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Novel multivariate statistical method for the detection of batches with more variability than others of the same drug

Authors :
Montesinos Sánchez, Adrià
Monleón Getino, Antonio
Universitat de Barcelona. Departament de Genètica, Microbiologia i Estadística
Universitat de Barcelona
Source :
UPCommons. Portal del coneixement obert de la UPC, Universitat Politècnica de Catalunya (UPC)
Publication Year :
2021
Publisher :
Universitat Politècnica de Catalunya, 2021.

Abstract

The thesis ended up providing a set of tools for assessing the variability differences between production batches of the same drug in pharmaceutical datasets. Its main feature is the Mahalanobis-Dispersion model which, based in the multivariate distance of Mahalanobis, computes various measures of data dispersion within each batch then, these measures can be statistically tested at a desired significance level. The chosen statistical test is the one-way analysis of variance (ANOVA), it can be performed as usual as well as using a iterative procedure which pops out of the dataset the batch with higher dispersion in each iteration, like what one would do with the Cochran's C test in univariate cases.

Details

Language :
English
Database :
OpenAIRE
Journal :
UPCommons. Portal del coneixement obert de la UPC, Universitat Politècnica de Catalunya (UPC)
Accession number :
edsair.dedup.wf.001..58efde6e5a474b2c7cdef734d8fc3fd1