Bioequivalence & Phase I Clinical Trials
BRFAA in collaboration with the University of Patras has organized a collaborative effort between the pharmacology facility and an adjacent hospital’s 30 bed clinical unit (Sotiria Hospital) for the execution of clinical trials, initially focusing on bioequivalence (BE) studies but with potential for Phase I clinical studies. This collaboration involves a number of partners (CRO, Physicians, IT experts, Project Management, Bioanalytical Mass Spectrometry based work, Statistical Experts). The work involves study protocol preparation, submission to the regulatory authorities, volunteer recruitment, drug administration, sample collection, drug level measurements and statistical evaluation, final report to the sponsor. The above expertise with BE studies is potentially transferable to Phase I Clinical Trials in which novel drugs will be evaluated.
The following services are provided to Industry and Academia:
- Design of phase I clinical trials and bioequivalence studies
- Protocol development for Phase I and bioequivalence studies
- Determination of pharmacokinetic parameters from in vivo drug concentration blood versus time data collected in preclinical and clinical studies using validated software (Phoenix 64 WinNonlin 7.0 software)
- Statistical analysis of bioequivalence studies using validated statistical software (SAS® version 9.4 or later)
- Training of young scientists and researchers on design and statistical analysis of bioequivalence studies and on the determination of pharmacokinetics parameters