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3281por Iblasi, Abdulkareem S., Aungsuroch, Yupin, Gunawan, Joko, Gede Juanamasta, I., Carver, Cheryl“…The repositioning practice is “turn a bedridden patient in a harmonized way and ends with anchor and documentation.” …”
Publicado 2022
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3282por Ruohonen, Jukka“…The review covers the historical background and the main laws, administration and enforcement, standardization and harmonization, laws enacted for specific products, notifications delivered by national safety authorities, recalls of dangerous products, and the liability of these. …”
Publicado 2022
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3283por Juengling, Freimut D., Wuest, Frank, Kalra, Sanjay, Agosta, Federica, Schirrmacher, Ralf, Thiel, Alexander, Thaiss, Wolfgang, Müller, Hans-Peter, Kassubek, Jan“…With an increase in multimodal neuroimaging data on ALS and an exponential improvement in neuroimaging technology, the need for harmonization of protocols and integration of their respective findings into a consistent model becomes mandatory. …”
Publicado 2022
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3284por Curtin, Richard T.“…Substantial progress on harmonization has been made by the EU in their member surveys. …”
Publicado 2022
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3285por Giusti, Alice, Tinacci, Lara, Verdigi, Francesco, Narducci, Roberto, Gasperetti, Laura, Armani, Andrea“…Also, a specific revision and harmonization of the EU labelling of mushrooms would be desirable to protect consumers.…”
Publicado 2022
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3286por Liu, Geoffrey, Cheung, Winson Y., Feilotter, Harriet, Manthorne, Jackie, Stockley, Tracy, Yeung, ManTek, Renouf, Daniel J.“…Among the 35 other programs evaluated, the main themes included the need for collaboration and systems to support data harmonization across multiple jurisdictions. In order to generate RWD in precision oncology that will prove acceptable to HTA bodies, Canada must take a national approach to biomarker strategy and unite all stakeholders at the highest level to overcome jurisdictional and technological barriers.…”
Publicado 2022
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3287por Savin, Marijana, Vrkatić, Aleksandra, Dedić, Danijela, Vlaški, Tomislav, Vorgučin, Ivana, Bjelanović, Jelena, Jevtic, Marija“…Increasing literacy about the presence and potential risk through continuous education of parents and young people as well as active monitoring of newly registered additives and harmonization of existing legal regulations by competent authorities can significantly prevent the unwanted effects of additives on children’s health.…”
Publicado 2022
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3288por Sampathi, Sunitha, Tiriya, Pankaj Kumar, Dodoala, Sujatha, Junnuthula, Vijayabhaskarreddy, Dyawanapelly, Sathish“…As per the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, stability studies were performed for 30 days under the following conditions: 2–8 °C, 25 ± 2 °C/60 ± 5% RH, and 40 ± 2 °C/75 ± 5% RH. …”
Publicado 2022
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3289“…However, the current rules raise several problems, in particular the risk, because technology is evolving, to have similar RNA drugs being covered by very different legal statuses and the lack of international harmonization. The objectives of this study are (i) to review how RNA medicinal products are currently legally categorized in the EU and especially whether they fall under the status of gene therapy medicinal products (GTMP), a regulatory status belonging to advanced therapy medicinal products (ATMP), (ii) to discuss the issues generated by this classification, with a focus on the heterogeneity of statuses of these products, the differences with the American and ICH definitions and the potential impact on the safety requirements.…”
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3290por Elsayed, Yomnah Y., Kühl, Toni, Dauer, Katharina, Sayin, Alina, Wagner, Karl G., Imhof, Diana“…The test lysozyme HMEs were subjected to extraction procedures and analytical methods following the International Council of Harmonization guidelines for testing the active protein ingredient Q 1 A (R2) in its pure and formulated form. …”
Publicado 2022
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3291por Mehmood, Tariq, Hanif, Sana, Azhar, Faiza, Ali, Ijaz, Alafnan, Ahmed, Hussain, Talib, Moin, Afrasim, Alamri, Mubarak A., Syed, Muhammad Ali“…In the current study, the reversed-phased high-pressure liquid chromatography (RP-HPLC) method was proposed for the estimation of lignocaine hydrochloride (LIG), hydrocortisone (HYD) and Ketoprofen (KET) according to International Conference for Harmonization (ICH) Q2 R1 guidelines, in a gel formulation. …”
Publicado 2022
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3292“…Key differences include the level of cohesiveness among stakeholders and the level to which each country promotes the international harmonization of standards. The evidence highlights a need for greater capacity‐building in risk assessment in China that may support greater stakeholders’ cohesion, improve hazard identification, and allow regulators to more readily keep abreast of changes to international standards. …”
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3293“…The findings confirm a poor robustness of the conventional analytical procedure for astaxanthin quantitation and a necessity for method revision and harmonization to improve its reproducibility.…”
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3294por Gauld, Christophe, Martin, Vincent P., Richaud, Alexandre, Baillieul, Sébastien, Vicente, Lucie, Perromat, Jean-Lorrain, Zreik, Issa, Taillard, Jacques, Geoffroy, Pierre Alexis, Lopez, Régis, Micoulaud-Franchi, Jean-Arthur“…Despite limitations related to the selection of questionnaires and the symptom extraction and harmonization, this study underlines the need to standardize sleep symptom contents for sleep medicine in order to enhance the practicability, reliability, and validity of sleep disorder diagnoses.…”
Publicado 2023
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3295por Hofmann, Nicola, Lafarge, Xavier, Antica, Mariastefania, Ferry, Nicolas, Girandon, Lenart, Gramignoli, Roberto, Jurga, Marcin, Kerdjoudj, Halima, Navakauskiene, Ruta, Schiavi, Jessica, Shablii, Volodymyr, Nicolás, Francisco J, Gindraux, Florelle“…To enable extended applications of PnD treatments within the EU community and worldwide, harmonization is highly recommended. This paper aims to provide an overview of the various options available to introduce PnD into clinical practice. …”
Publicado 2023
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3296“…Additionally, drugs recalled from the market in the US between 1996–2010 that were studies in these various models highlight the necessity for further harmonization and comparison of model characteristics. …”
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3297por Lepori, Benedetto, Lambrechts, Agata A., Wagner-Schuster, Daniel, Zahradnik, Georg“…ETER complies with OECD-UNESCO-EUROSTAT standards for educational statistics; most data are collected from National Statistical Authorities (NSAs) or ministries of participating countries and are subject to extensive checks and harmonization. The development of ETER has been funded by the European Commission and is part of the current efforts to establish a European Higher Education Sector Observatory; it is closely connected to the establishment of a broader data infrastructure in the field of science and innovation studies (RISIS). …”
Publicado 2023
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3298“…Recently proposed new predictive equations without the variable of race, together with the evidence on better accuracy of combined serum creatinine and cystatin C equations, and both race- and sex-free cystatin C-based equation, have enabled an improvement in the detection of DKD, but also require the harmonization of the recommended laboratory tests, wider availability of cystatin C testing and specific approach in various populations. …”
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3299por Mendez, Maria A., Canitano, Roberto, Oakley, Bethany, San José-Cáceres, Antonia, Tinelli, Michela, Knapp, Martin, Cusack, James, Parellada, Mara, Violland, Pierre, Derk Plas, Jan R., Murphy, Declan G. M., Quoidbach, Vinciane, Arango, Celso“…A major challenge is the lack of evidence-based harmonized guidelines for autism with co-occurring epilepsy in these countries. …”
Publicado 2023
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3300“…Appropriate codon optimization and harmonization for adaption to the genomic codon abundance of S. cerevisiae are expected to further improve the transcription and translation efficiency. …”
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