🇸🇱 Bioavailability & Bioequivalence (BA/BE) Studies Services for Sierra Leone
PBSL-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the requirements of the Pharmacy Board of Sierra Leone (PBSL).
All studies strictly follow PBSL guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring compliance for national pharmaceutical submissions and international regulatory acceptance.
💊 Core Services for Sierra Leone (PBSL) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel models recognized by PBSL.
• Volunteer Selection: Healthy volunteers or patient-based studies, depending on therapeutic area.
• Ethics Approval: Required approval from a national Ethics Committee/IRB in Sierra Leone.
• Protocol Development: PBSL-aligned BA/BE study protocols prepared according to ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Essential for generic submissions, variations, and formulation equivalence testing.
• Dissolution Media: Pharmacopeial and biorelevant media as per PBSL guidelines.
• Similarity Factor: Calculation of f2 similarity factor to compare dissolution behavior.
• Evaluation Models: Includes model-independent (f1, f2) and model-dependent analysis.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared per WHO TRS, ICH Q6A, and scientific standards accepted by PBSL.
• IVIVC Modeling: Level A, B, and C correlation models for predictive bioperformance analysis.
• Predictive PK Modeling: Supports regulatory justification for biowaiver eligibility.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV systems for accurate quantitative analysis.
• Validation: Conducted as per ICH M10, WHO TRS, and PBSL-compatible validation guidelines.
• Stability-Indicating Methods: Developed for APIs and finished formulations.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Conducted using ICH and WHO harmonized methods accepted by PBSL.
• Sample Size & Power: Scientifically determined to ensure reliable BE conclusions.
📑 PBSL-Ready Regulatory Documentation
We prepare comprehensive regulatory documentation suitable for submission to the Pharmacy Board of Sierra Leone, including:
• Clinical Study Protocol (Sierra Leone–compliant)
• Informed Consent Forms (ICF) aligned with national 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 PBSL submissions
✨ Why Choose BioEquiGlobal for the Sierra Leone Market?
• Local Regulatory Alignment: All BE protocols, analytical methods, PK reports, and dossier formats meet PBSL expectations.
• High International Standards: Compliance with GCP, GLP, WHO TRS, and ICH guidelines, supported by strong internal QA frameworks.
• Advanced Clinical & Analytical Facilities: Accredited clinical units and advanced analytical laboratories (including NABL-certified facilities where applicable).
• Global Regulatory Expertise: CTD/ACTD dossier preparation for PBSL and major authorities including US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.
🗺️ BA/BE Study Workflow for Sierra Leone
Feasibility & Gap Assessment: Evaluation of reference product availability and biowaiver possibilities.
Protocol Development: Drafting PBSL-compliant BA/BE study protocols and assisting with Ethics Committee approval.
Analytical Method Development: LC-MS/MS method development and validation per ICH M10 and WHO TRS.
Clinical Execution: GCP-guided volunteer recruitment, dosing, sampling, and medical supervision.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical analysis.
Documentation & Submission: Preparation of PBSL-ready CSR, dissolution reports, analytical validation documents, and CTD/ACTD modules.
Who We Support
• Sierra Leone pharmaceutical manufacturers seeking PBSL approval
• CROs requiring BA/BE outsourcing or analytical services
• Regulatory teams needing PBSL-compliant CTD/ACTD dossiers