Advances and Applications in Statistics
Volume 12, Issue 2, Pages 163 - 190
(August 2009)
|
|
A GENERALIZED INFERENCE ON ASSESSMENT OF SIMILARITY BETWEEN DISSOLUTION PROFILES
Hsin-Neng Hsieh (Taiwan), Hsiu-Yuan Su (Taiwan) and Xuewen Lu (Canada)
|
Abstract: In vitro dissolution testing has been assessed through dissolution profile comparison between the test and reference formulations for postapproval changes. The often used criteria for assessment of dissolution similarity between general profiles are functions of average squared mean differences and absolute mean difference. Because of the complexity of the distributions of estimators of two functions, it is difficult to obtain a test to test the hypothesis of dissolution similarity. Therefore, in this study, the generalized p-values (GPVs) are applied to construct a test procedure to assess the similarity of dissolution profiles. Simulation results show that when the numbers of dosage units are large, the GPVs testing procedure yields satisfactory results for size and power with ?and ?criteria recommended by the U.S. Food and Drug Administration (FDA). Through a simulation study, with the same ?and ?criteria, the performance of GPVs is as good as that of a bootstrap method. The proposed method is illustrated with a real example. |
Keywords and phrases: bioequivalence, profile similarity,
?factor,
?factor, bootstrap method, generalized p-values. |
|
Number of Downloads: 362 | Number of Views: 1170 |
|