Definitions #
When two different versions of a drug (like a brand-name and its generic) release the same amount of active ingredient into the bloodstream at the same rate and to the same extent.
Technical A regulatory standard (e.g., US FDA, EMA) requiring that a pharmaceutical product's rate and extent of absorption fall within a predefined equivalence margin (typically 80–125% for the 90% CI of Cmax and AUC) relative to a reference product.
Example The generic was approved after demonstrating bioequivalence to the innovator medicine in a crossover study.
Etymology #
From Greek 'bios' (life) + Latin 'aequivalentia' (equal worth), referring to equivalence in the body.
Collocations #
- bioequivalence study 生物等效性研究，对比试验制剂与参比制剂的吸收情况
- bioequivalence margin 生物等效性可接受范围（通常 80-125%）
- reference product 参比制剂，作为对照的品牌药
Real Business Examples #
- Proof of bioequivalence is required before a generic drug can be marketed.
- The BE study in healthy volunteers confirmed that the test product meets the acceptance criteria.
Register & Variants #
- Register: formal
- BrE/AmE: 全球通用（监管机构术语）
Synonyms & Antonyms #
- Synonyms: biopharmaceutical equivalence, therapeutic equivalence (when clinically demonstrated)
- Antonyms: bioinequivalence
Common Errors #
- 混淆生物等效性与生物利用度（BA） 生物利用度是测定药物吸收的量，生物等效性是比较两种制剂的吸收相似性
- 忽略食物效应 BE 研究通常需在空腹和进食条件下分别进行，以确保结果可靠
Confusable Terms #
- Therapeutic Equivalence vs Bioequivalence
- 治疗等效性还需考虑临床效果和安全性，比生物等效性更广泛
Frequently Asked Questions
为什么 BE 研究通常用健康志愿者？?
为减少疾病干扰，健康志愿者能更准确评估吸收差异
BE 研究需要多大的样本量？?
样本量取决于药物变异性，通常 24-36 人，但可能更多
BE 等效的通用名药与品牌药效果完全一样吗？?
监管机构认为满足 BE 标准的制剂可以在临床上替代，但非临床绝对等同
Published: 2026-09-23 Category: Pharmacology