Single-dose BE studies
The standard design for comparing a test formulation against its reference product.
A dedicated bioequivalence centre.
Clinical and bioanalytical services for pharmaceutical, medical and biotechnology companies internationally.
Confidence in bioequivalence
A successful study requires a scientifically sound study design. Our clinical pharmacology experts guide your product seamlessly through the clinical phase of the study and bring the best results to the table for you to make your decision.
Diligent planning and detailed foresight are crucial to the successful conduct of a bioequivalence study. We approach every project with the utmost care, and our team works hand in hand with the sponsor's team to guide them through the whole process, right from formulation R&D to securing market authorization.
Our specialization
- Healthy-subject bioequivalence studies
- Patient-based bioequivalence studies
In-house capabilities
Studies we perform in-house
Conducted for international markets and regulatory bodies including the US FDA, UK MHRA and EMA.
Multiple-dose BE studies
Repeated dosing for products where a single dose isn't enough to characterize exposure.
Steady-state BE studies
Comparisons at steady state, where required by the product or the regulator.
Food-effect studies
How food changes the rate and extent of absorption of your product.
Clinical drug-drug interaction (DDI) studies
Patients frequently take more than one medication at a time, so investigating drug-drug interactions is essential to drug development. BioRadius has expertise in designing and analyzing DDI studies at all phases of development.
Have a product in the pipeline?
Let's bring it to the market together. Tell us about your product and timelines, and we'll come back with a plan and a quote.