🇧🇫 Bioavailability & Bioequivalence (BA/BE) Studies Services for Burkina Faso
ANRP-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, delivers complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory standards of Burkina Faso’s Agence Nationale de Régulation Pharmaceutique (ANRP).
All studies strictly follow ICH, WHO TRS, GCP, GLP, and ANRP requirements, ensuring pharmaceutical compliance for national product registration and international submissions.
💊 Core Services for Burkina Faso (ANRP) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by ANRP.
• Volunteer Selection: Healthy volunteers or patient groups depending on therapeutic indication.
• Ethics Approval: Approval from a recognized Comité d’Éthique or Institutional Review Board (IRB) in Burkina Faso.
• Protocol Development: ANRP-aligned BA/BE protocols designed according to ICH E6 (R2) GCP and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic registration, dossier variations, and quality evaluations under ANRP.
• Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Assessment: f2 similarity factor for comparing dissolution profiles.
• Evaluation Methods: Both model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared in accordance with WHO TRS, ICH Q6A, and ANRP-recognized scientific criteria.
• IVIVC Modeling: Level A, B, and C correlation models for predicting in vivo drug behavior.
• Predictive PK Modeling: Supports regulatory justification for BE or biowaivers.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV systems for accurate drug quantification.
• Validation: Conducted per ICH M10, WHO standards, and ANRP-acceptable validation principles.
• Stability Methods: Stability-indicating method development for APIs and finished products.
Pharmacokinetic (PK) Analysis
• PK Analysis Type: Non-compartmental analysis (NCA).
• BE Statistics: Statistical comparison following WHO, ICH, and internationally harmonized BE methodologies recognized by ANRP.
• Power & Sample Size: Determined using globally accepted methodologies for conclusive BE outcomes.
📑 ANRP-Ready Regulatory Documentation
We prepare complete regulatory submission documentation for Burkina Faso’s Agence Nationale de Régulation Pharmaceutique (ANRP), including:
• Clinical Study Protocol (ANRP-aligned)
• Informed Consent Forms (ICF) following local ethical regulations
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for Burkina Faso regulatory submission
✨ Why Choose BioEquiGlobal for the Burkina Faso Market?
• Burkina Faso–Specific Expertise: BA/BE protocols, dissolution reports, PK analyses, and documentation aligned with ANRP guidelines.
• Stringent Quality Standards: Full compliance with GCP, GLP, ICH, and WHO TRS, backed by strong internal QA oversight.
• Modern Infrastructure: Accredited clinical units and world-class analytical laboratories (NABL-certified where applicable).
• Global Regulatory Support: CTD/ACTD dossier preparation suitable for ANRP and international authorities (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Burkina Faso
Feasibility & Gap Assessment: Review of reference products, dissolution method suitability, and biowaiver potential.
Protocol Development: Preparation of ANRP-compliant BA/BE protocols and support for Ethics Committee approval.
Analytical Method Development: Validated LC-MS/MS method creation per ICH M10 and WHO TRS.
Clinical Execution: GCP-based subject recruitment, dosing, sampling, and medical monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical assessments.
Documentation & Submission: Preparation of ANRP-ready CSR, dissolution profile report, validation data, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers in Burkina Faso seeking ANRP approval
• CROs requiring outsourced BA/BE or analytical support
• Regulatory teams needing ANRP-compliant CTD/ACTD dossiers