A sensitivity analysis of the modified chi-square ratio statistic for equivalence testing of aerodynamic particle size distribution

AAPS Journal

Volumn 15, Issue 2, 2013, Pages 465-476

  Weber, Benjamin ^a   Lee, Sau L ^b,d   Lionberger, Robert ^b   Li, Bing V ^b   Tsong, Yi ^c   Hochhaus, Guenther ^a  

^a UNIVERSITY OF FLORIDA HEALTH   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^d HFD 600   (United States)

Author keywords

aerodynamic particle size distribution; bioequivalence; cascade impactor; modified Chi square ratio statistic; orally inhaled drug products

Indexed keywords

AERODYNAMICS PARTICLE SIZE DISTRIBUTION; ARTICLE; BIOEQUIVALENCE; CASCADE IMPACTOR; CHI SQUARE DISTRIBUTION; CHI SQUARE RATIO STATISTIC; CONTROLLED STUDY; CORRELATION ANALYSIS; IMPACTOR SIZED MASS; MATHEMATICAL ANALYSIS; MONTE CARLO METHOD; PARTICLE SIZE; SENSITIVITY ANALYSIS;

ADMINISTRATION, INHALATION; AEROSOLS; CHEMISTRY, PHARMACEUTICAL; CHI-SQUARE DISTRIBUTION; COMPUTER SIMULATION; LINEAR MODELS; MODELS, STATISTICAL; MONTE CARLO METHOD; PARTICLE SIZE; TECHNOLOGY, PHARMACEUTICAL; THERAPEUTIC EQUIVALENCY;

EID: 84877015373     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-013-9453-y     Document Type: Article

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