Articles with "qualification" as a keyword



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Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020

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Published in 2022 at "Clinical Pharmacology and Therapeutics"

DOI: 10.1002/cpt.2554

Abstract: Regulatory qualification of biomarkers facilitates their harmonized use across drug developers, enabling more personalized medicine. This study reviews various aspects of the European Medicines Agency’s (EMA’s) biomarker qualification procedure, including frequency and outcome, common challenges,… read more here.

Keywords: qualification procedures; european medicines; biomarker; qualification ... See more keywords
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Performance qualification for reproducible Surface Plasmon Resonance analysis.

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Published in 2018 at "Analytical biochemistry"

DOI: 10.1016/j.ab.2017.12.027

Abstract: Surface Plasmon Resonance Biosensors (SPR) are one of the most powerful tools to characterize protein binding, e.g. for drug discovery, like target identification, ligand fishing, assay development, lead selection and manufacturing quality control. However, there… read more here.

Keywords: performance qualification; qualification; surface plasmon; performance ... See more keywords
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Qualification of ITER PF6 helium inlet

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Published in 2018 at "Fusion Engineering and Design"

DOI: 10.1016/j.fusengdes.2018.06.010

Abstract: Abstract The Poloidal Field (PF) coils are one of the main sub-systems of the ITER magnets. The PF6 coil is being manufactured by the Institute of Plasma Physics, Chinese Academy of Sciences (ASIPP) as per… read more here.

Keywords: inlet; pf6 helium; helium inlet; iter pf6 ... See more keywords
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Evaluating impact toughness as a qualification testing requirement for welds

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Published in 2020 at "Journal of Constructional Steel Research"

DOI: 10.1016/j.jcsr.2019.105839

Abstract: Abstract Steel structures with fracture-critical components and connections rightly require quality control to help prevent catastrophic failure. Specifically, fracture-critical welded connections require evidence of brittle fracture capacity, which can take the form of qualification testing… read more here.

Keywords: metal; toughness qualification; qualification; impact toughness ... See more keywords
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Modeling filtered building effluent stack sampling points for qualification criteria

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Published in 2020 at "Progress in Nuclear Energy"

DOI: 10.1016/j.pnucene.2020.103338

Abstract: Abstract Proposed construction of or changes to a radiological effluent stack must meet the mixing criteria at the sampled stack location required by the standards ANSI/HPS N13.1–2011 and ISO 2889. For more than a decade,… read more here.

Keywords: location; stack; qualification; effluent stack ... See more keywords
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Supplier pre-qualification method for the Portuguese construction industry

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Published in 2020 at "Procedia Manufacturing"

DOI: 10.1016/j.promfg.2020.10.237

Abstract: Abstract The construction process is so dependent on supply chain partners that selecting the best ones has an impact on its performance. The literature on supplier selection in the construction industry is little explored and… read more here.

Keywords: construction; industry; method; supplier ... See more keywords
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Universal Qualification of Near Ultraviolet Circular Dichroism Spectroscopy: Method Performance Parameters and Limits of Detection for Structural Differences.

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Published in 2020 at "Journal of pharmaceutical sciences"

DOI: 10.1016/j.xphs.2020.09.038

Abstract: Analytical methods must be qualified as part of the method development lifecycle for product characterization of biotherapeutics. For higher order structure characterization methods, such as near ultraviolet circular dichroism spectroscopy, qualification is performed to determine… read more here.

Keywords: product; method; ultraviolet circular; spectroscopy ... See more keywords
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Prognostics-based qualification of high-power white LEDs using Lévy process approach

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Published in 2017 at "Mechanical Systems and Signal Processing"

DOI: 10.1016/j.ymssp.2016.05.019

Abstract: Abstract Due to their versatility in a variety of applications and the growing market demand, high-power white light-emitting diodes (LEDs) have attracted considerable attention. Reliability qualification testing is an essential part of the product development… read more here.

Keywords: high power; power white; process; qualification ... See more keywords
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[Qualification requirements for the re-delegation of medical activities to nursing professionals (with extended competencies)].

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Published in 2022 at "Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen"

DOI: 10.1016/j.zefq.2021.12.005

Abstract: BACKGROUND For many years, the redistribution of tasks and thus a transfer of medical activities to nursing professionals with extended competencies has been discussed in Germany and is currently being regulated by the federal government.… read more here.

Keywords: nursing professionals; qualification requirements; qualification; medical activities ... See more keywords
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Bringing nuclear materials discovery and qualification into the 21st century

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Published in 2020 at "Nature Communications"

DOI: 10.1038/s41467-020-16406-2

Abstract: Time horizons for nuclear materials development and qualification must be shortened to realize future nuclear energy concepts. Inspired by the Materials Genome Initiative, we present an integrated approach to materials discovery and qualification to insert… read more here.

Keywords: qualification 21st; qualification; nuclear materials; bringing nuclear ... See more keywords
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Does workplace training participation vary by type of secondary level qualification? England and Germany in comparison

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Published in 2019 at "International Journal of Lifelong Education"

DOI: 10.1080/02601370.2019.1689434

Abstract: ABSTRACT Existing evidence shows that the higher the level of education the higher the likelihood to participate in workplace training. However, we know little about training participation of individuals educated to the secondary level, and… read more here.

Keywords: workplace training; germany; level; training participation ... See more keywords