General considerations and issues of special concern about the nonclinical study of modified new drugsDAI Xue-dong, SUN Tao, HUANG Fang-hua, WANG Qing-li2121-2127
Interpretation and thinking of contents of the application dossier for evaluation and approval of pharmaceutical excipients associated with drug productsREN Lian-jie, MA Yu-nan, JIANG Yu, ZHANG Ling-chao2128-2135
Introduction and analysis of CDE's effort in solving backlog of generic drug registration applicationsCHEN Xin, HUANG Qing-zhu, WEN Bao-shu2136-2142
Effects of manufacturing process and process control on related substances of synthetic peptide drugsHU Yu-xi, JIANG Yu, HAN Tian-jiao2143-2148
Discussion on the supervision and management methods of drug clinical trials in ChinaGAO Jian-chao, HUANG Yun-hong, YANG Huan, GAO Chen-yan2149-2153
Guideline on extrapolation of data from adults to pediatric population and relevant evaluation considerationsSUN Yan-zhe, GENG Ying, ZHAO De-heng, YANG Zhi-min2154-2158
Research & development of Austedo (deutetrabenazine) : a case studyGAO Guang-hua, WANG Hai-xue2159-2165
Reproductive toxicity profiles of direct-acting antiviral drugs for HCVYU Chun-rong, DA Hong-yuan, SHAN Xiao-lei, WANG Qing-li2166-2170