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Nonclinical Statistics for Pharmaceutical and Biotechnology IndustriesStatistical Applications in Design and Analysis of In Vitro Safety Screening Assays

Nonclinical Statistics for Pharmaceutical and Biotechnology Industries: Statistical Applications... [In this chapter, we introduce statistical applications used in the design and analysis of a high throughput in vitro screening assay, QTiSA-HT (an acronym for QT-inotropy-Screening Assay-High Throughput), a proprietary in vitro platform used to characterize concentration-dependent effects of drugs that affect cardiac repolarization and contractility. Specifically, we discuss the design and analysis of cumulative, ascending dose concentration response studies, calculation of appropriate sample sizes, and the use of statistical significance tests and equivalence margins to provide robust estimates of true drug effects based on both concurrent and historical vehicle-control data. The goal of this chapter is to showcase how we search for solutions to real scientific problems arising in early phases of drug safety screening using statistical methods and tools.] http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png

Nonclinical Statistics for Pharmaceutical and Biotechnology IndustriesStatistical Applications in Design and Analysis of In Vitro Safety Screening Assays

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Publisher
Springer International Publishing
Copyright
© Springer International Publishing Switzerland 2016
ISBN
978-3-319-23557-8
Pages
177 –198
DOI
10.1007/978-3-319-23558-5_8
Publisher site
See Chapter on Publisher Site

Abstract

[In this chapter, we introduce statistical applications used in the design and analysis of a high throughput in vitro screening assay, QTiSA-HT (an acronym for QT-inotropy-Screening Assay-High Throughput), a proprietary in vitro platform used to characterize concentration-dependent effects of drugs that affect cardiac repolarization and contractility. Specifically, we discuss the design and analysis of cumulative, ascending dose concentration response studies, calculation of appropriate sample sizes, and the use of statistical significance tests and equivalence margins to provide robust estimates of true drug effects based on both concurrent and historical vehicle-control data. The goal of this chapter is to showcase how we search for solutions to real scientific problems arising in early phases of drug safety screening using statistical methods and tools.]

Published: Dec 29, 2015

Keywords: Cardiac safety screening; Cumulative dose response design; Equivalence test; False positive control; Repeated measure analysis; Re-sampling method

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