FDA《特定药物的生物等效性指导原则》长半衰期药物生物等效性指导原则介绍分析

Introduction and Analysis of FDA Issued Guidance on Bioequivalence Recommendations for Specific Products Related with Long Half-life Drugs

目的研究FDA《特定药物的生物等效性指导原则》对长半衰期药物生物等效性研究相关规定,为我国仿制药质量和疗效一致性评价工作提供借鉴和帮助。方法针对长半衰期药物,从剂型、给药方式、试验设计、受试者选择、给药条件、检测物质选择、豁免条件、体外溶出试验等多个方面对FDA公布《特定药物的生物等效性指导原则》进行详细分析,并特别指出涉及我国仿制药质量与疗效一致性评价首批品种的长半衰期药物品种。结果 FDA公布的涉及长半衰期药物《特定药物的生物等效性指导原则》对具体化学仿制药的生物等效性评价从多个方面进行较为详细的规范,是对FDA相关生物等效性总则的补充和解读,对仿制药的发展有重要的推动作用。结论在我国国家食品药品监督管理总局尚未颁布针对具体长半衰期药物相关生物等效性指导原则的背景下,FDA特定药物的生物等效性指导原则中对长半衰期药物相关规范对我国正在进行的仿制药质量和疗效一致性评价具有一定指导和借鉴意义。

OBJECTIVE To study and analyze FDA issued guidance on Bioequivalence Recommendations for Specific Products related with long Half-life drugs. METHODS Bioequivalence Recommendations for Specific Products related with long Half-life drugs was analyzed from multiple aspects, including bioequivalence study designs, selection of bioequivalence subjects, dosage, selection of reference products, analytes to measure, bioequivalence waiver on multiple-strength products and implementation of the Biopharmaceu- tics Classification System. RESULTS Bioequivalence Recommendations for Specific Products issued by FDA are to further facilitate ge- netic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for devel- oping drugs and generating evidence needed to support ANDA approval or reassessment, as an extension and implement to the guideline involved in the aspect of bioequivalence. CONCLSUTION Bioequivalence Recommendations for Specific Products issued by FDA would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China, since there is not corresponding bioequivalence guidance on specific long Half-life drugs released by CFDA yet.