Biomedical Engineering Reference
In-Depth Information
Chapter 11
The Regulatory and Compendial Pathways
to Acceptance for AIM and EDA Concepts
Steven C. Nichols , Jolyon P. Mitchell , Terrence P. Tougas ,
J. David Christopher , and Susan Holmes
Abstract The acceptance by the regulatory and compendial authorities of AIM and
EDA concepts is a critical stage before their widespread adoption by the pharmaceu-
tical industry will likely take place. A prerequisite for such acceptance will be the
assemblage of a body of data in which close attention has been placed not only on
the methods themselves but also on their applicability across as wide a portion of the
spectrum of OIP classes as possible. In the case of AIM-based apparatuses, it will be
important to provide experimental data from many inhalers of each type, so that the
variability of the method can be assessed in the context of typical variability associ-
ated with the corresponding full-resolution method. Robust statistical analysis of
either full-resolution APSDs or AIM CI-generated APSD metrics by EDA, in com-
parison with existing data reduction methods (i.e., stage grouping, fi ne/total particle
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