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Biostudy Solutions

The Industry Source for Pharmacokinetic and Biostatistical Services

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Services

icons-green-04-04Pharmacokinetic/Biostatistical Consulting:

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

icons-green-03VCA 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

icons-green-01Stability Trending

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

icons-green-02Report Preparation

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

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Biostudy Solutions, LLC

228 N. Front Street
Suite 302 A
Wilmington, NC 28401
(910) 795-0379

Stop In Sometime

Biostudy Solutions is located in beautiful downtown Wilmington N.C. Positioned just minutes from the sandy Atlantic shoreline, our clients and friends always seem more than happy to come for a visit. We invite you to join us as well.

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