GENERIC DRUG DEVELOPERS

Integrated BA/BE, Pharmacokinetic and

Bioanalytical Support for Generic Development

CEBIS supports generic drug development programs with bioavailability and bioequivalence studies, pharmacokinetic activities, bioanalytical services, data management, biostatistics, clinical study reporting and regulatory support.

Services can be coordinated around the formulation, study population, development pathway and regulatory requirements.

GENERIC DEVELOPMENT

Clinical, Analytical and

Statistical Functions in One Program

BA/BE support can connect protocol design, clinical study conduct, analytical quantification, pharmacokinetics, biostatistics and final clinical study reporting in one coordinated workflow.

Study Planning

Define the appropriate BA/BE or pharmacokinetic study around the formulation and development objective.

Clinical Execution

Conduct the required study in the appropriate participant population.

Sample Analysis

Analyze clinical samples using the agreed bioanalytical methods.

Pharmacokinetics

Evaluate relevant concentration-time and PK information.

Biostatistics

Perform statistical evaluation aligned with study objectives.

Reporting

Compile study results into the required final documentation.

BA/BE STUDIES

Study Designs Based on the Product and Development Question

Study approaches can include single- and multiple-dose studies in fasting or fed conditions, food- or drug-interaction studies, patient-population PK/PD studies and clinical-endpoint bioequivalence studies.

Fasting & Fed Studies

Appropriate single- or multiple-dose study designs based on the formulation and program.

Interaction Studies

Drug-food or drug-drug interaction studies where required.

Healthy Volunteer PK Studies

Pharmacokinetic studies conducted in appropriate healthy populations.

Patient Population Studies

PK/PD or clinical-endpoint studies when the product or endpoint requires a patient population.

DOSAGE FORMS

Support Across Different Formulation Types

CEBIS BA/BE experience spans multiple formulation types, including solid oral and modified-release products, orally dispersible formulations, liquids, parenteral formulations, rectal creams, nasal sprays and dermatological patches.

Solid oral formulations
Modified-release products
Orally dispersible formulations
Syrups and suspensions
Parenteral formulations
Nasal products
Topical / dermatological formats
Other formulations subject to confirmed experience

BIOANALYSIS

Clinical Sample Analysis Connected to the Study

Bioanalytical support for generic-drug programs can include method development, assay validation and sample analysis.

Method Development

Develop analytical methods appropriate to the compound and study.

Method Validation

Validate the method before routine study-sample analysis.

Sample Analysis

Analyze study samples using the approved analytical approach.

Pharmacokinetic Support

Connect analytical results to PK evaluation and downstream study analysis.

Sample Storage

Coordinate appropriate study-sample storage where required.

STUDY OUTPUTS

From Clinical Data to Final Study Results

Pharmacokinetic scientists and biostatisticians can work with the clinical and analytical teams to prepare the analyses and outputs required for the final clinical study report.

Related services:

Bioanalytical Results

PK Evaluation

Statistical Analysis

Final Reporting

REGULATORY PATHWAY

Development Activities Aligned

With the Target Submission

Generic-drug development can coordinate BA/BE, bioanalytical, statistical and regulatory activities around the applicable filing pathway.

Study strategy
Regulatory requirements
BA/BE or PK design
Bioanalysis
Data and statistics
Clinical study reporting
Submission-supporting documentation

GENERIC DRUG DEVELOPMENT SUPPORT

Planning a Generic Drug Development Program?

Tell us about the product, formulation, reference product, planned study, target regulatory market and development timeline.