title: On the assessment of similarity for dissolution profiles of two drug products.
abstract: The assessment of similarity between dissolution profiles of two drug products is considered. After reviewing some existing approaches, we propose a statistical method of assessing local and global similarities based on a time series model for the ratio of the dissolution results from two drug products and a polynominal model for the mean of the ratio. An example is presented for illustration.
authors.affiliation: Stat Plus, Inc., Heston Hall, Yardley, PA 19067, USA.
authors.forename: Shein-Chung
authors.initials: SC
authors.lastname: Chow
authors.forename: Jun
authors.initials: J
authors.lastname: Shao
mesh_terms: D000465:Algorithms; D007700:Kinetics; D015233:Models, Statistical; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012995:Solubility
chemical_list: D004364:Pharmaceutical Preparations