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Titlebook: Nonclinical Statistics for Pharmaceutical and Biotechnology Industries; Lanju Zhang Book 2016 Springer International Publishing Switzerlan

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Regulatory Nonclinical StatisticsDA Chemistry Manufacturing, and Control (CMC) Statistics Team. In the second example, we illustrate the research activities of Pharmacological/Toxicological (Pharm-Tox) Statistics Team at FDA with the background and evaluation of multiple pairwise comparisons in animal carcinogenetic studies.
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Introduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industriesies, 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,
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Regulatory Nonclinical Statisticsstical consultation, and statistical methodology development in nonclinical regulations. In this chapter, we provide a brief description of the two teams and provide two examples in statistical research development. In the first example, we describe the historical background and evolution of statist
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High-Throughput Screening Data Analysisich are sequentially executed to progressively filter out the samples with undesired activities and properties and identify the ones of interest are outlined. The goal of a complete HTS campaign is to identify a validated set of chemical probes from a larger library of small molecules, antibodies, s
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GWAS for Drug Discoveryed this basic work will lead to a better understanding of the etiologies of such traits and disorders. In pharmacogenetics, application of GWAS methods is evolving. Here, the traits and disorders of interest derive from the diversity in patient response to medications. It is anticipated that GWAS wi
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