FDA对咀嚼片生物等效性要求的分析

研究国内外药品监管机构对咀嚼片仿制药品种的关键质量属性及生物等效性试验的要求及相关指导原则,为企业开展相关品种的一致性评价工作提供借鉴和帮助。从试验设计、检测物质选择、受试者选择、给药条件、豁免条件、体外溶出试验等多个方面对FDA发布的《单项品种的生物等效性指导原则》中相关内容进行详细分析,以指导我国咀嚼片仿制药质量与疗效的一致性评价。

Analysis on bioequivalence requirements of chewable tablets by FDA

To study regulatory considerations including critical quality attributes and bioequivalence guidelines of generic chewable tablets from different countries, in order provide reference and help for the consistency evaluation of related varieties. "Bioequivalence Recommendations for Specific Products" issued by FDA were analyzed from multiple aspects, including study design, selection of detectable substance and e subjects, dosage, conditions of to administration and exemption, dissolution tests, etc. These guidelines may have important inspiration of the consistency evaluation on quality and effect of generic chewable tablets in China.