The Experts below are selected from a list of 10782 Experts worldwide ranked by ideXlab platform
Debora Merrill - One of the best experts on this subject based on the ideXlab platform.
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plasma fibrinogen Qualification as a drug development Tool in chronic obstructive pulmonary disease perspective of the chronic obstructive pulmonary disease biomarker Qualification consortium
American Journal of Respiratory and Critical Care Medicine, 2016Co-Authors: Bruce E Miller, Ruth Talsinger, Stephen I Rennard, Armin Furtwaengler, Nancy Kline Leidy, Michael Lowings, Ubaldo J Martin, Thomas R Martin, Debora MerrillAbstract:The COPD Foundation Biomarker Qualification Consortium (CBQC) is a unique public-private partnership established in 2010 between the COPD Foundation, the pharmaceutical industry, and academic chronic obstructive pulmonary disease (COPD) experts with advisors from the U.S. NHLBI and the Food and Drug Administration (FDA). This was a direct response to the 2009 publication of a guidance on Qualification of drug development Tools by the FDA. Although data were believed to be available from publicly funded and industry-funded studies that could support Qualification of several Tools, the necessary data resided in disparate databases. The initial intent of the CBQC was to integrate these data and submit a dossier for the Qualification. This led to the FDA Qualification of plasma fibrinogen as a prognostic or enrichment biomarker for all-cause mortality and COPD exacerbations in July 2015. It is the first biomarker drug development Tool qualified for use in COPD under the FDA's drug development Tool Qualification program. This perspective summarizes the FDA's Qualification process, the formation of the CBQC, and the effort that led to a successful outcome for plasma fibrinogen and discusses implications for future biomarker Qualification efforts.
Stephen I Rennard - One of the best experts on this subject based on the ideXlab platform.
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plasma fibrinogen Qualification as a drug development Tool in chronic obstructive pulmonary disease perspective of the chronic obstructive pulmonary disease biomarker Qualification consortium
American Journal of Respiratory and Critical Care Medicine, 2016Co-Authors: Bruce E Miller, Ruth Talsinger, Stephen I Rennard, Armin Furtwaengler, Nancy Kline Leidy, Michael Lowings, Ubaldo J Martin, Thomas R Martin, Debora MerrillAbstract:The COPD Foundation Biomarker Qualification Consortium (CBQC) is a unique public-private partnership established in 2010 between the COPD Foundation, the pharmaceutical industry, and academic chronic obstructive pulmonary disease (COPD) experts with advisors from the U.S. NHLBI and the Food and Drug Administration (FDA). This was a direct response to the 2009 publication of a guidance on Qualification of drug development Tools by the FDA. Although data were believed to be available from publicly funded and industry-funded studies that could support Qualification of several Tools, the necessary data resided in disparate databases. The initial intent of the CBQC was to integrate these data and submit a dossier for the Qualification. This led to the FDA Qualification of plasma fibrinogen as a prognostic or enrichment biomarker for all-cause mortality and COPD exacerbations in July 2015. It is the first biomarker drug development Tool qualified for use in COPD under the FDA's drug development Tool Qualification program. This perspective summarizes the FDA's Qualification process, the formation of the CBQC, and the effort that led to a successful outcome for plasma fibrinogen and discusses implications for future biomarker Qualification efforts.
Bruce E Miller - One of the best experts on this subject based on the ideXlab platform.
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plasma fibrinogen Qualification as a drug development Tool in chronic obstructive pulmonary disease perspective of the chronic obstructive pulmonary disease biomarker Qualification consortium
American Journal of Respiratory and Critical Care Medicine, 2016Co-Authors: Bruce E Miller, Ruth Talsinger, Stephen I Rennard, Armin Furtwaengler, Nancy Kline Leidy, Michael Lowings, Ubaldo J Martin, Thomas R Martin, Debora MerrillAbstract:The COPD Foundation Biomarker Qualification Consortium (CBQC) is a unique public-private partnership established in 2010 between the COPD Foundation, the pharmaceutical industry, and academic chronic obstructive pulmonary disease (COPD) experts with advisors from the U.S. NHLBI and the Food and Drug Administration (FDA). This was a direct response to the 2009 publication of a guidance on Qualification of drug development Tools by the FDA. Although data were believed to be available from publicly funded and industry-funded studies that could support Qualification of several Tools, the necessary data resided in disparate databases. The initial intent of the CBQC was to integrate these data and submit a dossier for the Qualification. This led to the FDA Qualification of plasma fibrinogen as a prognostic or enrichment biomarker for all-cause mortality and COPD exacerbations in July 2015. It is the first biomarker drug development Tool qualified for use in COPD under the FDA's drug development Tool Qualification program. This perspective summarizes the FDA's Qualification process, the formation of the CBQC, and the effort that led to a successful outcome for plasma fibrinogen and discusses implications for future biomarker Qualification efforts.
Oscar Slotosch - One of the best experts on this subject based on the ideXlab platform.
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model based Tool Qualification
International Conference on Software Engineering, 2012Co-Authors: Oscar SlotoschAbstract:In this paper we describe the model-based approach to Tool Qualification starting from the process model for the determination of the Qualification need until the model for test and Qualification. The model-based approach can automate many steps from checking the syntactical requirements completeness until the determination whether all requirements have been implemented and successfully tested. Many required documents like the "Tool Requirements Specification" or "Tool Test Specification" can be generated from the model. The model-based approach has been shown to fulfill all requirements from the DO-330 standard which describes Tool Qualification for avionic, automotive and other industries. Therefore the Eclipse Foundation has chosen this standard and proposed a roadmap to provide support for the development of qualifiable Eclipse-based Tools. This paper describes the model-based approach and the roadmap of Eclipse to support this process.
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iso 26262 Tool chain analysis reduces Tool Qualification costs
Automotive - Safety & Security, 2012Co-Authors: Oscar Slotosch, Martin Wildmoser, Jan Philipps, Reinhard Jeschull, Rafael ZalmanAbstract:Software Tools in safety related projects are indispensable, but also introduce risks. A Tool error may lead to the injection or non-detection of a fault in the product. For this reason the safety norm for road vehicles, ISO 26262, requires determination of a Tool confidence level for each software Tool. In this paper we present a model-based approach to represent a Tool chain, its potential errors and the counter-measures for these. In this model Tools are not only error sources, but can also act as error sinks for other Tools by providing appropriate checks and restrictions. The Tool work flow in a project can be rearranged or extended to make the integrated Tool chain safer than its parts and to reduce Tool Qualification costs greatly. The Tool chain model not only identifies the critical Tools, but also exposes very specific Qualification requirements for these. The paper illustrates and augments this approach with experiences and results from an application to a real industrial automotive Tool chain consisting of 37 Tools.
Nancy Kline Leidy - One of the best experts on this subject based on the ideXlab platform.
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plasma fibrinogen Qualification as a drug development Tool in chronic obstructive pulmonary disease perspective of the chronic obstructive pulmonary disease biomarker Qualification consortium
American Journal of Respiratory and Critical Care Medicine, 2016Co-Authors: Bruce E Miller, Ruth Talsinger, Stephen I Rennard, Armin Furtwaengler, Nancy Kline Leidy, Michael Lowings, Ubaldo J Martin, Thomas R Martin, Debora MerrillAbstract:The COPD Foundation Biomarker Qualification Consortium (CBQC) is a unique public-private partnership established in 2010 between the COPD Foundation, the pharmaceutical industry, and academic chronic obstructive pulmonary disease (COPD) experts with advisors from the U.S. NHLBI and the Food and Drug Administration (FDA). This was a direct response to the 2009 publication of a guidance on Qualification of drug development Tools by the FDA. Although data were believed to be available from publicly funded and industry-funded studies that could support Qualification of several Tools, the necessary data resided in disparate databases. The initial intent of the CBQC was to integrate these data and submit a dossier for the Qualification. This led to the FDA Qualification of plasma fibrinogen as a prognostic or enrichment biomarker for all-cause mortality and COPD exacerbations in July 2015. It is the first biomarker drug development Tool qualified for use in COPD under the FDA's drug development Tool Qualification program. This perspective summarizes the FDA's Qualification process, the formation of the CBQC, and the effort that led to a successful outcome for plasma fibrinogen and discusses implications for future biomarker Qualification efforts.