“…Only one major metabolite M463‐2 (MSC2430422) was identified in plasma above the 10% of total drug exposure threshold, which classifies M463‐2 (MSC2430422) as a major metabolite according to the US Food and Drug Administration (FDA; metabolites in safety testing [MIST]) and the European Medicines Agency (EMA; International Conference on Harmonization [ICH] M3). These results support further development of evobrutinib and may help inform subsequent investigations.…”
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“…However, multiple site manufacturing requires harmonization of product testing and manufacturing in order to interpret the clinical trial results. …”
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“…To better meet the emergent challenges of transporting cryopreserved allogeneic HPC during pandemics, there is an urgent need for External Quality Assurance (EQA) programs to evaluate reproducibility and harmonization of viable CD34(+) cell (vCD34(+)) HPC enumeration, as the current EQA programs are unsuitable for analysis of vCD34(+). …”
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“…In particular, the harmonization of medication lists related to the use of time, expenditures, and challenges with technological solutions in the introduction phase was emphasized as a challenge. …”
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“…We then explain the rationale for a standardized hippocampal subfield segmentation quality control (QC) procedure for improved pipeline harmonization. To guide researchers to make optimal use of the algorithm, we discuss how global size and age effects can be modeled, how QC steps can be incorporated and how subfields may be aggregated into composite volumes. …”
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“…Then we reviewed methods for correcting batch effects by exploring the two main classes of approaches: Data Harmonization that uses data standardization, quality control protocols or other similar algorithms and procedures to explicitly understand and minimize unwanted batch effects; and Domain Adaptation that develops DL tools that implicitly handle the batch effects by using approaches to achieve reliable and robust results. …”
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“…CONCLUSION: This clinical practice guideline should facilitate pan‐European harmonization of diagnostic approaches to symptoms and disorders, which are very common in specialist and primary care gastroenterology practice, both in adult and pediatric patients. …”
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“…The development and implementation of AI-powered pipelines will enable advancement towards automating data deidentification, curation, annotation, integrity securing and image harmonization. By the end of the project, the usability and performance of the repository as a tool fostering AI experimentation will be technically validated, including a validation subphase by world-class European AI developers, participating in Open Challenges to the AI Community. …”
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“…CONCLUSION: Our study reinforces the relevance of AGFAD recommendations for forensic age assessment and calls for the harmonization of practices based on this methodology in the European countries.…”
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“…Despite positive outcomes of child- and family-focused programs, the fragmentation of services presents challenges. To enhance harmonization and diminish fragmentation of service policies, we implement a preventive collaborative service model for children and families. …”
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“…Substantial variability has been observed among researchers in phenotypes reported from similar studies, as well as a lack of consistent data annotation, indicating a need for both terminological and data harmonization. When examined from a data science perspective, many of these apparent differences can be parsed into the same or similar endpoints whose measurements differ only in time, methodology, or nomenclature. …”
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“…METHODS: The MIDAS platform was developed in an iterative and collaborative way with close involvement of academia, industry, healthcare staff and policy-makers, to solve tasks including data storage, data harmonization, data analytics and visualizations, and open and social data analytics. …”
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“…Since a substantial proportion of studies report discrepancies between PROs and biochemical outcomes, PROMs are pivotal in the evaluation of disease activity. Therefore, harmonization of PROs in clinical practice and research by development of core outcome sets is an important unmet need.…”
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“…The method satisfied International Council for Harmonization (ICH) validation guidelines. The study was extended to the estimation of the studied drugs in their co-formulated eye drops as well as in their single dosage forms with acceptable percentage recoveries. …”
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“…It also enabled to advance on a pragmatic harmonization strategy: EARS-Vet shall follow the European Committee on Antimicrobial Susceptibility Testing (EUCAST) standards, collect quantitative data and interpret AMR data using epidemiological cut-off values.…”
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“…MATERIALS AND METHODS: The study has been reviewed and approved by the Institutional Review Board (SRMU/MandHS/SRMDC/2018/S/025) and by the in-house Institutional Animal Ethics Committee (IAEC) of Pentagrit Research Lab and conducted with compliance to ICH harmonization and principles for animal housing and handling (IAEC Study No: 215/Go06/IAEC). …”
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“…The purpose of this commentary is to identify five major initiatives to stimulate focused discussion on how modernization might be achieved: (1) build systems for more rapid collection and integration of extant data relevant to NBS; (2) establish a national network of NBS research centers to design and conduct prospective research studies addressing critical NBS questions; (3) create a network of regional NBS laboratories to expedite state implementation of new methodologies or screening for newly recommended conditions; (4) establish a new stream of federal funding to provide financial support for states and incentivize national harmonization; and (5) integrate solutions in a way that is strategic and effective. …”
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“…Cross-model comparisons based on ROC curve analyses are the first step toward harmonization of proliferating NP methods that aim to “diagnose” high nutrient-density foods.…”
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“…The International Council for Harmonization (ICH) procedures were followed in the validation process and the results were evaluated in comparison with official HPLC methods, where no noteworthy differences were found. …”
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“…To facilitate a harmonized research strategy, a concerted effort is needed to catalogue available occupational exposure information. …”
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