Verification of the EDA Concept Through an Assessment of Theoretical Failure Modes, Failure Mode Analysis, and Case Studies with Real Data - Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products - page 243

Chapter 9
Verifi cation of the EDA Concept Through
an Assessment of Theoretical Failure Modes,
Failure Mode Analysis, and Case Studies
with Real Data
Helen Strickland , Beth Morgan , J. David Christopher , Volker Glaab ,
Adrian Goodey , Keyur Joshi , Lei Mao , and Jolyon P. Mitchell
Abstract Previous chapters have presented the robust theoretical case for EDA in
comparison with current ways of analyzing API mass distribution profi les from
OIPs. This chapter is in two distinct parts; the fi rst part examines from the theoreti-
cal 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 situa-
tion. 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.