Our Services

Comprehensive bioequivalence research services designed to meet the highest international standards.

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Bioequivalence Studies

Proving therapeutic equivalence with scientific precision

Bioequivalence (BE) studies are the cornerstone of generic drug approval. These studies determine if a generic test product is absorbed at the same rate and to the same extent as the branded reference product, ensuring patients receive identical therapeutic benefits.

Study Designs We Offer
01
Single-dose, two-way crossover
The gold standard for most bioequivalence assessments
02
Parallel design studies
For drugs with long half-lives where crossover designs are impractical
03
Replicate design studies
For highly variable drugs with within-subject variability exceeding 30%
04
Fasting & fed condition studies
To evaluate food effects on drug absorption
Service 01
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Clinical Services

Rigorous protocols, compassionate care

Our 42-bed clinical unit is designed to support the clinical component of bioequivalence studies while prioritizing subject safety and comfort.

01
IRB-approved protocol development and implementation
02
Healthy volunteer recruitment, screening, and enrollment
03
24-hour subject monitoring and medical oversight
04
Precise blood sampling and specimen handling
05
Adverse event monitoring, reporting, and documentation
06
Full compliance with ICH E6 (R2) Good Clinical Practice guidelines
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Service 02

Bioanalytical Services

Advanced instrumentation, validated methods

Our bioanalytical laboratory is equipped with state-of-the-art LC-MS/MS instrumentation operated by analysts with extensive experience in regulated studies.

01
Method development and optimization
For diverse drug compounds
02
Full method validation
Per ICH M10 guidelines
03
High-throughput sample analysis
With rigorous quality control
04
Incurred sample reanalysis (ISR)
For data verification
05
Study sample storage
With complete chain of custody documentation
Service 03

Clinical Pharmacology Services

Data-driven decisions, regulatory-ready reports

A digital, wireframe illustration of a syringe with a needle pointing right, glowing blue against a dark blue background.

Our pharmacokinetic and statistical analysis services transform raw data into actionable insights and submission-ready documentation.

  • Use of powerful industry standard PK analysis software

  • Statistical tools and methods accepted by major regulatory agencies

  • Comprehensive study reports formatted for regulatory submissions

What Sets Us Apart

Electronic Lab Notebook (ELN) System
Dr. Moise Khayrallah Center for Pharmaceutical and Medical Research is pioneering the utilization of ELN for bioanalysis in the MENA region. The use of ELN improves efficiency of operations, facilitates quality assurance audits and ensures data accuracy and traceability. This digital approach places Dr. Moise Khayrallah Center for Pharmaceutical and Medical Research on par with large multinational CROs who have switched from paper-based systems.
Multi-Country Regulatory Acceptance
Our studies are designed from the ground up for acceptance by regulatory authorities across multiple jurisdictions. Whether you need approval from the Lebanese Ministry of Public Health, Gulf Cooperation Council authorities, or other international bodies, Dr. Moise Khayrallah Center for Pharmaceutical and Medical Research's documentation and methodologies meet the requirements.
Academic-Industry Bridge
As part of LAU, Dr. Moise Khayrallah Center for Pharmaceutical and Medical Research uniquely bridges academic rigor with industry needs. Our team combines deep scientific expertise with practical understanding of pharmaceutical development timelines and commercial requirements.