Dissolution Method Development for Generic Products

This interactive course will address some of the issues facing those developing dissolution methods
for generic products, as well as the opportunities that exist for changing existing methodology. It will
discuss immediate release and extended release products, including addressing poorly water soluble compounds (BCS Class 2 and 4). Recommended approaches for proposing and justifying specifications will be covered. Attendees will participate in an exercise to ‘develop’ (virtually) dissolution methods for an immediate release and an extended release generic product. After discussions, attendees will have a hands-on opportunity to perform a dissolution test and witness recommended laboratory techniques.

Who Should Attend?

Chemists (Research, Quality Control, and CRO; Human, Veterinary or Generic) involved with dissolution method development or testing and their managers, formulators who rely on dissolution data and regulatory affairs/CMC personnel responsible for filings involving dissolution.

Learning Objectives

• Learn about expectations for dissolution methods for generic products, including opportunities to change compendial or FDA dissolution methods
• Learn how to approach dissolution method development for generic immediate release or extended release products
• Learn about taking advantages of biowaivers: using dissolution data in place of expensive bioequivalence testing
• Expectations for validation of dissolution methods for generic products
• Perform a group exercise ‘virtually’ developing dissolution methods for generic immediate release and extended release products