Chinese Journal of New Drugs - Digital Cluster of Scitech Periodicals

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Chinese Journal of New Drugs

CSCD

ISTIC

PKU

ISSN：1003-3734

CN：11-2850/R

Frequency：Semimonthly

Website：http://www.newdrug.cn

Email：bianjibu@newdrug.cn

Postcode：100098

Articles12737

Citations124451

Funded4496

Impact Factor：2.35

Official Website

Articles

2022 No.02

Total 14 articles

Progress and prospect of regulatory science in cell and gene therapy productsGAO Jian-chao, WEI Wei, ZHANG Min, GAO Chen-yan

105-108

Drug toxicity database and regulatory scienceGENG Xing-chao, LI Bo

109-118

Regulatory considerations for using surrogate endpoints to accelerate the development of COVID-19 vaccinesYANG Jing-shu, DING Sheng, YANG Yue

119-124

Research on the new drug marketing approval procedures based on surrogate endpoints in the US and EU and its enlightenment to ChinaYANG Li, WEI Yan-yi, WU Di, CHEN Yu-wen, WANG Zu-guang, YANG Ze-ying

132-141

Application of patient-reported outcome measurement tools in drug development and regulatory approval in the USGUAN Hong-feng, YANG Li-na, YANG Yue

142-146

Regulatory considerations about accelerating the approval of domestic HPV vaccinesYANG Jing-shu, DING Sheng, ZHANG Ya-juan, YANG Yue

147-154

Analysis of China regulatory strategy on post-approval changes of pharmaceutical productsLI Cheng, CHEN Gui-liang

155-159

Study on data management requirements of drug pre-approval inspectionYAN Ruo-xi, CAO Yi, DONG Jiang-ping

160-164

Analysis of some characteristics and management of drug changes in the whole life cycleLI Shuai, MEI Ni, CHEN Gui-liang

165-171

Consideration on formulation and implementation of administrative documents ICH M4 Module 1 of ChinaXIAO Fang, WEN Bao-shu, HE Yu-hong, DU Hai-ru, SUN Tao, YU Hong, ZHAI Yun, ZHOU Heng, XIE Song-mei

172-176