🇹🇭 Bioavailability & Bioequivalence (BA/BE) Studies Services for Thailand
Thai FDA–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 standards of the Thailand Food and Drug Administration (Thai FDA).
All studies strictly follow Thai FDA Bioequivalence Guidelines, ICH, WHO TRS, GCP, GLP, and ASEAN harmonized requirements to ensure compliance for Thailand’s drug registration and international submissions.
💊 Core Services for Thailand (Thai FDA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by Thai FDA.
• Volunteer Selection: Healthy volunteers or patient groups depending on therapeutic context.
• Ethics Approval: Approval from a Thai Institutional Review Board (IRB) accredited under national biomedical research ethics.
• Protocol Development: Thai FDA–aligned protocols based on ICH E6 (R2) GCP, WHO TRS, and ASEAN BE guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic product registration and post-approval variations in Thailand.
• Dissolution Media: Pharmacopeial and biorelevant media suitable for ASEAN submissions.
• Similarity Factor: Calculation of f2 similarity factor to compare test and reference profiles.
• Evaluation Methods: Model-independent (f1, f2) and model-dependent mathematical modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Developed in alignment with WHO TRS, ICH Q6A, and Thai FDA-supported scientific approaches.
• IVIVC Modeling: Level A, B, and C IVIVC models.
• Predictive PK Modeling: Used to justify expected in vivo drug performance.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical technologies.
• Validation: Conducted per ICH M10, WHO TRS, and standards recognized by Thai FDA.
• Stability Methods: Stability-indicating methods for APIs and finished products.
Pharmacokinetic (PK) Analysis
• PK Modeling: Non-compartmental analysis (NCA).
• BE Statistical Assessment: Aligned with Thai FDA, ICH, and WHO harmonized BE standards.
• Sample Size & Power: Calculated using international BE study methodologies.
📑 Thai FDA–Ready Regulatory Documentation
We prepare full regulatory documentation required for pharmaceutical submission to the Thailand Food and Drug Administration, including:
• Clinical Study Protocol (Thai FDA–compliant)
• Informed Consent Forms (ICF) aligned with Thai IRB requirements
• Investigator Brochure
• Clinical Study Report (CSR) following ICH/WHO TRS standards
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for Thai FDA drug registration
✨ Why Choose BioEquiGlobal for the Thailand Market?
• Thai Regulatory Expertise: BA/BE protocols, analytical reports, and CTD modules tailored to Thai FDA expectations.
• Quality and Compliance: GCP-, GLP-, WHO-, and ICH-based systems with strong internal QA processes.
• State-of-the-Art Facilities: Accredited clinical units and high-quality analytical laboratories (including NABL-certified labs where applicable).
• Global Regulatory Strength: Dossiers prepared for Thai FDA as well as US FDA, EMA, MHRA, TGA, GCC, ASEAN, and African regulators.
🗺️ BA/BE Study Workflow for Thailand
Feasibility & Gap Assessment: Review of reference product availability, dissolution methods, and biowaiver eligibility.
Protocol Development: Drafting of Thai FDA–compliant BA/BE protocols and assistance with IRB approval.
Analytical Method Development: LC-MS/MS method design and validation following ICH M10 and WHO TRS guidelines.
Clinical Execution: GCP-supervised volunteer recruitment, dosing, sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical assessment.
Documentation & Submission: Preparation of Thai FDA–ready CSR, dissolution reports, validation data, and CTD/ACTD modules.
Who We Support
• Thai pharmaceutical manufacturers seeking Thai FDA approval
• CROs requiring BA/BE, bioanalytical, or documentation outsourcing
• Regulatory teams needing Thai FDA–compliant CTD/ACTD dossiers