🇲🇲 Bioavailability & Bioequivalence (BA/BE) Studies Services for Myanmar
FDA Myanmar–Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory requirements of the Food and Drug Administration (FDA Myanmar).
All studies strictly follow GCP, GLP, WHO TRS, ICH guidelines, and Myanmar’s Drug Registration Guidance, ensuring compliance for local pharmaceutical submissions and international markets.
💊 Core Services for Myanmar (FDA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies in crossover or parallel formats accepted by FDA Myanmar.
• Volunteer Selection: Healthy volunteers or relevant patient groups depending on the therapeutic profile.
• Ethics Approval: Approval from an authorized Institutional Ethics Committee (IEC/IRB) in Myanmar.
• Protocol Development: Protocols aligned with Myanmar FDA expectations, ICH E6 (R2) GCP, and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Essential for generic product registration and variation submissions per Myanmar FDA guidelines.
• Dissolution Media: Standard pharmacopeial and biorelevant media.
• Similarity Factor: Evaluation using f2 similarity factor for test–reference comparison.
• Evaluation Models: Model-independent (f1, f2) and model-dependent dissolution comparisons.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared following WHO TRS, ICH Q6A, and Myanmar FDA-accepted scientific principles.
• IVIVC Models: Level A, B, and C correlations to support regulatory justification.
• Predictive Modeling: Dissolution–PK modeling for accurate performance prediction.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV systems for sensitive drug quantification.
• Validation: Conducted as per ICH M10, WHO TRS, and bioanalytical validation standards recognized by Myanmar FDA.
• Stability-Indicating Methods: Developed for APIs and drug products.
Pharmacokinetic (PK) Analysis
• PK Method: Non-compartmental analysis (NCA).
• BE Statistical Evaluation: BE statistics aligned with ICH and WHO harmonized requirements.
• Sample Size & Power Calculation: Designed to meet regulatory expectations and study objectives.
📑 FDA Myanmar–Ready Regulatory Documentation
We prepare complete documentation required for pharmaceutical registration with the Food and Drug Administration, Ministry of Health Myanmar, including:
• Clinical Study Protocol (Myanmar FDA–aligned)
• Informed Consent Forms (ICF) per Myanmar ethical guidelines
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO structures
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for FDA Myanmar registration submissions
✨ Why Choose BioEquiGlobal for the Myanmar Market?
• Myanmar-Focused Expertise: BA/BE protocols, dissolution studies, and dossier preparation aligned with Myanmar FDA standards.
• Quality-Driven Processes: GCP- and GLP-compliant workflows with strong QA oversight.
• Advanced Laboratory & Clinical Capabilities: Accredited clinical units and high-precision analytical laboratories (including NABL-certified labs where applicable).
• Global Dossier Experience: Preparation of CTD/ACTD files suitable for Myanmar FDA, as well as US FDA, EMA, GCC, MHRA, TGA, ASEAN, and African authorities.
🗺️ BA/BE Study Workflow for Myanmar
Feasibility & Gap Assessment: Review of reference drug availability in Myanmar, dissolution method suitability, and biowaiver potential.
Protocol Development: Drafting of FDA Myanmar–compliant BA/BE protocols and facilitating IEC/IRB approval.
Analytical Method Development: LC-MS/MS method design and validation following ICH M10 and WHO TRS guidelines.
Clinical Study Execution: GCP-monitored volunteer dosing, safety assessment, and sample collection.
Bioanalysis & PK Evaluation: Detailed PK modeling, QC verification, and statistical BE assessment.
Documentation & Submission: Preparation of Myanmar FDA–ready CSR, dissolution reports, analytical validations, and CTD/ACTD modules.
Who We Support
• Myanmar-based pharmaceutical companies seeking FDA product registration
• CROs requiring analytical or BA/BE study outsourcing
• Regulatory teams needing Myanmar FDA–compliant CTD/ACTD dossiers