🇪🇹 Bioavailability & Bioequivalence (BA/BE) Studies Services for Ethiopia
EFDA-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory requirements of the Ethiopian Food and Drug Authority (EFDA).
All studies strictly adhere to EFDA guidelines, ICH, WHO TRS, GCP, GLP, ensuring suitability for national drug registration and international submissions.
💊 Core Services for Ethiopia (EFDA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by EFDA.
• Volunteer Selection: Healthy volunteers or patient-based studies depending on therapeutic indication.
• Ethics Approval: Approval by an authorized Institutional Review Board (IRB)/Ethics Committee in Ethiopia.
• Protocol Development: EFDA-aligned BA/BE protocols developed according to ICH E6 (R2) GCP and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Essential for generic medicine registration and post-approval variations.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media per EFDA expectations.
• Similarity Assessment: f2 similarity factor used to compare test and reference dissolution profiles.
• Evaluation Models: Model-independent (f1, f2) and model-dependent dissolution comparisons.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Aligned with EFDA, WHO TRS, and ICH Q6A scientific principles.
• IVIVC Models: Level A, B, and C correlation models for predicting in vivo performance.
• Predictive PK Modeling: Supports regulatory justification for waiving BE requirements.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV for accurate quantitative bioanalysis.
• Validation: Conducted as per ICH M10, WHO TRS, and EFDA-accepted standards.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Following ICH and WHO harmonized BE standards recognized by EFDA.
• Sample Size & Power: Determined using globally accepted statistical methods.
📑 EFDA-Ready Regulatory Documentation
We prepare complete regulatory documentation aligned with the requirements of the Ethiopian Food and Drug Authority, including:
• Clinical Study Protocol (EFDA-compliant)
• Informed Consent Forms (ICF) following Ethiopian 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 EFDA drug registration
✨ Why Choose BioEquiGlobal for the Ethiopian Market?
• Deep Understanding of EFDA Requirements: Protocols, PK analyses, and dissolution studies tailored to Ethiopia’s regulatory expectations.
• Global-Standard Quality Systems: Fully GCP-, GLP-, WHO-, and ICH-compliant workflows with strong QA oversight.
• Advanced Laboratory & Clinical Facilities: Accredited analytical labs and GCP-compliant clinical units (including NABL-certified facilities where applicable).
• International Dossier Capability: Preparation of submission-ready CTD/ACTD dossiers for EFDA and global authorities including US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and ASEAN bodies.
🗺️ BA/BE Study Workflow for Ethiopia
Feasibility & Gap Assessment: Review of reference product availability, biowaiver eligibility, and dissolution method requirements.
Protocol Development: Drafting EFDA-compliant BA/BE protocols and assisting IRB approval.
Analytical Method Development: LC-MS/MS method creation and validation per ICH M10 and WHO TRS.
Clinical Execution: GCP-monitored volunteer recruitment, dosing, sampling, and safety supervision.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical analysis.
Documentation & Submission: Preparation of EFDA-ready CSR, dissolution reports, validation packages, and CTD/ACTD modules.
Who We Support
• Ethiopian pharmaceutical manufacturers seeking EFDA approval
• CROs requiring outsourced BA/BE or analytical services
• Regulatory teams needing EFDA-compliant CTD/ACTD dossiers