Setting Specifications for Drug Products

Abstract

Developing specifications for global drug products requires a multi-faceted approach that begins with an understanding of the attributes of the formulation, and how to assess those attributes that are critical to the safety, efficacy and quality of the final drug product. An understanding of global regulatory requirements, as well as requirements that are specific to significant markets adds additional complexity. In addition to developing specifications for the drug product to meet through shelf-life, many drug products require the development of release specifications which require an understanding of stability trends and batch-to-batch variability. This session will include several examples of how these approaches were used.