The AIM and EDA Concepts: Why They Are Needed and How They Fit Together - Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products - page 115

Chapter 5
The AIM and EDA Concepts: Why They Are
Needed and How They Fit Together

Jolyon P. Mitchell and Terrence P. Tougas

Abstract AIM and EDA concepts were developed to address the high variability
and susceptibility to error of the conventional full-resolution CI methods in OIP
quality control. Abbreviated measurements allow increased throughput during
product development and routine quality control testing. Effi cient data analysis sim-
plifi es data analysis (by using only two metrics for making decisions about presence
or absence of APSD changes while in most cases, reducing the rate of false-positive
and false-negative decisions). Each of these aspects is explored in more detail in
later chapters. This chapter presents an overall rationale for the development of
these alternative approaches, with emphasis placed on how they could fi t into the
OIP life cycle.

5.1 Current Experience with CI Measurements:

The Need for Strict Controls

The previous chapter highlighted the fact that full-resolution multistage CI mea-
surements, when carried out to best current practices, are labor-intensive, involv-
ing numerous steps with the possibility of error likely even when stringent
precautions are taken [ 1 ]. In 2003, an across-industry survey of CI users was
undertaken by the Particle Size Distribution Mass Balance Working Group of the
Product Quality Research Institute (PQRI) to assess the frequency of CI-based