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3881por Zhang, Shunli, Cheng, Fei, Wang, Hua, Wen, Jiangping, Zeng, Jie, Zhang, Chuanbao, Liu, Wensong, Wang, Ning, Jia, Tingting, Wang, Mo, Zhang, Rui, Yue, Yuhong, Xu, Jing, Wang, Zhanyong, Li, Yilong, Chen, Wenxiang, Wang, Qingtao“…After correction for systematic and commutability -related biases, the slopes indicating interassay relatedness ranged from 0.801 to 1.299 using individual human sera, from 0.735 to 1.254 using NCCL EQA data, and from 0.729 to 1.115 using pooled human serum EQA(the commutable EQA). CONCLUSIONS: The harmonization of TSH measurement is challenging; hence, systematic and commutability-related biases should be determined and corrected for accurate comparisons among assays when using human individual serum and the commercial EQA materials.…”
Publicado 2021
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3882por Hata, Tomomi, Nakamura, Kenichi, Yonemori, Kan, Noguchi, Emi, Watanabe, Makiko, Sohn, Joohyuk, Lu, Yen‐Shen, Yap, Yoon‐Sim, Tamura, Kenji, Fujiwara, Yasuhiro“…In conclusion, the observed differences among Asian regions should be harmonized to facilitate international academic trials in Asia and thus resolve unmet patient needs worldwide. …”
Publicado 2021
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3883por Yamashita, Ayumu, Sakai, Yuki, Yamada, Takashi, Yahata, Noriaki, Kunimatsu, Akira, Okada, Naohiro, Itahashi, Takashi, Hashimoto, Ryuichiro, Mizuta, Hiroto, Ichikawa, Naho, Takamura, Masahiro, Okada, Go, Yamagata, Hirotaka, Harada, Kenichiro, Matsuo, Koji, Tanaka, Saori C., Kawato, Mitsuo, Kasai, Kiyoto, Kato, Nobumasa, Takahashi, Hidehiko, Okamoto, Yasumasa, Yamashita, Okito, Imamizu, Hiroshi“…In particular, for the discovery dataset with 477 participants from 4 imaging sites, we removed site differences using our recently developed harmonization method and developed a brain network prediction model of depression symptoms (Beck Depression Inventory-II [BDI] score). …”
Publicado 2021
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3884por Keller, Jutta, Hammer, Heinz F., Afolabi, Paul R., Benninga, Marc, Borrelli, Osvaldo, Dominguez‐Munoz, Enrique, Dumitrascu, Dan, Goetze, Oliver, Haas, Stephan L., Hauser, Bruno, Pohl, Daniel, Salvatore, Silvia, Sonyi, Marc, Thapar, Nikhil, Verbeke, Kristin, Fox, Mark R.“…CONCLUSION: This clinical practice guideline should improve 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. …”
Publicado 2021
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3885“…To characterize the potential pro‐arrhythmic risk of this novel sarcomere activator, we evaluated OM in a series of International Conference on Harmonization S7B core and follow‐up assays, including an in silico action potential (AP) model. …”
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3886por Abdel-Kader, Maged S., Alam, Prawez, Soliman, Gamal A., Al-Shdefat, Ramadan, Afzal, Obaid“…SLD was subjected to stress conditions according to the International Conference on Harmonization (ICH) guidelines. The drug undergoes significant structural changes under oxidative stress condition to the N-oxide derivative. …”
Publicado 2021
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3887“…Although some clinical quality considerations do exist in Health Authorities (HA) guidances and regulations (e.g., International Conference of Harmonization Good Clinical Practices—GCP), there is currently no holistic GxP-like detailed framework for pharmaceutical sponsors using NGS service providers in clinical trials, or for the development of CDx and CGP. …”
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3888por Hossain, Md. Shohel, Amin, Mohammad Nurul, Das, Abhijit, Khan, A. K. M. Jahirul Hossain, Sohel, Md, Ahmed, Jamiuddin, Islam, Md. Monirul, Hossain, Md. Shahadat, Rahman, Md. Masudur, Nesa, Mst. Luthfun, Islam, Mohammad Safiqul“…Inter‐element‐relationship established a strong positive harmonization between these studied elements in both the cases of patients and control subjects. …”
Publicado 2021
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3889“…There is a need for better training of researchers at all career stages about ethics issues in research, more support to researchers from research organizations to follow the funding agencies requirements, as well as further development and harmonization of the ethics appraisal process during grant assessment.…”
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3890por Munyangaju, Isabelle, Langa, Matias Alberto Seth, Clemens, Sue Ann Costa, Marchetti, Elisa“…CONCLUSION: through the various efforts outlined the MOH and INGOs are moving towards an environment of mutual accountability, joint planning and coordination as well as harmonization of activities; but there are still challenges to be addressed. …”
Publicado 2021
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3891por Luna, Alex, Bernanke, Joel, Kim, Kakyeong, Aw, Natalie, Dworkin, Jordan D., Cha, Jiook, Posner, Jonathan“…Brain age prediction was more accurate using ComBat‐harmonized brain data (MAE = 0.26). Associations with psychometric measures remained consistent after ComBat harmonization, though only the association with CGAS reached statistical significance in the reduced sample. …”
Publicado 2021
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3892por Jackson, Rebecca, Matentzoglu, Nicolas, Overton, James A, Vita, Randi, Balhoff, James P, Buttigieg, Pier Luigi, Carbon, Seth, Courtot, Melanie, Diehl, Alexander D, Dooley, Damion M, Duncan, William D, Harris, Nomi L, Haendel, Melissa A, Lewis, Suzanna E, Natale, Darren A, Osumi-Sutherland, David, Ruttenberg, Alan, Schriml, Lynn M, Smith, Barry, Stoeckert Jr., Christian J, Vasilevsky, Nicole A, Walls, Ramona L, Zheng, Jie, Mungall, Christopher J, Peters, Bjoern“…The Open Biological and Biomedical Ontologies (OBO) Foundry was created to address this by facilitating the development, harmonization, application and sharing of ontologies, guided by a set of overarching principles. …”
Publicado 2021
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3893por Toroitich, Anthony Martin, Gebeyehu, Workneh, Adan, Fatuma Ibrahim, Ogola, Christine, Mohamed, Hassan Muktar, Ombeka, Victor, Ogolla, Charles, Oiye, Shadrack“…The TB control guidelines were not harmonized between the countries and the inter-country referral systems were either absent or inappreciable, contributing to ineffective cross-border referrals and transfers. …”
Publicado 2021
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3894por Chui, Ray W., Baublits, Joel, Chandra, Fiona A., Jones, Zack W., Engwall, Michael J., Vargas, Hugo M.“…The in vivo correct QT (QTc) assay is used by the pharmaceutical industry to characterize the potential for delayed ventricular repolarization and is a core safety assay mentioned in International Conference on Harmonization (ICH) S7B guideline. The typical telemetry study involves a dose‐response analysis of QTc intervals over time using a crossover (CO) design. …”
Publicado 2021
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3895por Kaul, Arvind, Mistry, Jatin, Iagnocco, Annamaria, Baraliakos, Xenofon, Bosworth, Ailsa, McNicol, Iain“…Inequality of access was found between regions, mirroring the variability that occurs between countries throughout Europe. Harmonization of access needs to be addressed by policymakers to ensure fairness in the way that clinicians and patients can access AT.…”
Publicado 2021
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3896“…Methods: We present a site-wise de-meaning (SWD) strategy in multi-site FC analysis and compare its performance with two common site-effect mitigation methods, i.e., generalized linear model (GLM) and Combining Batches (ComBat) Harmonization. For SWD, after FC was calculated and Fisher z-transformed, the site-wise FC mean was removed from each subject before group-level statistical analysis. …”
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3897por Koshiyama, Daisuke, Miura, Kenichiro, Nemoto, Kiyotaka, Okada, Naohiro, Matsumoto, Junya, Fukunaga, Masaki, Hashimoto, Ryota“…Further replication and harmonization of the ENIGMA consortium and COCORO will contribute to the generalization of their research findings.…”
Publicado 2020
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3898por Al Khalili, Sulien, Al Maani, Amal, Al Wahaibi, Adil, Al Yaquobi, Fatma, Al-Jardani, Amina, Al Harthi, Khalid, Alqayoudhi, Abdullah, Al Manji, Abdullah, Al Rawahi, Bader, Al-Abri, Seif“…The opportunities identified during response stages in the harmonization of the multisectoral response, streamlining communication channels, addressing vulnerable communities (dormitories, residences at border regions), and providing professional technical leadership provide an excellent precursor for expediting the transformation of Oman's health care system to one with a multisectoral holistic approach. …”
Publicado 2021
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3899por Sun, Jennifer K., Josic, Kristin, Melia, Michele, Glassman, Adam R., Bailey, Clare, Chalam, Kakarla V., Chew, Emily Y., Cukras, Catherine, Grover, Sandeep, Jaffe, Glenn J., Lee, Richard, Nielsen, Jared S., Thompson, Darby J. S., Wiley, Henry E., Ferris, Frederick L.“…CONCLUSIONS: Conversion equations developed in this study allow the harmonization of CST measurements for eyes with DME using a mix of current Cirrus and Spectralis device images. …”
Publicado 2021
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3900por Mudaranthakam, Dinesh Pal, Brown, Alexandra, Kerling, Elizabeth, Carlson, Susan E, Valentine, Christina J, Gajewski, Byron“…METHODS: A National Institute of Child Health and Human Development–funded phase 3 trial, the ADORE (assessment of docosahexaenoic acid [DHA] on reducing early preterm birth) trial fully utilized CRIS to provide automated accrual reports, centralize data capture, automate trial completion reports, and streamline data harmonization. RESULTS: Using the ADORE trial as an example, we describe the utility of CRIS in database design, regulatory compliance, training standardization, study management, and automated reporting. …”
Publicado 2021
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