Dissolution Testing in Pharma - From Development to Regulatory Approval

Dissolution testing is a critical performance test in pharmaceutical development, ensuring drug bioavailability, effectiveness, and quality control. Regulatory agencies like the FDA, USP, and ICH emphasize its importance in drug formulation, validation, and batch consistency.

This expert-led webinar will provide a comprehensive understanding of dissolution, covering scientific principles, apparatus selection, regulatory requirements, and method validation. Learn how to optimize dissolution testing to enhance drug performance, meet compliance standards, and prevent regulatory setbacks.

WHY YOU SHOULD ATTEND:

Inconsistent or inadequate dissolution testing can lead to batch failures, regulatory warnings, and product recalls. Without a strong dissolution strategy, ensuring drug bioavailability, stability, and compliance becomes challenging.

By attending this webinar, you will:

• Understand the science behind dissolution and its impact on drug bioavailability.
• Learn regulatory expectations from FDA, USP <711>, and ICH Q6A.
• Master apparatus selection, calibration, and method validation techniques.
• Gain insights into IVIVC (In Vitro-In Vivo Correlation) for predicting drug absorption.
• Avoid common dissolution pitfalls that lead to FDA 483 findings.

AREAS COVERED:

• Fundamentals of Dissolution Testing: Definitions, scientific principles, and real-world applications.
• Regulatory Framework & Compliance: Understanding FDA, USP <711>, ICH Q2(R2), and 21 CFR Part 211 dissolution guidelines.
• Dissolution Apparatus & Calibration: Overview of USP Apparatus 1-7, mechanical calibration, and Performance Verification Testing (PVT).
• Factors Affecting Dissolution Rate: Particle size, pKa, solubility, diffusion layer models (Noyes-Whitney, Fick’s Law), and more.
• Developing Discriminating Dissolution Methods: Establishing quality attributes and ensuring method robustness.
• In Vitro-In Vivo Correlation (IVIVC): How to predict bioavailability and absorption based on dissolution data.
• Dissolution in Formulation Development: Impact of polymorphism, excipients, and manufacturing processes.
• Validation & Life Cycle Management: Implementing phase-appropriate validation and continuous improvement strategies.
• Troubleshooting & FDA 483 Avoidance: Common failures, root cause analysis, and corrective actions.

WHO SHOULD ATTEND:

• Quality Assurance Departments
• Quality Control Departments
• Research and Development Departments
• Analytical & Formulation Development
• Regulatory Affairs Departments
• Compliance Departments
• Manufacturing Departments
• CMC & Process Development Professionals
• GMP Auditors & Lab Scientists

Course Director: SCOTT R. THATCHER

Scott Thatcher is a 20+ year veteran of the pharma/biopharma industry. He is a published author in analytical chemistry and photostability studies.  He has contributed to the CMC development and launch of multiple drug programs in different delivery systems. He has executed stress studies for the development and validation of 100s of analytical methods. He is an expert in the interpretation of the ICH Q1B guideline and has contributed to multiple regulatory submissions that met regulatory requirements and subsequent agency approval.