化学口服固体制剂仿制药质量和疗效一致性评价研究思考

仿制药质量的差异直接影响群众用药的安全性和有效性。为整体提升我国药品质量水平，《国家药品安全“十二五”规划》（国发〔2012〕5号）明确提出把全面提高仿制药质量作为一项重要任务。本文梳理了化学普通口服固体制剂仿制药质量和疗效一致性评价研究的重点，主要从参比制剂、药学研究和体内研究等方面进行阐述，以期为我国仿制药质量和疗效一致性评价工作提供参考。

The medication safety and efficacy of the masses are directly influenced by the variable quality of generic drugs.To improve the quality of generics,the Nation Program for Drug Safety ‘12th Five-Year Plan’ had clearly proposed enhancing the quality of generic drugs and undertaking the generic drugs consistency evaluation.This article investigates the research focus of the quality and efficacy consistency evaluation of chemical oral solid generic drugs,including the selection of reference preparations,pharmaceutical research and in vivo studies in the consistency evaluation of generic drug.