19. October 2015

BY AJIT S. NARANG, MIKE TOBYN, AND ROBERT A. REED Excipient variability has been studied in areas such as particle characteristics, cross-linking, or reactive impurities with the goals of (a) identifying and quantitating potential variability in commonly used excipients, and (b) either designing formulations and processes that can accommodate expected variability or developing an understanding of the excipient variability design space and a control strategy for drug product and excipients....