🇹🇷 Bioavailability & Bioequivalence (BA/BE) Studies Services for Turkey
TİTCK-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the regulatory requirements of the Turkish Medicines and Medical Devices Agency (TİTCK).
All studies follow TİTCK Bioequivalence Guidelines, ICH, WHO TRS, GCP, GLP, and EU harmonized scientific standards to fully support pharmaceutical submissions in Türkiye and international markets.
💊 Core Services for Turkey (TİTCK) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BE studies using crossover or parallel designs required by TİTCK.
• Volunteer Selection: Healthy volunteers or patient-based studies depending on the product category.
• Ethics Approval: Approval from a TİTCK-recognized Ethics Committee (EC) following Ministry of Health regulations.
• Protocol Development: TİTCK-aligned study protocols based on ICH E6 (R2) GCP, WHO TRS, and EU/EMA BE standards.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug submissions, variations, and post-approval changes in Türkiye.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Factor: Use of f2 similarity factor to compare dissolution profiles of test and reference formulations.
• Evaluation Models: Model-independent (f1, f2) and model-dependent analysis.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, EMA guidance, and TİTCK-supported principles.
• IVIVC Modeling: Level A, B, and C models for predictive correlation.
• PK Predictive Modeling: Dissolution–PK modeling for regulatory justification.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical technologies.
• Validation: Conducted in accordance with ICH M10, WHO TRS, EMA guidelines, and accepted TİTCK standards.
• Stability Studies: Stability-indicating methods for APIs and finished dosage forms.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Performed according to ICH, WHO, and EMA harmonized BE methodologies recognized by TİTCK.
• Sample Size Optimization: Power analysis and design calculations aligned with regulatory expectations.
📑 TİTCK-Ready Regulatory Documentation
We prepare complete regulatory dossiers suitable for submission to the Turkish Medicines and Medical Devices Agency (TİTCK), including:
• Clinical Study Protocol (Türkiye-compliant)
• Informed Consent Forms (ICF) aligned with Turkish EC requirements
• Investigator Brochure
• Clinical Study Report (CSR) as per ICH & EMA structures
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules 1–5 formatted for TİTCK drug registration
✨ Why Choose BioEquiGlobal for the Turkish Market?
• Regulatory Precision: Study protocols, dissolution testing, PK analysis, and documentation tailored to TİTCK requirements.
• High Compliance Standards: Full adherence to GCP, GLP, ICH, WHO TRS, and EMA-aligned quality requirements.
• Advanced Clinical & Analytical Capabilities: Accredited clinical units and high-performance analytical laboratories (including NABL-certified labs where applicable).
• Global Submission Expertise: Dossiers prepared for TİTCK as well as US FDA, EMA, MHRA, TGA, GCC, ASEAN, SAHPRA, and other international authorities.
🗺️ BA/BE Study Workflow for Turkey
Feasibility & Regulatory Assessment: Evaluation of Turkish reference products, dissolution requirements, and biowaiver eligibility.
Protocol Development: Drafting TİTCK-compliant BA/BE protocols and facilitating Ethics Committee approval.
Analytical Method Development: LC-MS/MS method creation and validation per ICH M10 and EMA/WHO TRS guidelines.
Clinical Execution: GCP-based volunteer recruitment, dosing, sampling, and monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE evaluation.
Documentation & Submission: Preparation of TİTCK-ready CSR, dissolution data, validation reports, and CTD Modules 1–5.
Who We Support
• Turkish pharmaceutical companies seeking TİTCK approval
• CROs requiring BE, analytical, or documentation outsourcing
• Regulatory teams needing TİTCK-compliant CTD dossiers