Skip to main content

Lecture 2: Dissolution Method Development and Validation for Solid Oral Dosage Forms

Want a FREE preview of this lecture? Click Here

Learning Objectives:
  • List/describe the necessary elements of a suitable dissolution method
  • Identify the choices of the components of the dissolution test that are necessary for the test method
  • Describe how to interpret dissolution results to assist in developing the most suitable method
  • List regulatory expectations for a suitable dissolution test
  • Outline the necessary elements of validation of the dissolution test
  • List the criteria for passing validation of the dissolution test elements
  • Describe the utility of Design of experiments (DOE)
  • Describe the concept of clinically relevant dissolution methods and specifications