🇻🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Vietnam
DAV/MOH Vietnam–Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, delivers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory standards of the Drug Administration of Vietnam (DAV) under the Ministry of Health (MOH).
All studies fully comply with MOH Vietnam regulations, ASEAN Guidelines for BE Studies, ICH, WHO TRS, GCP, and GLP, ensuring suitability for Vietnam’s drug registration system and international submissions.
💊 Core Services for Vietnam (DAV) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BE studies using crossover or parallel designs as required by DAV.
• Volunteer Selection: Healthy volunteers or patient populations as per product category and MOH guidelines.
• Ethics Approval: Approval from an MOH-recognized Ethics Committee/IRB, following Vietnam’s biomedical research ethics regulations.
• Protocol Development: DAV-compliant BA/BE protocols based on ICH E6 (R2) GCP, WHO TRS, and ASEAN harmonized BE guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic product registration and post-approval amendments in Vietnam.
• Dissolution Media: Pharmacopeial and biorelevant media according to DAV and ASEAN expectations.
• Similarity Factor: f2 similarity factor evaluation for dissolution comparison.
• Evaluation Approaches: Model-independent (f1, f2) and model-dependent comparative dissolution methodologies.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Developed following WHO TRS, ICH Q6A, and DAV/ASEAN scientific principles.
• IVIVC Models: Level A, B, and C predictive models.
• Predictive Dissolution–PK Analysis: Supports regulatory decision-making for biowaiver or BE justification.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV systems for high-sensitivity drug quantification.
• Validation: Conducted as per ICH M10, WHO TRS, and ASEAN/ MOH Vietnam bioanalytical requirements.
• Stability-Indicating Methods: Prepared for APIs and finished dosage forms.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• Statistical BE Assessment: Performed according to ASEAN, WHO, and ICH harmonized BE methods recognized by DAV.
• Study Power & Sample Size: Determined based on regulatory expectations for BE conclusion.
📑 DAV/MOH Vietnam–Ready Regulatory Documentation
We prepare complete registration-ready documentation for submission to the Drug Administration of Vietnam (DAV), including:
• Clinical Study Protocol (Vietnam-compliant)
• Informed Consent Forms (ICF) aligned with Vietnamese ethical standards
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & ASEAN structures
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for Vietnam drug registration
✨ Why Choose BioEquiGlobal for the Vietnamese Market?
• DAV-Aligned Expertise: Study protocols, dissolution profiles, PK analyses, and dossier designs aligned with MOH/DAV guidelines.
• Rigorous Quality Systems: GCP-, GLP-, WHO-, and ICH-compliant operations with robust internal QA.
• Advanced Testing & Clinical Facilities: Accredited clinical units and high-performance analytical labs (NABL-certified where applicable).
• Global Dossier Preparation: CTD/ACTD submission packages suitable for Vietnam and global agencies such as US FDA, EMA, MHRA, TGA, GCC, ASEAN, and African regulators.
🗺️ BA/BE Study Workflow for Vietnam
Feasibility & Gap Assessment: Review of reference product availability and Vietnam-specific regulatory expectations, including biowaiver eligibility.
Protocol Development: Drafting of DAV-compliant BA/BE protocols and facilitation of IRB approval processes.
Analytical Method Development: LC-MS/MS method design and validation per ICH M10 and WHO TRS.
Clinical Study Execution: GCP-guided subject recruitment, dosing, sampling, and medical oversight.
Bioanalysis & PK Evaluation: PK computation, QC checks, and statistical BE analysis.
Documentation & Submission: Preparation of DAV-ready CSR, dissolution reports, method validation data, and CTD/ACTD modules.
Who We Support
• Vietnamese pharmaceutical manufacturers seeking MOH/DAV drug registration
• CROs needing BA/BE study outsourcing or analytical support
• Regulatory teams requiring DAV-compliant CTD/ACTD dossiers