🇱🇧 Bioavailability & Bioequivalence (BA/BE) Studies Services for Lebanon
MoPH-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling services tailored for Lebanon’s pharmaceutical regulatory requirements under the Ministry of Public Health (MoPH).
Our studies comply with ICH, WHO TRS, GLP, GCP, and the scientific expectations of the Lebanese Pharmaceutical Registration Department, ensuring suitability for national drug registration and international submissions.
💊 Core Services for Lebanon (MoPH) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs.
• Volunteer Selection: Healthy volunteers or patient groups depending on therapeutic indication and MoPH requirements.
• Ethics Approval: Approval from a recognized Institutional Review Board (IRB)/Ethics Committee as per Lebanese research ethics standards.
• Protocol Development: MoPH-aligned protocols based on ICH E6 (R2) GCP and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug registration and variation submissions under the MoPH framework.
• Media: Pharmacopeial and biorelevant dissolution media suitable for regulatory submissions.
• Similarity Factor: f2 similarity factor calculation for test and reference product comparison.
• Evaluation Methods: Model-independent (f1, f2) and model-dependent dissolution analyses.
IVIVC & Biowaiver Support
• BCS Biowaiver: Prepared following WHO TRS, ICH Q6A, and scientific criteria recognized by MoPH.
• IVIVC Models: Level A, B, and C predictive correlation models.
• PK Predictive Modeling: Linking dissolution characteristics with expected in vivo behavior.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV systems used for precise quantification.
• Validation: Conducted in accordance with ICH M10, WHO TRS, and MoPH-accepted validation principles.
• Stability Methods: Stability-indicating methods for APIs and finished formulations.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA) for BA/BE evaluations.
• BE Statistics: Bioequivalence statistical calculations aligned with ICH and WHO methods recognized by MoPH.
• Sample Size & Power: Determination using internationally harmonized methodologies.
📑 MoPH-Ready Regulatory Documentation
We prepare complete submission-ready documentation for the Lebanon Ministry of Public Health (MoPH) – Pharmaceutical Product Registration Department, including:
• Clinical Study Protocol (MoPH-aligned)
• Informed Consent Forms (ICF) meeting Lebanese ethical standards
• Investigator Brochure
• Clinical Study Report (CSR) structured per ICH and WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for Lebanon MoPH drug registration
✨ Why Choose BioEquiGlobal for the Lebanese Market?
• Local Regulatory Alignment: BA/BE protocols, dissolution strategies, and analytical reporting tailored to MoPH expectations.
• Compliance & Quality: GCP-, GLP-, WHO-, and ICH-driven operations supported by robust SOPs and internal QA audits.
• Advanced Facilities: Accredited clinical units and high-standard analytical laboratories (including NABL-certified labs where applicable).
• Global Submission Expertise: Dossiers prepared for Lebanon MoPH and agencies such as US FDA, EMA, GCC, MHRA, TGA, and others.
🗺️ BA/BE Study Workflow for Lebanon
Feasibility & Assessment: Review of reference product availability, BCS classification, and biowaiver suitability.
Protocol Development: Preparation of MoPH-compliant BA/BE protocols and IRB ethical approval support.
Analytical Method Development: LC-MS/MS method design and validation following ICH M10 and WHO TRS.
Clinical Execution: GCP-compliant dosing, sample collection, and safety monitoring.
Bioanalysis & PK: QC-verified analysis, PK computations, and statistical BE assessment.
Documentation & Submission: Preparation of Lebanon MoPH-ready CSR, dissolution reports, validation data, and CTD/ACTD modules.
Who We Support
• Lebanese pharmaceutical companies seeking MoPH drug registration
• CROs requiring BA/BE or analytical outsourcing
• Regulatory affairs teams needing MoPH-compliant CTD/ACTD dossiers