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3721por Sammartano, Antonino, Migliari, Silvia, Serreli, Giulio, Scarlattei, Maura, Baldari, Giorgio, Ruffini, Livia“…MATERIALS AND METHODS: The method was validated to fulfill International Conference on Harmonization requirements and EDQM guidelines, and it included specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, and precision. …”
Publicado 2023
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3722por Schmithorst, Vanessa, Ceschin, Rafael, Lee, Vincent, Wallace, Julia, Sahel, Aurelia, Chenevert, Thomas L., Parmar, Hemant, Berman, Jeffrey I., Vossough, Arastoo, Qiu, Deqiang, Kadom, Nadja, Grant, Patricia Ellen, Gagoski, Borjan, LaViolette, Peter S., Maheshwari, Mohit, Sleeper, Lynn A., Bellinger, David C., Ilardi, Dawn, O’Neil, Sharon, Miller, Thomas A., Detterich, Jon, Hill, Kevin D., Atz, Andrew M., Richmond, Marc E., Cnota, James, Mahle, William T., Ghanayem, Nancy S., Gaynor, J. William, Goldberg, Caren S., Newburger, Jane W., Panigrahy, Ashok“…Technical challenges that emerged early in the study were related to the acquisition, harmonization, and transfer of neuroimages. These hurdles were successfully overcome with protocol modifications and frequent site visits that involved human and synthetic phantoms.…”
Publicado 2023
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3723“…All the parameters satisfied the acceptability criteria suggested by international organizations, such as the International Council for Harmonization, AOAC International, and the International Union of Pure and Applied Chemistry. …”
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3724por Grosser, Franziska, Herrmann, Sandra, Bretschneider, Maxi, Timpel, Patrick, Schildt, Janko, Bentrup, Markus, Schwarz, Peter E. H.“…The DAVOS study will be conducted in accordance with the valid version of the present study protocol and the internationally recognized International Conference on Harmonization–Good Clinical Practice (ICH-GCP) Guidelines. …”
Publicado 2022
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3725“…This has required systematic spatiotemporal harmonization, efficient compression, and imputation of missing values. …”
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3726“…If pharmacological neuroenhancers are going to be considered neurotechnologies, then new law proposals should seek harmonization with the already existing legislation regulating pharmacological health and consumer rights (both globally, taking into account international drug laws, and locally, according to each country's internal regulations) and of course, with the whole system of fundamental rights. …”
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3727por Bradshaw, Angela, Hughes, Nigel, Vallez-Garcia, David, Chokoshvili, Davit, Owens, Andrew, Hansen, Clint, Emmert, Kirsten, Maetzler, Walter, Killin, Lewis, Barnes, Rodrigo, Brookes, Anthony J., Visser, Pieter Jelle, Hofmann-Apitius, Martin, Diaz, Carlos, Steukers, Lennert“…Focusing on real-world, neuroimaging and digital biomarker data, we highlight particular challenges and learnings for data sharing, such as data management planning, development of ethical codes of conduct, and harmonization of protocols and curation processes. Cross-cutting solutions and enablers include the principles of transparency, standardization and co-design – from open, accessible metadata catalogs that enhance findability of data, to measures that increase visibility and trust in data reuse.…”
Publicado 2023
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3728por Shao, Huihui, Feng, Jing, Zhang, Hanyilan, Zhang, Yuanyuan, Qin, Tong, Hu, Yuhua, Zhang, Wenxuan, Wang, Tiesong, Wu, Song, Yang, Qingyun“…The methods were validated based on the International Council for Harmonization guidelines. Satisfactory linearity was obtained for the analytes over the range of 0.1–2.0 μg/mL for impurities I–IV and 0.3–30.0 ng/mL for impurity V, and in all cases, the fitting correlation coefficients exceeded 0.999. …”
Publicado 2023
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3729por Panchakul, Chitralada, Thongdeeying, Pakakrong, Itharat, Arunporn, Pipatrattanaseree, Weerachai, Kongkwamcharoen, Chonthicha, Davies, Neal M.“…Validated analytical procedures were conducted according to International Conference on Harmonization (ICH) guidelines. FINDINGS/RESULTS: An ethanolic extract of BRL exerted potent DPPH radical scavenging activity and moderate antioxidant and anti-inflammatory activity. …”
Publicado 2023
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3730por Lütgehetmann, Marc, Albert, Eliseo, Hamilton, Aaron, Jarem, Daniel, Pfefferle, Susanne, Stucki, Heinz, Navarro, David“…In general, high levels of automation and calibration to the international standard will lead to improvements in the harmonization of quantitative EBV DNA test results across laboratories.…”
Publicado 2023
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3731“…The stability studies of bakuchiol in cosmetic products were conducted under various conditions, including thermal and photolytic degradation, according to International Conference on Harmonization Guidelines. The calibration curve was linear in the range of 0.5–50.0 μg g(−1) with a correlation coefficient greater than 0.9999. …”
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3732“…Further research in the harmonization and standardization of panel-based TMB is essential for its widespread clinical utility. …”
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3733por Enomoto, Takayuki, Okamoto, Aikou, Kim, Jae-Hoon, Lai, Chyong-Huey, Wu, Xiaohua, Kim, Yong-Man“…EAGOT, the largest healthcare/investigational innovation network in Asia in the area of gynecologic cancers, will become a platform for establishing standards of care and lead to guidelines for Asian women suffering from gynecologic cancer. The harmonization of regulatory/investigator-initiated clinical trials, simultaneous approval of unapproved drugs in the four countries under a common protocol, and expansion of indications will improve the prognosis of gynecologic cancers in Asia in the near future.…”
Publicado 2023
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3734por Seyhan, Attila A.“…However, a limited understanding and validation of the specific roles of miRNAs, lack of tissue specificity, methodological, technical, or analytical reproducibility, harmonization of miRNA isolation and quantification methods, the use of standard operating procedures, and the availability of automated and standardized assays to improve reproducibility between independent studies limit bench-to-bedside translation of the miRNA biomarkers for clinical applications. …”
Publicado 2023
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3735por Sang, Lu, Wu, Chunying, Chen, Huijuan, Liu, Wei, Huang, Dawei, Yang, Xi, Guo, Xinrui, Cui, Ruifang, Wang, Ning, Zhang, Rui, Yue, Yuhong, Guo, Hong, Wang, Minghao, Miao, Yutong, Wang, Qingtao, Zhang, Shunli“…BACKGROUND: This study aimed to assess the commutability of frozen pooled human serum (PHS), high concentration of Immunoglobulin M (IgM) pure diluted materials (HPDM), commercialized pure materials (CPM), and dilutions of ERM‐DA470k/IFCC in IgM detection using the CLSI and IFCC approaches, to support standardization or harmonization of IgM measurement. METHODS: Twenty‐four serum samples, relevant reference materials (PHS, HPDM, CPM), and different ERM‐DA470k/IFCC dilutions were analyzed in triplicate using six routine methods. …”
Publicado 2023
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3736“…Recent innovations in biological therapy include international standards for infliximab and adalimumab for the global harmonization of bioactivity and monotest devices with an accuracy equivalent to that of conventional enzyme-linked immunosorbent assays and quicker turnaround times. …”
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3737por Oppen, Kjersti, Brede, Cato, Skadberg, Øyvind, Steinsvik, Trude, Holter, Jan Cato, Michelsen, Annika E, Heggelund, Lars“…These findings should be considered in local method validations and in future harmonization and standardization optimization of hepcidin measurements.…”
Publicado 2023
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3738“…Within the domain of contrast learning, we unite the tasks of contrast and recommendation. This harmonization streamlines the cross-layer contrast process, simplifying the information propagation and concurrently curtailing computational complexity. …”
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3739por Zijtregtop, Eline A. M., Zeal, Jamie, Metzger, Monika L., Kelly, Kara M., Mauz-Koerholz, Christine, Voss, Stephan D., McCarten, Kathleen, Flerlage, Jamie E., Beishuizen, Auke“…The International Staging Evaluation and Response Criteria Harmonization for Childhood, Adolescent, and Young Adult Hodgkin Lymphoma (SEARCH for CAYAHL) seeks to provide an appropriate, universal differentiation between E-lesions and stage IV extranodal disease in Hodgkin lymphoma (HL). …”
Publicado 2023
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3740por Toader, Corneliu, Eva, Lucian, Tataru, Catalina-Ioana, Covache-Busuioc, Razvan-Adrian, Bratu, Bogdan-Gabriel, Dumitrascu, David-Ioan, Costin, Horia Petre, Glavan, Luca-Andrei, Ciurea, Alexandru Vlad“…The discussion extends to radiosurgery and radiotherapy, focusing on the harmonization of precision and efficacy through advanced modalities such as Gamma Knife and CyberKnife. …”
Publicado 2023
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