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Generic medicines have become a cornerstone in healthcare as they allow healthcare systems to provide more affordable and accessible healthcare. Generic medicines must undergo significant scientific evaluations to ensure that they are as safe, high-quality, and therapeutically effective as the branded medications. Bioavailability (BA) and Bioequivalence (BE) studies are a key component in this scientific evaluation.
Bioavailability (BA) refers to the degree and rate at which a drug (or an active pharmaceutical ingredient (API) of a drug) is made available in the body and at the site where the drug is needed to work. Bioequivalence (BE) means that a generic medicine and its predecessor (the reference medicine) are the same in both safety and efficacy.
BA and BE studies make safe the use of both branded and generic medicines by patients with no adverse effect to their therapeutic outcome.
BA and BE studies become even more significant as the cost of healthcare continues to climb, especially in aged populations with an increasing incidence of chronic illness.
The absence of comprehensive BA/BE studies would severely impede the development of generic medicines and their acceptance by patients.
Pharmaceutical companies have started moving on from traditional, simple generics. Many are now working on complex generics, modified release generics, and patient-centric dosage forms.
These all create ways of studying things more rapidly and accurately.
All regulatory authorities emphasize BA/BE studies and for good reason. Patient safety and product quality should always come first.
These all create an assurance measuring to evaluate BA/BE studies. See the Compliance box on the previous page for more information on the compliance of regulatory authorities.
Studies are becoming more efficient and data integrity is improved with the introduction of real-time analysis, remote monitoring, and electronic data capture.
The need for sophisticated BA/BE studies arises with the development of generics for injectables, inhalers, long-acting formulations, transdermal patches, etc.
AI is shifting the paradigms of study design, outcome prediction, and informed study-related decisions.
Researchers are now more heavily focused on ensuring their products work for all patients.
Working to fix the above will call for collaboration from pharmaceutical companies, CROs (Contract Research Organizations), regulatory agencies, and research institutions.
These studies assure that patients of generics will receive the same therapeutic value and expand the world’s assurance of low cost healthcare. With the ongoing improvements and changes in technology, science, and regulations, BA/BE studies will continue to be a supporting industry for the improvement of the next generation of generic medicines, and of therapeutic value globally.
“I am convinced that every quality generic medicine begins with a commitment to providing the same therapeutic outcome, and BA/BE studies are the best way to affirm that.”
