Bioequivalence生物等效性
Bioequivalence is the demonstration that two pharmaceutical products, such as a generic and a reference product, have no significant difference in the rate and extent to which the active ingredient reaches the systemic circulation under comparable conditions. It appears in generic-drug dossiers, pharmacokinetic study reports, and regulatory product information where substitution and interchangeability are assessed.
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Where this term appears
Translators encounter bioequivalence in generic drug submissions, clinical study protocols, pharmacokinetic reports, summary documents, and regulatory correspondence. It appears in tables of AUC and Cmax ratios, 90% confidence intervals, and statements about reference products, often in expert reports, patient information, and product labeling used for marketing authorization and interchangeability assessments.
Translation checks
A common mistake is translating bioequivalence as 'same effect' or 'therapeutic equivalence.' Bioequivalence is a pharmacokinetic comparison of rate and extent of absorption, not a direct clinical outcome claim. Using a broader term can overstate conclusions in regulatory dossiers or patient labeling and blur the distinction from clinical equivalence assessments.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
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Walvax Biotechnology
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Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.