BIOANALYTICAL SERVICES

Bioanalytical Support from Method

Development Through Sample Analysis

CEBIS supports pharmaceutical research and clinical development with bioanalytical services including method development, method validation, sample analysis and pharmacokinetic support.

Bioanalytical activities can be coordinated with clinical, BA/BE, data and statistical services where required by the program.

CAPABILITIES

Support Across the

Bioanalytical Workflow

Bioanalytical services can include method development, method validation, sample analysis, pharmacokinetic analysis, BA/BE support and sample storage.

Method Development

Development of analytical methods based on the analyte, matrix and intended study requirements.

Method Validation

Validation activities designed to confirm that an analytical method is suitable for its intended use.

Sample Analysis

Analysis of clinical or study samples using the validated analytical method.

Pharmacokinetic Analysis

Analytical support connected to the evaluation of pharmacokinetic study data.

BA/BE Support

Bioanalytical activities supporting bioavailability and bioequivalence programs.

Sample Storage

Short- and long-term sample storage where required and confirmed for the study.

ASSAY DEVELOPMENT

Methods Developed Around the Study Requirements

Bioanalytical method development is tailored to the compound, biological matrix, expected concentration range and intended use of the data. CEBIS can work with sponsor scientific teams on assays for parent drugs and metabolites, including programs involving generics and new chemical entities.

METHOD VALIDATION

Preparing the Method for Study Use

Once an analytical method has been developed, validation helps confirm that the method is appropriate for its intended application.

Validation activities should be planned around the assay, matrix and study requirements before routine sample analysis begins.

Development

Validation

Sample Analysis

SAMPLE ANALYSIS

From Collected Samples to

Analytical Results

Clinical samples generated during BA/BE, pharmacokinetic and other development studies need to be handled and analyzed through a controlled analytical workflow. Bioanalytical activities can be coordinated with the clinical-study timeline so sample analysis, data review and pharmacokinetic evaluation remain aligned.

CLINICAL DEVELOPMENT

Bioanalysis Connected to

the Wider Program

Bioanalytical services are often one part of a larger clinical-development program.

CEBIS can connect analytical work with:

BA/BE Studies

Clinical and analytical support for bioavailability and bioequivalence programs.

Pharmacokinetic Studies

Analysis supporting evaluation of drug exposure and other pharmacokinetic endpoints.

New Chemical Entity Programs

Method-development and analytical support for early clinical development.

Generic Drug Programs

Bioanalytical support connected to BA/BE and other required studies.

Clinical Data & Statistics

Bioanalytical activities can be coordinated with pharmacokinetic analysis, biostatistics and final reporting across BA/BE, generic and new-chemical-entity programs.

BIOANALYTICAL OPERATIONS

Infrastructure Supporting Sample Analysis

CEBIS’s laboratory infrastructure supports sample preparation, analysis, storage and data management.

Examples include:

LC-MS/MS
Dedicated sample preparation areas
Solid-phase extraction systems
Refrigerated centrifugation
Frozen sample storage
Temperature and humidity monitoring
Data storage and backup
Support for light-sensitive samples

QUALITY

Quality Oversight Across Bioanalytical Activities

Bioanalytical results need to be generated, reviewed and documented through controlled processes.

Defined analytical procedures
Method documentation
Study-data review
Quality oversight
Data integrity
Issue follow-up
Controlled sample and data handling

Need Bioanalytical Support for Your Program?

Tell us about the compound, biological matrix, method status, study type, expected sample volume and timeline. A member of the CEBIS team can discuss the appropriate bioanalytical support.