🇱🇦 Bioavailability & Bioequivalence (BA/BE) Studies Services for Laos

FDD Laos–Aligned BA/BE Studies & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies and Comparative Dissolution Profiling, tailored for regulatory submissions to the Food and Drug Department (FDD), Ministry of Health, Lao PDR.

Laos follows a harmonized ASEAN pharmaceutical regulatory framework, and therefore relies on:

• ASEAN Guidelines for the Conduct of Bioequivalence Studies

• FDD Laos Requirements for Drug Registration

• WHO TRS Bioequivalence Guidelines

• ICH Guidelines (E6 R2, Q2, Q6A, M10)

• EMA BE Guideline (accepted as scientific reference)

• GCP, GLP & GMP global quality standards

• USP / Ph. Eur. dissolution specifications

This ensures BE data generated by BioEquiGlobal is suitable for Laos and all ASEAN markets.

💊 Core BA/BE Services for Laos (FDD/ASEAN-Aligned)

Clinical BA/BE Studies (Human)

• Conducted per ASEAN BE Guidelines, FDD Laos expectations, WHO & ICH.
• Single-dose and multiple-dose BE studies (crossover/parallel).
• Healthy volunteer studies or patient PK studies when required.
• Ethics approval through international ICH-GCP ethical review systems.
• Protocol design following ICH E6 (R2) & ASEAN BE requirements.

Comparative Dissolution Profiling (CDP)

• Required for generic submissions in Laos.
• Dissolution testing using USP, Ph. Eur., ASEAN, and biorelevant media.
• Similarity factor (f2) for profile comparison.
• Model-independent & model-dependent dissolution analysis.

IVIVC & Biowaiver Support

• BCS-based biowaiver justification per ASEAN + WHO + ICH Q6A.
• Level A/B/C IVIVC modeling for dissolution–PK predictability.
• Suitable for BCS Class I & III APIs.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV bioanalytical method development.
• Validation per ICH M10, accepted by FDD Laos & ASEAN authorities.
• Stability-indicating method development for APIs & final products.
• Accuracy, precision, linearity, selectivity & stability assessments.

Pharmacokinetic (PK) & Bioequivalence Statistical Analysis

• Non-compartmental PK calculations (AUC, Cmax, Tmax, t½).
• ASEAN BE acceptance range: 90% CI within 80–125%.
• Scaled BE methodology for Highly Variable Drugs (HVDs) when needed.
• Sample-size & power calculations based on ASEAN/ICH statistical guidance.

📑 Laos (FDD)–Ready ASEAN CTD Documentation

We prepare complete ASEAN CTD (ACTD) & FDD-submission-ready documentation:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per ICH E3
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• ACTD Modules 1–4, including:

• Module 1: Country-specific requirements for Laos

• Generic medicine dossier (BE study / biowaiver justification)

• Stability & product quality documentation

✨ Why Choose BioEquiGlobal for Laos?

• ASEAN-Harmonized BE Expertise: Ensures regulatory acceptance across Laos and other ASEAN member states.
• Strong Alignment with WHO & ICH: Ensures high global credibility and data integrity.
• Support for Complex Generic Products: MR formulations, HVDs, ophthalmic, inhalation, injectable & topical generics.
• Ideal for ASEAN Market Entry: Documentation easily extended to Cambodia, Myanmar, Vietnam, Thailand, Malaysia, etc.
• End-to-End BE Capabilities: From feasibility review to PK/BE analysis and final ACTD module preparation.

🗺️ BA/BE Study Workflow for Laos (FDD Submission)

1. Feasibility & ASEAN Guideline Mapping
   (Reference product identification, biowaiver eligibility, BE requirements assessment)

2. Protocol Development & Ethics Compliance (ICH-GCP)
   (Aligned with ASEAN BE protocol structure)

3. Analytical Method Development & Validation
   (ICH M10-compliant LC-MS/MS validation)

4. Clinical BA/BE Study Execution
   (Volunteer recruitment, dosing, monitoring under GCP)

5. Bioanalysis & PK/BE Statistical Interpretation
   (NCA, BE evaluation, scaled BE where applicable)

6. Laos-Ready ACTD Documentation
   (CSR, CDP, validation package & ACTD Modules 1–4)

Who We Support in Laos & ASEAN Region

• Pharmaceutical manufacturers entering Laos or ASEAN markets
• ACTD-based generic medicine applicants
• CROs outsourcing BA/BE components
• R&D teams reformulating products for Southeast Asia
• Export-oriented pharma targeting emerging markets
• Specialty pharma & biotech companies