An analysis for recent years’ innovative drug registration applications in China
ZHANG Xiao-dong;WANG Hong-liang;YANG Zhi-min;Center for Drug Evaluation;China Food and Drug Administration;

..............page:2041-2045

Discussion on the issues of batch size for registration of chemical drug
WANG Hong-liang;CHEN Zhen;Center for Drug Evaluation;China Food and Drug Administration;School of Pharmaceutical Sciences;Zhengzhou University;

..............page:2046-2051

Non-clinical safety considerations for the development of pediatric drugs
HUANG Fang-hua;WANG Qing-li;Jim Ridings;WANG Ying;ZHANG Yun;Center for Drug Evaluation;China Food and Drug Administration;Toxicology and Biometabolism;Glaxo Smith Kline;GSK Shanghai R&D;Safety Assessment;

..............page:2052-2058

Formal dispute resolution of drug review in the United State and its implications for China
GENG Xiao-ya;WEI Tian-ying;MA Kun;Center for Drug Evaluation;China Food and Drug Administration;

..............page:2059-2066

Influence of new registration on chemical generic drug R&D and registration management
JIANG Yu;Center for Drug Evaluation;China Food and Drug Administration;

..............page:2067-2073

Endpoints and common methods for assessing efficacy in clinical trials of new drugs
LIU Bing-lin;Center for Drug Evaluation;China Food and Drug Administration;

..............page:2074-2077

Consideration on protecting the rights of subjects with mental disease in drug clinical trials
CHANG Mai-hui;GENG Ying;ZHAO De-heng;YANG Zhi-min;The Second Hospital Affiliated to Xinxiang Medical College of Henan Province;Center for Durg Evaluation;China Food and Drug Administration;

..............page:2078-2081

An analysis of common issues in clinical study reports’ writing of new TCM
XUE Fei-ran;Center for Drug Evaluation;State Food and Drug Administration;

..............page:2082-2084

Brief introduction of pivotal clinical trials for the human papillomavirus vaccines approved abroad
AI Xing;WANG Zhao-yun;YANG Zhi-min;YANG Huan;Center for Drug Evaluation;China Food and Drug Administration;

..............page:2085-2089

Considerations on the manufacture of drug substances from fermentations
LIU Zong-ying;Ma Lei;Center for Drug Evaluation;China Food and Drug Administration;

..............page:2090-2093

Evolution of the control of metal impurities by regulatory authorities
WANG Yang;LI Mei;Center for Drug Evaluation;China Food and Drug Administration;

..............page:2094-2098

Biostatistical review in drug regulation in China
WANG Jun;ZENG Xin;PAN Jian-hong;HUANG Qin;Center for Drug Evaluation;China Food and Drug Administration;

..............page:2099-2102

Brief introduction to the new requirements of submission documents for chemical generic drugs
HUANG Xiao-long;Center for Drug Evaluation;China Food and Drug Administration;

..............page:2103-2108

Interpretation of characterisation in the form CTD
KANG Jian-lei;Center for Drug Evaluation;China Food and Drug Administration;

..............page:2109-2112

Main problems and analysis of the in vitro transdermal absorption comparative test of skin’s external semisolid preparations
TIAN Jie;Center for Drug Evaluation;State Food and Drug Administration;

..............page:2113-2115

Challenge and thinking in antiviral drug research and development for chronic hepatitis C
YU Chun-rong;DA Hong-yuan;WANG Qing-li;Center for Drug Evaluation;China Food and Drug Administration;

..............page:2116-2119

Writing patent documents of drug polymorph learnt from patent invalidation cases
MA Xiao-tian;TAN Ai-min;MING Zhi-hui;LIU Cai-lian;Jiangsu Simcere Pharmaceutical Co.;Ltd.;School of Engineering;China Pharmaceutical University;

..............page:2120-2123

Histopathological and immunohistochemical evaluation of vaccine neurovirulence in monkeys
QU Zhe;YANG Yan-wei;L Jian-jun;LI Wei;ZHANG Shuo;LI Ping-ping;LI Shan-shan;WANG Xue;WANG Ju-feng;LI Bo;Beijing Key Laboratory;National Center for Safety Evaluation of Drugs;National Institutes for Food and Drug Control;Wuhan Institute of Biological Products Co.;Ltd.;National Institutes for Food and Drug Control;

..............page:2124-2128

Progress in research of drugs for the treatment of hyperuricemia
ZHOU Qi-meng;DU Guan-hua;Beijing Key Laboratory of Drug Targets Identification and Drug Screening;Institute of Materia Medica;Chinese Academy of Medical Sciences and Peking Union Medical College;

..............page:2129-2135

Research on the policy orientation of China’s drug patent compulsory license——based on a quantitative analysis for the implementation cases of global compulsory license of drug patent
DING Jin-xi;YAO Xue-fang;LIU Wei-jing;China Pharmaceutical University;

..............page:2136-2141

Research on Chinese patent drug price negotiation“Five Links”mechanism design
DING Jin-xi;LI Wei;TOU Jiang-yuan;ZHAO Yu-ming;DONG Rui;ZHENG Cui-wei;CHEN Ye;China Pharmaceutical University;

..............page:2142-2148

Patent research progress in precision medicine of HER2-positive cancer
WANG Jing;MA Qiu-juan;QU Kai;LI You-zhao;WANG Kuan;Patent Examination Cooperation Center of the Patent Office;SIPO;

..............page:2149-2153

Antitumor and immunomodulatory activities of KangAi injection
FAN Hui-ting;DING Shi-lan;PEI Ying-xia;GUAN Nian-bo;QI Xin;LI Jie;LIN Hong-sheng;Oncology Department of Guang’anmen Hospital of China Academy of Chinese Medical Science;

..............page:2154-2160