BA/BE & PHARMACOKINETIC STUDIES

Bioavailability, Bioequivalence &

Pharmacokinetic Study Support

CEBIS supports bioavailability, bioequivalence and pharmacokinetic studies with coordinated clinical, regulatory, bioanalytical, data, statistical and reporting services.

Study support can be structured around the product, formulation, participant population and regulatory requirements of the program.

END-TO-END SUPPORT

From Study Design

Through Final Reporting

BA/BE and pharmacokinetic programs can combine protocol design, regulatory support, clinical study execution, analytical quantification, pharmacokinetic analysis, biostatistics and clinical study report preparation.

Study Design

Develop the study approach around the product, formulation, participant population and required pharmacokinetic endpoints.

Regulatory Support

Coordinate relevant regulatory and ethics activities before and during study conduct.

Clinical Execution

Manage dosing, participant visits, sample collection and other study activities according to the protocol.

Bioanalytical Analysis

Analyze clinical samples using methods developed and validated for the study.

Pharmacokinetics & Biostatistics

Evaluate study data and determine the required pharmacokinetic and statistical outputs.

Study Reporting

Bring clinical, analytical and statistical results together into the final study documentation.

STUDY CAPABILITIES

Support for Different

Pharmacokinetic Study Designs

Study designs can be selected around the product, development question and pharmacokinetic objectives.

Single-Dose Studies

Clinical studies evaluating pharmacokinetic behavior following a single dose.

Multiple-Dose Studies

Studies designed to evaluate pharmacokinetics following repeated administration.

Fasting Studies

Study execution under defined fasting conditions.

Fed Studies

Studies evaluating product performance following food intake.

Drug-Food Interaction Studies

Studies designed to evaluate how food may affect drug exposure.

Drug-Drug Interaction Studies

Studies assessing potential pharmacokinetic interactions between products.

Healthy Volunteer PK/PD Studies

Pharmacokinetic and pharmacodynamic studies conducted in healthy participants where appropriate.

Patient Population PK/PD Studies

Studies conducted in defined patient populations when required by the development program.

Clinical Endpoint BE Studies

Bioequivalence studies using defined clinical endpoints in patient populations where appropriate.

FORMULATION TYPES

Study Support Across a Range of Product Forms

CEBIS supports BA/BE studies across multiple formulation types, with study design adapted to the dosage form and product requirements.

Formulation and study examples include:

Solid oral formulations
Modified-release products
Orally dispersible formulations
Liquid syrups and suspensions
Intramuscular products
Intravenous products
Subcutaneous products
Rectal creams
Nasal sprays
Dermatological patches

INTEGRATED DELIVERY

Connecting Participant Visits, Samples and Study Data

BA/BE studies depend on close coordination between clinical activities and bioanalytical analysis.

CEBIS can connect participant dosing and sample collection with method development, sample analysis, pharmacokinetic evaluation and statistical review.

This allows the clinical and analytical parts of the study to follow one coordinated timeline.

Relevant support includes:

Clinical study execution
Sample collection and handling
Bioanalytical method development
Method validation
Sample analysis
Pharmacokinetic analysis
Biostatistics
Study reporting

STUDY POPULATIONS

Study Delivery Based on the

Required Population

The study design determines whether a BA/BE or pharmacokinetic program is conducted in healthy participants or a defined patient population. CEBIS supports healthy-volunteer PK/PD studies, patient-population studies, studies in postmenopausal healthy participants and clinical-endpoint bioequivalence studies.

Healthy Volunteers

Support for BA/BE, PK and PK/PD studies conducted in healthy participants where appropriate.

Patient Populations

Support for studies requiring participants with a defined condition or disease.

Special Populations

Support for protocol-defined populations when required by the study design.

STUDY RESULTS

From Pharmacokinetic Data to Final Study Outputs

Clinical and analytical data need to move through a clear review and analysis process before final study conclusions can be prepared.

CEBIS can coordinate:

Clinical data management
Data review and validation
Pharmacokinetic analysis
Biostatistics
Statistical interpretation
Clinical study report preparation

Pharmacokinetic and biostatistical analysis can be coordinated with clinical study reporting so the final report reflects the complete study dataset and analyses.

Planning a BA/BE or Pharmacokinetic Study?

Tell us about the product, formulation, study design, participant population and expected timeline. A member of the CEBIS team can discuss the appropriate clinical, analytical and statistical support.