Bioequivalence Studies to Aid FDA Approval

Generic drug developers can utilize bioequivalence studies to expedite marketing approval decisions from the FDA.

Bioequivalence - Gateway Analytical

The U.S. Food and Drug Administration’s Critical Path Initiative created incentives for improving clinical outcomes and streamlining the drug development process through a deeper understanding of pharmacology and, more specifically, pharmacokinetics. Bioequivalence plays a central role in expedited drug evaluations for generic drug developers by comparing the expected uptake, mode of action, and effects of two drug preparations, traditionally an innovator drug and a generic challenger.

Gateway Analytical has unique expertise deploying a variety of chemical imaging technologies to provide bioequivalence studies for generic drug developers. We utilize both Raman-based systems (SPE-Raman, RCI) and elemental analysis systems (SPE-LIBS, SEM-EDS) to provide particle size distribution on specified materials, including MDI’s, DPI’s, nebulizers, and nasal drug products within a matrix. For example, we have the ability to provide particle size distribution information on an API within a nasal spray suspension as part of our Ingredient Specific Particle Sizing service.

We also are able to conduct in vitro bioequivalence studies, including sameness of polymorphic form, sameness of shape, and comparative drug particle and agglomerate Particle Size Distribution (PSD) in the suspension (in the ampoule) for most drug substances, including budesonide.

These types of analyses are crucial during the development of generics, proving bioequivalence, and in reverse-engineering of innovator drugs. Complete an inquiry today to learn how Gateway Analytical can help you get to market faster.