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Everything you want to know about bioequivalence study
Posted by :Elizabeth WebsterPosted date : January 27, 2020In HealthComments Off on Everything you want to know about bioequivalence study
If you want to know about the therapeutic equalize between two drug products, it is possible only through bioequivalence study. They demonstrate the above-discussed idea. It will help us to save a lot of time and money on the development of molecules.
Many companies work on the development of molecules. The companies include pharmaceutical companies, contract manufacturing organizations and many other institutions. As these companies deal with much sensitive information they require comprehensive, framework, plan, design, research and development.
In the consumer market, there are many generic products available this has raised public concern. It is because; both in terms of safety and efficiency the products are similar. In this situation, it is necessary to have a strong statistical evaluation.
Agencies are requesting approval to start the bioequivalence study to work on the Pharmaceutical dosage to save people’s health. Through this, they can ensure whether the generic products available in the market are safe for consumption by humans.
How does the study take place?
Bioequivalence study compares any two medicinal products which contain the same active substances. This study can reveal whether alternate use of them is good for health or not. To use a medicinal product interchangeably, they should be therapeutically equivalent. But nowadays two products that contain the same active ingredients are marketed with different licenses.
There are many tried and tested methods to assess the equal lengths of two products
Comparative bioavailability studies
Under this study, the active drug substance will be measured by inaccessible biological fluids. Biological Fluids are something like plasma, blood or urine.
Comparative Pharma core dynamic studies
Comparative clinical trials
In vitro dissolution test
The pharmaceutical companies are mandated to get approval before conducting any bioequivalence study. There are many other mandatory documents like the protocol, investigator undertaking and regulatory status of the drug.
Contract manufacturing organization
Contract Research and manufacturing services is a booming industry under the Pharmaceutical and Biotechnology industry. The contract manufacturing organization is basically and Outsourcing service. It is used by Pharmaceutical organizations.
The need for this kind of company is obvious. The cost of research and development is increasing day by day. Poor bottom Lines and low productivity are other reasons. Furthermore, the current economic crisis doubled by the pricing pressure has made the Pharma Companies take the service of the contract manufacturing organization.
It is still a Nightmare for the Pharma Companies to get the right contract research and manufacturing services. Research Organisation must have validated corporate procedures to conduct all the clinical studies. Procedures include laboratory analysis, data management, paralytics, medical writing, bioanalytical capabilities, timeline assessment and many more.
Clinical data management
Pharma Companies must first assess the validation of the data collection system. Next, the priority should be on evaluating the query generation and also the technical deliverables. The candidates for bioanalytical laboratory work should also be assessed. The laboratory project manager should be assessed to maintain exact coordination between the client Clinic and the Pharma Kinetic.