🇳🇪 Bioavailability & Bioequivalence (BA/BE) Studies Services for Niger
DPM Niger–Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory framework of Niger’s Direction de la Pharmacie et de la Médecine Traditionnelle (DPM).
All studies strictly follow DPM Niger guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for local drug registration and international submissions.
💊 Core Services for Niger (DPM) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by DPM.
• Volunteer Selection: Healthy volunteers or patient populations depending on therapeutic indication.
• Ethics Approval: Approval required from a recognized Comité National d’Éthique/IRB in Niger.
• Protocol Development: Niger-specific BA/BE protocols developed according to ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Necessary for generic registration, dossier variations, and bioequivalence justification.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media recommended for Niger submissions.
• Similarity Assessment: Calculation of f2 similarity factor to compare test and reference profiles.
• Evaluation Techniques: Model-independent (f1, f2) and model-dependent approaches.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared in line with WHO TRS, ICH Q6A, and DPM-accepted scientific guidelines.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Modeling: Supports regulatory justification for BE waiver or reduced clinical requirements.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV systems for accurate bioanalytical assays.
• Validation: Conducted following ICH M10, WHO TRS, and Niger-relevant validation principles.
• Stability-Indicating Methods: Created for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Performed using WHO and ICH harmonized approaches recognized by DPM.
• Sample Size & Power: Scientifically determined for conclusive BE demonstration.
📑 Niger DPM–Ready Regulatory Documentation
We prepare complete regulatory documentation tailored to the Direction de la Pharmacie et de la Médecine Traditionnelle, including:
• Clinical Study Protocol (Niger-compliant)
• Informed Consent Forms (ICF) aligned with national ethics laws
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for DPM submissions
✨ Why Choose BioEquiGlobal for the Niger Market?
• Regulatory Precision: BE protocol development, analytical methods, PK analysis, and CTD preparation aligned with DPM standards.
• International Quality Systems: Full GCP, GLP, WHO TRS, and ICH compliance supported by strong QA infrastructure.
• Modern Analytical & Clinical Capabilities: Accredited clinical units and high-end analytical laboratories (including NABL-certified facilities where applicable).
• Global Dossier Expertise: CTD/ACTD submissions prepared for DPM and global agencies such as US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and others.
🗺️ BA/BE Study Workflow for Niger
Feasibility & Gap Assessment: Evaluation of reference product availability, dissolution requirements, and biowaiver eligibility.
Protocol Development: Drafting DPM-compliant BA/BE study protocols and facilitating Ethics Committee approval.
Analytical Method Development: LC-MS/MS method development and validation per ICH M10 and WHO TRS.
Clinical Execution: GCP-guided recruitment, dosing, sample collection, and medical oversight.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE analysis.
Documentation & Submission: Preparation of Niger DPM–ready CSR, dissolution reports, validation data, and CTD/ACTD modules.
Who We Support
• Niger-based pharmaceutical manufacturers seeking DPM approval
• CROs requiring outsourced BA/BE or analytical services
• Regulatory teams needing DPM-compliant CTD/ACTD dossiers