Methods for identifying out-of-trend data in analysis of stability measurements-Part I: Regression control chart

Máté Mihalovits, S. Kemény

Research output: Review article

Abstract

The regulation of pharmaceutical stability studies still lacks universally accepted techniques regarding the identification of out-of-trend data. Three methods have been suggested for identifying out-of-trend data in pharmaceutical stability studies: the regression control chart, the by-time-point method, and the slope control chart. In Part I of this article series, the regression control chart method is investigated, and an improved approach is suggested. The method is illustrated using realistic data. In Part II, the by-time-point method and the multivariate control chart method will be discussed.

Original languageEnglish
Pages (from-to)32-39
Number of pages8
JournalPharmaceutical Technology Europe
Volume29
Issue number11
Publication statusPublished - nov. 1 2017

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ASJC Scopus subject areas

  • Pharmaceutical Science

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abstract = "The regulation of pharmaceutical stability studies still lacks universally accepted techniques regarding the identification of out-of-trend data. Three methods have been suggested for identifying out-of-trend data in pharmaceutical stability studies: the regression control chart, the by-time-point method, and the slope control chart. In Part I of this article series, the regression control chart method is investigated, and an improved approach is suggested. The method is illustrated using realistic data. In Part II, the by-time-point method and the multivariate control chart method will be discussed.",
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AB - The regulation of pharmaceutical stability studies still lacks universally accepted techniques regarding the identification of out-of-trend data. Three methods have been suggested for identifying out-of-trend data in pharmaceutical stability studies: the regression control chart, the by-time-point method, and the slope control chart. In Part I of this article series, the regression control chart method is investigated, and an improved approach is suggested. The method is illustrated using realistic data. In Part II, the by-time-point method and the multivariate control chart method will be discussed.

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