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.
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© 2016 Springer International Publishing Switzerland
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Zhang, L., Su, C. (2016). Introduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industries. In: Zhang, L. (eds) Nonclinical Statistics for Pharmaceutical and Biotechnology Industries. Statistics for Biology and Health. Springer, Cham. https://doi.org/10.1007/978-3-319-23558-5_1
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DOI: https://doi.org/10.1007/978-3-319-23558-5_1
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-23557-8
Online ISBN: 978-3-319-23558-5
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