In the world of generic drug development, clinical endpoint bioequivalence (BE) studies come into play when traditional PK-based BE studies (using Cmax, AUC) are not feasible or relevant.
So, when are they needed?
Locally Acting Drug Products
- For products like topical creams, ointments, or dermatological gels, where the drug acts at the site of application and not systemically.
No Reliable PK Marker
- When plasma drug levels are too low or do not correlate with clinical efficacy — such as with inhaled corticosteroids, ophthalmic solutions, or certain nasal sprays.
Complex Delivery Systems
- Such as transdermal systems or rectal/vaginal products, where drug delivery and absorption pathways are unique and cannot be assessed solely by PK.
These studies help ensure therapeutic equivalence, safety, and efficacy for patients — even when standard BE approaches fall short.
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Resource Person: Vijay Agrawal