🇧🇴 Bioavailability & Bioequivalence (BA/BE) Studies Services for Bolivia
AGEMED–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling, aligned with Bolivia’s regulatory requirements under:
AGEMED – Agencia Estatal de Medicamentos y Tecnologías en Salud
Ministerio de Salud y Deportes (MSyD)
All studies strictly follow AGEMED regulations, ICH guidelines, WHO TRS, GCP, and GLP, ensuring full compliance for pharmaceutical submissions in Bolivia and broader Latin American markets.
💊 Core Services for Bolivia (AGEMED) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose crossover or parallel BE study designs accepted by AGEMED.
• Volunteer Selection: Healthy volunteers or patient groups depending on therapeutic indication.
• Ethics Approval: Mandatory approval from a Bolivian Comité de Ética en Investigación (CEI).
• Protocol Development: Prepared in accordance with ICH E6 (R2) GCP, WHO TRS, and AGEMED’s regulatory framework.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generics, post-approval changes, and pharmaceutical equivalence assessments.
• Dissolution Media: Pharmacopeial and biorelevant media accepted by AGEMED.
• Similarity Factor: f2 similarity factor for dissolution profile comparison.
• Evaluation Approaches: WHO/ICH-aligned model-independent (f1, f2) and model-dependent methods.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and AGEMED scientific criteria.
• IVIVC Modeling: Level A, B, and C correlation models for in vitro–in vivo predictability.
• Predictive PK Modeling: Supports regulatory justification for biowaivers and BE strategy optimization.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV analytical platforms for precise quantification.
• Validation: Conducted per ICH M10, WHO TRS, and AGEMED-recognized validation requirements.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Analysis: Non-compartmental analysis (NCA).
• Statistical BE Testing: Performed using WHO/ICH harmonized statistical methods.
• Sample Size & Power: Scientifically computed for conclusive BE outcomes.
📑 Bolivia AGEMED–Ready Regulatory Documentation
We prepare complete regulatory documentation for submissions to AGEMED, including:
• Clinical Study Protocol (Bolivia-compliant)
• Informed Consent Forms (ICF) meeting CEI/ethical guidelines
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) tailored for AGEMED submission
✨ Why Choose BioEquiGlobal for the Bolivian Market?
• Regulatory Expertise: BE protocols, dissolution studies, and CTD dossiers aligned with AGEMED standards.
• Global-Standard Compliance: Strict adherence to GCP, GLP, WHO TRS, and ICH guidelines supported by robust QA systems.
• Advanced Clinical & Analytical Facilities: Accredited clinical units and cutting-edge analytical laboratories (including NABL-certified labs).
• Regional & International Support: CTD dossiers prepared for Bolivia and major international agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Bolivia
Feasibility & Gap Assessment: Evaluation of reference product availability, dissolution comparison, and biowaiver eligibility.
Protocol Development: Drafting AGEMED-compliant BA/BE protocols and securing CEI ethics approval.
Analytical Method Development: LC-MS/MS method design & validation per ICH M10 & WHO TRS.
Clinical Study Execution: GCP-supervised dosing, sampling, monitoring, and medical oversight.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and statistical BE assessment.
Documentation & Submission: Preparation of AGEMED-ready CSR, dissolution profile, validation package, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers targeting Bolivia and Latin American markets
• CROs requiring BA/BE or analytical outsourcing
• Regulatory teams needing AGEMED-compliant CTD/ACTD dossiers