基于一致性评价理念的药剂学实验教学的探讨

Discussion on Experimental Teaching of Pharmaceutics Based on the Concept of Consistency Evaluation

摘要: 开展仿制药质量和疗效一致性评价是近年来制药行业的头等大事，关系到我国制药行业的发展、众多药企的生死存亡和广大人民群众的用药安全，并将成为今后衡量药品质量的重要标准。现阶段，学生对仿制药一致性评价了解很少，难以满足制药行业新形势下对人才培养的要求。本文提出在药剂学实验教学中引入仿制药一致性评价的理念，让学生了解仿制药一致性评价的意义，熟悉一致性评价要求与方法，进一步改进药剂学实验教学。

Abstract: Consistency evaluation for generic drugs is the top priority in recent years in the pharmaceutical industries, and it is related to the development of the pharmaceutical industry in China and the drug safety for the people. Furthermore, it will become an important standard of drug quality in the future. At the present stage, students know little about the consistency evaluation, which is hard to meet the requirement of talent cultivation in the new situation of pharmaceutical industry. In this paper, the concept of consistency evaluation for generic drugs is introduced in the experimental teaching of pharmaceutics, which can make the students understand the significance of consistency evaluation, be familiar with the requirements and methods of consistency evaluation, and further improve the experimental teaching of pharmaceutics.