable to conduct the drug clinic trials, especially for the study protocol design.Accordingly, CFDA issues the guidance for clinical investigation of medicinal products in the pediatric population, which ensure the clinical trials are more sci-entific and ethic.This paper means to interpret the guidance and there-fore to help the development of clinical trials in pediatric population.
