🇺🇿 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

1. Feasibility & Gap Assessment: Evaluation of reference product availability, dissolution suitability, and biowaiver eligibility.

2. Protocol Development: Drafting Uzbekistan MoH–compliant BA/BE protocols and obtaining Ethics Committee approval.

3. Analytical Method Development: LC-MS/MS method validation per ICH M10 & WHO TRS.

4. Clinical Execution: GCP-based recruitment, dosing, sampling, and safety oversight.

5. Bioanalysis & PK Evaluation: PK modeling, QC checks, and statistical BE assessment.

6. 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