Globally, 2005 sales of pharmaceuticals have been estimated at approximately $550 billion. A significant fraction of this amount was due to the top pharmaceutical companies in the world. The top five companies alone were responsible for total revenues of $168 billion, or 30% of the entire market.
Guest columnist Walter Jennings reflects on the early days of capillary gas chromatography (GC) and how chromatographers become experts in the technology by constructing their own columns, thereby achieving a more thorough understanding of the chromatographic process.
The authors define robustness, instroduce a few approaches to designing a robustness study, and discuss data analysis necessary to help ensure successful method implementation and transfer as a part of method validation protocol.