Two medicinal products containing the same active substance are considered bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and their bioavailabilities (rate and extent) after administration in the same molar dose lie within acceptable predefined limits.

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This section includes the European Medicines Agency's (EMA) product-specific bioequivalence guidance, which summarises in a standardised format the relevant study design principles for demonstration of bioequivalence.

ema特定药物be原则是欧洲药品管理局ema建设的特定产品生物等效性指南数据库，以标准化格式总结了用于证明生物等效性的相关研究设计原则，属于欧洲药品管理局ema官网监管板块下。

本文旨对不同注射剂的评价要求进行简单梳理和总结，尤其关注FDA和EMA对特定注射剂品种的指导原则，主要体现在体内BE试验方面，以期对当前注射剂的一致性评价工作提供参考和帮助。 普通注射剂. 对于普通的注射剂，如水溶液型、配制后呈水溶液型的无菌粉等，可直接豁免或进行一定的体外研究豁免体内临床试验. 水溶液型. 配制后呈水溶液型的无菌粉. 一般水溶液型注射液、配制后呈水溶液型注射液不需要进行体内BE试验. CDE：氯化钠注射液、葡萄糖注射液、葡萄糖 …

生物等效性评价是我国进行仿制药质量与疗效一致性评价的重点内容之一，中国食品药品检定研究院对欧洲药品管理局（European Medicines Agency，EMA）《特定药物的生物等效性指导原则》（Product-specific bioequivalence guidance）的有关内容开展了翻译工作，以期对我国 ...

中国食品药品检定研究院（以下简称中检院，原名中国药品生物制品检定所)，是国家药品监督管理局的直属事业单位，是国家检验药品生物制品质量的法定机构和最高技术仲裁机构，依法承担实施药品、生物制品、医疗器械、食品、保健食品、化妆品、实验动物 ...

Compared to the previous BE guideline of the EMA, clearer guidance is now given on several topics including BE assessment of highly variable drugs/drug products (HVDs/HVDPs), the use of metabolite data, acceptance criteria for narrow therapeutic index drugs (NTIDs), BCS-based biowaivers, and dose strength to be used in case of application for ...

The European Medicines Agency (EMA) protects and promotes human and animal health by evaluating and monitoring medicines within the European Union (EU) and the European Economic Area (EEA). The Agency's main responsibilities are authorising and monitoring medicines in the EU.

2023年7月19日 · The European Medicines Agency (EMA) publishes product-specific guidance for the demonstration of bioequivalence on its website under the heading "Product-specific bioequivalence guidance". The relevant principles for study design can be found there in a standardised format.