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Design, and Analysis of Phase I Clinical Trials and Bioequivalence Studies
Design, and Analysis of Phase I Clinical Trials and Bioequivalence Studies

Services

Design, and Analysis of Phase I Clinical Trials and Bioequivalence Studies

The Pharmacology Unit of UoP provides the following services:

Phase I clinical trials

  • 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

Determination of the pharmacokinetic (PK) parameters from the blood versus time concentration data are done using the Phoenix 64 WinNonlin 7.0 software, which has been installed in a dedicated hardware system.  The statistical evaluation of the pharmacokinetics data and the assessment of bioequivalence (in bioequivalence phase 1 clinical trials) is performed using the SAS® Version 9.4 or higher statistical package.

Coordinator

Partner Institute

Biomedical Research Foundation of the Academy of Athens

Biomedical Research Foundation of the Academy of Athens

Konstantinos Avgoustakis
Collaborating Researcher of Biomedical Research Foundation of Athens Academy
Laboratory of Pharmaceutical Technology
Department of Pharmacy
University of Patras
Rio 26504, Patras, Greece
Tel: +2610-962317
Email: avgoust@upatras.gravgoust@bioacademy.gr

HTRI Infrastructures Associated with the Design and Analysis of Phase I clinical Trials and Bioequivalence Studies Services