🇭🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Honduras
ARSA–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with Honduran pharmaceutical regulatory requirements under:
ARSA – Agencia de Regulación Sanitaria
Secretaría de Salud de Honduras
All studies strictly follow ARSA guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for national submissions and broader Central American regulatory acceptance.
💊 Core Services for Honduras (ARSA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose BE studies using crossover or parallel designs accepted by ARSA.
• Volunteer Selection: Healthy volunteers or patient populations depending on therapeutic indication.
• Ethics Approval: Required approval from a Comité de Ética en Investigación (CEI) authorized in Honduras.
• Protocol Development: Prepared per ICH E6 (R2) GCP, WHO TRS, and ARSA regulatory expectations.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic submissions, formulation variations, and pharmaceutical equivalence assessments.
• Dissolution Media: Pharmacopeial & biorelevant media as recommended by ARSA.
• Similarity Factor: f2 similarity factor to compare dissolution profiles.
• Evaluation Methods: WHO/ICH-recognized model-independent (f1, f2) and model-dependent approaches.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS and ICH Q6A, with justification aligned to ARSA standards.
• IVIVC Modeling: Level A, B, and C models.
• Predictive PK Modeling: Used to optimize regulatory strategy and support biowaiver applications.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV systems for precise drug quantification.
• Validation: Per ICH M10, WHO TRS, and ARSA-recognized criteria.
• Stability-Indicating Methods: Developed for APIs and finished products.
Pharmacokinetic (PK) Analysis
• PK Method: Non-compartmental analysis (NCA).
• BE Statistics: Conducted using WHO/ICH standardized approaches.
• Sample Size & Power: Calculated scientifically for statistically reliable BE conclusions.
📑 Honduras ARSA–Ready Regulatory Documentation
We prepare complete documentation suitable for ARSA submission, including:
• Clinical Study Protocol (Honduras-compliant)
• Informed Consent Forms (ICF) meeting CEI ethical norms
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) formatted for ARSA applications
✨ Why Choose BioEquiGlobal for the Honduran Market?
• Regulatory Expertise: BA/BE protocols, PK analysis, dissolution studies, and CTD dossiers aligned to ARSA requirements.
• High International Standards: Full compliance with GCP, GLP, WHO TRS, and ICH guidance under strong QA oversight.
• Advanced Facilities: Accredited clinical units and modern analytical laboratories (including NABL-certified setups).
• Global Submission Support: CTDs prepared for Honduras and major regulators (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Honduras
Feasibility & Gap Assessment: Evaluation of reference product availability, dissolution comparability, and biowaiver feasibility.
Protocol Development: Drafting of ARSA-compliant BA/BE protocols and securing CEI approval.
Analytical Method Development: LC-MS/MS method design & validation as per ICH M10 & WHO TRS.
Clinical Execution: GCP-supervised volunteer recruitment, dosing, blood sampling, and monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and statistical BE evaluation.
Documentation & Submission: Preparation of ARSA-ready CSR, dissolution reports, validation documents, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers targeting Honduras and Central America
• CROs requiring BE research or analytical outsourcing
• Regulatory teams needing ARSA-compliant CTD/ACTD dossiers