Redefining Bioequivalence for Topical Drug Products: The Case for In Vitro Methodologies in ANDA Submissions
As regulatory expectations continue to evolve, in vitro methodologies like IVRT and IVPT are rapidly becoming the preferred tools for demonstrating bioequivalence (BE) of topically applied generic drugs.
This white paper authored by Diteba Inc. following participation in the FDA-CRCG 2025 Workshop, offers how in vitro methods IVRT and IVPT are transforming the way we approach BE for topically applied generic drugs.
Backed by FDA guidance and real-world data, this paper outlines:
- Why IVPT/IVRT is preferred over clinical endpoint trials
- How the FDA’s regulatory shift is shaping ANDA strategy
- Comparative Breakdown of In Vitro and Clinical Endpoint Bioequivalence
- Common pitfalls in IVPT method development and validation
- Strategies for successful ANDA submissions
With nearly 20 years of experience in topical product evaluation, Diteba Inc. is proud to help clients navigate the complexities of modern BE studies using science-driven, FDA-aligned solutions. Whether you’re developing a topical cream, gel, ointment, or lotion, this white paper is a must-read for regulatory teams, formulators, and strategic decision-makers.
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