🇳🇬 Bioavailability & Bioequivalence (BA/BE) Studies Services for Nigeria
NAFDAC-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 requirements of the National Agency for Food and Drug Administration and Control (NAFDAC).
All studies strictly comply with NAFDAC Guidelines, ICH, WHO TRS, GCP, and GLP, ensuring suitability for Nigerian drug registration and international submissions.
💊 Core Services for Nigeria (NAFDAC) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BE studies using crossover or parallel designs recognized by NAFDAC.
• Volunteer Selection: Healthy volunteers or patient cohorts, depending on therapeutic indication.
• Ethics Approval: Mandatory approval from a National Health Research Ethics Committee (NHREC)–registered IRB.
• Protocol Development: NAFDAC-aligned BA/BE protocols based on ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Essential for generic registration (Form D-REG/001), variations, and quality equivalence.
• Dissolution Media: Pharmacopeial and biorelevant media per NAFDAC/WHO guidelines.
• Similarity Factor: f2 similarity factor for direct dissolution comparison.
• Evaluation Models: Includes model-independent (f1, f2) and model-dependent modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and scientific criteria recognized by NAFDAC.
• IVIVC Models: Level A, B, and C models for predicting in vivo drug performance.
• Predictive PK Modeling: Supports scientific justification for waiving BE requirements where applicable.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV for high-sensitivity quantification.
• Validation: As per ICH M10, WHO TRS, and NAFDAC-recognized analytical validation standards.
• Stability-Indicating Methods: Developed for APIs and finished dosage forms.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA).
• BE Statistics: Conducted based on WHO and ICH harmonized BE criteria accepted by NAFDAC.
• Power & Sample Size: Designed to ensure statistically conclusive BE results.
📑 NAFDAC-Ready Regulatory Documentation
We provide complete submission-ready documentation aligned to NAFDAC’s Drug Registration & Clinical Trial Directorate, including:
• Clinical Study Protocol (NAFDAC-compliant)
• Informed Consent Forms (ICF) following NHREC ethical requirements
• Investigator Brochure
• Clinical Study Report (CSR) structured per ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules (1–5) formatted for NAFDAC drug registration
✨ Why Choose BioEquiGlobal for the Nigerian Market?
• NAFDAC-Focused Expertise: All BE protocols, analytical validation, PK analyses, and dossier formats tailored to Nigerian regulatory expectations.
• Global Standards: GCP-, GLP-, WHO-, and ICH-compliant operations with strong internal QA frameworks.
• Advanced Infrastructure: Accredited clinical units and precision analytical laboratories (including NABL-certified labs where applicable).
• International Regulatory Capability: Preparation of CTD dossiers for NAFDAC and global authorities (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Nigeria
Feasibility & Gap Assessment: Product review, availability of reference standard, dissolution evaluation, and biowaiver eligibility.
Protocol Development: Drafting NAFDAC-compliant BA/BE protocols and obtaining NHREC ethics approval.
Analytical Method Development: LC-MS/MS method development and validation as per ICH M10 and WHO TRS.
Clinical Execution: GCP-guided volunteer recruitment, dosing, sample collection, and safety supervision.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and full statistical BE assessment.
Documentation & Submission: Delivery of NAFDAC-ready CSR, dissolution report, validation package, and CTD modules.
Who We Support
• Nigerian pharmaceutical manufacturers seeking NAFDAC approval
• CROs needing BA/BE outsourcing or bioanalytical services
• Regulatory teams requiring NAFDAC-compliant CTD dossiers