Bioequivalence Studies and Its Multiple Implications Bioequivalence studies are in human methods set up to compare the bioavailability of a medical product to an appropriate reference product when it is studied under comparable experimental conditions. These studies can be vest defined as complimentary tests that are performed on a specific medicine apart from the routine laboratory tests. Eminent medical institutes and CRO’s go by the most accepted definition of Bioequivalence, i.e. “It is the absence of a profound difference in the extent and rate to which an active moiety or ingredient in pharmaceutical alternatives or equivalents become available at the site of any drug action when monitored at the similar molar dose under same conditions in a suitable designed study.” Going by the above mentioned definition both product quality Bioavailability and Bioequivalence concentrates on the release of drug substance from a drug product and consequent absorption into the systematic circulation. Bioavailability can be explained as the attempt to benchmark an oral solution suspension or an intravenous formulation with comparison. Bioequivalence sometimes is taken as a formal comparative test that makes use of a certain criteria for Bioequivalence limits that has been predetermined. Whilst discussing on bioequivalence studies, the plasma concentration curve is normally utilized to access the extent and rate of absorption. There are chosen preset acceptance limits and pharmacokinetic parameters that helps in the final decision on bioequivalence of tested products. The specifics are listed below:
AUC is the area under the concentration time curve and denotes the exposure extent. Cmax is the maximum plasma concentration Tmax is the time to maximum plasma concentration
These parameters are influenced by the absorption rate. However, mulling at the dark moments that existed in medical history, there have been situation where medical products used have resulted in failures. This is the reason why Phase I studies and Bioequivalence studies have gained prominence. Bioequivalence trials help in carrying out blood-level trails that explains that generics result in equivalent blood-level profiles in human profiles. Today India is ranks as a prominent hub for medical tourism and researches. CRO’s and medical institutions are fast rising up to the importance of Bioequivalence studies. The southern part of the country, such as Bangalore, Chennai, and Vellore has already taken significant steps for the same. Click here for more on regulatory compliance services
Published on Feb 21, 2012
Bioequivalence studies are in human methods set up to compare the bioavailability of a medical product to an appropriate reference product w...