Advanced Dissolution

Course Description

Drug release and drug product performance explained beyond the mechanics of dissolution testing. Connecting the "how" of dissolution methods to the "why" contained within the USP-NF, this course will strengthen the participant's ability to develop methods, interpret data, and most importantly identify root causes and suggest corrective actions when issues relating to compliance arise.

Who Should Participate

Scientists, Chemists, and Lab Technicians who perform dissolution testing in the lab, Lab Managers, QC, as well as Product Development professional who review dissolution data. These individuals should have a good grasp of how to execute basic dissolution testing.

Format

Traditional classroom, 2 days

Learning Objectives

Provide overview of dissolution, with a focus on formulation development, IVIVC, and quality control
Explore compendial aspects of dissolution – applicable General Chapters and Monographs
Gain thorough understanding of method development
Explain validation, verification, and method transfer as it relates to dissolution
Discuss control of variables, with an emphasis on sources of variability
Demonstrate understanding and application through case study exercises