Bioavailability (BA) is the rate and extent to which the active substance is absorbed and is available in the systemic circulation. It is essential during the development of drugs as it is one of the main properties of drug formulation. In short, bioavailability is defined as the amount of drug from an administered dosage and the rate at which the drug appears in the systemic circulation. The rate and extent of drug absorption is the predictor of clinical outcomes.
Bioavailability is the key metric of drug absorption. These studies usually differ between species and are critical in both the preclinical and clinical stages in drug research and development.
This type of study is used to establish similarities between a generic drug and reference drug.This study refers to a human study that applies bioavailability study methods with pharmacokinetic parameters. It is the absence of a significant difference in the rate and extent of drug that is available at the site of action once the dosing of a test product is completed when compared to a reference product.To be short, it is evaluated by comparing the bioavailability of the test and the reference products .
These studies are vital for the development of a pharmaceutical development of the pharmaceutical industry. Their main principle is monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs. This study is entirely used to evaluate the therapeutic compatibility of tested drugs.Due to the large growth of the production and consumption of generic products, bioequivalence is on the increase
Through the conduct of bioavailability and bioequivalence studies, the United States Food and Drug Administration (FDA) authorised the approval of generic drug products based on average bioequivalence in drug absorption.These studies are done by measuring the concentration of the drug present in the plasma or blood by following a systemic protocol of studies.This systemic protocol is much helpful in the early development of drug during a clinical trials and the data that was obtained in the process are used in the bioequivalence studies.
Bioavailability and Bioequivalence studies ensure therapeutic equivalence between a pharmaceutical test drug and a reference drug. Therapeutic uniformity means standards of quality, efficacy and also safety of pharmaceutical products. Bioavailability studies contribute to bioequivalence determination as bioavailabilities of the test and reference products constitute bioequivalence.
Makolet Pharma is a leading clinical research organisation that provides knowledge-based research services for pharmaceutical, Biotechnology and Generic Drug Industries. We provide laboratory services exclusively in the areas of Clinical studies and BA/BE studies. We also do site monitoring in BA/BE studies.