1Continue to deepen the reform of drug review and approval system and greet the successful holding of the 20 th National Congress of CPC with outstanding achievementsKONG Fan-pu1761-17662Study on the"patent dance"system in the United States and its implication for ChinaWANG Xiu, LI Jia-ming, YAO Xue-fang, DING Jin-xi1767-17733A case study of comprehensive efficacy evaluation of traditional Chinese medicines based on partial least squares second-order latent variable modelZHAO Yang, SUN Ming-yue, GAO Hong-yang, ZHANG Wan-tong, PU Xin-yi, YANG Xiao-chen, YI Dan-hui, GAO Rui1774-17784Bylvay, a new drug for the treatment of progressive familial intrahepatic cholestasisLI Yan, LIU Xiao-yan, HE Xin1779-17835Analysis of risk factors of monoclonal antibody drugs and general considerations of non-clinical research and evaluationDAI Xue-dong, WANG Yin, ZHOU Heng, YIN Hua-jing, FU Shu-jun, YIN Mao-shan, WU Shuang, YU Bing, SUN Tao, WANG Qing-li1784-17926The development history and current implementation status of drug registration administrative acceptance in ChinaDONG Min, WU Zhi-ang, CUI Jing1793-18007Considerations for designing observational studies using targeted trial emulation conceptZHAO Jun, WANG Jun1801-18038Problems faced in the operation of clinical trials for diseases involving fever during the regular COVID-19 prevention and control period and countermeasuresCHENG Jin-lian, ZHU Xue-qi, LIU Lin, XIAO Shuang, WANG Shuo, WANG Yan, LIU Qing-quan1804-18099Risk assessment of β-lactamase gene in mammalian cell expression systemLI Jing, WEI Su-zhen, HE Hua, CHEN Zong-meng, WU Qiang, ZHANG Xue-ying, LAI Yong-jie1810-181410The progresses of clinical trials of roxadustat in the treatment of renal anemiaSHEN Fang-li, SONG Cang-sang, LI Xing-de, ZHANG Yang, LIU Lu, ZHANG Han-shu1815-182211Quality control in phase I clinical trials of traditional Chinese medicine injectionsZHANG Jing-jing, LIU Xiao-yuan, QIU Run-ze, FAN Hong-wei1823-182712Checklist management of risk prevention in phaseIclinical trialsGUO Wei-yi, FENG Shi-yin, CAI Lin-rui, ZOU Qin, CHEN Zhuo, SU Xu, YU Qin1828-183013Enzymatic transformation of hesperidin and Citri Reticulatae Pericarpium and comparison of their promoting effects on small intestine of normal miceYANG Yuan-feng, LI Yan-gang, LUO Xiao-quan, GAO Meng, XIONG Hao, YU Jin-bao, YUAN Jin-bin, YANG Wu-liang1831-183714The stimulation induced by Vitamin B Complex Injection in rabbit muscle irritation testWU Yan-lin, GENG Ying, ZHANG Yuan, ZHANG Ming-lu, HE Lan, GAO Hua1838-184415Response surface methodology to optimize the extraction process of Yixin Sanhuang Ointment and multiple indexes quantitative fingerprinting researchYU Qian, CHEN Jia-jun, SHEN Ying-xin, XIAO Feng-qin, WANG Hai-dong, PANG Hui-na, ZHAO Da-qing, YAN Ming-ming1845-185216Simultaneous determination of polyethylene glycol and nonoxinol by HPLC-CADZHANG Wei, SUN Yue, ZHANG Hui, LIANG Cheng-gang1853-185717Retrospective analysis of clinical application of polymyxins B in 104 patients in our hospitalLIU Hong, WANG Xiao-hua, SHAO Min, WANG Yan-yan, WANG Xin-ming, GE Chao-liang1858-1864 