Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols. Part 3. Final report on a statistical procedure for determining equivalence

AAPS PharmSciTech
David ChristopherBruce Wyka

Abstract

The purpose of this article is to report final results of the evaluation of a chi-square ratio test proposed by the US Food and Drug Administration (FDA) for demonstrating equivalence of aerodynamic particle size distribution (APSD) profiles of nasal and orally inhaled drug products. A working group of the Product Quality Research Institute previously published results demonstrating some limitations of the proposed test. In an effort to overcome the test's limited discrimination, the group proposed a supplemental test, a population bioequivalence (PBE) test for impactor-sized mass (ISM). In this final report the group compares the chi-square ratio test to the ISM-PBE test and to the combination of both tests. The basis for comparison is a set of 55 realistic scenarios of cascade impactor data, which were evaluated for equivalence by the statistical tests and independently by the group members. In many instances, the combined application of these 2 tests appeared to increase the discriminating ability of the statistical procedure compared with the chi-square ratio test alone. In certain situations the chi-square ratio test alone was sufficient to determine equivalence of APSD profiles, while in other situations neither of the te...Continue Reading

References

Oct 24, 2003·Journal of Aerosol Medicine : the Official Journal of the International Society for Aerosols in Medicine·Dave ChristopherUNKNOWN PQRI Particle Size Distribution Mass Balance Working Group
Sep 30, 2005·American Journal of Respiratory and Critical Care Medicine·Omar S UsmaniPeter J Barnes

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Citations

Feb 6, 2010·Journal of Aerosol Medicine and Pulmonary Drug Delivery·Wallace P AdamsLawrence Yu
Jan 10, 2008·AAPS PharmSciTech·Jolyon MitchellHak-Kim Chan
Feb 28, 2013·Therapeutic Delivery·Gabriela Apiou-SbirleaAnthony Hickey
Jun 28, 2011·Pharmaceutical Development and Technology·Barbara D AlexanderAnthony J Hickey
Sep 6, 2012·Health Services Research·Dana B MukamelYue Li

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