WelcomeIn vitro release and dissolution testing plays a vital role in several areas during drug development. Dissolution can be affected by drug substance factors (solubility, permeability, dissolution rate), dosage form factors (dissolution characteristics and manufacturing processes), and the methods used for its assessment (apparatus, method, dissolution medium).
Course ObjectivesThis course will step through the fundamentals of in vitro release and dissolution testing, focus primarily on the dissolution of solid oral dosage forms, and the effects of these factors in development and execution of successful dissolution testing.
Upon completion the learner should be able to:
- Discuss the BCS classification and dissolution method development,
- Describe IVIVC and dissolution testing,
- List biowaiver considerations from development drugs to generics,
- Distinguish between instrument performance verification vs. physical calibration,
- Describe apparatus 3 and 4 and novel testing apparatus applications,
- Identify how to overcome cross-linking in dissolution of gelatin capsule, and
- List/describe ways to Analyze automation and industrialization of dissolution testing for manufacturing quality control and late-phase stability testing.
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