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4081por Arba, Francesco, Rinaldi, Chiara, Caimano, Danilo, Vit, Federica, Busto, Giorgio, Fainardi, Enrico“…However, more efforts are needed for harmonization of protocols and methodology for implementation of BBB disruption as a neuroradiological marker in clinical practice.…”
Publicado 2021
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4082por Pane, Josep, Verhamme, Katia M C, Villegas, Dorian, Gamez, Laura, Rebollo, Irene, Sturkenboom, Miriam C J M“…CONCLUSION: Data source harmonization, the development of gold standard signal detection methodologies and the standardization of coding dictionaries are amongst the recommendations to support the implementation of a new proactive approach to signal detection. …”
Publicado 2021
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4083por Engelmann, Ilka, Alidjinou, Enagnon Kazali, Ogiez, Judith, Pagneux, Quentin, Miloudi, Sana, Benhalima, Ilyes, Ouafi, Mahdi, Sane, Famara, Hober, Didier, Roussel, Alain, Cambillau, Christian, Devos, David, Boukherroub, Rabah, Szunerits, Sabine“…While ideally each clinical laboratory should perform its own correlation, we believe this perspective article could be a reference point for others, in particular medical doctors and researchers interested in COVID-19 diagnostics, and a first step toward harmonization.…”
Publicado 2021
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4084por van Trotsenburg, Paul, Stoupa, Athanasia, Léger, Juliane, Rohrer, Tilman, Peters, Catherine, Fugazzola, Laura, Cassio, Alessandra, Heinrichs, Claudine, Beauloye, Veronique, Pohlenz, Joachim, Rodien, Patrice, Coutant, Regis, Szinnai, Gabor, Murray, Philip, Bartés, Beate, Luton, Dominique, Salerno, Mariacarolina, de Sanctis, Luisa, Vigone, Mariacristina, Krude, Heiko, Persani, Luca, Polak, Michel“…When CH is diagnosed, the expert panel recommends the immediate start of correctly dosed levothyroxine treatment and frequent follow-up including laboratory testing to keep thyroid hormone levels in their target ranges, timely assessment of the need to continue treatment, attention for neurodevelopment and neurosensory functions, and, if necessary, consulting other health professionals, and education of the child and family about CH. Harmonization of diagnostics, treatment, and follow-up will optimize patient outcomes. …”
Publicado 2021
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4085“…International Conference on Harmonization (ICH) guidelines Q8–Q11 give guidance on QbD applications with ICH Q8 (R2)—approved in 2009—describing the principles of QbD in detail. …”
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4086por Setyaningsih, Dewi, Santoso, Yosua Agung, Hartini, Yustina Sri, Murti, Yosi Bayu, Hinrichs, Wouter L.J., Patramurti, Christine“…The method was validated according to the International Council for Harmonization (ICH) guideline. Chromatographic separation of three curcuminoids and piperine could be achieved using acetonitrile-methanol-water of 65:5:35 %, at a flow rate of 1 mL/min and a wavelength of 353 nm for detection. …”
Publicado 2021
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4087“…In this area, regulatory authorities and the pharmaceutical industry will routinely use guidelines of the “International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use” (ICH). …”
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4088por Pezzani, Maria Diletta, Tornimbene, Barbara, Pessoa-Silva, Carmem, de Kraker, Marlieke, Rizzardo, Sebastiano, Salerno, Nicola Duccio, Harbarth, Stephan, Tacconelli, Evelina“…CONCLUSION: Efforts to improve harmonization, representativeness, quality of AMR surveillance data and cohort studies to determine AMR attributable mortality and morbidity are urgently required. …”
Publicado 2021
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4089por Koracin, Vanesa, Mlinaric, Matej, Baric, Ivo, Brincat, Ian, Djordjevic, Maja, Drole Torkar, Ana, Fumic, Ksenija, Kocova, Mirjana, Milenkovic, Tatjana, Moldovanu, Florentina, Mulliqi Kotori, Vjosa, Nanu, Michaela Iuliana, Remec, Ziga Iztok, Repic Lampret, Barbka, Platis, Dimitrios, Savov, Alexey, Samardzic, Mira, Suzic, Biljana, Szatmari, Ildiko, Toromanovic, Alma, Zerjav Tansek, Mojca, Battelino, Tadej, Groselj, Urh“…We suggest establishing an international task-force to assist with implementation and harmonization of basic NBS services where needed.…”
Publicado 2021
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4090“…A fast and simple method for the extraction and Flame Atomic Absorption Spectroscopy (FAAS) quantification of ZnO in different cosmetic matrices, including lipsticks, water-in-oil foundations, and oil-in-water creams, was developed and validated, according to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the United States Pharmacopeial Convention guidelines. …”
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4091por Tamura, Naohisa, Watanabe, Erika, Shirakawa, Rumi, Nakatani, Eiji, Yamada, Kanako, Hatakeyama, Hiroshi, Torii-Hanakita, Mizuki, Kyo, Chika, Kosugi, Rieko, Ogawa, Tatsuo, Kotani, Masato, Usui, Takeshi, Inoue, Tatsuhide“…Although validation studies are awaited, the present study will become priming water of harmonization of renin and aldosterone immunoassays.…”
Publicado 2021
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4092por Sithole, Tariro, Mahlangu, Gugu, Capote, Velma, Sitoie, Tania, Shifotoka, Saren, Gaeseb, Johannes, Danks, Lorraine, Nkambule, Portia, Juma, Alex, Fimbo, Adam, Munkombwe, Zuma, Mwale, Bernice, Salek, Sam, Walker, Stuart“…Introduction: Regulatory reliance, harmonization and work sharing have grown over the last few years, resulting in greater sharing of work and information among regulators, enabling efficient use of limited resources and preventing duplication of work. …”
Publicado 2021
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4093por Schymanski, Darena, Oßmann, Barbara E., Benismail, Nizar, Boukerma, Kada, Dallmann, Gerald, von der Esch, Elisabeth, Fischer, Dieter, Fischer, Franziska, Gilliland, Douglas, Glas, Karl, Hofmann, Thomas, Käppler, Andrea, Lacorte, Sílvia, Marco, Julie, Rakwe, Maria EL, Weisser, Jana, Witzig, Cordula, Zumbülte, Nicole, Ivleva, Natalia P.“…With these aims, we hope to make an important step toward harmonization of microplastic particle analysis in clean water samples and, thus, allow the comparability of results obtained in different studies by using similar or harmonized methods. …”
Publicado 2021
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4094por Riva, Giovanni, Nasillo, Vincenzo, Ottomano, Anna Maria, Bergonzini, Giuliano, Paolini, Ambra, Forghieri, Fabio, Lusenti, Beatrice, Barozzi, Patrizia, Lagreca, Ivana, Fiorcari, Stefania, Martinelli, Silvia, Maffei, Rossana, Marasca, Roberto, Potenza, Leonardo, Comoli, Patrizia, Manfredini, Rossella, Tagliafico, Enrico, Trenti, Tommaso, Luppi, Mario“…However, specific prognostic values of MRD in different hematological settings, as well as its appropriate clinical uses (basically, when to measure it and how to deal with different MRD levels), still need further investigations, aiming to improve standardization and harmonization of MRD monitoring protocols and MRD-driven therapeutic strategies. …”
Publicado 2021
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4095“…However, one of the current roadblocks to the clinical translation of MSC therapies relates to the lack of standardization and harmonization of MSC manufacturing protocols, which currently hinders inter-study comparability. …”
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4096por Marchetti, Antonio, Barbareschi, Mattia, Barberis, Massimo, Buglioni, Simonetta, Buttitta, Fiamma, Fassan, Matteo, Fontanini, Gabriella, Marchiò, Caterina, Papotti, Mauro, Pruneri, Giancarlo, Scarpa, Aldo, Stanta, Giorgio, Tallini, Giovanni, Troncone, Giancarlo, Veronese, Silvio Marco, Truini, Mauro, Sapino, Anna“…The implementation of activities that favors harmonization, the logistics and the convergence of biological material in reference centers for molecular analyses is a priority for the development of a functional laboratory network.…”
Publicado 2021
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4097“…Addressing myths around contraceptives, and harmonization of Education and Sexual and Reproductive Health policies in the country would motivate adolescents to use contraceptives.…”
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4098por Verjans, Robin, Bruggink, Annette H., Kibbelaar, Robby, Bart, Jos, Debernardi, Aletta, Schaaij-Visser, Tieneke B. M., Willems, Stefan M., Van Kemenade, Folkert J.“…The DNTP consists of (1) a centrally organized internet portal to improve the assessing, processing, harmonization, and monitoring of the procurement process, while (2) dedicated HUB-employees provide practical support at peripheral pathology departments. …”
Publicado 2021
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4099“…Most “GRAS” chemicals are associated with at least one Global Harmonization System (GHS) warning class, ranging from irritant to toxic. …”
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4100por Bros, Marie, Zaragori, Timothée, Rech, Fabien, Blonski, Marie, Hossu, Gabriela, Taillandier, Luc, Marie, Pierre-Yves, Verger, Antoine“…This is a significant advantage for multicentric study harmonization.…”
Publicado 2021
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