Bioavailability is defined as the rate and the absorption of drug that reaches the biological system in an active form, capable of exerting the desired pharmacological effect, including its onset, intensity and duration of its action.
Bioavailability studies provide and estimate of the fraction of the orally administered dose that is absorbed into the systemic circulation when compared to the bioavailability for a solution, suspension, or intravenous dosage form that is completely available
Bioavailability studies provide other useful information that is important to establish dosage regimen and to support drug labeling, such as distribution and elimination characteristics of the drug
Bioavailability studies provide information regarding the performance of the formulation
The aim of bioavailability study is to find out the dosage form influence on the biological performance of the drug, sensitivity to detect differences in the rate and extent of absorption.
Study Objective
Study Design
Methods of assessment of bioavailability plasma data and urine data acute pharmacological effect and clinical response
Analysis and Presentation of Data
Absolute Bioavailability – Absolute bioavailability of a drug in a formulation administered by an extravascular, including the oral route reaching the systemic circulation is the fraction of the same dose of the drug administered intravenously.
Relative Bioavailability – Relative bioavailability is a measure of the fraction of the given drug that is absorbed in the systemic circulation from a particular dose compared to a clinically proven standard dose of the same drug.
For assessing the bioavailability or clinical availability of a drug, its rate and extent of absorption and its first-pass metabolism must be evaluated.
These criteria are difficult or even impossible to quantify.
The method used to assess bioavailability depend upon the assumption that measurement of the drug concentration in a suitable body fluid, such as blood, plasma, serum, urine or sometime saliva, can be correlated with its clinical availability.
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