🇹🇯 Bioavailability & Bioequivalence (BA/BE) Studies Services for Tajikistan
SSSHSPP-Aligned BA/BE & Comparative Dissolution Profiling Services — By BioEqui
MoHSP-Compliant & EAEU-Aligned BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to Tajikistan’s regulatory framework under the:
Ministry of Health and Social Protection of the Population (MoHSP)
State Service for Supervision over Medicines and Pharmaceutical Activities
All studies strictly follow MoHSP guidelines, ICH standards, WHO TRS, GCP/GLP, and where applicable, EAEU BE guidelines.
💊 Core Services for Tajikistan (MoHSP) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs recognized by MoHSP.
• Volunteer Selection: Healthy volunteers or patient cohorts depending on therapeutic requirements.
• Ethics Approval: Required approval from a Tajikistan-recognized Ethics Committee/IRB.
• Protocol Development: Prepared in accordance with ICH E6 (R2) GCP, WHO TRS, and MoHSP expectations.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug registration, quality comparison, and formulation variations.
• Dissolution Media: Pharmacopeial and biorelevant media accepted by Tajik authorities.
• Similarity Factor: f2 similarity factor to compare dissolution curves.
• Evaluation Methods: Both model-independent (f1, f2) and model-dependent approaches, consistent with WHO/EAEU standards.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and harmonized pharmacopoeial requirements.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Modeling: Used to support biowaiver applications and BE assessment strategies.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical capabilities.
• Validation: As per ICH M10, WHO TRS, and MoHSP-recognized validation criteria.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical formulations.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA).
• BE Statistics: Performed using ICH/WHO harmonized standards accepted by Tajikistan’s regulatory system.
• Sample Size & Power: Scientifically justified to ensure statistically reliable BE outcomes.
📑 Tajikistan MoHSP–Ready Regulatory Documentation
We prepare complete regulatory documentation for Tajikistan’s State Service for Supervision over Medicines, including:
• Clinical Study Protocol (Tajikistan-compliant)
• Informed Consent Forms (ICF) following national ethical requirements
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) suitable for Tajikistan submissions
✨ Why Choose BioEquiGlobal for the Tajik Market?
• Local Regulatory Expertise: BE protocols, analytical validations, and CTD preparation aligned to MoHSP expectations.
• Global Quality Standards: Full compliance with GCP, GLP, WHO TRS, and ICH guidelines supported by strong QA systems.
• State-of-the-Art Infrastructure: Accredited clinical facilities and high-performance analytical laboratories (including NABL-certified labs).
• Global Submission Capability: CTD dossiers for Tajikistan, EAEU markets, and other major agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Tajikistan
Feasibility & Gap Assessment: Review of reference product availability, dissolution requirements, and biowaiver options.
Protocol Development: Drafting MoHSP-compliant BA/BE protocols and securing Ethics Committee approval.
Analytical Method Development: LC-MS/MS development & validation per ICH M10 & WHO TRS.
Clinical Execution: GCP-supervised recruitment, dosing, sampling, and safety oversight.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and full BE statistical analysis.
Documentation & Submission: Preparation of Tajikistan-ready CSR, dissolution profiles, validation reports, and CTD modules.
Who We Support
• Pharmaceutical manufacturers targeting Tajikistan
• CROs requiring analytical or BA/BE outsourcing
• Regulatory teams needing MoHSP-compliant CTD/ACTD submissions