Chinese Journal of New Drugs

Consideration in top-level design and conduct of clinical study systems in China中国外商投资企业协会药品研制和开发行业委员会, 中国药学会药物临床评价研究专业委员会, 北京大学亚太经合组织监管科学卓越中心, 北京大学临床研究所, 中国医药企业管理协会, 中国化学制药工业协会, 中国医药保健品进出口商会

1209-1216

Advices on improving clinical research regulatory system in China中国外商投资企业协会药品研制和开发行业委员会, 中国药学会药物临床评价研究专业委员会, 北京大学亚太经合组织监管科学卓越中心, 北京大学临床研究所, 中国医药企业管理协会, 中国化学制药工业协会, 中国医药保健品进出口商会

1217-1224

Current difficulties and challenges during the design and conduct stages of clinical trials in China中国外商投资企业协会药品研制和开发行业委员会, 中国药学会药物临床评价研究专业委员会, 北京大学亚太经合组织监管科学卓越中心, 北京大学临床研究所, 中国医药企业管理协会, 中国化学制药工业协会, 中国医药保健品进出口商会

1225-1232

Study on classification system of pharmaceutical patentsMING Zhi-hui, HUANG Wen-jie, LIU Cai-lian, TAN Ai-min, LUO Wei-jia, REN Jin-sheng

1233-1237

Introduction of ICH E17 General Principle on Planning and Designing Multi-Regional Clinical Trials from clinical considerationYANG Huan, JI Shuang-min, GAO Chen-yan, ZHOU Si-yuan, XU Jia-qi

1238-1244

Considerations about the requirements to the pediatric population clinical trials according to the new classification of chemical drugsGENG Ying, ZHAO Deng-heng, YANG Zhi-min

1245-1248

Several thoughts on accepting non-registered clinical trials in IND registration evaluationGAO Jian-chao, WEI Wei, HUANG Yun-hong, YANG Huan, GAO Chen-yan

1249-1253

Design and quality control of traditional Chinese medicine formula placebo for the clinical trialsWU Fei, LU Zhang-qi, HU Jia-liang, WU Mei, FENG Yi, ZHANG Ji-quan, WANG You-jie

1254-1261

New requirements for statistics of clinical trial by ICH E9 (R1)YAN Xiao-yan, YAO Chen

1262-1265

Cultural environment and development of CRC and SMO in ChinaLI Shu-ting, LIU Yang, GAO Zhi-gang, WANG Yue, HU Si-jia, XIONG Meng-zhen, GAO Li-xin, WANG Zhe-yuan, GUI Shang-yuan, SUO Wei, LIU Yan-fei, YANG Li, WANG Xin, REN Ke

1266-1272