Impact of Discordance Among Regulations for Biopharmaceutics Classification System-Based Waivers of Clinical Bioequivalence Studies Article Swipe
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· 2015
· Open Access
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· DOI: https://doi.org/10.14227/dt220215p6
· OA: W2605091467
Approximately 10 years ago, the FDA issued a guidance whereby dissolution could be used to establish bioequivalence for highly soluble and highly permeable immediate-release products.This pathway has advantages in lower costs for pharmaceutical companies and avoids unnecessary exposure of human subjects who would derive no medical benefit from participating in bioequivalence studies.Subsequently, other agencies have also adopted similar guidances.However, there are differences among agency guidances that significantly impact the number of compounds eligible for BCS-based biowaivers across all regulatory agencies.These include differences in BCS Classes for which biowaivers are considered, differences in the definition of highly permeable, and differences in the definition of highly soluble.The currently low rate of biowaiver submissions may in part be due to these differences.
