BA / BE Studies
BioRadius is a dedicated bioequivalence centre providing clinical and bioanalytical services to pharmaceutical, medical and biotechnology companies internationally. A successful study requires scientifically-sound study design. Our clinical pharmacology experts guide your product seemlesly through the clinical phase of the study and bring the best results to the table for you to make your decision.
Confidence in Bioequivalence:
Diligent planning and detailed foresight are crucial for successful conduct of a bioequivalence study. We approach every project with utmost care and our team work hand-in-hand with the sponsor’s team to guide them through the whole process, right from formulation R&D till securing a market authorization approval.
Our specialization includes:
- Healthy subject bioequivalence studies and
- Patient based bioequivalence studies
BioRadius has conducted more than 150+ Studies for various international markets and regulatory bodies like US FDA, UK MHRA and EMA and can perform the following studies inhouse:
- Single dose bioequivalence studies
- Multiple dose bioequivalence studies
- Steady-sate bioequivalence studies
- Food effect studies
- Clinical Drug -Drug interaction (DDI) studies: Patients frequently use more than one medication at a time, thus investigating drug-drug interactions is essential to drug development. BioRadius has expertise in designing and analyzing DDI studies at all phases of development.