Phoenix® WinNonlin® program is used for statistical analysis.
For Bioavailability and Bioequivalence studies;
• Sample size estimation
• Determination of experimental design.
• Planning statistical analysis.
• Making raw data suitable for statistical analysis.
• Reporting of participant-based data, tables and graphics together with statistical analysis results.
• Preparation of Final Study Report in accordance with ICH E-3 format
• An active role is taken in sharing the reports with the sponsor in soft copy and electronic media.
Within the scope of “In-vitro Bioequivalence” analyses defined by the guidelines for locally acting nasal products, the following services are provided:
• Statistical Plan
• Statistical Analysis
• Reporting