Dissolution is generally accepted as a required test for oral dosage forms. This presentation will review some of the drivers for requiring dissolution testing, and then provide a practical, science-based approach to developing and validating methods to facilitate regulatory compliance and meeting business needs. Upon completion the learner will be able to: * Identify the reasons for the particular test which is being developed.
* Systematically select appropriate parameters for the dissolution procedure.
* Validate the analytical procedure.
* Identify appropriate acceptance criteria for the product being tested. Areas Covered in the seminar: * What are the historical, regulatory and business drivers for developing a dissolution procedure?
* What are the critical characteristics for a dissolution procedure?
* What is the Biopharmaceutical Classification System and how does it apply to my product?
* Is there a systematic approach to selection of the dissolution medium and apparatus?
* What crucial role do observations play in the development of a dissolution procedure?
* What modes of analysis are most commonly used for dissolution samples, and how are they selected?
* What are the differences between manual and automated dissolution, from a development and validation perspective?
* Why validate dissolution procedures? How is this accomplished?
* How are acceptance criteria developed?