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Nonclinical Statistics for Pharmaceutical and Biotechnology Industries

Part of the Statistics for Biology and Health Book Series

Editors: Zhang, Lanju

DOI: 10.1007/978-3-319-23558-5

ISBN: 978-3-319-23557-8

Publisher: Springer International Publishing - Springer Journals

Dec 29, 2015

1 - 10 of 26 Chapters

Available

Introduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industries

Zhang, Lanju; Su, Cheng

Pages: 3 –17

[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...
Available

Regulatory Nonclinical Statistics

Rahman, Mohammad Atiar; Shen, Meiyu; Dong, Xiaoyu (Cassie); Lin, Karl K.; Tsong, Yi

Pages: 19 –31

[The nonclinical statistics teams in the Center of Drug Review and Research of the Food and Drug Administration (FDA) conduct regulatory reviews, statistical consultation, and statistical methodology development in nonclinical regulations. In this chapter, we provide a brief description of the...
Available

How To Be a Good Nonclinical Statistician

Pikounis, Bill; Bijnens, Luc

Pages: 33 –50

[All fields profess commonly expressed criteria for its individual professionals to be successful. For the pharmaceutical/biotechnology industry that is the scope of this book, there are many accounts in the field of statistics of what it takes to be a good statistician. The goal of this chapter...
Available

Statistical Methods for Drug Discovery

Kuhn, Max; Yates, Phillip; Hyde, Craig

Pages: 53 –81

[This chapter is a broad overview of the drug discovery process and areas where statistical input can have a key impact. The focus is primarily in a few key areas: target discovery, compound screening/optimization, and the characterization of important properties. Special attention is paid to...
Available

High-Throughput Screening Data Analysis

Gubler, Hanspeter

Pages: 83 –139

[An overview over the role and past evolution of High Throughput Screening (HTS) in early drug discovery is given and the different screening phases which are sequentially executed to progressively filter out the samples with undesired activities and properties and identify the ones of interest...
Available

Quantitative-Structure Activity Relationship Modeling and Cheminformatics

Kuhn, Max

Pages: 141 –155

[This chapter describes quantitative tools for analyzing chemical structures and relating them to assay results using statistical models. The focus is on prediction of new compounds as well as the exploratory analysis and data mining of large compound databases. Other issues related to how these...
Available

GWAS for Drug Discovery

Lu, Yang; Perez-Morera, Katherine; Cantor, Rita M.

Pages: 157 –176

[Genome-wide association studies (GWAS) are playing a major role in identifying genetic associations with complex traits and disorders. It is anticipated this basic work will lead to a better understanding of the etiologies of such traits and disorders. In pharmacogenetics, application of GWAS...
Available

Statistical Applications in Design and Analysis of In Vitro Safety Screening Assays

Shu, Lei; Gintant, Gary; Zhang, Lanju

Pages: 177 –198

[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...
Available

Nonclinical Safety Assessment: An Introduction for Statisticians

Peers, Ian S.; South, Marie C.

Pages: 201 –230

[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...
Available

General Toxicology, Safety Pharmacology, Reproductive Toxicology, and Juvenile Toxicology Studies

Bailey, Steven A.; Li, Dingzhou; Potter, David M.

Pages: 231 –261

[This chapter provides a survey of key nonclinical safety assays. For each study type, we discuss the typical study designs employed, including a summary of the type of endpoints collected. We then provide an overview of common statistical approaches in each setting. There are some general themes...

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