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AAPS PharmSciTech. 2007 March; 8(1): E32–E37.
Published online 2007 January 19. doi:  10.1208/pt0801004
PMCID: PMC2750439

Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 1: Background for a statistical method

Abstract

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distribution (APSD) of aerosolized drug formulations, which was proposed in a US Food and Drug Administration (FDA) draft guidance for industry; and (2) to explain the background and process for evaluation of that test through a working group involving scientists from the FDA, industry,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). The article and the referenced additional statistical information posted on the PQRI Web site explain the reasoning and methods used in the development of the APSD test, which is one of the key tests required for demonstrating in vitro equivalence of orally inhaled and nasal aerosol drug products. The article also describes the process by which stakeholders with different perspectives have worked collaboratively to evaluate properties of the test by drawing on statistical models, historical and practical information, and scientific reasoning. Overall, this article provides background information to accompany the companion article's discussion of the study's methods and results.

Keywords: Chi-square ratio, bioequivalence, cascade impactor, particle size distribution

Full Text

The Full Text of this article is available as a PDF (94K).

Selected References

These references are in PubMed. This may not be the complete list of references from this article.
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Articles from AAPS PharmSciTech are provided here courtesy of American Association of Pharmaceutical Scientists