Impact of Discordance Among Regulations for Biopharmaceutics Classification System-Based Waivers of Clinical Bioequivalence Studies

Abstract

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.

Quantitative evaluation of dissolution profiles: From simple approaches to advanced chemometrics

“…Similar documents were later published by the World Health Organization (WHO) and the European Medicines Agency (EMA). The last one extends the possibility of waiving to class 3 drugs (6).…”

Undertaking Bioequivalence Studies: The Challenges and Way Forward

“…Sample of the test product is from industrial scale batch (or ≥1/10th of production batch or larger or 100,000 units) which is an additional cost to the generic manufacturer. Considering that an between 555 and 639 BE studies are carried out annually [2] this billions of dollars can be saved by considering the magic word "harmonization". II.…”

Untitled

“…Sample of the test product is from industrial scale batch (or ≥1/10 th of production batch or larger or 100,000 units) which is an additional cost to the generic manufacturer. Considering that and between 555 and 639 BE studies are carried out annually [2] this billions of dollars can be saved by considering the magic word "harmonization".…”