Methods for identifying out-of-trend data in analysis of stability measurements—Part II: By-time-point and multivariate control chart

M. Mihalovits, S. Kemény

Research output: Contribution to journalReview article

Abstract

This article is a continuation of Part I, in which the authors discussed the identification of out-of-trend (OOT) data in the stability studies of single batches using a regression control chart method (1). If several batches are considered, there are two different time scales. The first one is the life within batches, which has been covered in Part I (1). The regression control chart uses this within-batch context. The second time scale is the order of batches. Two approaches are followed in this Part II article. The by-time-point method uses the between-batches context only, while the multivariate approach uses both between-batches and within-batches contexts.

Original languageEnglish
Pages (from-to)38-43
Number of pages6
JournalPharmaceutical Technology
Volume41
Issue number12
Publication statusPublished - Dec 1 2017

ASJC Scopus subject areas

  • Biophysics
  • Pharmaceutical Science

Cite this

Methods for identifying out-of-trend data in analysis of stability measurements—Part II : By-time-point and multivariate control chart. / Mihalovits, M.; Kemény, S.

In: Pharmaceutical Technology, Vol. 41, No. 12, 01.12.2017, p. 38-43.

Research output: Contribution to journalReview article

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