Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements—Part II: By-Time-Point and Multivariate Control Chart

In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.
Dec 02, 2017
Volume 41, Issue 12, pg 38–43, 45


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.

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Peer-Review Article
Submitted: April 5, 2017
Accepted: June 27, 2017

About the Authors

Máté Mihalovits is a PhD student, [email protected]; and Sándor Kemény* is an emeritus professor, Tel.: +36 309936307, [email protected], both at Budapest University of Technology and Economics, Faculty of Chemical Technology and Biotechnology, Department of Chemical and Environmental Process Engineering Hungary, 1111. Budapest, Műegyetem rakpart 3.

* To whom all correspondence should be addressed.

Article Details

Pharmaceutical Technology
Vol. 41, No. 12
December 2017
Pages: 38–43, 45


When referring to this article, please cite it as M. Mihalovits and S. Kemény, "Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part II: By-Time-Point and Multivariate Control Chart," Pharmaceutical Technology 41 (12) 2017.

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