On the assessment of similarity for dissolution profiles of two drug products.
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.
Chow
Shein-Chung
SC
Stat Plus, Inc., Heston Hall, Yardley, PA 19067, USA.
Shao
Jun
J
D000465:Algorithms; D007700:Kinetics; D015233:Models, Statistical; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012995:Solubility
D004364:Pharmaceutical Preparations