创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

口服固体仿制制剂质量和疗效持续一致性的技术考量

Technical Considerations for Continuous Consistency in the Quality and Efficacy of Oral Solid Generic Formulations

  • 摘要: 仿制药质量和疗效一致性评价包括临床试验/申报批次与原研制剂质量和疗效一致性的评价(第一个一致性),以及仿制药商业化生产批次与临床试验/申报批次持续一致性的评价(第二个一致性)。从产品开发、控制策略建立、个药指导原则完善、上市后变更管理等几个方面探讨如何实现第二个一致性,避免仿制药“一致性评价”变为“一次性评价”,确保一致性评价成果得以持续和扩大。

     

    Abstract: The equivalency evaluation of quality and efficacy for generic drugs encompasses two aspects:(1) the evaluation of equivalency between the clinical trial/submission batches and the reference listed drug(the first consistency), and(2) the evaluation of continuous consistency between commercial batches and the clinical trial/submission batches(the second consistency). This article discusses how to achieve the second consistency, focusing on product development, establishment of control strategies, refinement of product-specific guidelines, and management of post-approval changes. These considerations aim to prevent the transformation of generic drug "equivalency evaluation" into a "one-time evaluation", thereby ensuring that the outcomes of equivalency evaluation are maintained and expanded.

     

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