🇹🇩 Bioavailability & Bioequivalence (BA/BE) Studies Services for Chad
ANRP-Chad–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 framework of Chad’s Agence Nationale de Régulation Pharmaceutique (ANRP-Chad).
All studies comply with ICH, WHO TRS, GCP, GLP, and the pharmaceutical registration guidelines recognized by the Ministry of Public Health and National Solidarity of Chad.
💊 Core Services for Chad (ANRP) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel study designs accepted by ANRP.
• Volunteer Selection: Healthy volunteers or patient groups depending on therapeutic requirements.
• Ethics Approval: Approval by a recognized Ethics Committee/IRB in Chad.
• Protocol Development: ANRP-aligned study protocols developed in line with ICH E6 (R2) GCP and WHO TRS recommendations.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Mandatory for generic drug registration and post-approval variations in Chad.
• Dissolution Media: Biorelevant and pharmacopeial dissolution media.
• Similarity Factor: Calculation of f2 similarity factor for dissolution comparison.
• Evaluation Approaches: Includes model-independent (f1, f2) and model-dependent modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Developed according to WHO TRS, ICH Q6A, and scientific frameworks recognized by Chad's regulatory authority.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Modeling: Supports regulatory acceptance of biowaivers and BE assessments.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV methods for quantitative bioanalysis.
• Validation: Conducted according to ICH M10, WHO TRS, and ANRP-acceptable standards.
• Stability-Indicating Methods: Developed for APIs and finished formulations.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• BE Statistics: Conducted using ICH and WHO harmonized statistical methodologies.
• Power & Sample Size: Determined to ensure conclusive bioequivalence demonstration.
📑 ANRP-Chad–Ready Regulatory Documentation
We prepare complete drug registration documentation in accordance with the requirements of ANRP-Chad, including:
• Clinical Study Protocol (Chad-compliant)
• Informed Consent Forms (ICF) aligned with local ethical standards
• Investigator Brochure
• Clinical Study Report (CSR) structured per ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for ANRP regulatory submissions
✨ Why Choose BioEquiGlobal for the Chadian Market?
• Chad-Focused Expertise: All BE protocols, analytical documents, and dossier formats match ANRP requirements.
• High-Quality Standards: Compliance with GCP, GLP, WHO, and ICH supported by strong internal QA systems.
• Advanced Infrastructure: Modern clinical units and high-performance analytical laboratories (including NABL-certified labs where applicable).
• Global Submission Support: CTD/ACTD dossier preparation for Chad and agencies such as US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and others.
🗺️ BA/BE Study Workflow for Chad
Feasibility & Gap Assessment: Review of reference products in Chad, BCS biowaiver eligibility, and dissolution requirements.
Protocol Development: Drafting ANRP-compliant BA/BE protocols and assisting with Ethics Committee approvals.
Analytical Method Development: LC-MS/MS method creation and validation per ICH M10 and WHO TRS.
Clinical Execution: GCP-supervised volunteer recruitment, dosing, sample collection, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical evaluation.
Documentation & Submission: Preparation of ANRP-ready CSR, dissolution data, validation documents, and CTD/ACTD modules.
Who We Support
• Chadian pharmaceutical manufacturers seeking ANRP drug registration
• CROs requiring BA/BE outsourcing or analytical support
• Regulatory teams needing Chad ANRP–compliant CTD/ACTD dossiers