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Design Considerations for High Throughput Screening and In Vitro Diagnostic Assays

术语 计算机科学 范围(计算机科学) 背景(考古学) 高含量筛选 质量(理念) 数据科学 管理科学 风险分析(工程) 医学 化学 工程类 哲学 古生物学 认识论 程序设计语言 生物 细胞 生物化学 语言学
作者
Komandoor E. Achyuthan,David G. Whitten
出处
期刊:Combinatorial Chemistry & High Throughput Screening [Bentham Science Publishers]
卷期号:10 (6): 399-412 被引量:25
标识
DOI:10.2174/138620707781996475
摘要

This paper reviews the several different factors that must be considered during the development of assays for high throughput screening (HTS) or in vitro diagnostic (IVD) applications. The reader is introduced to the terminology used in assay development as well as the statistical approaches for evaluating the data. The review is intended to serve as a tutorial to biotechnology, pharmaceutical and clinical professionals, the academic researcher, as well as a guide for established investigators of HTS and IVD. This review is not a comprehensive treatise in its scope or content, but is meant to introduce the reader to key concepts of assay development. Elementary mathematical and statistical tools for designing robust assays and data management are described. While certain design concepts overlap HTS and IVDs, others are more pertinent to one or the other topic. An overview of the regulatory requirements for IVDs is included in the context of the United States Food and Drug Administration. Quality concepts and high content screening are also briefly described. The review does not focus upon any particular assay technology nor does it provide detailed laboratory procedures on specific assays. The references cited are not exhaustive, but meant to steer the reader toward a general status report of the various technologies discussed. The information presented in this review is not intended to replace the judgment of the experienced laboratory scientist. However, this review should assist the scientific professional in executing well designed assays and being aware of design considerations.

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