Course Overview
Developing a robust In Vitro-In Vivo Correlation (IVIVC) model is one of the most powerful strategies in modern pharmaceutical development. This advanced training module provides a complete blueprint for establishing reliable mathematical models that link laboratory dissolution data with human bioavailability. Designed for pharma professionals, this course will teach you how to reduce the need for expensive clinical trials, streamline post-approval changes, and meet strict global regulatory expectations (including EU-GMP, EMA, and FDA).
What You Will Learn:
- Module 1: Fundamentals of IVIVC
- Understanding the relationship between in vitro dissolution and in vivo pharmacokinetics.
- Biopharmaceutics Classification System (BCS) and its role in IVIVC.
- Module 2: Developing the Mathematical Model
- Level A, B, and C correlations explained.
- Data collection, deconvolution, and convolution techniques.
- Module 3: Regulatory Strategies & Biowaivers
- Navigating EU-GMP and global guidelines for IVIVC submissions.
- How to successfully justify and secure biowaivers.
- Module 4: Practical Applications & Post-Approval Changes (SUPAC)
- Using IVIVC for formulation modifications, scale-ups, and site transfers.
- Troubleshooting common validation failures.
Who Should Enroll?
- Formulation and R&D Scientists
- Regulatory Affairs Professionals
- QA/QC Managers
- Pharmacokineticists and Clinical Researchers
Course Features:
- Duration: 4 Weeks (Online/Self-Paced)
- Language: English (Vietnamese support available upon request)
- Certification: AIM Intellix Certificate of Completion in IVIVC Strategies
Lessons:
