On the assessment of similarity for dissolution profiles of two drug products.

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Chow, S-C; Shao, J

Published Date

  • August 2002

Published In

Volume / Issue

  • 12 / 3

Start / End Page

  • 311 - 321

PubMed ID

  • 12448573

International Standard Serial Number (ISSN)

  • 1054-3406

Digital Object Identifier (DOI)

  • 10.1081/bip-120014561


  • eng

Conference Location

  • England