Bioavailability & Bioequivalence (BA/BE) Studies for Zanzibar
ZFDA-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, specifically aligned with the regulatory framework of the Zanzibar Food and Drug Agency (ZFDA).
All studies are conducted according to ZFDA Guidelines, WHO TRS, ICH standards, GCP, and GLP, ensuring acceptance for Zanzibar’s drug registration and international submissions.
💊 Core Services for Zanzibar (ZFDA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose BA/BE studies using crossover or parallel designs accepted by ZFDA.
• Volunteer Selection: Healthy subjects or patient cohorts depending on the drug category.
• Ethics Approval: Required from the Zanzibar Health Research Institute (ZHRI) Ethics Committee or another recognized IRB.
• Protocol Development: ZFDA-aligned protocols prepared according to ICH E6 (R2) GCP and WHO TRS recommendations.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Mandatory for generic submissions, variations, and post-approval quality equivalence testing.
• Dissolution Media: Pharmacopeial & biorelevant media used to meet ZFDA expectations.
• Similarity Factor: f2 similarity factor calculated for comparing dissolution profiles.
• Evaluation Methods: Includes both model-independent (f1, f2) and model-dependent modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared per WHO TRS, ICH Q6A, and ZFDA-compatible scientific principles.
• IVIVC Models: Level A, B, and C predictive in vitro–in vivo correlation models.
• Predictive PK Modeling: Used for regulatory justification of biowaiver applications.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical systems for drug quantification.
• Validation: Conducted according to ICH M10, WHO TRS, and validation requirements recognized by ZFDA.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Conducted using WHO and ICH harmonized statistical principles accepted by ZFDA.
• Sample Size & Power: Scientifically determined for conclusive BE outcomes.
📑 ZFDA-Ready Regulatory Documentation
We prepare complete documentation suitable for submission to the Zanzibar Food and Drug Agency (ZFDA), including:
• Clinical Study Protocol (Zanzibar-compliant)
• Informed Consent Forms (ICF) aligned with Zanzibar’s ethical requirements
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) formatted for ZFDA submissions
✨ Why Choose BioEquiGlobal for the Zanzibar Market?
• ZFDA-Focused Expertise: All BA/BE study protocols, dissolution profiles, PK analyses, and CTD dossiers developed according to ZFDA standards.
• High Global Standards: Operations fully compliant with GCP, GLP, ICH, and WHO TRS guidelines, supported by robust QA.
• Advanced Infrastructure: Accredited clinical facilities and high-performance analytical laboratories (including NABL-certified labs where applicable).
• Global Regulatory Experience: CTD/ACTD dossier preparation for ZFDA and other global agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Zanzibar (ZFDA)
Feasibility & Gap Assessment: Evaluation of reference drug availability, dissolution suitability, and biowaiver potential.
Protocol Development: Drafting ZFDA-compliant BA/BE protocols and facilitating ZHRI Ethics Committee approval.
Analytical Method Development: LC-MS/MS method development and validation per ICH M10 & WHO TRS.
Clinical Study Execution: GCP-supervised subject recruitment, dosing, sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and statistical BE evaluation.
Documentation & Submission: Preparation of ZFDA-ready CSR, dissolution reports, validation packages, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers targeting Zanzibar’s ZFDA market
• CROs needing BA/BE or analytical outsourcing
• Regulatory teams requiring ZFDA-compliant CTD/ACTD dossiers