The Biostatistics and Reporting Department ensures that data are processed, statistically analyzed, and reported in compliance with national and international standards (TITCK, ICH, EMA, FDA), covering all stages of clinical research from study design to final reporting.
Services provided for Bioavailability/Bioequivalence studies include:
• Study design and determination of sample size and planing of statistical analysis,
• Preparation of raw data obtained from analytical instruments for statistical analysis,
• Calculation of pharmacokinetic parameters and evaluation of bioavailability/bioequivalence criteria using appropriate methods in the validated and up-to-date version of the Phoenix WinNonlin statistical software,
• Reporting subject-based concentration–time data in tabular and graphical formats together with statistical analysis results,
• Preparation of the Clinical Study Report in accordance with the ICH E3 format,
• Sharing Clinical Study Report with the sponsor in soft copy and electronic formats,
• Providing the necessary support to the sponsor in case of questions from regulatory authorities following the marketing authorization application.
In addition, within the scope of Phase 3 clinical studies, we provide comprehensive statistical support, including study design, sample size calculations, and statistical analyses.
Within the scope of “In-vitro Bioequivalence”, statistical analysis services are provided in accordance with the FDA's product-specific guidelines published for molecules such as Budesonide, Fluticasone Propionate, and similar compounds, as well as the guideline titled "FDA - Bioavailability and Bioequivalence Studies for Nasal Aerosols and Sprays for Local Action."
In this context, “Population Bioequivalence (PBE)” analyses for in-vitro tests (e.g., spray pattern, droplet size, plume geometry) are conducted using Phoenix WinNonlin Software and include the following steps:
• Statistical Plan
• Statistical Analysis
• Reporting