🇬🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Guinea
DNPL–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 customized for the regulatory requirements of Guinea’s Direction Nationale de la Pharmacie et du Laboratoire (DNPL) under the Ministry of Health.
All studies strictly follow ICH, WHO TRS, GCP, GLP, and internationally recognized regulatory standards accepted by DNPL to support pharmaceutical registration in Guinea and other international markets.
💊 Core Services for Guinea (DNPL) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs recognized by DNPL.
• Volunteer Selection: Healthy volunteers or patient studies depending on the therapeutic indication.
• Ethics Approval: Approval from a registered Ethics Review Committee (ERC/IRB) in accordance with Guinean health regulations.
• Protocol Development: Protocols aligned with WHO TRS, ICH E6 (R2) GCP, and DNPL requirements for pharmaceutical evaluation.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug registration and post-approval changes under DNPL guidelines.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Factor: Calculation of f2 similarity factor for dissolution comparison between test and reference products.
• Evaluation Models: Model-independent (f1, f2) and model-dependent analytical approaches.
IVIVC & Biowaiver Support
• BCS Biowaiver: Developed following WHO TRS, ICH Q6A, and DNPL-recognized scientific principles.
• IVIVC Models: Level A, B, and C in vitro–in vivo predictive correlations.
• Predictive PK Modeling: Dissolution–PK relationship modeling to support regulatory acceptance.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV systems for accurate and validated drug quantification.
• Validation: Conducted as per ICH M10, WHO TRS, and globally accepted analytical validation standards used by DNPL.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Modeling: Non-compartmental PK analysis (NCA) for BA/BE study evaluation.
• BE Statistics: Statistical BE assessment aligned with ICH and WHO guidelines accepted by DNPL.
• Study Optimization: Sample-size and power calculations for optimal study design.
📑 DNPL-Ready Regulatory Documentation
We prepare complete drug registration documentation for submission to the Direction Nationale de la Pharmacie et du Laboratoire (DNPL) in Guinea:
• Clinical Study Protocol (DNPL-aligned)
• Informed Consent Forms (ICF) per Guinea ethical requirements
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO structures
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for Guinea drug registration procedures
✨ Why Choose BioEquiGlobal for the Guinean Market?
• DNPL-Focused Regulatory Alignment: All study protocols, PK reports, and dissolution evaluations prepared to meet Guinea’s regulatory requirements.
• High-Quality Standards: Operations aligned with GCP, GLP, WHO TRS, supported by strong internal QA systems.
• Advanced Facility Capabilities: Accredited clinical units and high-standard analytical laboratories (including NABL-certified labs where applicable).
• International Dossier Preparation: Expertise in CTD/ACTD dossier development for Guinea, as well as US FDA, EMA, MHRA, TGA, GCC, and African regulators.
🗺️ BA/BE Study Workflow for Guinea
Feasibility & Gap Assessment: Review of reference products in Guinea, dissolution method suitability, and biowaiver eligibility.
Protocol Development: Preparation of DNPL-compliant BA/BE protocols and support for Ethics Committee approval.
Analytical Method Development: LC-MS/MS method development and validation following ICH M10 & WHO TRS.
Clinical Execution: GCP-monitored volunteer recruitment, dosing, sampling, and safety assessment.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and statistical BE analysis.
Documentation & Submission: Preparation of DNPL-ready reports (CSR, dissolution profile, method validation) and CTD/ACTD dossier modules.
Who We Support
• Guinean pharmaceutical manufacturers seeking DNPL drug registration
• CROs and distributors requiring BA/BE outsourcing or analytical support
• Regulatory teams needing DNPL-compliant CTD/ACTD dossiers