This three-day course is aimed at professionals in the field of pharmaceutical solids who would like to expand their knowledge base. The course will next be held April 11-13, 2007 in Arlington, Virginia. 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

Solid-State Chemistry of Biopharmaceuticals:
Essential Knowledge and Advanced Concepts

This two-day course is a fast-paced overview of the analysis, characterization, behavior, and clinical formulation of biopharmaceutical solids. The course will be held February 27-28, 2007 in San Francisco, California. The presenters will cover strategic approaches to ensure that the same drug substance/drug product is used for each clinical trial and will discuss factors involved in understanding and predicting the properties and pharmaceutical behavior of biopharmaceutical solids. The following are some of the questions to be addressed by presenters:

• What types of studies are required to determine the identity and sameness of solid forms of biopharmaceuticals?
• What information can be gained from analytical studies of biopharmaceuticals and their formulations?
• What should be done to characterize amorphous solids?
• How can stability and rates of transformation be analyzed and predicted?
• What role does water play in the identity and sameness of biopharmaceuticals?
• What specifications should be set and how can analytical procedures for mixtures of solids be developed and validated?
• What is recommended in a regulatory submission (Q6A) and how should it be approached?

Course Details