Introduction - Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products - page 10

Fig. 1.5 Derivation of EDA metrics

mechanisms that might result in changes to the APSD of the sampled aerosol from
these products. Chapter 4 reviews good cascade impactor practice (GCIP) from the
standpoint of the laboratory manager or technical staff implementing either
full-resolution or abbreviated impactor measurements. The twin concepts of AIM
and EDA are introduced in Chap. 5 , where a detailed explanation is given as to why
these new approaches are needed and how they fi t together. Chapter 6 presents the
typical lifecycle of an OIP and develops an approach that can be used to help decide
when it is more appropriate to use AIM or full-resolution measurements. Chapter 7
sets out the theoretical basis for EDA, based on a measurement systems analysis
(MSA) approach. Chapter 8 elaborates on how EDA can improve the decision-
making process in the context of OIP quality control, based on statistical arguments.
Chapter 9 introduces a series of case studies, in which EDA has been applied, to
guide the reader in best practices; this chapter also takes a look at ways in which
EDA might theoretically fail to detect shifts in APSD. Chapter 10 presents the out-
comes from a large number of experimental studies undertaken to validate the AIM
concept, largely by member organizations of the European Pharmaceutical Aerosol
Group (EPAG) and the Cascade Impaction Working Group of the International
Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). Chapter
11 examines the regulatory and compendial pathways that will likely need to be
followed as AIM and EDA concepts mature into the mainstream of OIP perfor-
mance testing. Chapter 12 suggests how the AIM concept might be developed to
provide measures of OIP performance that are more closely linked with particle
deposition behavior in the human respiratory tract. Chapter 13 is a summary of