摘要
目的:研究美国食品药品管理局(FDA)《特定药物的生物等效性指导原则》对高变异性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: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美国FDA公布的高变异性药物《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高变异性药物。结果:美国FDA公布的涉及高变异性药物《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,是对美国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(CFDA)尚未颁布针对具体高变异性药物相关生物等效性指导原则的背景下,美国FDA《特定药物的生物等效性指导原则》中对高变异性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 investigate FDA issued guidance on Bioequivalence Recommendations for Specific Products related with highly variable drugs. Methods：Bioequivalence Recommendations for Specific Products related with highly variable drugs was investiga- ted in multiple aspects, including bioequivalence study designs, selection of bioequivalence subjects, dosage, selection of reference prod- ucts, analytes to measure, bioequivalence waiver on multiple-strength products and implementation of the Biopharmaceutics Classification System. Results： Bioequivalence Recommendations for Specific Products issued by FDA is to further facilitate generic drug product availa- bility and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing 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. Conclusion： 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 CFDA haven＇ t released similar guidance on specific highly variable drugs.
出处
《中国药物评价》
2016年第5期397-401,共5页
Chinese Journal of Drug Evaluation
基金
国家食品药品监督管理总局仿制药质量和疗效一致性评价专项
中国科协学会能力提升专项
