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3761“…The impact of the nontherapeutic proteins identified has not yet been evaluated. For harmonization of the analysis for drug release, we recommend the establishment of regulatory requirements for purity determination and the implementation of threshold levels in C1-INH concentrates.…”
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3762por Cho, Soo-Jin, Yu, Kyung-Ho, Oh, Mi Sun, Jung, San, Lee, Ju-Hun, Koh, Im-Seok, Bae, Hee-Joon, Kang, Yeonwook, Lee, Byung-Chul“…METHODS: A prospective multicenter study enrolled 353 acute ischemic stroke patients who underwent evaluation using the Korean Vascular Cognitive Impairment Harmonization Standard Neuropsychological Protocol at three months after onset. …”
Publicado 2014
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3763“…It can also be useful to grantees and funding administrators in suggesting potential collaborators or identifying those that share common research interests for data harmonization or other purposes. The incorporation of temporal analysis can be employed to assess the change over time in TRS as new projects are funded and the extent to which new research reflects the funding priorities of the FDA. …”
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3764“…For comparability and international harmonization, all parties assessing causality in DILI and HILI cases should attempt this standardized approach using the updated CIOMS scale.…”
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3765“…This is the first harmonization of its kind, providing a proof-of-concept. …”
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3766por Komenda, Martin, Víta, Martin, Vaitsis, Christos, Schwarz, Daniel, Pokorná, Andrea, Zary, Nabil, Dušek, Ladislav“…CONCLUSIONS: We have proposed, developed, and implemented an original framework for medical and healthcare curriculum innovations and harmonization, including: planning model, mapping model, and selected academic analytics extracted with the use of data mining.…”
Publicado 2015
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3767por Tupasi, Thelma, Gupta, Rajesh, Danilovits, Manfred, Cirule, Andra, Sanchez-Garavito, Epifanio, Xiao, Heping, Cabrera-Rivero, Jose L, Vargas-Vasquez, Dante E, Gao, Mengqiu, Awad, Mohamed, Gentry, Leesa M, Geiter, Lawrence J, Wells, Charles D“…The programme included: (i) site identification and needs assessment; (ii) achieving International Conference on Harmonization – Good Clinical Practice (ICH-GCP) standards; (iii) establishing trial management; and (iv) increasing knowledge of global and local regulatory issues. …”
Publicado 2016
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3768por Romore, Idda, Njau, Ritha J. A., Semali, Innocent, Mwisongo, Aziza, Ba Nguz, Antoinette, Mshinda, Hassan, Tanner, Marcel, Abdulla, Salim“…It is influenced by contextual factors; Promoting factors include; epidemiological and intervention characteristics, country experiences of malaria treatment policy change, presentation and dissemination of evidence, coordination and harmonization of the process, use of international scientific evidence. …”
Publicado 2016
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3769por Rabin, Borsika A., Lewis, Cara C., Norton, Wynne E., Neta, Gila, Chambers, David, Tobin, Jonathan N., Brownson, Ross C., Glasgow, Russell E.“…Meeting participants included 23 researchers, practitioners, and decision makers from the USA and Canada who concluded that the field would greatly benefit from measurement resources to enhance the ease, harmonization, and rigor of D&I evaluation efforts. This paper describes the findings from an environmental scan and literature review of resources for D&I measures. …”
Publicado 2016
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3770por D’Costa, Susan, Blouin, Veronique, Broucque, Frederic, Penaud-Budloo, Magalie, François, Achille, Perez, Irene C, Le Bec, Christine, Moullier, Philippe, Snyder, Richard O, Ayuso, Eduard“…Although the field is advancing quickly, vector analytics and harmonization of dosage units are still a limitation for commercialization. …”
Publicado 2016
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3771“…According to prescribed guidelines by International Conference on Harmonization (ICH) and European Medicine Agency (EMA) developed methods were validated in terms of specificity, accuracy, precision, linearity, and robustness. …”
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3772por Casaregola, Serge, Vasilenko, Alexander, Romano, Paolo, Robert, Vincent, Ozerskaya, Svetlana, Kopf, Anna, Glöckner, Frank O., Smith, David“…Curators also consider that overall harmonization—including Standard Operating Procedures, data structure, and software tools—is necessary to facilitate their work and to make high-quality data easily accessible to their users. …”
Publicado 2016
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3773por Ford, Elizabeth, Carroll, John A, Smith, Helen E, Scott, Donia, Cassell, Jackie A“…Conclusions Text in EMRs is accessible, especially with open source information extraction algorithms, and significantly improves case detection when combined with codes. More harmonization of reporting within EMR studies is needed, particularly standardized reporting of algorithm accuracy metrics like positive predictive value (precision) and sensitivity (recall).…”
Publicado 2016
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3774por Jaishetty, Nagadeep, Palanisamy, Kamaraj, Maruthapillai, Arthanareeswari, Jaishetty, Rajamanohar“…The developed method was validated as per international council on harmonization (ICH) guidelines in terms of LOD, LOQ, linearity, precision, accuracy, specificity, and robustness.…”
Publicado 2015
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3775por Oltedal, Leif, Bartsch, Hauke, Sørhaug, Ole Johan Evjenth, Kessler, Ute, Abbott, Christopher, Dols, Annemieke, Stek, Max L, Ersland, Lars, Emsell, Louise, van Eijndhoven, Philip, Argyelan, Miklos, Tendolkar, Indira, Nordanskog, Pia, Hamilton, Paul, Jorgensen, Martin Balslev, Sommer, Iris E, Heringa, Sophie M, Draganski, Bogdan, Redlich, Ronny, Dannlowski, Udo, Kugel, Harald, Bouckaert, Filip, Sienaert, Pascal, Anand, Amit, Espinoza, Randall, Narr, Katherine L, Holland, Dominic, Dale, Anders M, Oedegaard, Ketil J“…This includes data harmonization across sites and MRI platforms, and a method for obtaining unbiased estimates of structural change based on longitudinal measurements with serial MRI scans. …”
Publicado 2017
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3776por Gates, L. S., Leyland, K. M., Sheard, S., Jackson, K., Kelly, P., Callahan, L. F., Pate, R., Roos, E. M., Ainsworth, B., Cooper, C., Foster, C., Newton, J. L., Batt, M. E., Arden, N. K.“…The definition of PA in an OA context and methods of harmonization were established via an international expert consensus meeting and modified Delphi exercise using a geographically diverse committee selected on the basis of individual expertise in physical activity, exercise medicine, and OA. …”
Publicado 2017
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3777“…In addition to the functional activity value, assignment of an antigen value to the 2(nd) IS would allow harmonization of antigen assay methods and differentiation of patients who have low functional activity but normal antigen FXI levels from patients who have both low functional and antigen FXI levels. …”
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3778por Tahmasebi, Houman, Higgins, Victoria, Fung, Angela W.S., Truong, Dorothy, White-Al Habeeb, Nicole M.A., Adeli, Khosrow“…Finally, limitations, future perspectives and harmonization of pediatric reference intervals to improve pediatric diagnostics in Canada and worldwide will be discussed.…”
Publicado 2017
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3779por Liehr, Thomas, Carreira, Isabel M, Aktas, Dilek, Bakker, Egbert, Rodríguez de Alba, Marta, Coviello, Domenico A, Florentin, Lina, Scheffer, Hans, Rincic, Martina“…Therefore a Europe-wide recognition of the profession ‘European registered Clinical Laboratory Geneticist (ErCLG)' based on a syllabus of core competences was established which allows for harmonization in professional education. The ‘European Board of Medical Genetics division − Clinical Laboratory Geneticist' provides now since 3 years the possibility to register as an ErCLG. …”
Publicado 2017
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3780por Broglio, Steven P., McCrea, Michael, McAllister, Thomas, Harezlak, Jaroslaw, Katz, Barry, Hack, Dallas, Hainline, Brian“…CONCLUSIONS: Challenges have included coordinating regulatory issues across civilian and military institutions, operationalizing study procedures, neuroimaging protocol harmonization across sites and platforms, construction and maintenance of a relational database, and data quality and integrity monitoring. …”
Publicado 2017
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