ELISA validation in the pharmaceutical industry: a mixed-effects models approach with R

In the first part of this work, a methodology to gain insight into ELISA performance and finally obtain accuracy and precision estimates using linear mixed effects models is presented. Also, in the second part, non-linear mixed effects models are applied as a tool to establish parallelism between te...

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Bibliographic Details
Author: Mayola Coromina, Albert
Format: master thesis
Publication Date:2018
Country:España
Institution:Universitat Oberta de Catalunya (UOC)
Repository:O2, repositorio institucional de la UOC
OAI Identifier:oai:openaccess.uoc.edu:10609/91346
Online Access:http://hdl.handle.net/10609/91346
Access Level:Open access
Keyword:mixed effects models
ELISA
models d'efectes mixtes
modelos de efectos mixtos
Bioinformatics -- TFM
Bioinformàtica -- TFM
Bioinformática -- TFM
Description
Summary:In the first part of this work, a methodology to gain insight into ELISA performance and finally obtain accuracy and precision estimates using linear mixed effects models is presented. Also, in the second part, non-linear mixed effects models are applied as a tool to establish parallelism between test and reference product preparations when conducting full dose-response assays. Overall, both linear and non-linear mixed effects have demonstrated to be complex yet extremely powerful and versatile tools. Great knowledge on the impact of potential nuisance factors has been extracted using the workflows presented and more precise estimates of important assay parameters have been established. The work has been developed in R statistical programming language which contributes to the potential of the framework itself.