“…Thus, we conducted a systematic review to determine the status of regulatory-approved ML/DL-based medical devices in Japan, a leading stakeholder in international regulatory harmonization. Information about the medical devices were obtained from the Japan Association for the Advancement of Medical Equipment search service. …”
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“…The principles of the International Conference on Harmonization Q6 were used to characterize the new salts and their stability-indicating parameters were evaluated at 0, 3, and 6 months under accelerated conditions of 40 °C and 75% relative humidity. …”
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“…This analysis allowed for proposing some recommendations for approximation and harmonization of international regulatory practices for the assessment of the risk/benefit balance of these products, considering as well the public expectations as regards efficacy and safety of nanomaterials used in Health products, in terms of human and environmental health.…”
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“…It includes current indications for pathologic programmed death-ligand 1 (PD-L1) assessment and important pathologic considerations on PD-L1 testing harmonization including interassay and algorithm variabilities. …”
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“…Our analysis maps elements of data governance across emerging NIH-funded cloud platforms and as such provides a key resource for stakeholders seeking to understand and utilize data access and analysis options across platforms and to surface aspects of governance that may require harmonization to achieve the desired interoperability.…”
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“…While regulatory uncertainties still prevail, it is anticipated that through the pilot program established by the European Medicines Agency (EMA) and the FDA, harmonization of the regulatory requirements will be achieved, thereby facilitating the development of follow-on versions of NBCDs.…”
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“…Citability, comprehensive metadata descriptions, interoperability of data and metadata, a high degree of structural and semantic harmonization of the data inventory as well as the commitment of the hosting institutions ensures the long-term usability of archived data. …”
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“…Conclusions: In this paper, the expansion of facial volumes in orthognathic surgery is proposed as a key point for facial harmonization. Beauty could be scientifically interpreted as a balanced distribution of facial volumes, and the virtual study of this distribution can become an important part of the preoperative analysis, such as a “volumetric” 3D cephalometry, where the surgeon could use average values of aesthetic volumetric distribution as preoperative surgical references.…”
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“…However, the quality of the studies using CT radiomics-based models varies widely, and further harmonization and prospective validation are needed before the generalization of these models.…”
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“…In addition to these clinically focused comparisons, we describe opportunities for guideline improvement and harmonization. Specifically, these include opportunities regarding HFrEF sequencing, the need for timely updates, shared decision-making, Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework adoption, and the creation of recommendations where high-quality evidence is lacking. …”
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“…Radiologically, we observed premature bone healing with subsequent harmonization. Post hoc power analysis demonstrated a power of 0.99. …”
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“…Moreover, they promote international harmonization and data interoperability, enabling information exchange and research collaboration. …”
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“…Conclusion: To better analyze trends in the characteristics of heatwaves, and their impact on cardiovascular health, an international harmonization effort to define a common standard is recommendable.…”
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“…Further studies of the use of BTMs in individuals with metabolic bone disease, coupled with the harmonization of commercial assays to provide equivalent results, will further enhance their clinical applications.…”
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“…OBJECTIVE: The diversity of nomenclature and naming strategies makes therapeutic terminology difficult to manage and harmonize. As the number and complexity of available therapeutic ontologies continues to increase, the need for harmonized cross-resource mappings is becoming increasingly apparent. …”
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“…This study proposes a diagnostic-integrated approach combining Empirical Bayes Harmonization (EBS), Jensen–Shannon Divergence (JSD), deep learning, and contour mathematics for cancer detection using gene expression data. …”
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“…The optional substitution of a second 2-year rodent carcinogenicity study with an alternative study such as an in vivo transgenic carcinogenicity study is part of the International Conference on Harmonization guidance S1B: Testing for Carcinogenicity of Pharmaceuticals. …”
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“…However, the information for harmonization and standardization of GMO analysis methods at global level is needed. …”
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“…In conclusion, gastric ulcer healing induced by eAE was driven in a dose-specific manner through the harmonization of the antioxidative property and modulation of anti-inflammatory cytokine level.…”
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“…According to the guidelines of the International Conference on Harmonization (ICH), the method was validated for precision, accuracy, and recovery. …”
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