Assessment of similarity between dissolution profiles

Mi-Chia Ma, Betty B.C. Wang, Jen Pei Liu, Yi Tsong

研究成果: Review article

26 引文 斯高帕斯(Scopus)

摘要

In vitro dissolution equivalence has been assessed through profile comparison between the test and reference formulations for postapproval changes. Functions of the absolute mean difference and average squared mean differences were two of the often-used criteria to evaluate distance or similarity between general profiles. The two functions and their methods of moment estimators are studied in this paper as an application to similarity assessment of two dissolution profile. Due to the complexity of the distributions of these estimators, the confidence intervals obtained from the bootstrap method were used for testing the hypothesis of dissolution similarity. The size and power of two procedures are examined with a simulation study. A numerical example is used to illustrate the application of the procedures.

原文English
頁(從 - 到)229-249
頁數21
期刊Journal of Biopharmaceutical Statistics
10
發行號2
DOIs
出版狀態Published - 2000 九月 26

    指紋

All Science Journal Classification (ASJC) codes

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

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