“…Potential solutions include policy harmonization between regulatory and HTA authorities, commitment to generating robust post-marketing efficacy-safety data, managing uncertainties through risk-sharing agreements, and using value frameworks. …”
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“…CONCLUSIONS: Our dataset may be useful for human retinal endothelial cell transcriptomic assemblies, functional gene annotating and/or gene expression and enrichment analyses, as well as cross-dataset harmonization. TRANSLATIONAL RELEVANCE: The molecular profile of the human retinal endothelium is a source of candidate biologic targets for retinal vasculopathies.…”
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“…While the policy literature generally favors more flexible compliance mechanisms that increase the cost of polluting to reflect its costs to society, important policy design factors include policy co-benefits, distributional concerns, and inter-regional harmonization. In addition to these key themes, we find that further study is needed both to improve the availability of cost information for adaptation interventions and to localize technology and policy cost estimates to the Saudi context.…”
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“…Herein, we applied a meta-analysis to harmonize environmental tradeoff data through a comprehensive literature review. …”
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“…The method was validated as per International Conference on Harmonization (ICH) guidelines and was confirmed to be specific, precise, accurate, and linear. …”
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“…RESULTS: Applying the CDM to the DISCOVER CKD retrospective cohort, secondary data from 1,857,593 patients with CKD were harmonized from five data sources, across three countries, into a discrete database for rapid real-world evidence generation. …”
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“…Interestingly, we found 248 articles, of which most use the OMOP for harmonizing their data, but only 5 make use of predictive algorithms on OMOP-based data and fulfill our criteria. …”
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“…When it comes to when along the data life cycle, DQF is expected operate when data needs harmonization at data processor level (ie, the effective application of interoperability standards), in the publication of the data sources (ie providing users knowledge on the provenance of data and the content of data source); or, when data sources have to be integrated and sensitive data pseudonymized (ie, the quality of the linkage and losses after pseudonymisation). …”
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“…Among those services: data discovery; data harmonization services (e.g., discovery and use of common data models and interoperability standards); technological services (e.g., playgrounds with synthetic data, secure process environments); research outputs archival (e.g., maintenance and dissemination of the knowledge base generated in the infrastructure); and, training and capacity building. …”
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“…Validation of the developed spectrofluorimetric method was done along with the International Council of Harmonization requirements.…”
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“…Multiple validation parameters of AIA were evaluated to qualify the assay following International Conference on Harmonization (ICH) Q2(R1) guidelines. The AIA is a high throughput assay and demonstrated excellent precision (3.2 and 5.4% coefficients of variance for intra- and inter-assay variability, respectively) and high sensitivity (>12% impurity in a sample can be detected). …”
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“…Ethics and dissemination: The LEONE-HT study is carried out in accordance with the principles set out in the Declaration of Helsinki and the International Conference on Harmonization guidelines for good clinical practice and following national laws and regulations. …”
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“…Finally, some recommendations are given for future research, from study design to newer developments in analysis, and the need for harmonization of sequences and methods within the field. …”
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“…Data destined for ICE undergo rigorous harmonization, standardization, and formatting processes using both automated and manual expert-driven approaches. …”
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“…Therefore, the International Guideline Harmonization Group (IGHG) on late effects of childhood cancer therefore recommends surveillance. …”
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“…RESULTS: We propose a curation and data integration pipeline for harmonizing diagnosis. We also report challenges identified in mapping Read codes from UK Biobank GP tables to ICD and SNOMED CT. …”
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“…This review will help regulators build regulatory frameworks, and lead to harmonization of the framework between the countries.…”
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“…The validation parameters such as linearity (R(2) of ≥ 0.9842 for 1-naphthol and ≥ 0.9897 for 1-naphthol acetate), precision (94.21–96.41%), accuracy (85.2%–99.6% and 82.6%–99.3% for 1-naphthol and 1-naphthol acetate respectively), and robustness were validated according to International Conference on Harmonization (ICH) guidelines. Blood samples were collected from healthy people, farmers exposed to spraying of pesticides, and suicidal patients who ingested pesticides and were hospitalized and were analyzed by the developed method. …”
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“…Interdisciplinary team-based models focus on the synthesis and harmonization of knowledge and methods from different disciplines to create an integrative approach to patient care that both maximizes the expertise of each involved specialist and encourages thought beyond each specialist’s discipline. …”
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“…Besides, HUSCH integrated different datasets in the single tissue module and performs data integration, batch correction, and cell type harmonization. This allows a comprehensive visualization and analysis of gene expression within each tissue based on single-cell datasets from multiple sources and platforms. …”
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