Services

• Population bioequivalence analyses for In-vitro trials
• Equilibrium and kinetic binding analysis
• GI and NG Tube analysis
• EMD analysis for the comparison of bimodal distributions
• Dissolution comparisons using BCa or MSD

Biostudy Solutions works with the client throughout their product development process.

• Protocol development
• Research and design, including sample size evaluations, for Phase I BA/BE PK studies
• Level C IV/IVC evaluations
• PK/Statistical analyses for BA/BE studies (complete or confirmatory)
• Sample size evaluations for therapeutic equivalence trials
• Population bioequivalence analyses for In-vitro trials

Using linear regression modeling, Biostudy Solutions provides its clients with support from specification determination through stability expiration dating.

• Exploratory analyses to assist in determining specifications that support the data
• Stability trend analysis and expiration dating

From design through analysis, Biostudy Solutions provides its clients the service they need for demonstrating bioequivalence of topical corticosteroids.

• Design of VCA trial
• Dose response modeling and interpretation
• Bioequivalence evaluations