1@@前插12An analysis for recent years' innovative drug registration applications in ChinaZHANG Xiao-dong, WANG Hong-liang, YANG Zhi-min2041-20453Discussion on the issues of batch size for registration of chemical drugWANG Hong-liang, CHEN Zhen2046-20514Non-clinical safety considerations for the development of pediatric drugsHUANG Fang-hua, WANG Qing-li, Jim Ridings, WANG Ying, ZHANG Yun2052-20585Formal dispute resolution of drug review in the United State and its implications for ChinaGENG Xiao-ya, WEI Tian-ying, MA Kun2059-20666Influence of new registration on chemical generic drug R&D and registration managementJIANG Yu2067-20737Endpoints and common methods for assessing efficacy in clinical trials of new drugsLIU Bing-lin2074-20778Consideration on protecting the rights of subjects with mental disease in drug clinical trialsCHANG Mai-hui, GENG Ying, ZHAO De-heng, YANG Zhi-min2078-20819An analysis of common issues in clinical study reports' writing of new TCMXUE Fei-ran2082-208410Brief introduction of pivotal clinical trials for the human papillomavirus vaccines approved abroadAI Xing, WANG Zhao-yun, YANG Zhi-min, YANG Huan2085-208911Considerations on the manufacture of drug substances from fermentationsLIU Zong-ying, Ma Lei2090-209312Evolution of the control of metal impurities by regulatory authoritiesWANG Yang, LI Mei2094-209813Biostatistical review in drug regulation in ChinaWANG Jun, ZENG Xin, PAN Jian-hong, HUANG Qin2099-210214Brief introduction to the new requirements of submission documents for chemical generic drugsHUANG Xiao-long2103-210815Interpretation of characterisation in the form CTDKANG Jian-lei2109-211216Main problems and analysis of the in vitro transdermal absorption comparative test of skin's external semisolid preparationsTIAN Jie2113-211517Challenge and thinking in antiviral drug research and development for chronic hepatitis CYU Chun-rong, DA Hong-yuan, WANG Qing-li2116-211918Writing patent documents of drug polymorph learnt from patent invalidation casesMA Xiao-tian, TAN Ai-min, MING Zhi-hui, LIU Cai-lian2120-212319Histopathological and immunohistochemical evaluation of vaccine neurovirulence in monkeys2124-212820Progress in research of drugs for the treatment of hyperuricemiaZHOU Qi-meng, DU Guan-hua2129-2135 