A gamma process modeling approach for the comparison of dissolution profiles

Hon Keung Tony NG, Man Ho Alpha LING, Ping Shing CHAN

Research output: Contribution to journalArticle

Abstract

In this paper, we propose a stochastic gamma process model for assessing the similarity of two dissolution profiles. Based on the proposed stochastic model, we utilize the difference factor and similarity factor to test the similarity of two dissolution profiles based on bootstrap confidence intervals. The performances of the proposed methods are compared with a multivariate test procedure via Monte Carlo simulation studies. The proposed testing methods are shown to be powerful and effectively controlling the error rate. The proposed model provides a simple yet useful alternative parametric statistical model for assessing the similarity of two dissolution profiles. All the methods are illustrated with a numerical example. Copyright © 2017 Informa UK Limited, trading as Taylor & Francis Group.
LanguageEnglish
Pages553-562
JournalDrug Development and Industrial Pharmacy
Volume44
Issue number4
Early online dateDec 2017
DOIs
Publication statusPublished - 2018

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Dissolution
Stochastic models
Stochastic Processes
Statistical Models
Testing
Confidence Intervals
Monte Carlo simulation

Citation

Ng, H. K. T., Ling, M. H., & Chan, P. S. (2018). A gamma process modeling approach for the comparison of dissolution profiles. Drug development and industrial pharmacy, 44(4), 553-562. doi: 10.1080/03639045.2017.1405430

Keywords

  • Degradation
  • Gamma process
  • Difference factor
  • Similarity factor
  • Multivariate normal
  • Percentile bootstrap