🇺🇿 Bioavailability & Bioequivalence (BA/BE) Studies Services for Uzbekistan
UzPharmAgency / MoH Uzbekistan–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling, fully aligned with the regulatory expectations of:
Agency for Development of the Pharmaceutical Industry (UzPharmAgency)
Ministry of Health of the Republic of Uzbekistan
All studies strictly follow Uzbekistan MoH guidelines, ICH standards, WHO TRS, GCP, GLP, and where appropriate, EAEU harmonized BE requirements.
💊 Core Services for Uzbekistan (UzPharmAgency / MoH) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose BA/BE studies using crossover or parallel designs.
• Volunteer Selection: Healthy volunteers or patient groups depending on therapeutic class.
• Ethics Approval: Required approval from a recognized Uzbekistan Ethics Committee/IRB.
• Protocol Development: Aligned with ICH E6 (R2) GCP, WHO TRS, and Uzbekistan MoH guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic product registration, formulation comparisons, and variation filings.
• Dissolution Media: Pharmacopeial & biorelevant dissolution media accepted by UzPharmAgency.
• Similarity Factor: f2 similarity factor calculation for dissolution equivalence.
• Evaluation Models: Model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and Uzbekistan MoH scientific expectations.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Modeling: Supports biowaiver justifications and regulatory BE assessments.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV bioanalytical methods.
• Validation: Per ICH M10, WHO TRS, and Uzbekistan MoH-compatible validation guidelines.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical forms.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• BE Statistics: Conducted using ICH/WHO harmonized statistical approaches recognized by Uzbekistan authorities.
• Sample Size & Power: Scientifically determined for conclusive BE results.
📑 Uzbekistan MoH–Ready Regulatory Documentation
We prepare complete documentation tailored to Uzbekistan’s pharmaceutical regulatory system, including:
• Clinical Study Protocol (Uzbekistan-compliant)
• Informed Consent Forms (ICF) aligned with national ethics rules
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) formatted for UzPharmAgency submissions
✨ Why Choose BioEquiGlobal for the Uzbekistan Market?
• Local Regulatory Expertise: Deep familiarity with UzPharmAgency and Ministry of Health BE requirements.
• High Global Compliance Standards: Adherence to GCP, GLP, WHO TRS, and ICH with strong QA systems.
• Modern Infrastructure: Accredited clinical units and advanced analytical laboratories (including NABL-certified labs).
• International Submission Capability: CTD/ACTD dossiers prepared for Uzbekistan and global agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Uzbekistan
Feasibility & Gap Assessment: Evaluation of reference product availability, dissolution suitability, and biowaiver eligibility.
Protocol Development: Drafting Uzbekistan MoH–compliant BA/BE protocols and obtaining Ethics Committee approval.
Analytical Method Development: LC-MS/MS method validation per ICH M10 & WHO TRS.
Clinical Execution: GCP-based recruitment, dosing, sampling, and safety oversight.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and statistical BE assessment.
Documentation & Submission: Preparation of Uzbekistan-ready CSR, dissolution reports, validation documentation, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers targeting Uzbekistan’s regulatory system
• CROs requiring BA/BE outsourcing or analytical development
• Regulatory teams needing UzPharmAgency-compliant CTD dossiers