🇧🇾 Bioavailability & Bioequivalence (BA/BE) Studies Services for Belarus
CETHS / Ministry of Health–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 tailored to the regulatory requirements of the Center for Examinations and Tests in Health Service (CETHS) under the Ministry of Health of Belarus.
All studies strictly adhere to Belarus MoH/CETHS guidelines, EAEU regulations, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for national drug registration and Eurasian Economic Union (EAEU) submissions.
💊 Core Services for Belarus (CETHS / MoH) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BE studies using crossover or parallel models accepted by Belarusian authorities.
• Volunteer Selection: Healthy volunteers or patients depending on therapeutic category.
• Ethics Approval: Required from a Belarus-registered Ethics Committee/IRB.
• Protocol Development: Belarus MoH– and EAEU-aligned BA/BE protocols following ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Mandatory for generic submissions, formulation modifications, and equivalence demonstration under Belarus MoH/EAEU rules.
• Dissolution Media: Pharmacopeial and biorelevant media (EAEU-compliant).
• Similarity Factor: f2 similarity factor used for dissolution profile comparison.
• Evaluation Approaches: Includes both model-independent (f1, f2) and model-dependent modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared in accordance with WHO TRS, ICH Q6A, and EAEU scientific justification guidelines.
• IVIVC Modeling: Level A, B, and C in vitro–in vivo correlation models.
• Predictive PK Modeling: Supports evidence-based justification for biowaiver acceptance.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical systems for precise drug quantification.
• Validation: In accordance with ICH M10, WHO TRS, and EAEU/Belarus acceptable validation standards.
• Stability-Indicating Methods: Developed for both APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• BE Statistical Evaluation: Performed following ICH and EAEU harmonized requirements recognized by Belarus MoH.
• Study Power & Sample Size: Scientifically planned for conclusive BE outcomes.
📑 Belarus MoH / CETHS–Ready Regulatory Documentation
We prepare full regulatory documentation suitable for submission to the Center for Examinations and Tests in Health Service, including:
• Clinical Study Protocol (Belarus-compliant)
• Informed Consent Forms (ICF) following national ethical standards
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & WHO TRS structures
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules (1–5) formatted for Belarus MoH/EAEU submissions
✨ Why Choose BioEquiGlobal for the Belarusian Market?
• Belarus/EAEU Regulatory Expertise: All BA/BE protocols, analytical validations, PK reports, and CTD documentation are aligned with Belarusian and EAEU requirements.
• High International Standards: Compliance with GCP, GLP, WHO TRS, and ICH guidelines under strict QA oversight.
• Advanced Infrastructure: Accredited clinical units and high-precision analytical laboratories (including NABL-certified facilities).
• Global Submission Capability: CTD/ACTD dossiers prepared for Belarus MoH, EAEU markets, and global authorities such as US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.
🗺️ BA/BE Study Workflow for Belarus
Feasibility & Gap Assessment: Review of reference product availability, dissolution suitability, and biowaiver feasibility.
Protocol Development: Drafting Belarus MoH/EAEU–compliant BA/BE protocols and securing Ethics Committee approval.
Analytical Method Development: LC-MS/MS method validation per ICH M10 & WHO TRS.
Clinical Execution: GCP-supervised recruitment, dosing, sample collection, and medical monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and BE statistical assessment.
Documentation & Submission: Preparation of CETHS-ready CSR, dissolution report, validation documents, and CTD modules.
Who We Support
• Pharmaceutical manufacturers targeting Belarus or EAEU markets
• CROs requiring BA/BE outsourcing or analytical services
• Regulatory teams needing CETHS/MoH-compliant CTD dossiers