Our Biostatistics Services for Bioavailability / Bioequivalence studies:
• Sample size estimation
• Determination of experimental design
•2x2 Crossing Design
• Repetitive Crossing Design
• Two-stage Crossing Design
• Multiple Dose (Steady State) Design
• Experimental design for more than two formulations
• Parallel Design
• Planning statistical analysis
• Making raw data suitable for statistical analysis
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