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201por Kim, Doyeong, Lee, Jihoo, Bal, Jyotiranjan, Seo, Seul Ki, Chong, Chom-Kyu, Lee, Jong Ho, Park, Hyun“…Retrospectively, 130 residual nasopharyngeal swabs transferred in viral transport medium (VTM), pre-examined for COVID-19 through emergency use authorization (EUA)-approved real-time RT-PCR assay and tested with GenBody™ COVAG025, revealed a sensitivity and specificity of 90.00% (27/30; 95% CI: 73.47% to 97.89%) and 98.00% (98/100; 95% CI: 92.96% to 99.76%), respectively, fulfilling WHO guidelines. …”
Publicado 2021
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202“…EUA has been widely discussed in the medical literature and the general public. …”
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203por Khehra, Nimrat, Padda, Inderbir, Jaferi, Urooj, Atwal, Harshan, Narain, Shreya, Parmar, Mayur S.“…This review article encompasses tozinameran (BNT162b2) vaccine journey, summarizing the BNT162b1 and BNT162b2 vaccines from preclinical studies, clinical trial phases, dosages, immune response, adverse effects, and FDA-EUA.…”
Publicado 2021
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204“…BACKGROUND: The Emergency Use Authorization (EUA) of remdesivir for coronavirus disease 2019 raised questions on transparency of applied strategy, and how to equitably allocate and prioritize eligible patients given limited supply of the medication. …”
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205por Alasandro, Mark, Choudhury, Dilip, Huynh-Ba, Kim, Kochling, Jianmei, Latoz, Christopher, Larkin, Laure, McCaig, Lori, Subbarao, Nanda, Wu, Yan, Zhang, Yajie“…The mRNA vaccine developers were represented in the panel discussions, where experts involved in the EUA approval/deployment stages for this vaccine type could discuss the challenges as applied to their vaccines.…”
Publicado 2021
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206por Ng, Teresa I., Correia, Ivan, Seagal, Jane, DeGoey, David A., Schrimpf, Michael R., Hardee, David J., Noey, Elizabeth L., Kati, Warren M.“…To date, neutralizing antibodies that block viral entry by targeting the viral spike protein make up the largest class of antivirals that has received US FDA emergency use authorization (EUA) for COVID-19 treatment. In addition to the spike protein, other key targets for the discovery of direct-acting antivirals include viral enzymes that are essential for SARS-CoV-2 replication, such as RNA-dependent RNA polymerase and proteases, as judged by US FDA approval for remdesivir, and EUA for Paxlovid (nirmatrelvir + ritonavir) for treating COVID-19 infections. …”
Publicado 2022
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207por Estrada, Josue Antonio, Cheng, Chien-Yu, Ku, Shin-Yen, Hu, Hui-Chun, Yeh, Hsiu-Wen, Lin, Yi-Chun, Chen, Cheng-Pin, Cheng, Shu-Hsing, Janssen, Robert, Lin, I-Feng“…Both the GMT ratio and sero-response rate exceeded the criteria established by the Taiwan regulatory authority, leading to EUA approval of MVC-COV1901 in Taiwan.…”
Publicado 2022
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208“…FDA authorized the Pfizer-BioNTech and Moderna COVID-19 (SARS-CoV-2) vaccines for emergency use (EUA) in children ages 6 months–4 years. Seroprevalence has increased during the current Omicron variant wave for children under 5 years, and the burden of hospitalization for this age group is similar or exceeds other pediatric vaccine-preventable diseases. …”
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209por Duivelshof, Bastiaan, Zöldhegyi, Arnold, Guillarme, Davy, Lauber, Matthew, Fekete, Szabolcs“…With an EUA submission, scientific data on a drug candidate is often collected near simultaneously alongside drug development. …”
Publicado 2022
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210por Braambati, Dieimes, Monteiro, Renata de Castro, Coelho, Marcelo Santos, Soares, Adriana de Jesus, Frozoni, Marcos“…Headquarters, Wayne, New Jersey, EUA). The following kinematic parameters were assessed: CCW angle, CW angle, speed (RPM) at both directions, and, standstill time at each change of directions. …”
Publicado 2022
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211por Huang, David T., McCreary, Erin K., Bariola, J. Ryan, Wadas, Richard J., Kip, Kevin E., Marroquin, Oscar C., Koscumb, Stephen, Collins, Kevin, Shovel, Judith A., Schmidhofer, Mark, Wisniewski, Mary Kay, Sullivan, Colleen, Yealy, Donald M., Axe, Meredith, Nace, David A., Haidar, Ghady, Khadem, Tina, Linstrum, Kelsey, Snyder, Graham M., Seymour, Christopher W., Montgomery, Stephanie K., McVerry, Bryan J., Berry, Lindsay, Berry, Scott, Meyers, Russell, Weissman, Alexandra, Peck-Palmer, Octavia M., Wells, Alan, Bart, Robert, Albin, Debbie L., Minnier, Tami, Angus, Derek C.“…INTERVENTION AND COMPARATOR: The interventions are the COVID-19 specific mABs authorized by the EUAs. All aspects of mAB treatment, including eligibility criteria, dosing, and post-infusion monitoring, are as per the EUAs. …”
Publicado 2021
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213Publicado 1983Procedimiento de la Conferencia Libro
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215Publicado 2011Tabla de Contenidos: “…Don Pedro y los murciélagos y cómo acabó llamándose el pueblo -- Los dos compadres -- Una historia de duendes -- Juan tonto -- El señor y los rayos -- Tein ki eua taltikpak (Lo oculto de la tierra) -- Valimos madre -- El médico chiquito -- Se miket semi yolpakini (el difunto alegre).…”
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216por Kim, Woo Joo, Roberts, Christine C., Song, Joon Young, Yoon, Jin Gu, Seong, Hye, Hyun, Hak-Jun, Lee, Hyojin, Gil, Areum, Oh, Yeeun, Park, Ji-Eun, Lee, Ji-Eun, Jeon, Bohyun, Kane, Deborah, Spruill, Susan, Kudchodkar, Sagar B., Muthumani, Kar, Park, Young K., Kwon, Ijoo, Maslow, Joel N.“…Receipt of EUA-approved mRNA vaccines after GLS-5310 vaccination was well-tolerated, with no reported adverse events. …”
Publicado 2023
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217por Sharma, Priyanka, Gupta, Priyanka, Virmani, Rashmi, Pandey, Anil, Sharma, Jagadish C, Sarkar, Avir“…Remdesivir was one of the front-running therapeutic options that received emergency use authorization (EUA) and subsequent approval for the management of moderate to severe COVID-19 infections. …”
Publicado 2023
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218por Almeida, Isuru Sampath, Jayarajah, Umesh, Wickramasinghe, Dakshitha Praneeth, Samarasekera, Dharmabandhu Nandadeva“…All patients subsequently had surgical exploration under anaesthesia (EUA), irrespective of 3D-EAUS findings. The 3D-EAUS results were compared with the surgical findings to determine the accuracy of 3D-EAUS. …”
Publicado 2019
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219por Lim, Sarah, DeBruin, Debra A., Leider, Jonathon P., Sederstrom, Nneka, Lynfield, Ruth, Baker, Jason V., Kline, Susan, Kesler, Sarah, Rizza, Stacey, Wu, Joel, Sharp, Richard R., Wolf, Susan M.“…On May 1, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to allow use of the antiviral drug remdesivir to treat patients with severe coronavirus disease-2019 (COVID-19). …”
Publicado 2020
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220por Creager, Hannah M., Cabrera, Barbara, Schnaubelt, Andy, Cox, Jesse L., Cushman-Vokoun, Allison M., Shakir, Salika M., Tardif, Keith D., Huang, Meei-Li, Jerome, Keith R., Greninger, Alexander L., Drobysheva, Daria, Spaulding, Usha, Rogatcheva, Margarita, Bourzac, Kevin M., Hinrichs, S.H., Broadhurst, M.J., Fey, P.D.“…We evaluated the performance of the BioFire® Respiratory Panel 2.1 (RP2.1) in the detection of SARS CoV-2 in comparison against three other SARS CoV-2 EUA assays. In these studies, the RP2.1 panel had 98 % positive percent agreement (48/49) and 100 % negative percent agreement (49/49). …”
Publicado 2020
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