🇱🇾 Bioavailability & Bioequivalence (BA/BE) Studies Services for Libya
NCFDC-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the regulatory requirements of Libya’s National Center for Food and Drug Control (NCFDC).
All studies strictly comply with NCFDC guidelines, ICH, WHO TRS, GCP, and GLP, ensuring full suitability for Libya’s pharmaceutical registration system and international submissions.
💊 Core Services for Libya (NCFDC) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel models recognized by NCFDC.
• Volunteer Selection: Healthy volunteers or patient-based studies depending on therapeutic category.
• Ethics Approval: Approval from a Libyan Ethics Committee/IRB according to national biomedical research requirements.
• Protocol Development: NCFDC-aligned BA/BE protocols based on ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug applications, variations, and equivalence assessments.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Factor: f2 similarity factor used to compare dissolution behavior of test vs. reference products.
• Evaluation Techniques: Model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared as per WHO TRS, ICH Q6A, and NCFDC-compatible scientific guidelines.
• IVIVC Models: Level A, B, and C correlation models for predictive analysis.
• Predictive PK Modeling: Supports BE justification and potential biowaiver acceptance.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical systems for robust drug quantification.
• Validation: Conducted according to ICH M10, WHO TRS, and validation criteria accepted by NCFDC.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Performed in alignment with ICH and WHO harmonized BE requirements recognized by NCFDC.
• Study Power & Sample Size: Calculated to ensure conclusive BE demonstration.
📑 NCFDC-Ready Regulatory Documentation
We prepare complete drug registration documents suitable for submission to Libya’s National Center for Food and Drug Control (NCFDC), including:
• Clinical Study Protocol (Libya-compliant)
• Informed Consent Forms (ICF) aligned with Libyan ethical standards
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS formats
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for NCFDC submission
✨ Why Choose BioEquiGlobal for the Libyan Market?
• Libya-Specific Expertise: BE protocols, dissolution studies, PK analyses, and CTD documentation designed to meet NCFDC expectations.
• High Global Standards: Operations aligned with GCP, GLP, WHO TRS, and ICH, supported by rigorous internal QA.
• Advanced Facilities: Accredited clinical units and high-performance analytical laboratories (including NABL-certified facilities).
• International Dossier Capability: CTD/ACTD submissions prepared for NCFDC and global agencies including US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and more.
🗺️ BA/BE Study Workflow for Libya
Feasibility & Gap Assessment: Review of reference product availability, dissolution compliance, and biowaiver eligibility.
Protocol Development: Preparation of NCFDC-compliant BA/BE protocols and support for Ethics Committee approval.
Analytical Method Development: LC-MS/MS method validation following ICH M10 and WHO TRS guidelines.
Clinical Execution: GCP-monitored volunteer recruitment, dosing, sampling, and safety oversight.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and BE statistical assessment.
Documentation & Submission: Preparation of NCFDC-ready CSR, dissolution reports, validation documents, and CTD/ACTD modules.
Who We Support
• Libyan pharmaceutical manufacturers seeking NCFDC approval
• CROs requiring BA/BE outsourcing or analytical support
• Regulatory teams needing NCFDC-compliant CTD/ACTD dossiers