This two or three-day course is aimed at professionals in the field of pharmaceutical solids who would like to expand their knowledge base. Presenters will discuss strategic approaches to understanding and predicting the properties and pharmaceutical behavior of solids, as well as the important area of regulatory aspects of pharmaceutical solids. The 1999 edition of Solid-State Chemistry of Drugs will be provided to all participants. The course will address the following questions:

• When are polymorphs important?
• What types of studies are required to characterize polymorphs?
• What should be done to characterize amorphous solids?
• How can stability and rates of transformation be analyzed and predicted?
• How is the polymorph or hydrate present related to stability?
• What specifications should be set and how can analytical procedures for mixtures of solids be developed and validated?
• What is required in a regulatory submission (Q6A) and how should it be approached?

Course Details