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. These efforts in many different drug products and scenarios have raised a common question: Is excipient variability a fuss, or is it a big deal?

Join us at this year’s 2015 AAPS Annual Meeting and Exposition for the session Excipient Variability: A Fuss or a Big Deal? where Mike and Bob will take us through a roller-coaster ride of a lively debate—sampled below.