🇧🇴 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

1. Feasibility & Gap Assessment: Evaluation of reference product availability, dissolution comparison, and biowaiver eligibility.

2. Protocol Development: Drafting AGEMED-compliant BA/BE protocols and securing CEI ethics approval.

3. Analytical Method Development: LC-MS/MS method design & validation per ICH M10 & WHO TRS.

4. Clinical Study Execution: GCP-supervised dosing, sampling, monitoring, and medical oversight.

5. Bioanalysis & PK Evaluation: PK modeling, QC checks, and statistical BE assessment.

6. 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