Application of the Modified Chi-Square Ratio Statistic in a Stepwise Procedure for Cascade Impactor Equivalence Testing
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmaceutical Science
Link
http://link.springer.com/content/pdf/10.1208/s12248-014-9698-0.pdf
Reference15 articles.
1. Lee SL, Adams WP, Li BV, Conner DP, Chowdhury BA, Yu LX. In vitro considerations to support bioequivalence of locally acting drugs in dry powder inhalers for lung diseases. AAPS J. 2009;11:414–23.
2. Evans C, Cipolla D, Chesworth T, Agurell E, Ahrens R, Conner D, et al. Equivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European workshop report. J Aerosol Med Pulm Drug Deliv. 2012;25:117–39.
3. Weber B, Hochhaus G, Adams W, Lionberger R, Li B, Tsong Y, et al. A stability analysis of a modified version of the chi-square ratio statistic: implications for equivalence testing of aerodynamic particle size distribution. AAPS J. 2013;15:1–9.
4. Weber B, Lee SL, Lionberger R, Li BV, Tsong Y, Hochhaus G. A sensitivity analysis of the modified chi-square ratio statistic for equivalence testing of aerodynamic particle size distribution. AAPS J. 2013;15:465–76.
5. Adams WP, Christopher D, Lee DS, Morgan B, Pan Z, Singh GJ, et al. Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 1: background for a statistical method. AAPS PharmSciTech. 2007;8:E32–7.
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