摘要
安全性、有效性和质量可控性对仿制药的质量至关重要。国内目前采用溶出度实验评价仿制药和原研药的质量一致性。这种仅以"有效"一致性作为标准评价仿制药优劣的方法,明显忽略了对药品内在质量和安全性的评价。本研究基于风险控制的新理念,将仿制药与原研药的有效性、安全性与质量可控性纳入到一致性评价体系,结合仿制药具体品种的剂型、剂量、给药途径、工艺等因素,设定贯穿于药品整个生命周期的高风险因素,然后建立针对性的评估模型,排查仿制药的高危安全性隐患;开展与原研产品杂质谱的对比研究,从物质基础层面揭示仿制药的安全性,并最终改进和提升质量标准;结合前期溶出度工作基础,全面评估仿制品与参比制剂的质量一致性。本项目的实施,为全面评估仿制药的质量一致性,保障人民群众安全合理用药有着十分重要的意义。
The safety, efficiency and quality control are critical for generic drugs. The quality conformance assessment in our country mainly uses a dissolution test, which only assesses the efficiency and mainly focuses on the efficiency, and ignores the safety and inherent quality of drugs. In this study the quality conformance was comprehensively assessed with a risk-based approach. The safety, efficiency and quality control were systematically assessed. Based on the formulation, dose, route of administration, specific technology of the generic drug, high risk factors covering the whole life-cycle were pointed out, and a risk-action recognition model was established. We then investigated the high risk hidden trouble of the safety. The method of related substances was established by conducting a comparative study on the impurity profile, and the safety of generic drugs was proved by material level. Quality standard was then revised and improved. The dissolution test results obtained previously were integrated to fully assess the quality conformance of the generic drugs. This research has a great impact on the comprehensive assessment of quality conformance and rational use of the drug.
出处
《中南药学》
CAS
2015年第6期663-666,共4页
Central South Pharmacy
关键词
一致性评价
仿制药
风险控制
conformance evaluation
generic drug
risk-based control
