Analysis of the meanings of equivalence and the required statistical evaluation methodsTAN De-jiang, FENG Guo-shuang, ZHU Rong-die, YANG Hua-xin2881-2886
Policies to promote use of generic drugs in developed countriesCHEN Jing, SANG Xiao-dong, REN Qiao-yu, SHI Lu-wen2887-2891
Sample size determination and post hoc statistical power in bioequivalence studiesDAI Jun-hao, ZHENG Qiang2892-2897
Sample size calculation for average bioequivalence studies of generic drugsMEI He-kun, WANG Jin, CHAI Dong, CAI Yun, WANG Rui2898-2902
Generic drug labeling management of FDA and EMAGAO Li-li, LI Min, WANG Yu-zhu, LI Rui-feng, YANG Jin-bo2903-2907
Lessons learned from filing inspection of FDA to assist quality consistency evaluation of generic drugsWANG Yang, LI Mei2908-2912
The requirements for in vivo bioequivalence studies for solid products of oral drugs with narrow therapeutic indexes by FDA, HC, EMA, PMDA and CFDAXU Wen-pin, LI Li, CHEN Li-xun, HE Rui-rui, HAN Hong-can, YANG Jin-bo2913-2917
Evaluation methods of in vitro release rate of peptide microsphere injections: a reviewLIANG Yuan-ying-zhu, LIN Xiao-ming, LIU Wan-hui, YU Li-ju, YANG Hua-xin2918-2923
The application of European Public Assessment Reports in the identification of reference medicinal products for generic medicinal productsXU Ming-di, NIU Jian-zhao, YANG Dong-sheng, LI Tao, QIAO Li-tao, GAO Tian-tian2924-2927
Introduction of the WHO prequalification of medicines programme and comparator productCHEN Jie, YANG Dong-sheng, NIU Jian-zhao2928-2932