🇵🇭 Bioavailability & Bioequivalence (BA/BE) Studies Services for the Philippines

FDA Philippines–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 tailored to the regulatory requirements of the Food and Drug Administration (FDA Philippines) under the Center for Drug Regulation and Research (CDRR).

Our studies are conducted in full compliance with ICH, WHO TRS, ASEAN Guidelines for the Conduct of Bioequivalence Studies, GCP, GLP, and FDA Philippines drug registration standards.

💊 Core Services for Philippines (FDA/CDRR) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by CDRR.
• Volunteer Selection: Healthy volunteers or patient studies depending on therapeutic indication and regulatory requirements.
• Ethics Approval: Clearance from a certified Institutional Review Board (IRB) in accordance with Philippine Health Research Ethics Board (PHREB) guidelines.
• Protocol Development: FDA Philippines–aligned protocols based on ICH E6 (R2) GCP, WHO TRS, and ASEAN guidelines.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Required for generic drug applications, post-approval variations, and dossier updates under FDA Philippines regulations.
• Dissolution Media: Biorelevant and pharmacopeial media as per ASEAN and FDA requirements.
• Similarity Assessment: Calculation of f2 similarity factor for comparing dissolution profiles.
• Evaluation Techniques: Model-independent (f1, f2) and model-dependent dissolution approaches.

IVIVC & Biowaiver Support

• BCS Biowaiver: Prepared according to ASEAN, WHO TRS, ICH Q6A, and FDA Philippines standards.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Modeling: In vitro–in vivo performance modeling to support regulatory acceptance.

Analytical Method Development & Validation

• Platforms: LC-MS/MS and HPLC-UV systems for high-precision drug analysis.
• Validation: Conducted as per ICH M10, WHO, and FDA Philippines–recognized validation guidelines.
• Stability-Indicating Methods: Developed for APIs and finished products.

Pharmacokinetic (PK) Analysis

• PK Modeling: Non-compartmental analysis (NCA).
• BE Statistical Analysis: Statistical BE calculations following ICH, WHO, and ASEAN harmonized requirements.
• Sample Size & Power: Designed to meet the regulatory expectations of the CDRR.

📑 FDA Philippines–Ready Regulatory Documentation

We prepare complete pharmaceutical registration dossiers for the FDA Philippines – Center for Drug Regulation and Research (CDRR), including:

• Clinical Study Protocol (Philippines-aligned)
• Informed Consent Forms (ICF) as per PHREB ethical guidelines
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & ASEAN structures
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for FDA Philippines submissions

✨ Why Choose BioEquiGlobal for the Philippine Market?

• Local Regulatory Expertise: Protocols, analytical documents, and BE reports tailored to FDA Philippines and ASEAN regulatory frameworks.
• Quality & Compliance: Operations aligned with GCP, GLP, WHO TRS, ASEAN guidelines, and strong internal QA oversight.
• Advanced Infrastructure: Accredited clinical facilities and high-precision analytical laboratories (including NABL-certified labs where applicable).
• Global Submission Strength: Dossiers prepared for FDA Philippines and global authorities such as US FDA, EMA, GCC, MHRA, TGA, ASEAN, and African regulators.

🗺️ BA/BE Study Workflow for the Philippines

1. Feasibility & Gap Assessment: Evaluation of reference product availability in the Philippines and BCS/biowaiver eligibility.

2. Protocol Development: Preparation of FDA Philippines–compliant BA/BE protocols and support for IRB approval.

3. Analytical Method Development: LC-MS/MS method creation and validation per ICH M10 and ASEAN requirements.

4. Clinical Study Execution: Volunteer recruitment, dosing, sampling, and medical monitoring under GCP compliance.

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

6. Documentation & Submission: Preparation of FDA Philippines–ready CSR, dissolution profile, validation data, and CTD/ACTD modules.

Who We Support

• Philippine pharmaceutical companies seeking FDA CDRR drug registration
• CROs requiring BA/BE outsourcing or bioanalytical support
• Regulatory affairs teams needing FDA Philippines–compliant CTD/ACTD dossiers