bioavailability, bioequivalence, bcs

Bioavailability

The total amount of an intact drug available systematically after administration of the drug.

Bioequivalence

A term used to compare the bioavailability of the same drug from different formulations.

Purpose of Bioavailability Studies

To assess the bioavailability of drug formulations and ensure safety and efficacy before marketing.

Absolute Bioavailability

The extent of absorption of a drug after extravascular administration compared to intravenous administration.

Relative Bioavailability

The extent of absorption of a drug compared to a recognized standard or reference product.

Cmax

The peak plasma concentration of a drug following administration.

Tmax

The time required to reach maximum drug concentration in the blood after administration.

Area Under the Curve (AUC)

The area under the drug plasma level-time curve, reflecting the total amount of active drug reaching systemic circulation.

In-vitro studies

Laboratory tests that assess drug dissolution and release characteristics.

In-vivo studies

Clinical studies conducted on living organisms to assess how drugs behave in the body.

Pharmacokinetics

The study of how a drug is absorbed, distributed, metabolized, and eliminated from the body.

FDA

The Food and Drug Administration, the agency responsible for regulating drug approval and marketing.

Therapeutic Equivalence

When two drug products provide the same clinical effect and safety profile.

Bioavailability Assessment Methods

Methods to evaluate drug absorption based on blood or urine data.

Dissolution Rate

The speed at which a drug dissolves in a solvent, affecting its bioavailability.

Biopharmaceutics Classification System (BCS)

A system that classifies drugs based on their solubility and permeability characteristics.

IVIVC

In-Vitro/In-Vivo Correlation; a predictive relationship between in-vitro properties of drug formulations and their in-vivo performance.