bioequivalence

Drug absorption equality

Bioequivalence is a pharmaceutical term describing when two drug formulations deliver the same active ingredient to the body at the same rate and to the same extent.

It matters most when comparing generic drugs to brand-name versions: if a generic is bioequivalent to the original, it should produce identical therapeutic effects.

Regulatory agencies require bioequivalence studies before approving generic medications.

The FDA approved the generic after studies confirmed bioequivalence with the brand-name drug.

pharmacokinetics

bioavailability

Fraction reaching active circulation

absorptionProcess of taking in
distributionAllocation across recipients
metabolismCellular nutrient conversion

excretion · half-life · steady state · dose-response · active ingredient · drug interaction · pharmacogenomics · clearance · first-pass effect · AUC

generics

interchangeable

Able to replace another

substitutionExchange of one for another
brand-nameProprietary product name
formularyApproved medication inventory

sameness · comparability · follow-on

testing

dissolution

Breaking up completely

comparative studyExamination of similarities and differences
in vitroIn an artificial environment
in vivoWithin living tissue

reference standard · confidence interval · statistical analysis · protocol · assay · formulation · tablet · capsule · pilot study · sampling

regulatory

FDA approval

Official drug safety certification

clinical trialsControlled health research experiments
guidelinesSuggested rules for behavior
complianceAdhering to requirements

premarket · inspection · certification · dossier · labeling · audit

Family

equivalent, equivalence, biodegradable, equivalently, equivalency, biomarker, biocompatible, biotransformation, biosimilar

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