With the development of new drugs, pharmacokinetics has emerged as one of the most important parts. Bioavailability (BA) and Bioequivalence (BE) studies play a vital role during the phase development of both types of innovator and generic drugs. In this particular article, we will understand the importance of BA & BE studies in the world of drug manufacturing.
BA requires that it defines the rate and extent to which active ingredient is absorbed by the drug product and is available at the site of action. For the drug products that are not intended to be incorporated into the bloodstream, BA is assessed by measurement so that the ratio of the ingredient that is actively required at the site is known.
Whereas BE is defined as the absence of a significant difference in the rate and extent to which an active ingredient in pharmaceutical equivalents becomes available at the site of drug action administered at the same molar under similar conditions and appropriately designed study.
The standard and quality of generic things needs to be in par with the original products. BA & BE is the comparative studies have emerged very important issues in the evaluation of drug products. The importance of BA & BE studies required so that the generic product is therapeutically equivalent and interchangeable with the innovator products.
Many of the biopharmaceutical drugs whose patent have expired but are blockbuster drugs for many chronic diseases encourage the studies of BA & BE so that there is an evolution of generic drugs in the market. The cost of the product gets reduced hence highlighting the importance of BA & BE studies. The FDA & EMA (European Medicines Agency) have released their guidance for BA & BE studies.
BE studies have done when small changes required in the drug product that develops during the drug development process to ensure that the dosage forms prove to be safe and effective. Moreover, the importance of BA & BE Studies plays a key role in the drugs having a narrow therapeutic index.
There are many journals like Contract Research Organization or Indian Journal of Pharmaceutical Research, which will make you understand the importance of BA & BE studies.