【作者】 尹莉芳；

【Author】 Lifang Yin;China Pharmaceutical University;

【机构】 中国药科大学；

【摘要】 仿制药一致性评价作为提升仿制药质量重要举措,对促进医药产业升级、推进国家供给侧改革、提高公众健康有着重要意义。仿制药一致性评价研究工作是企业目前重中之重的工作,品种多,时间紧,任务重。本报告将针对一致性评价研究的特点,结合案例,重点探讨固体口服制剂的关键质量属性、关键工艺参数和关键辅料质量在仿制药开发过程中的重要性,为仿制药质量和疗效一致性评价提供参考。更多还原

【Abstract】 The consistency evaluation of generic drugs is vital for advancing the upgrading of pharmaceutical industries, promoting the supply side reform as well as improving public health benefits. At present, the consistency evaluation of generic drugs is the first-class work for pharmaceutical companies. Since the variety of drug products, tight time schedule and heavy tasks, it is necessary to strengthen the design and develop process of consistency evaluation of generic drugs, thus in this presentation, the critical quality attributes, critical process steps and key martials of solid dosage form were focused and discussed carefully. It could be used for evaluation of consistency evaluation effect and quality of generic drugs.更多还原