🇨🇱 Bioavailability & Bioequivalence (BA/BE) Studies Services for Chile

ISP–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with Chile’s pharmaceutical regulatory framework under:

• ISP – Instituto de Salud Pública de Chile

• Ministerio de Salud (MINSAL)

All studies strictly follow ISP regulations, ICH guidelines, WHO TRS, GCP, and GLP, ensuring compliance for Chilean regulatory submissions and broader Latin American market approvals.

💊 Core Services for Chile (ISP / MINSAL) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose crossover or parallel BE study designs approved by ISP.
• Volunteer Selection: Healthy volunteers or relevant patient groups depending on therapeutic category.
• Ethics Approval: Required approval from a Comité Ético Científico (CEC) accredited in Chile.
• Protocol Development: Prepared in accordance with ICH E6 (R2) GCP, WHO TRS, and ISP’s technical guidelines for BE studies.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Mandatory for pharmaceutical equivalence, generics, formulation changes, and ISP drug registration.
• Dissolution Media: Pharmacopeial and biorelevant media accepted by ISP.
• Similarity Factor: f2 similarity factor for dissolution comparison.
• Evaluation Methods: WHO/ICH-recognized model-independent (f1, f2) and model-dependent approaches.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and ISP biowaiver criteria (when applicable).
• IVIVC Modeling: Level A, B, and C models for in vitro–in vivo correlation.
• Predictive PK Modeling: Supports regulatory justification for biowaiver and BE strategy optimization.

Analytical Method Development & Validation

• Platforms: LC-MS/MS and HPLC-UV analytical systems.
• Validation: Conducted per ICH M10, WHO TRS, and ISP’s analytical validation requirements.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.

Pharmacokinetic (PK) Analysis

• PK Approach: Non-compartmental analysis (NCA).
• BE Statistics: Executed using WHO/ICH harmonized statistical methodologies.
• Sample Size & Power: Scientifically calculated to meet ISP confidence standards.

📑 Chile ISP–Ready Regulatory Documentation

We prepare comprehensive Chile-specific regulatory documentation, including:

• Clinical Study Protocol (Chile/ISP-compliant)
• Informed Consent Forms (ICF) per CEC ethical norms
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) structured for ISP submission

✨ Why Choose BioEquiGlobal for the Chilean Market?

• In-Depth Regulatory Expertise: BE protocols, dissolution studies, analytical validation, and CTD dossiers tailored to ISP requirements.
• International Quality Compliance: GCP, GLP, WHO TRS, and ICH standards enforced through robust QA systems.
• Advanced Clinical & Analytical Facilities: Accredited clinical units and modern analytical laboratories (including NABL-certified labs).
• Global Dossier Support: CTD preparation for Chile and major global authorities (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).

🗺️ BA/BE Study Workflow for Chile

1. Feasibility & Gap Assessment: Reference product feasibility, dissolution assessment, and biowaiver eligibility.

2. Protocol Development: Drafting ISP-compliant BA/BE protocols and securing ethics approval from a CEC.

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

4. Clinical Study Execution: GCP-monitored recruitment, dosing, blood sampling, and medical oversight.

5. Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical analysis.

6. Documentation & Submission: Preparation of ISP-ready CSR, dissolution reports, validation documentation, and CTD/ACTD modules.

Who We Support

• Pharmaceutical companies targeting Chile and the Latin American region
• CROs needing BA/BE outsourcing or analytical services
• Regulatory teams seeking ISP-compliant CTD/ACTD dossiers