Nonclinical features of small nucleic acid drugs and the pharmacology and toxicology evaluation strategyWANG Heng, LI Hua, WANG Xi-jie, QIU Yun-liang, TANG Na-ping, HUANG Fang-hua, CHANG Yan1137-1145
Analysis of regulatory measures in response to"N-nitrosodimethylamine impurity"pharmaceuticals incidentsWANG Li-jie, ZHAI Tie-wei1146-1150
The inspiration to new drug research and development in China from the drug patent time extended in KoreaGU Dong-lei, PAN Xiao-mei, ZHENG Yong-nan, JIAN Yu-cong, XING Xing1151-1156
Over-the-counter monograph reform of the US FDA and the perspectiveSUN Bo, CHEN Gui-liang, NING Li-li1157-1162
New progress in application of juvenile animal studies for pediatric drug safety evaluationSONG Fei-ling, TIAN Yong-zhang, GU Huai-yuan, QU Wen-sheng, WU Chun-qi, YIN Ji-ye1163-1168
Validation of method for assay of residual protein A in antibody drugsFU Zhi-hao, ZHONG Xin, XU Gang-ling, YU Chuan-fei, WANG Lan1169-1177
Bioequivalence study of epinastine hydrochloride tablets after single dose administration in healthy volunteersYANG Ke-xu, JING Shan, GAO Kun, LI Xing-yu, TAN Li, LIU Wen-fang, LU Chun-yan, LIN Yang1178-1182
Effect of high fat meal on pharmacokinetics and pharmacodynamics of DDO-3055 tablets in healthy Chinese volunteersXU Li, TIAN Lei, LI Zi-xu, CUI Wen, JIA You-hong, GAO Yu-xiong, HU Bin1183-1187
Consensus on the risk evaluation and quality management during clinical trials of anti-cancer drugs (2021 version)ZHANG Ling1188-1194
Comparison of the management mode and project initiation efficiency of clinical trial institutions between China and the U. S.FANG Hong, TANG Qi-yu, HE Jing, SHEN Ye, FAN Qi, HUANG Hui-yao, WU Da-wei, SUN Chao, WANG Shu-hang, TAO Wei, FANG Yuan, LI Ning, TANG Yu1195-1200