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Nonclinical Statistics for Pharmaceutical and Biotechnology IndustriesIntroduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industries

Nonclinical Statistics for Pharmaceutical and Biotechnology Industries: Introduction to... [Drug discovery and development is a long, complicated, risky, and costly process. Most decisions in the process are made based on data with uncertainties, which provides a natural field for statistics. Clinical statistics is a shining example of how an industry has embraced statistics as an equal partner. However, it is not the case of nonclinical statistics. In this chapter, we give a brief introduction to drug discovery and development process, including chemistry, manufacturing and controls (CMC), statistical applications in these nonclinical areas, and the current landscape of clinical and nonclinical statistics in pharmaceutical and biotechnology companies. Then we try to define nonclinical statistics, discuss the nonclinical statistical profession, identify possible causes of predicaments in nonclinical statistics, and point out potential directions to change the status quo.] http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png

Nonclinical Statistics for Pharmaceutical and Biotechnology IndustriesIntroduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industries

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Publisher
Springer International Publishing
Copyright
© Springer International Publishing Switzerland 2016
ISBN
978-3-319-23557-8
Pages
3 –17
DOI
10.1007/978-3-319-23558-5_1
Publisher site
See Chapter on Publisher Site

Abstract

[Drug discovery and development is a long, complicated, risky, and costly process. Most decisions in the process are made based on data with uncertainties, which provides a natural field for statistics. Clinical statistics is a shining example of how an industry has embraced statistics as an equal partner. However, it is not the case of nonclinical statistics. In this chapter, we give a brief introduction to drug discovery and development process, including chemistry, manufacturing and controls (CMC), statistical applications in these nonclinical areas, and the current landscape of clinical and nonclinical statistics in pharmaceutical and biotechnology companies. Then we try to define nonclinical statistics, discuss the nonclinical statistical profession, identify possible causes of predicaments in nonclinical statistics, and point out potential directions to change the status quo.]

Published: Dec 29, 2015

Keywords: CMC; Drug research and development; Nonclinical statistics; Target identification

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