Abstract：OBJECTIVE To provide help for better understanding and implementation of the biologic tests and assays in the Chinese Pharmacopoeia (Ch.P) 2020 Edition Volume Ⅳ. METHODS This paper introduces the formation mechanism of the relevant standards and the general situation of the addition and revision, summarizes the main features and the contents of the revision, and briefly describes the work prospect in the next step. RESULTS AND CONCLUSION The revision of the biologic tests and assays in the Ch.P 2020 Edition Volume Ⅳ further improves the standard system of safety and effectiveness evaluation. Safety control methods will be also further established to ensure the safety of public drug use and serve drug supervision.
朱冉, 许华玉, 宋宗华. 2020年版《中国药典》四部生物检定相关内容的增修订概况及展望[J]. 中国药学杂志, 2020, 55(19): 1569-1572.
ZHU Ran, XU Hua-yu, SONG Zong-hua. Review on Revision of the Biologic Tests and Assays in General Chapters of the Chinese Pharmacopoeia 2020 Edition Volume Ⅳ. Chinese Pharmaceutical Journal, 2020, 55(19): 1569-1572.