title: A multivariate test for similarity of two dissolution profiles.
abstract: A multivariate test of size a for assessing the similarity of two dissolution profiles is proposed. The inferential procedure is developed by using the approach for the common mean problem in a multivariate setup due to Halperin (1961). The performance of the proposed method is compared with Intersection Union Test as well as f2 criterion recommended by the FDA through a simulation study. All the methods are illustrated with real examples.
authors.affiliation: Pharmaceutical Sourcing Group Americas, Ortho McNeil Pharmaceutical, Inc Johnson & Johnson Company, Raritan, NJ 08869-0602, USA. hsaranad@psgus.jnj.com
authors.forename: H
authors.initials: H
authors.lastname: Saranadasa
authors.forename: K
authors.initials: K
authors.lastname: Krishnamoorthy
mesh_terms: D000465:Algorithms; D002627:Chemistry, Physical / Q000379:methods / Q000706:statistics & numerical data*; D003198:Computer Simulation; D015233:Models, Statistical; D015999:Multivariate Analysis; D012995:Solubility; D014481:United States; D014486:United States Food and Drug Administration