USP Course (II)
"Dissolution - Method Development with Case Studies"
Building on your basic understanding of USP’s approach to dissolution, this course provides a foundation for developing and validating dissolution, disintegration and drug release methods used in product development, batch release and stability testing. These tests are in vitro performance tests for dosage forms, such as tablets, capsules, suspensions, transdermal patches and suppositories. They are important components of the
specifications that establish the strength, quality, purity and bioavailability of a drug product. On the second day, real case studies will be discussed in an interactive group activity.
By taking this course, you will learn about:
• Development of dissolution and drug release testing methods based on physicochemical characterization of drug substances
• Physiological considerations when setting up tests
• Selection of dissolution testing conditions, such as instruments and media
• Interpretation of dissolution test results