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

发布时间：2018-01-19 07:16

  本文关键词： 长半衰期药物 生物等效性试验 检测物质 生物等效性豁免　出处：《中国药学杂志》2017年02期 　论文类型：期刊论文

【摘要】：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。
[Abstract]:Objective to study the guidelines for bioequivalence of specific drugs in FDA. Methods for the evaluation of quality and efficacy consistency of generic drugs in China, methods for long half-life drugs, from dosage form, method of administration, experimental design, subject selection, drug delivery conditions, detection of substance selection. Exemption conditions in vitro dissolution test and other aspects of the FDA published "guidelines for the bioequivalence of specific drugs" were analyzed in detail. In particular, it is pointed out that the long half-life drug varieties involving the consistency of quality and efficacy of the first batch of generic drugs in China are evaluated. The guidelines for Bioequivalence of specific drugs published by FDA on long Half-Life drugs have been applied to the evaluation of bioequivalence of specific chemically generic drugs from many aspects in detail. It is the supplement and interpretation of the general principles of bioequivalence related to FDA. Conclusion under the background that the State Administration of Food and Drug Administration of our country has not promulgated the guidelines for specific long half-life drug related bioequivalence. The guidelines for bioequivalence of specific drugs in FDA have a certain guiding and referential significance for the evaluation of the quality and efficacy consistency of generic drugs in China.
【作者单位】： 华北制药股份有限公司;中国药学会;中国食品药品检定研究院;
【分类号】：R95
【正文快照】： 生物等效性(bioequivalence,BE)是指在相似试验条件下,单次或多次给予相同剂量试验药物后,受试制剂中药物的吸收速度和吸收程度与参比制剂的差异在可接受范围内[1]。我国正在开展的仿制药质量和疗效一致性评价工作将生物等效性作为评价仿制药是否通过评价的重点指标。由于长半，

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