Development and Validation of Dissolution Procedures (Live Webcast)

This course discusses the recommendations for dissolution method development and validation stated in the USP General Chapter <1092>. Building on your basic understanding of USP’s approach to dissolution, this course provides a foundation for developing and validating dissolution methods used for batch release and stability testing. These tests are in vitro performance tests for most dosage forms, such as tablets, capsules, suspensions, transdermal systems, suppositories, and other pharmaceutical dosage forms. They are important components of the specifications that establish the strength, quality, purity, and bioavailability of a drug product.
By taking this course, you will learn:

• Describe development of dissolution and drug release testing methods based on physicochemical characterization of drug substances
• Identify physiological considerations when setting up tests
• List dissolution testing conditions, such as instruments and media, etc.
• Describe automation, validation and interpretation of dissolution test results
• Describe performance verification tests

Who Should Participate:

• Scientists
• Chemists who perform dissolution testing
• Lab managers
• Product/formulation development
• Regulatory professionals