Review of Methodologies for the Comparison of Dissolution Profile Data
Graphical comparisons i.e. a plot of the mean profiles of the Test and Reference Formulations with error bars at each time point,
Statistical methods which compare the dissolution profiles at each time point e.g. perform a t-test comparing the Test and Reference means separately at each time point,
Statistical methods which compare the entire dissolution profile for Test and Reference formulations, and
Mathematical methods which compare the entire dissolution profile for Test and Reference formulations, without taking the variability or covariance structure in the data into account.
KeywordsTest Formulation Dissolution Profile Reference Formulation Dissolution Data Solid Oral Dosage Form
Unable to display preview. Download preview PDF.
- 1.Morrison, D.F. (1978) Multivariate Statistical Methods, McGraw-Hill, Singapore.Google Scholar
- 2.Crowder, M.J. and Hand, D.J. (1990) Analysis of Repeated Measures. Chapman and Hall, London.Google Scholar
- 4.SUPAC Guidance for Industry, Immediate Release Solid Oral Dosage Forms. Center for Drug Evaluation and Research (CDER), November, 1995. Section VII, Page 23Google Scholar
- 5.Moore, J.W. and Flanner, H.H. Mathematical Comparison of Dissolution Profiles. Pharmaceutical Technology, June 1996, 64–74.Google Scholar
- 6.Dunne, A. Approaches to IVIVR Modelling ans Statistical Analysis. Talk presented at IVIVR Workshop, Baltimore, Maryland, 4-6 September 1996.Google Scholar