Development and Validation of Dissolution Procedures (On-Demand)

Curriculum

This course has been entirely revised in order to reflect the content of the complete overhaul of USP General Chapter <1092> published in USP 38–NF 33 First Supplement with the official date of August 1, 2015. 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 patches, and suppositories. They are important components of the specifications that establish the strength, quality, purity, and bioavailability of a drug product.

The live version of this webcast took place on May 7-8, 2018. This curriculum includes eight videos, that were recorded durring the live two day course.The accompanying USP General Chapter(s) available as resources with this on-demand course, were official as of this date. Please check www.uspnf.com for relevant updates.

Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.

By taking this course, you will learn:

  • Development of dissolution and drug release testing methods base on physicochemical characterization of drug substances
  • Physiological considerations when setting up tests
  • Selection of dissolution testing conditions, such as instruments and media, etc.
  • Automation
  • Interpretation of dissolution test results
  • Validation
  • Performance verification tests

Who Should Participate?:

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