🇰🇬 Bioavailability & Bioequivalence (BA/BE) Studies Services for Kyrgyzstan
DDPMD (MoH Kyrgyz Republic) & EAEU-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the regulatory requirements of Kyrgyzstan’s Department of Drugs Provision and Medical Devices (DDPMD) and the Eurasian Economic Union (EAEU) framework.
All studies strictly follow Kyrgyz MoH regulations, EAEU BE guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for both national and regional regulatory submissions.
💊 Core Services for Kyrgyzstan (DDPMD / EAEU) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose BA/BE studies using crossover or parallel models accepted by EAEU and DDPMD.
• Volunteer Selection: Healthy volunteers or patient cohorts depending on therapeutic requirements.
• Ethics Approval: Required approval from an accredited Ethics Committee/IRB in the Kyrgyz Republic.
• Protocol Development: DDPMD/EAEU-aligned BA/BE protocols designed according to ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Mandatory for generic applications, formulation modifications, and BE justification under EAEU and MoH Kyrgyzstan.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media recognized by EAEU.
• Similarity Factor: f2 similarity factor for dissolution curve comparison.
• Evaluation Approaches: Both model-independent (f1, f2) and model-dependent analysis.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared based on WHO TRS, ICH Q6A, and EAEU scientific standards.
• IVIVC Modeling: Level A, B, and C predictive in vitro–in vivo correlation models.
• Predictive PK Modeling: Supports regulatory justification for biowaivers or reduced clinical requirements.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical instrumentation.
• Validation: Conducted according to ICH M10, WHO TRS, and EAEU/ Kyrgyz MoH validation criteria.
• Stability-Indicating Methods: Developed for active ingredients and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Performed using ICH/EAEU harmonized methods accepted by DDPMD.
• Sample Size & Power: Calculated scientifically for conclusive BE results.
📑 Kyrgyzstan MoH / DDPMD / EAEU–Ready Documentation
We prepare full regulatory documentation tailored for submission to the Department of Drugs Provision and Medical Devices and EAEU markets, including:
• Clinical Study Protocol (Kyrgyz/EAEU-compliant)
• Informed Consent Forms (ICF) meeting national ethical requirements
• Investigator Brochure
• Clinical Study Report (CSR) per EAEU + ICH format
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• EAEU CTD Modules (1–5) formatted for Kyrgyzstan and regional submissions
✨ Why Choose BioEquiGlobal for the Kyrgyz Market?
• Regulatory Expertise: Experience with Kyrgyz MoH, DDPMD, and EAEU unified pharmaceutical regulations.
• Global Quality Standards: Compliance with GCP, GLP, ICH, WHO TRS—supported by strong internal QA frameworks.
• Advanced Analytical & Clinical Facilities: Accredited clinical units and modern analytical laboratories (including NABL-certified labs).
• International Reach: CTD/ACTD preparation for Kyrgyzstan and major international regulators (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Kyrgyzstan
Feasibility & Gap Assessment: Evaluation of reference product suitability, dissolution method needs, and biowaiver potential.
Protocol Development: Drafting DDPMD/EAEU-compliant BA/BE study protocols and coordinating Ethics Committee approval.
Analytical Method Development: LC-MS/MS method design and validation per ICH M10 & EAEU standards.
Clinical Study Execution: GCP-supervised recruitment, dosing, blood sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and full BE statistical evaluation.
Documentation & Submission: Preparation of Kyrgyz/EAEU-ready CSR, dissolution data, validation documentation, and CTD modules.
Who We Support
• Pharmaceutical manufacturers targeting Kyrgyzstan or the EAEU region
• CROs requiring analytical or BA/BE outsourcing
• Regulatory teams needing DDPMD/EAEU-compliant CTD dossiers