口服固体仿制制剂质量和疗效一致性评价过程中的几点思考

Considerations on Quality and Efficacy Equivalency Evaluation of Generic Oral Solid Formulations

仿制药质量和疗效一致性评价是CFDA于2012年开始的一项系统工程,旨在提高市场上现有仿制药质量,最终实现临床应用上仿制药与原研药的"可替代性"。一致性评价可确保仿制药与原研药之间的质量一致,在产品开发过程中使用质量源于设计理念,对产品处方和工艺等影响因素进行全面的了解和有效的控制,将有助于实现高质量产品的一贯一致性。同时,在一致性评价工程及质量源于设计理念的应用中均体现了仿制药开发中的创新精神。结合实际工作经验,试从体外溶出一致与体内生物等效的关系、如何在开发质量一致的仿制制剂中体现创新精神、如何确保已经通过质量一致性评价的产品一贯的质量一致性等方面对此项工程提出几点自身认识与思考。

Quality and efficacy equivalency evaluation of generic products is a systematic initiative started by CFDA in 2012 to improve the quality of commercialized generic products, and ultimately to achieve the inter-changeabilily of generic products and innovators. Eqtivalency evaluation can ensore the clinical equivalency between generic and brand products, and the concept of Quality by Design （QbD） during product development can help with thorough understanding and effective controls of the product lbrmulation and production process to ensure the consistency of products. In addition, both equiwdcncy evaluation and QbD concept reflect the spirit of innovation in generic product development. This article is about some reflections on this project, including the relationship between in vitro dissokltion similarity and in vivo bioequivalence, how to utilize the spirit of innovation in the development of bioequivalent products and how to ensure consistent equivalency of commercialized products that have passed equivalency evaluation.