When Are Bioavailability Studies Required?

Bioequivalence studies are used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two pharmaceutical products are said to be bioequivalent, then they would be expected to be the same for all intents and purposes.

Why do we need bioequivalence studies?

Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs.

What is the importance of bioavailability?

Bioavailability is a key indicator of drug absorption. It represents the administered dose fraction which achieves success in reaching the systemic circulation when administered orally or through any other extravascular dosing route.