🇺🇸 Bioavailability & Bioequivalence (BA/BE) Studies Services for the United States
FDA–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides end-to-end Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned entirely with U.S. FDA requirements under:
FDA – Food and Drug Administration
CDER – Center for Drug Evaluation and Research
All studies follow FDA guidance, Product-Specific Guidances (PSG), 21 CFR Part 320, ICH guidelines, GCP, GLP, and WHO TRS, ensuring compliance for ANDA submissions and global approvals.
💊 Core Services for U.S. FDA Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: FDA-required single-dose & multiple-dose BE studies (crossover, parallel, replicate designs).
• Volunteer Selection: Healthy volunteers or patient-specific cohorts based on the product label.
• Ethics & Compliance: Conducted under 21 CFR Parts 50, 56, and IRB-approved protocols.
• Protocol Development: Fully aligned with FDA Product-Specific Guidance (PSG), ICH E6 (R2), and 21 CFR 320.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Used for ANDA submission, waiver of in vivo studies (biowaiver), post-approval changes, and QbD.
• Dissolution Media: FDA-recommended media per PSG and USP.
• Similarity Factor: f2 similarity factor used for profile comparison.
• Evaluation Models: Model-independent (f1, f2) & model-dependent analysis acceptable to the FDA.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to FDA Guidance, WHO TRS, and ICH Q6A.
• Levels of IVIVC: Level A, B, and C correlations to support alternative BE pathways.
• Predictive PK Modeling: Used for formulation optimization and regulatory justification.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV compatible with FDA expectations.
• Validation: As per FDA Bioanalytical Method Validation Guidance (2018) and ICH M10.
• Stability-Indicating Methods: Developed for APIs & finished dosage forms per FDA/ICH.
Pharmacokinetic (PK) Analysis
• Approach: Non-compartmental PK analysis (NCA) performed using FDA-acceptable software.
• Statistical BE Assessment: Based on 90% confidence intervals & FDA BE criteria (80–125%).
• Sample Size & Power: Calculated scientifically per FDA BE variance expectations.
📑 FDA-Ready Regulatory Documentation
We prepare complete documentation specifically formatted for U.S. FDA submissions, including:
• FDA-Compliant BA/BE Protocol
• Informed Consent Forms (ICF) per 21 CFR Part 50
• Investigator Brochure
• Clinical Study Report (CSR) aligned with FDA & ICH E3
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report (per FDA Q&A guidance)
• ANDA CTD Modules (1–5) formatted according to FDA eCTD requirements
✨ Why Choose BioEquiGlobal for the U.S. Market?
• FDA Expertise: BA/BE study designs, analytical methods, and dissolution profiles aligned to FDA Product-Specific Guidances.
• High-Quality Compliance: GCP, GLP, ICH, WHO TRS, and FDA standards with strong QA oversight.
• Modern Clinical & Analytical Infrastructure: Accredited clinical units, NABL-certified labs, and FDA-aligned documentation systems.
• Global Submission Support: ANDA-ready CTD modules, plus EMA, MHRA, TGA, GCC, and other international regulators.
🗺️ BA/BE Study Workflow for the United States
Feasibility & PSG Gap Assessment: Evaluation of FDA PSG, reference product, and biowaiver potential.
Protocol Development: Designing FDA-compliant BE protocols & preparing IRB submissions.
Analytical Method Development: LC-MS/MS validation per FDA & ICH M10.
Clinical Execution: Conducted under full GCP with FDA-aligned sampling windows and monitoring.
Bioanalysis & PK Evaluation: Performs PK modeling, QC, and statistics per 21 CFR 320.
Documentation & Submission: Delivery of FDA-ready CSR, dissolution reports, validation documents, and complete ANDA CTD.
Who We Support
• ANDA filers seeking U.S. market approval
• Generic pharmaceutical manufacturers
• CROs needing BA/BE outsourcing or analytical support
• Regulatory teams requiring FDA eCTD-compliant dossiers