🇦🇿 Bioavailability & Bioequivalence (BA/BE) Studies Services for Azerbaijan
AEC/MoH–Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, delivers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory framework of Azerbaijan’s Analytical Expertise Center (AEC) under the Ministry of Health (MoH).
All studies strictly follow Azerbaijan MoH/AEC requirements, ICH guidelines, WHO TRS, GCP, and GLP, ensuring suitability for national drug registration and global regulatory acceptance.
💊 Core Services for Azerbaijan (AEC/MoH) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose BA/BE studies using crossover or parallel models accepted by Azerbaijan’s MoH/AEC.
• Volunteer Selection: Healthy volunteers or patient-based studies, depending on therapeutic indication.
• Ethics Approval: Required from an Ethics Committee/IRB recognized by the Ministry of Health.
• Protocol Development: Azerbaijan MoH–aligned BA/BE protocols following ICH E6 (R2) GCP and WHO TRS guidance.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic applications, formulation changes, and equivalence assessments.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Factor: f2 similarity factor for comparing dissolution curves.
• Evaluation Approaches: Model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared per WHO TRS, ICH Q6A, and scientific principles accepted by Azerbaijan’s MoH.
• IVIVC Models: Level A, B, and C correlation models for predicting in vivo performance.
• Predictive PK Modeling: Supports biowaiver justification and regulatory approval strategy.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV technologies for accurate drug quantification.
• Validation: Conducted following ICH M10, WHO TRS, and AEC-acceptable standards.
• Stability-Indicating Methods: Developed for APIs and finished dosage forms.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Performed according to ICH and WHO harmonized standards recognized by Azerbaijan’s regulators.
• Sample Size & Power: Designed to ensure statistically conclusive BE results.
📑 Azerbaijan MoH/AEC–Ready Regulatory Documentation
We prepare complete regulatory documents tailored to Azerbaijan’s Analytical Expertise Center (AEC), including:
• Clinical Study Protocol (Azerbaijan-compliant)
• Informed Consent Forms (ICF) meeting local ethical requirements
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules 1–5 formatted for MoH/AEC submission
✨ Why Choose BioEquiGlobal for the Azerbaijani Market?
• AEC Regulatory Expertise: BE protocols, statistical approaches, analytical validation, and CTD preparation aligned with national requirements.
• International Quality Systems: GCP-, GLP-, ICH-, and WHO-compliant processes backed by strong internal QA.
• Advanced Infrastructure: Modern analytical laboratories (including NABL-certified labs) and accredited clinical research units.
• Global Submission Readiness: CTD/ACTD dossiers suitable for MoH/AEC and international agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Azerbaijan
Feasibility & Gap Assessment: Review of reference product availability, dissolution method requirements, and biowaiver potential.
Protocol Development: Drafting MoH/AEC-compliant BA/BE protocols and facilitating Ethics Committee approval.
Analytical Method Development: LC-MS/MS method design and validation according to ICH M10 & WHO TRS.
Clinical Study Execution: GCP-based recruitment, dosing, blood sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC validation, and complete BE statistical assessment.
Documentation & Submission: Preparation of AEC-ready CSR, dissolution data, validation reports, and CTD modules (1–5).
Who We Support
• Pharmaceutical manufacturers targeting Azerbaijan’s regulatory system
• CROs requiring outsourced BA/BE or analytical services
• Regulatory teams needing AEC/MoH-compliant CTD dossiers