Novel tolerance interval model for the estimation of the shelf life of pharmaceutical products

Kinga Komka, Sándor Kemény, Balázs Bánfai

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

The main objective of the stability study of pharmaceutical products is to estimate the shelf life indicated on the container label. For the determination of the label shelf life the International Conference on Harmonisation (ICH) Guideline recommends the confidence interval approach, but its adequacy is questionable. Instead of the current regulation, several proposals are known in the literature applying the tolerance interval approach. The aimof our paper is to extend the tolerance intervalmodel assuming two distinct influence sources, namely the tablet-to-tablet variability and the analytical measurement error. Anothermain concept in the paper is that the tolerance interval is constructed for the true (and not for the measured) assay content. Investigating the influence of several factors on the width of the tolerance interval, a simulation is performed applying different number of samples and repeated analysis, as well as different variance components regarding the tablet-to-tablet variability and the analytical measurement error. An example is also given to illustrate the difference between the former and the proposed tolerance interval models and to compare them with the present regulation of the ICH.

Original languageEnglish
Pages (from-to)131-139
Number of pages9
JournalJournal of Chemometrics
Volume24
Issue number3-4
DOIs
Publication statusPublished - Mar 1 2010

Keywords

  • Non-central t-distribution
  • Pharmaceutical stability study
  • True assay content

ASJC Scopus subject areas

  • Analytical Chemistry
  • Applied Mathematics

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