Description
Why Should You Attend:
This interactive course is designed to provide practical tools for those developing dissolution methods at various stages (including biorelevant methods), and to provide an understanding of the development process for managers, formulators and regulatory affairs/CMC personnel.
Building on the history of dissolution, the participants will be presented with a systematic approach for developing dissolution methods. Validation and transfer of methods will also be addressed. The course emphasizes troubleshooting methods, when changes in dissolution profiles are observed, and understanding the causes for those changes, with ample opportunities to discuss real or hypothetical situations.
The topics of correlations between dissolution and in vivo data (IVIVC) and setting specifications will be introduced. Next, we will discuss several key regulatory and compendial documents to assist participants in connecting regulatory expectations with their methods. Following this, the presenter will lead you into a discussion on dissolution instrument qualification.
The course will provide ample time for discussing challenges faced by participants and questions.
