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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,…
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Keywords:
qualification procedures;
european medicines;
biomarker;
qualification ... See more keywords
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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…
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Keywords:
performance qualification;
qualification;
surface plasmon;
performance ... See more keywords
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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…
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Keywords:
inlet;
pf6 helium;
helium inlet;
iter pf6 ... See more keywords
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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…
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Keywords:
metal;
toughness qualification;
qualification;
impact toughness ... See more keywords
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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,…
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Keywords:
location;
stack;
qualification;
effluent stack ... See more keywords
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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…
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Keywords:
construction;
industry;
method;
supplier ... See more keywords
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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…
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Keywords:
product;
method;
ultraviolet circular;
spectroscopy ... See more keywords
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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…
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Keywords:
high power;
power white;
process;
qualification ... See more keywords
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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.…
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Keywords:
nursing professionals;
qualification requirements;
qualification;
medical activities ... See more keywords
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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…
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Keywords:
qualification 21st;
qualification;
nuclear materials;
bringing nuclear ... See more keywords
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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…
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Keywords:
workplace training;
germany;
level;
training participation ... See more keywords