Executive Director Bristol-Myers Squibb Company Skillman, New Jersey
This presentation will provide an overview of the history in compendial excipient performance testing, and drivers for change at each milestone. Next, novel characterization techniques, including chemical imaging, PAT & chemometrics, advanced NMR, functionalized atomic force microscopy and excipients-drug interactions will be used to show how excipient functionality can impact the formulation. Finally, the FRCs and FRTs in enabling technologies will be discussed to illustrate the difference between functionality characteristics and functionality tests of excipients.
Upon completion, participant will be able to demonstrate an understanding of the organization, scope and context of USP <1059> Excipient Performance chapter
Upon completion, participant will be able to obtain an understanding of excipient functionality, critical material attributes and performance
Upon completion, participant will be able to understand novel characterization techniques can be useful in assessing excipient properties which may impact their performance in drug products