A Rational Approach to Developing and Troubleshooting Dissolution Methods for a Variety of Purposes (Laboratory Training)

Venue: Online Event

Location: Online Event,Palo Alto, California, United States

Event Date/Time: Sep 14, 2011 End Date/Time: Sep 14, 2011
Report as Spam


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.

Learning Objectives:

- Upon completion of this course the learner should be able to:

- Develop a dissolution method for a pharmaceutical dosage form, appropriate to the stage of development, using the target product profile and drug substance solubility data.
- Validate a dissolution method in a manner consistent with the intent of the method.
- Evaluate changes in dissolution profiles and determine probable root causes and potential solutions.
- Understand the basic principles and application of correlating dissolution and in vivo data and setting specifications.
Locate the appropriate regulatory or compendial documents which may be pertinent to the situation under evaluation, including those related to dissolution method development and dissolution instrument qualification.


Online Event
2600 E. Bayshore Road
United States