Bioequivalence (BA/BE) studies are essential for demonstrating that a generic formulation is therapeutically equivalent to an innovator or reference drug. These studies are critical for regulatory approval, market entry, and patient safety, ensuring that generics deliver the same clinical benefit as the original product.
At Xcene Research, we provide end-to-end BA/BE study services, designed to support pharmaceutical companies, biotech firms, and academic partners in bringing safe and effective generic medicines to market. By leveraging our expertise in clinical trial management and drug development, we ensure that BA/BE programs meet both local and international regulatory requirements.
We provide the following services:
- Study Design & Protocol Development
Tailored study designs that address both scientific and regulatory expectations optimized to meet NAFDAC, EMA, FDA, and WHO submission requirements. - Clinical Conduct
Recruitment and management of healthy volunteers under strict ICH-GCP and GLP standards, ensuring participant safety and data integrity.
Our clinical units are equipped for dosing, sample collection, and real-time monitoring in compliance with global bioequivalence guidelines. - Pharmacokinetic (PK) Analysis
Comprehensive PK assessment, evaluating absorption, distribution, metabolism, and elimination profiles of test and reference products. We calculate critical bioavailability parameters such as Cmax, AUC, and Tmax to determine equivalence with scientific accuracy. - Bioanalytical Support
Sample analysis performed through Xcene Laboratories & Diagnostics (XLD) using validated LC/MS-MS methods. Our bioanalytical facility operates under GCLP and ISO 15189 standards to ensure precision, reproducibility, and regulatory readiness. - Statistical & Comparative Assessment
Advanced statistical modeling and comparative analysis to confirm pharmacokinetic equivalence between test and reference products, supporting regulatory acceptance and global submissions. - Regulatory Submission Packages
Preparation of comprehensive technical reports, including summary tables, PK analyses, and full datasets suitable for NAFDAC, EMA, and FDA filings.
How We Help
- We deliver robust, audit-ready data packages that support accelerated generic approvals and global market entry.
- Our integrated clinical, analytical, and regulatory teams ensure seamless coordination from study design through submission.
- Sponsors gain time and cost efficiencies while maintaining the highest scientific and ethical standards.
Outcome:
Reliable, compliant, and reproducible data that expedite approval timelines, reduce development costs, and enable patients worldwide to access safe, effective, and affordable generic therapies.
