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Mari Terada Satoshi Kutsuna Tomiteru Togano Sho Saito Noriko Kinoshita Yumiko Shimanishi Tetsuya Suzuki Yusuke Miyazato Makoto Inada Takahito Nakamoto Hidetoshi Nomoto Satoshi Ide Mitsuhiro Sato Kenji Maeda Akihiro Matsunaga Masahiro Satake Keiji Matsubayashi Hirokazu Tsuno Makiko Kojima Madoka Kuramistu Kenta Tezuka Emi Ikebe Kazu Okuma Isao Hamaguchi Katsuyuki Shiratori Motohiko Sato Yuiko Kawakami Kumi Inaba Saori Igarashi Reina Yamauchi Mina Matsumura Keiko Ishimaru Bijuan Zhang Chika Kuge Maiko Ishihara Miho Gouda Keiko Tanaka Yukihito Ishizaka Norio Ohmagari 《Transfusion》2021,61(7):1998-2007
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Ana Paula H. Yokoyama Silvano Wendel Carolina Bonet-Bub Roberta M. Fachini Ana Paula F. Dametto Fernando Blumm Valeria F. Dutra Gabriela T. P. Candelaria Araci M. Sakashita Rafael Rahal Guaragna Machado Rita Fontão-Wendel Nelson Hamerschlak Ruth Achkar Murillo Santucci Cesar Assunção Patrícia Scuracchio Victor Nudelman Laerte Pastore João R. R. Pinho Mirian Dal Ben Roberto Kalil Filho Alexandre R. Marra Mariane T. Amano Esper G. Kallás Alfredo Salim Helito Carlos Roberto Ribeiro de Carvalho Danielle Bastos Araujo Edison Luiz Durigon Anamaria A. Camargo Luiz V. Rizzo Luiz F. L. Reis Jose M. Kutner 《Transfusion》2021,61(8):2295-2306
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Winona Rei Bolislis Maria Lucia de Lucia Felipe Dolz Runyi Mo Makoto Nagaoka Heraclio Rodriguez May Li Woon Wei Yu Thomas C. Kühler 《Clinical therapeutics》2021,43(1):124-139
PurposeCrucial steps have been adopted by health and regulatory authorities around the world to respond to the COVID-19 pandemic. This review aims to highlight these steps by providing an overview of the regulatory approaches adopted during the onset of the pandemic, provide an assessment of observed trends, and offer some reflections and proposals to leverage learnings and opportunities from this current pandemic.MethodsDocuments and informational materials on regulating the development and management of medical products during the COVID-19 pandemic were collected and classified. These materials were sourced from official websites and press releases from health authorities and international bodies from selected markets across the globe, and covered the period between January and July 2020. Additional information to support this study was gathered through a literature review and analysis of related data available from the public domain, and was complemented with the authors' personal experience.FindingsCommunication has been vital in addressing the impact of COVID-19. A total of 1705 documents and informational materials related to health or regulatory response to the COVID-19 pandemic were gathered. Of these, 343 (around 20%) were identified as regulatory agilities. These agile approaches were classified into 3 categories, namely, where health and regulatory authorities had: (1) facilitated product management across the entire lifecycle, notably in expediting medical product use for COVID-19, ensuring the continuity of clinical trials, and addressing supply chain issues; (2) strengthened international cooperation; and (3) addressed regulatory burden with the adoption of electronic and digital tools.ImplicationsWhile many regulatory measures have been introduced temporarily as a response to the COVID-19 crisis, there are opportunities for leveraging an understanding from these approaches in order to collectively achieve more efficient regulatory systems and to mitigate and address the impact of COVID-19 and further future-proof the regulatory environment. 相似文献
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Roseline Porignaux Vincent Vuiblet Coralie Barbe Yohan Nguyen Sylvie Lavaud Olivier Toupance Laurent Andréoletti Philippe Rieu Nicolas Lévêque 《Journal of medical virology》2013,85(6):1115-1121
Described for the first time in 1986, Parvovirus B19 (B19V) infection in kidney transplant recipients remains little‐known and probably underestimated. The aims of this study were to establish B19V infection frequency during the first year after kidney transplant and to determine predisposing factors and manifestations of the infection in renal transplant recipients. Sixty consecutive adult patients, transplanted less than a year before, were included in this study. B19V and other opportunistic viral infections were detected retrospectively in plasma samples collected every 15 days during the first 3 months and every month from 3 months to 1 year following the kidney transplant. Demographic characteristics, immunosuppressive treatment and biological findings were recorded on each sampling date. Six patients (10%) presented B19V viremia, while eight CMV (13.3%), seven EBV (11.7%), five HHV‐6 (8.3%), five BKV (8.3%), and two adenovirus (3.3%) infections were detected. The mean value of B19V viral load was 149 UI/ml. B19V infections were either reactivation or reinfection due to genotype two in five cases, while one case of primary infection with genotype 1 was observed. Neither risk factors nor biological consequences of B19V infection have been identified. These results rank B19V third among opportunistic viral infections occurring during the first year after a kidney transplant. With regard to this high incidence, and even if the risk factors and biological consequences of the infection should be assessed in larger studies, the question of systematic screening and follow‐up of B19V infection in kidney transplant recipients is relevant. J. Med. Virol. 85: 1115–1121, 2013. © 2013 Wiley Periodicals, Inc. 相似文献