🇾🇪 Bioavailability & Bioequivalence (BA/BE) Studies Services for Yemen
SBDMA-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 regulatory requirements of the Supreme Board of Drugs and Medical Appliances (SBDMA), Yemen.
All studies strictly comply with ICH, WHO TRS, GCP, GLP, and SBDMA’s pharmaceutical registration requirements, ensuring suitability for Yemeni submissions and international markets.
💊 Core Services for Yemen (SBDMA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BE studies using crossover or parallel designs accepted by SBDMA.
• Volunteer Selection: Healthy volunteers or patient-based studies depending on therapeutic class and SBDMA’s expectations.
• Ethics Approval: Required approval from a recognized Institutional Review Board (IRB)/Ethics Committee in Yemen or an internationally certified board.
• Protocol Development: SBDMA-aligned BA/BE protocols developed as per ICH E6 (R2) GCP and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Needed for generic drug registration, dossier variations, and quality assessments under SBDMA guidelines.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Assessment: f2 similarity factor analysis to compare test and reference products.
• Evaluation Methods: Model-independent (f1, f2) and model-dependent dissolution modeling approaches.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and SBDMA-recognized scientific frameworks.
• IVIVC Models: Level A, B, and C predictive models.
• Predictive PK Modeling: Dissolution–PK correlation to justify BE or biowaiver decisions.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical systems designed for sensitive drug quantification.
• Validation: Conducted per ICH M10, WHO TRS, and validation standards accepted by SBDMA.
• Stability-Indicating Methods: Developed for APIs and finished drug products.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA).
• BE Statistical Evaluation: Performed according to ICH and WHO harmonized methodologies recognized by SBDMA.
• Power & Sample Size: Determined using globally accepted BE statistical principles.
📑 SBDMA-Ready Regulatory Documentation
We prepare complete documentation for pharmaceutical product submission to the Supreme Board of Drugs and Medical Appliances (SBDMA), Yemen, including:
• Clinical Study Protocol (Yemen-specific compliance)
• Informed Consent Forms (ICF) aligned with local ethical requirements
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO formats
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for Yemen SBDMA drug registration
✨ Why Choose BioEquiGlobal for the Yemeni Market?
• Local Regulatory Alignment: Study designs, analytical documentation, and dissolution profiles tailored to SBDMA requirements.
• High Compliance: GCP-, GLP-, WHO-, and ICH-driven operations with thorough QA oversight.
• Advanced Clinical & Analytical Facilities: Accredited research units and high-performance analytical laboratories (with NABL certification where applicable).
• Global Dossier Expertise: CTD/ACTD dossier development for SBDMA, as well as agencies such as US FDA, EMA, MHRA, TGA, GCC, ASEAN, SAHPRA, and others.
🗺️ BA/BE Study Workflow for Yemen
Feasibility & Gap Assessment: Review of reference product needs, dissolution methods, and biowaiver eligibility for Yemen.
Protocol Development: Preparation of SBDMA-compliant BA/BE protocols and facilitation of ethical approvals.
Analytical Method Development: LC-MS/MS method design and validation following ICH M10 and WHO TRS requirements.
Clinical Execution: GCP-monitored volunteer/patient recruitment, dosing, sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical assessment.
Documentation & Submission: Preparation of SBDMA-ready CSR, validation documents, dissolution profiles, and CTD/ACTD modules.
Who We Support
• Yemeni pharmaceutical manufacturers seeking SBDMA product registration
• CROs requiring BA/BE outsourcing or analytical method development
• Regulatory teams needing SBDMA-compliant CTD/ACTD dossiers