对注射剂一致性评价的再思考

药物注射剂可分为普通(水溶性)注射剂和特殊注射剂,特殊注射剂应更重视对其体内疗效的评价;通过对已有的临床/质量数据、文献资料的系统梳理,揭示国产仿制药与参比制剂的质量/关键质量属性差异;评估国产仿制药与参比制剂疗效/安全性的一致性;并通过提高产品的工艺控制能力,保证产品质量的持续一致性,是注射剂一致性评价的基本方法;对国内独有的品种,应在明确其临床价值后再进行评价研究。

Rethought on quality consistency evaluation for domestic drug injections

Drug injections can be divided into two kinds, ordinary (water-soluble) injection and special injection in the quality consistency evaluation for drug injections, and it should be paid more attention to the efficacy of special injection in vivo. The basic strategy for the evaluation includes a systematic analysis of the existing clinical/quality data and literature, revealing the differences of quality/critical quality attributes between domestic generic drugs and the reference drug. The efficacy/safety between the generic drugs and the reference drug needs to be evaluated, and then the process control capability of the product should be improved to ensure the quality consistency. As for the domestic unique drugs, the clinical value should be evaluated before the quality