Your Data. Our World.
The industry source for pharmacokinetic and biostatistical services.
Biostudy Solutions is a pharmacokinetic and biostatistical consulting firm. Our staff has worked with hundreds of companies, helping them advance their generic and new drug submissions to U.S. and foreign regulatory authorities. A depth of experience – combined with a vast partner network within the industry – allows BSS to provide complete solutions to statistical and report preparation needs.
Pharmacokinetic/Biostatistical ConsultingBiostudy 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
VCA Study Support
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
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 receipt of data to completion of Module 5.3, Biostudy Solutions offers its clients an effective, cost-efficient, approach to the backend services of a trial.
- Report compilation for BA/BE studies (ICH compliant)
- eCTD Publishing