Bioavailability (BA) and bioequivalence (BE) studies play a major role in the development of both new drug products and their generic equivalents. There are several approaches to assess BE, and each regulatory authority has its own regulations for conducting BA/BE studies. Worldwide Clinical Trials experts know to size the study properly to achieve sufficient statistical power; ensure that the appropriate overall design can adequately address the question at hand; standardize the environment (eg, fasting/fed, ambulatory/supine); and strictly adhere to and document Good Clinical Practices (GCP). For the smooth execution of BE studies, all such factors are deliberated in advance and included in the protocol and study plan.
Our bioanalysts employ meticulous laboratory practices and careful operating procedures. They are fully informed about each regulatory authority’s specifications and requirements. Our bioanalysts select an appropriate analyte to be measured and enroll the correct number of subjects to provide adequate power for testing the hypothesis.
Comprehensive Bioequivalence Solutions
- Protocol design and development
- Phase I trial operation and management
- Data management
- Pharmacokinetic research
- Statistical analysis
- Report production