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3621“…During the last few years, the fields of genomics and cancer research have seen significant advancement in terms of molecular genetics technology, disease concepts, data standard harmonization as well as data availability, in an increasingly structured and systematic manner. …”
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3622A systematic review of adverse events following immunization during pregnancy and the newborn periodpor Fulton, T. Roice, Narayanan, Divya, Bonhoeffer, Jan, Ortiz, Justin R., Lambach, Philipp, Omer, Saad B.“…A key challenge identified was the continued need for harmonization of maternal adverse event following immunization (AEFI) research and surveillance efforts within developing and developed country contexts. …”
Publicado 2015
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3623por Jeiziner, C., Suter, K., Wernli, U., Barbarino, J. M., Gong, L., Whirl-Carrillo, M., Klein, T. E., Szucs, T. D., Hersberger, K. E., Meyer zu Schwabedissen, H. E.“…Unstandardized wording, appearance of PGx information in different sections and unclear instructions challenge HCPs to identify and interpret PGx information and translate it into practice. HCPs need harmonization and standardization of PGx information in DLs to personalize drug therapies and tailor pharmaceutical care.…”
Publicado 2020
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3624por Tang, Weifeng, Huang, Ying, Zhou, Diansong, Huang, Yao, Chen, Yingxue, Ren, Song, Li, Yan, Wu, Shengqian, Zhao, Xiaoying, Song, Xuyang, Wang, Haidong, Jin, Yuwen, Yu, Hongtao, Zhang, Li, Li, Yunfei, Boulton, David, Shen, Kevin“…In order to understand the fast‐changing landscape and to enable planning of more global drug development programs and study designs in China, we reviewed 15 published clinical pharmacology‐related guidances by the National Medical Products Administration (NMPA), and compared them with reference guidances from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), or the International Conference on Harmonization (ICH), to understand the similarities and differences, especially any China‐specific requirements, such as ethnic sensitivity analysis. …”
Publicado 2021
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3625por Virostko, John, Craddock, Richard C., Williams, Jonathan M., Triolo, Taylor M., Hilmes, Melissa A., Kang, Hakmook, Du, Liping, Wright, Jordan J., Kinney, Mara, Maki, Jeffrey H., Medved, Milica, Waibel, Michaela, Kay, Thomas W. H., Thomas, Helen E., Greeley, Siri Atma W., Steck, Andrea K., Moore, Daniel J., Powers, Alvin C.“…Following harmonization, pancreas size, surface area to volume ratio, diffusion, and longitudinal relaxation time were reproducible, with coefficients of variation less than 10%. …”
Publicado 2021
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3626por Kim, Yoonjoo, Lee, Ji Hyun, Ko, Geon Young, Ryu, Ji Hyeong, Jang, Joo Hee, Bae, Hyunjoo, Yoo, Seung-Hyo, Choi, Ae-Ran, Jung, Jin, Lee, Jongmin, Oh, Eun-Jee“…Further standardization and harmonization of immunoassays might be helpful in monitoring immune status after COVID-19 infection or vaccination.…”
Publicado 2021
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3627“…Weighted gene co-expression network analysis showed that transcription factors FUS3 and bHLH played a critical role in the seed oil biosynthesis. The perfect harmonization of the high expression of FAD2 with the extremely low expression of FAD3 regulated the accumulation of C18:2. …”
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3628por Kwambana-Adams, Brenda Anna, Cohen, Adam L, Hampton, Lee, Nhantumbo, Aquino Albino, Heyderman, Robert S, Antonio, Martin, Bita, Andre, Mwenda, Jason Mathiu“…With this new structure, countries will establish comprehensive and sustainable meningitis surveillance systems integrated with greater harmonization between population-based and sentinel surveillance systems. …”
Publicado 2021
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3629por Khaled, Salma M., Petcu, Catalina, Bader, Lina, Amro, Iman, Al‐Assi, Marwa, Le Trung, Kien, Mneimneh, Zeina N., Sampson, Nancy A., Kessler, Ronald C., Woodruff, Peter W.“…RESULTS: Standard translation and harmonization procedures were used to develop the WMHQ instrument. …”
Publicado 2021
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3630“…In this vein, we present a means to combine codon harmonization and a maltose-binding protein fusion tag to produce CCR3 from E. coli. …”
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3631por Bashkin, Osnat, Dopelt, Keren, Mor, Zohar, Leighton, Lore, Otok, Robert, Duplaga, Mariusz, MacLeod, Fiona, De Nooijer, Jascha, Neumark, Yehuda, Paillard-Borg, Stephanie, Tulchinsky, Theodore, Zelber-Sagi, Shira, Davidovitch, Nadav“…This project report describes the conceptual framework of “Sharing European Educational Experience in Public Health for Israel (SEEEPHI): harmonization, employability, leadership, and outreach”—a multinational Erasmus+ Capacity Building in Higher Education funded project. …”
Publicado 2021
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3632por Hu, Xin, Walker, Douglas I., Liang, Yongliang, Smith, Matthew Ryan, Orr, Michael L., Juran, Brian D., Ma, Chunyu, Uppal, Karan, Koval, Michael, Martin, Greg S., Neujahr, David C., Marsit, Carmen J., Go, Young-Mi, Pennell, Kurt D., Miller, Gary W., Lazaridis, Konstantinos N., Jones, Dean P.“…The simplicity of the method can facilitate harmonization of environmental biomonitoring between laboratories and enable population level human exposome research with limited sample volume.…”
Publicado 2021
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3633por Snowden, John A., McGrath, Eoin, Orchard, Kim, Kröger, Nicolaus, Sureda, Anna, Gratwohl, Alois“…To reach this goal, EBMT/JACIE will be challenged to start the process by further fostering harmonization within and between organizations at institutional, national, and European levels. …”
Publicado 2021
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3634por Jokic, Anja, Rimac, Vladimira, Vlasic Tanaskovic, Jelena, Podolar, Sonja, Honovic, Lorena, Lenicek Krleza, Jasna“…INTRODUCTION: The detection and prevention of errors in the postanalytical phase can be done through the harmonization and standardization of constituent parts of this phase of laboratory work. …”
Publicado 2021
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3635“…Several RBM tools were developed after the International Council for Harmonization gave sponsors the flexibility to initiate an approach to enhance quality management in a clinical trial. …”
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3636por Ubalde-Lopez, Monica, Garani-Papadatos, Tina, Scelo, Ghislaine, Casas, Maribel, Lissåker, Claudia, Peters, Susan, Nohr, Ellen Aagaard, Albin, Maria, Lucas, Raquel, Papantoniou, Kyriaki, Polańska, Kinga, Ramlau-Hansen, Cecilia H, Šarac, Jelena, Selander, Jenny, Skröder, Helena, Vasileiou, Elena, Kogevinas, Manolis, Bültmann, Ute, Mehlum, Ingrid Sivesind, Maule, Milena“…We address the technical difficulties implied by data harmonization and the ethical challenges related to the repurposing of data, and provide scientific, ecological and economic arguments in favor of improving the value of data already available as a result of a serious investment in human and material resources. …”
Publicado 2021
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3637por Liu, Siman, Wang, Yin-Shan, Zhang, Qing, Zhou, Quan, Cao, Li-Zhi, Jiang, Chao, Zhang, Zhe, Yang, Ning, Dong, Qi, Zuo, Xi-Nian“…Additionally, data were collected on children’s learning, daily life and emotional states during the COVID-19 pandemic in 2020. We address data harmonization across the two sites and demonstrated its promise of characterizing the growth curves for the overall brain morphometry using multi-center longitudinal data. …”
Publicado 2021
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3638por Abouir, Kenza, Samer, Caroline F, Gloor, Yvonne, Desmeules, Jules A, Daali, Youssef“…PBPK for DDI prediction is a promising approach in clinical, and harmonization of clearance prediction may be helped by a consensus on selecting the best data to use for PBPK model development.…”
Publicado 2021
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3639por John, Oommen, Gummudi, Balaji, Jha, Anubhuti, Gopalakrishnan, Natarajan, Kalra, Om P., Kaur, Prabhdeep, Kher, Vijay, Kumar, Vivek, Machiraju, Ravi Shankar, Osborne, Nicolas, Palo, Subrata Kumar, Parameswaran, Sreejith, Pati, Sanghamitra, Prasad, Narayan, Rathore, Vinay, Rajapurkar, Mohan M., Sahay, Manisha, Tatapudi, Ravi Raju, Thakur, Jarnail S., Venugopal, Vidhya, Jha, Vivekanand“…Guidelines are needed for clinical evaluation, referral, management, and harmonization of clinical documentation and health records. …”
Publicado 2021
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3640“…Under the International Council for Harmonization (ICH)‐E1 guideline for drugs intended for chronic or repeated intermittent use in non‐life‐threatening diseases, data from 100 patients exposed for a minimum of 1 year are required to be included in the safety data base of a new drug application. …”
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