儿童用化学药品改良型新药2.2 类临床试验申请与审评情况分析
及立题合理性关注点
耿莹, 张豪, 蒋永麟, 孙艳喆, 李强, 杨志敏
Analysis of Application and Review of 2.2 Category Improved New Chemical Drugs
for Pediatric and Concerns on the Reasonableness of Its Proposal
GENG Ying, ZHANG Hao, JIANG Yonglin, SUN Yanzhe, LI Qiang, YANG Zhimin
中国医药工业杂志
.
2022, (11): 1539
-1545
.
DOI: 10.16522/j.cnki.cjph.2022.11.002