🇰🇪 Bioavailability & Bioequivalence (BA/BE) Studies Services for Kenya
PPB Kenya–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 the Pharmacy and Poisons Board (PPB Kenya).
All studies strictly comply with PPB guidelines, ICH, WHO TRS, GCP, GLP, ensuring full acceptability for Kenyan drug registration and global submissions.
💊 Core Services for Kenya (PPB) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by PPB.
• Volunteer Selection: Healthy volunteers or patient-based studies, as required by therapeutic class.
• Ethics Approval: Approval from a recognized Institutional Review Board (IRB)/Ethics Committee, accredited under Kenyan law.
• Protocol Development: PPB-aligned protocols developed in accordance with ICH E6 (R2) GCP and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug registration and post-approval variations in Kenya.
• Dissolution Media: Pharmacopeial and biorelevant media suitable for PPB guidelines.
• Similarity Factor: f2 similarity factor used for dissolution comparison between test and reference products.
• Evaluation Approaches: Model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared based on WHO TRS, ICH Q6A, and PPB-recognized scientific frameworks.
• IVIVC Models: Level A, B, and C models to correlate in vitro dissolution with in vivo performance.
• Predictive PK Modeling: Supports regulatory justification for BE waivers.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical technologies.
• Validation: Conducted following ICH M10, WHO TRS, and PPB-acceptable validation standards.
• Stability Studies: Stability-indicating analytical methods for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA).
• BE Statistics: Statistical evaluation conducted per ICH and WHO harmonized frameworks recognized by PPB.
• Sample Size & Power: Calculated using scientifically validated approaches.
📑 PPB Kenya–Ready Regulatory Documentation
We prepare complete registration-ready documentation aligned with the Pharmacy and Poisons Board (PPB Kenya), including:
• Clinical Study Protocol (Kenya-compliant)
• Informed Consent Forms (ICF) per Kenyan biomedical ethics regulations
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO structures
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for PPB submissions
✨ Why Choose BioEquiGlobal for the Kenyan Market?
• Kenya Regulatory Expertise: BE protocols, PK analyses, dissolution profiles, and CTD dossiers aligned with PPB standards.
• Global-Quality Systems: Full compliance with GCP, GLP, WHO TRS, and ICH guidelines backed by strong QA oversight.
• Advanced Infrastructure: Accredited clinical units and NABL-certified analytical labs where applicable.
• International Dossier Capability: Preparation of CTD/ACTD submissions for PPB and other agencies including US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and ASEAN regulators.
🗺️ BA/BE Study Workflow for Kenya
Feasibility & Gap Assessment: Review of reference product availability, dissolution requirements, and biowaiver eligibility.
Protocol Development: Drafting PPB-compliant BA/BE protocols and facilitating Ethics Committee approvals.
Analytical Method Development: LC-MS/MS method creation and validation per ICH M10 & WHO TRS guidelines.
Clinical Execution: GCP-guided recruitment, dosing, sampling, and medical oversight.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE assessment.
Documentation & Submission: Preparation of PPB-ready CSR, validation data, dissolution profiles, and CTD/ACTD modules.
Who We Support
• Kenyan pharmaceutical manufacturers seeking PPB approval
• CROs needing BA/BE outsourcing or analytical development
• Regulatory teams requiring PPB-compliant CTD/ACTD dossiers