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Defining validation as a significant correlation between gene and compound patterns, the percent validated increased with the increasing correlation coefficient of the nominated gene-drug relationship in the NCI39 training set.
Defining validation is complex, and terms such as accreditation, certification and assessment are often used interchangeably.
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Since there are no clearly defined validation requirements for a SPR-based binding kinetic assay, the validation strategy was based on the guidelines stipulated by the International Conference on Harmonization for Analytical Method Validation.
In the future, we anticipate that RNAi HTS will be applied as the very first step of many research endeavors, and the results of the screens will provide lead information to design defined validation experiments.
Here we used both qualitative (direction) and quantitative agreement between the two methods to define "validation".
Based on our experience and on published data [ 20- 24], we defined validation criteria for each type of analysis.
Our four real-time NASBA assays offer these benefits and also the five features that define validation of any assay: accuracy, sensitivity, precision, robustness, and specificity.
Wurmbach et al. (4) reported 100% validation of results for genes exhibiting at least 1.6 fold change; however, they defined validation as directional confirmation only and large discrepancies in the amount of change were not addressed in their study.
The ISO 17025 international quality standard defines validation generically as the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled.
The users can define validation rules and options for the recorded concepts, which results in higher quality and more consistent patient data to be gathered for quality control and clinical research.
The United States Food and Drug Administration FDAA) has defined validation as "confirmation by examination and provision of objective evidence that computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled" [ 1].
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