What is the Difference Between Bioavailability and Bioequivalence?
🆚 Go to Comparative Table 🆚The difference between bioavailability and bioequivalence lies in their definitions and applications in drug development:
- Bioavailability refers to the rate and extent to which the active ingredient of a drug is absorbed systemically after dosing. It quantifies the amount of drug from an administered dose that enters the systemic circulation, as well as the rate at which this occurs. Bioavailability is essential for understanding the efficacy and safety of a drug product.
- Bioequivalence refers to the establishment of generic drugs as interchangeable to the branded drug compounds with similar therapeutic and side effect profiles. When two formulations of the same drug or two drug products are claimed to be bioequivalent, their bioavailability is not significantly different. Bioequivalence is determined by comparing the relative bioavailability of the brand name drug versus the generic drug.
In summary, bioavailability focuses on the absorption and systemic circulation of a drug's active ingredient, while bioequivalence compares the relative bioavailability of different drug formulations or products to ensure their interchangeability.
Comparative Table: Bioavailability vs Bioequivalence
Bioavailability and bioequivalence are related concepts in drug development, but they have distinct meanings and applications. Here is a table comparing the two:
| Feature | Bioavailability | Bioequivalence |
|---|---|---|
| Definition | Bioavailability refers to the fraction of an administered dose that reaches the target site in the body, such as the bloodstream, and is available for effect. | Bioequivalence refers to the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions. |
| Purpose | Bioavailability studies help determine how much of a drug is absorbed and available at the target site, which can influence the drug's effectiveness. | Bioequivalence studies are used to establish links between early and late clinical trial formulations, formulations used in clinical trials, and final marketed formulations, as well as to evaluate the similarity between generic and reference listed drugs. |
| Testing | In vitro and in vivo bioavailability studies can be conducted. In vivo studies typically have larger variability (20-30%), while in vitro studies have less variability (<10%). | In vivo bioequivalence studies are conducted, and they usually have larger variability (20-30%). |
| Application | Bioavailability studies are used to compare two or more products containing the same chemical substance. | Bioequivalence studies are used to compare the bioavailability of different formulations of the same drug or different drug products. |
In summary, bioavailability focuses on the amount of a drug that reaches the target site, while bioequivalence compares the rate and extent to which the active ingredient in different formulations or products becomes available at the site of drug action. Both concepts are important in drug development and evaluation, but they serve different purposes and are assessed through distinct methods.
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