Verification of the EDA concept through an assessment of theoretical failure modes, failure mode analysis, and case studies with real data

Abstract

Previous chapters have presented the robust theoretical case for EDA in comparison with current ways of analyzing API mass distribution profiles from OIPs. This chapter is in two distinct parts; the first part examines from the theoretical standpoint, ways in which changes in APSD could potentially go undetected by EDA; the second presents a series of case studies with a variety of OIP types that demonstrate the appropriateness of EDA as a powerful, yet simple-to-use tool for in vitro assessment of CI data. Discussion of theoretical failure modes is presented for general awareness. In a given product/method development, each sponsor would have to conduct their own analysis of potential failure modes based on their situation. Similarly, the case studies are presented as illustrations of EDA and AIM applications for several real OIPs. Each sponsor may develop a different way to implement AIM and EDA, depending on their purpose.