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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. Attendees are strongly encouraged to ask questions or present challenges throughout the course. 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.
- Assessment of attendees goals
- What are the expectations and opportunities for dissolution methods for generic products?
- Development of dissolution tests for generic immediate release products
- Development of dissolution tests for generic extended release products
- Validation of dissolution methods for generic products
- Setting specifications for a generic product based on available dissolution data
- Problem-solving exercise:
- Given a USP monograph for an immediate release product, proceed to develop a dissolution method for a generic product and propose a specification
- Given a USP monograph for an extended release product, proceed to develop a dissolution method for a generic product and propose a specification
- Learner challenges and questions
- 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 product
Upon completion of this course the attendee will be able to:
- Understand the expectations and opportunities associated with developing a dissolution method for a generic product.
- Develop a dissolution method for a generic immediate release or extended release product.
- Develop a dissolution method for an extended release product.
- Validate the dissolution method.
- Propose and justify dissolution specifications.