🇹🇬 Bioavailability & Bioequivalence (BA/BE) Studies Services for Togo
DPML-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 aligned with the regulatory requirements of Togo’s Direction de la Pharmacie, du Médicament et des Laboratoires (DPML).
All studies strictly follow DPML guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for national drug registration and international dossier acceptance.
💊 Core Services for Togo (DPML) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel formats recognized by DPML.
• Volunteer Selection: Healthy volunteers or patient studies depending on therapeutic requirements.
• Ethics Approval: Approval from a recognized Comité National d’Éthique/IRB in Togo.
• Protocol Development: DPML-aligned BA/BE protocols developed according to ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic submissions, formulation changes, and therapeutic equivalence assessments.
• Dissolution Media: Pharmacopeial and biorelevant media to satisfy DPML expectations.
• Similarity Factor: f2 similarity factor for dissolution profile comparison.
• Evaluation Approaches: Model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and DPML-recognized scientific methodology.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Modeling: Supports regulatory justification for biowaiver applications.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV instrumentation for accurate bioanalysis.
• Validation: Conducted per ICH M10, WHO TRS, and DPML-acceptable validation criteria.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical dosage forms.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Based on WHO and ICH harmonized BE methods recognized by DPML.
• Study Power & Sample Size: Determined to ensure conclusive BE results.
📑 DPML Togo–Ready Regulatory Documentation
We prepare complete regulatory documentation tailored to Togo’s Direction de la Pharmacie, du Médicament et des Laboratoires, including:
• Clinical Study Protocol (Togo-compliant)
• Informed Consent Forms (ICF) following national ethical requirements
• Investigator Brochure
• Clinical Study Report (CSR) compliant with ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules structured for DPML submissions
✨ Why Choose BioEquiGlobal for the Togolese Market?
• DPML-Focused Regulatory Expertise: BE protocols, PK reports, dissolution studies, and CTD dossier preparation aligned with Togo’s regulations.
• International Quality Systems: Compliance with GCP, GLP, WHO TRS, and ICH standards supported by strong internal QA processes.
• Advanced Facilities: Accredited clinical units and high-performance analytical laboratories (including NABL-certified facilities where applicable).
• Global Dossier Capabilities: CTD/ACTD submissions for DPML and global agencies such as US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.
🗺️ BA/BE Study Workflow for Togo
Feasibility & Gap Assessment: Evaluation of reference product availability, dissolution requirements, and BCS biowaiver potential.
Protocol Development: Drafting DPML-compliant BA/BE protocols and facilitating Ethics Committee approvals.
Analytical Method Development: LC-MS/MS assay development and validation as per ICH M10 & WHO TRS guidelines.
Clinical Execution: GCP-supervised recruitment, dosing, sampling, and safety oversight.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and full BE statistical assessment.
Documentation & Submission: Preparation of DPML-ready CSR, dissolution profile, validation package, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers in Togo seeking DPML authorization
• CROs requiring BA/BE outsourcing or analytical services
• Regulatory teams needing DPML-compliant CTD/ACTD dossiers