Integrated Bioavailability,
CEBIS supports bioavailability, bioequivalence and pharmacokinetic programs with coordinated clinical, bioanalytical, data, statistical, regulatory and quality services.
From study planning and participant activities through sample analysis, pharmacokinetics and reporting, services can be aligned around the needs of the program.
Clinical and Analytical
BA/BE & Pharmacokinetic Studies
Clinical support for bioavailability, bioequivalence and pharmacokinetic programs, including study planning, clinical execution, analysis and reporting activities.
Healthy Volunteer & Patient Studies
Study support for healthy participants and defined patient populations based on protocol requirements, eligibility criteria and study objectives.
Bioanalytical Services
Method development, method validation, sample analysis and pharmacokinetic support for clinical development, BA/BE, generic and other pharmaceutical programs.
One Connected Clinical and
BA/BE and pharmacokinetic programs can require close coordination between study design, clinical execution, analytical work, pharmacokinetic analysis and final reporting. CEBIS can bring these activities together through one connected workflow.
Study Design
Define the protocol, study population, dosing conditions, endpoints and operational requirements.
Regulatory Preparation
Coordinate applicable regulatory and ethics activities before study execution.
Clinical Execution
Conduct study activities according to the approved protocol and required participant population.
Sample Analysis
Analyze clinical samples using validated bioanalytical methods.
Pharmacokinetic & Statistical Analysis
Evaluate study data using pharmacokinetic and statistical methods.
Study Reporting
Bring clinical, analytical and statistical results together into the required study outputs.
Support for Different BA/BE and PK Study Designs
Support for single-dose and multiple-dose study designs.
Studies designed around fasting or fed conditions based on protocol requirements.
Studies evaluating the relationship between food and product pharmacokinetics.
Studies assessing potential pharmacokinetic interactions between products.
Pharmacokinetic and pharmacodynamic studies in healthy participants.
Studies conducted in specific patient groups where required by the development program.
Bioequivalence studies using defined clinical endpoints in patient populations where appropriate.
Support for Different
From Method Development
Through Sample Analysis
Bioanalytical activities support the measurement and evaluation of study samples generated through clinical and pharmacokinetic programs. CEBIS can support the analytical process from method development through sample analysis and pharmacokinetic evaluation.
Method Development
Development of analytical methods based on the analyte, matrix and study requirements.
Method Validation
Validation of analytical methods for their intended study use.
Sample Analysis
Analysis of clinical samples generated during the study.
Pharmacokinetic Support
Connection of analytical results with pharmacokinetic evaluation.
Sample Storage
Short- and long-term sample storage where required and confirmed for the program.
Planning a BA/BE, Pharmacokinetic or Bioanalytical Program?
Tell us about the product, formulation, study design, participant population, analytical requirements and expected timeline. A member of the CEBIS team can discuss the appropriate clinical and bioanalytical support.