Product Quality Research Institute Evaluation of Cascade Impactor Profiles of Pharmaceutical Aerosols, Part 1: Background for a

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The purpose of this article is 2-fold: (1) to document in the public domain the considerations that led to the development of a regulatory statistical test for comparison of aerodynamic particle size distribution (APSD) of aerosolized drug formulations, which was proposed in a US Food and Drug Administration (FDA) draft guidance for industry; and (2) to explain the background and process for evaluation of that test through a working group involving scientists from the FDA, industry, academia, and the US Pharmacopeia, under the umbrella of the Product Quality Research Institute (PQRI).

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Author(s): 
Wallace P. Adams, David Christopher, Douglas S. Lee, Beth Morgan, Ziqing Pan, Gur Jai Pal Singh, Yi Tsong, Svetlana Lyapustina
Journal: 
AAPS PharmSciTech ,Volume 8, Issue 1 ,2007
Copyright: 
Copyright © All Rights Reserved. ISSN 1550-7416.