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Nonclinical Statistics for Pharmaceutical and Biotechnology IndustriesNonclinical Safety Assessment: An Introduction for Statisticians

Nonclinical Statistics for Pharmaceutical and Biotechnology Industries: Nonclinical Safety... [This chapter provides an overview of the nonclinical drug safety testing process, and the statistical challenges associated with work in this area. Whilst other chapters in this book focus on specific types of designs and analyses which you may encounter during nonclinical drug development, we provide here the context for a statistician working in nonclinical safety assessment, and seek to prepare them for some of the practical issues and decisions they are likely to face. We will describe the scope and framework for the studies run within a nonclinical safety assessment programme, and recommend when and how a statistician needs to engage to add value. We will look generally at design and analysis considerations for safety studies which, whilst not unique to this context, are particularly pertinent to this area of work. Finally we will highlight some practical considerations and industry trends. If this chapter provides you with insight that complements rather than replicates what is taught in conventional statistics courses, and inspires you to believe that statistical work in this area can be both valuable and rewarding, we will have achieved our goal.] http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png

Nonclinical Statistics for Pharmaceutical and Biotechnology IndustriesNonclinical Safety Assessment: An Introduction for Statisticians

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Publisher
Springer International Publishing
Copyright
© Springer International Publishing Switzerland 2016
ISBN
978-3-319-23557-8
Pages
201 –230
DOI
10.1007/978-3-319-23558-5_9
Publisher site
See Chapter on Publisher Site

Abstract

[This chapter provides an overview of the nonclinical drug safety testing process, and the statistical challenges associated with work in this area. Whilst other chapters in this book focus on specific types of designs and analyses which you may encounter during nonclinical drug development, we provide here the context for a statistician working in nonclinical safety assessment, and seek to prepare them for some of the practical issues and decisions they are likely to face. We will describe the scope and framework for the studies run within a nonclinical safety assessment programme, and recommend when and how a statistician needs to engage to add value. We will look generally at design and analysis considerations for safety studies which, whilst not unique to this context, are particularly pertinent to this area of work. Finally we will highlight some practical considerations and industry trends. If this chapter provides you with insight that complements rather than replicates what is taught in conventional statistics courses, and inspires you to believe that statistical work in this area can be both valuable and rewarding, we will have achieved our goal.]

Published: Dec 29, 2015

Keywords: Drug safety; Toxicity; Safety pharmacology; Experimental design; Monitoring; Validation; Analysis; Continuous improvement

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