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2981“…We created a map of the programs based on the degree of integration of the included disciplines, which ranged from a juxtaposition of few components to a complex harmonization of different perspectives obtained through teamwork strategies. …”
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2982“…The method was validated according to international conference of harmonization (ICH) guidelines and United States pharmacopoeia (USP). …”
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2983“…In order to elucidate the inherent stability and sensitivity characteristics of ritonavir sulfate, it was investigated under forced thermal and hydration stress conditions as recommended by the International Conference on Harmonization guidelines. In addition, competency of vibrational (infrared and Raman) spectroscopy was assessed to identify structural changes of the drug symbolizing its stress degradation. …”
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2984“…The assessment of a drug’s cardiac liability has undergone considerable metamorphosis by regulators since International Council for Harmonization of Technical Requirement for Pharmaceuticals for Human Use E14 guideline was introduced in 2005. …”
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2985por Logrieco, Antonio F., Miller, J. David, Eskola, Mari, Krska, Rudolf, Ayalew, Amare, Bandyopadhyay, Ranajit, Battilani, Paola, Bhatnagar, Deepak, Chulze, Sofia, De Saeger, Sarah, Li, Peiwu, Perrone, Giancarlo, Poapolathep, Amnart, Rahayu, Endang S., Shephard, Gordon S., Stepman, François, Zhang, Hao, Leslie, John F.“…As part of the MycoKey project, a Mycotoxin Charter (charter.mycokey.eu) was launched to share the need for global harmonization of mycotoxin legislation and policies and to minimize human and animal exposure worldwide, with particular attention to less developed countries that lack effective legislation. …”
Publicado 2018
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2986por Cave, Emma“…This article extols the virtues of harmonization with the EU and attempts to counter some of the media focus on the advantages of a deregulated bespoke approach.…”
Publicado 2018
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2987“…Other International Conference on Harmonization (ICH) parameters for validation of analytical procedures were also evaluated and discussed. …”
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2988por Capobianco, Enrico“…Additionally, new protocols for sharing digital information and effectively integrating patients data will need to be CDSS-embedded features in view of suitable data harmonization aimed at improved diagnosis, therapy assessment and prevention.…”
Publicado 2019
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2989por Yao, Wenrong, Guo, Ying, Qin, Xi, Yu, Lei, Shi, Xinchang, Liu, Lan, Zhou, Yong, Hu, Jinpan, Rao, Chunming, Wang, Junzhi“…Our stringent validation was completely focused on specificity, linearity, accuracy, precision, and robustness according to the International Council for Harmonization (ICH) Q2 (R1) guidelines, AAPS/FDA Bioanalytical Workshop and the Chinese Pharmacopoeia. …”
Publicado 2019
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2990por Alshehri, Feras, Suárez, Víctor García, Rueda Torres, José L., Perilla, Arcadio, van der Meijden, M.A.M.M.“…First, the current framework of ancillary services is reviewed and discussed, emphasizing the ongoing European harmonization plans for future frequency balancing markets. …”
Publicado 2019
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2991por Vigliar, Elena, Malapelle, Umberto, Bono, Francesca, Fusco, Nicola, Cortinovis, Diego, Valtorta, Emanuele, Spyridon, Alexiadis, Bimbatti, Manuela, Zocchi, Mario, Piva, Chiara, Gaudioso, Gabriella, Iaccarino, Antonino, Morbini, Patrizia, Pagni, Fabio“…An important harmonization effort was produced by the scientific community to standardize both the preanalytical and interpretative phases of programmed death-ligand 1 (PD-L1) immunohistochemical (IHC) testing in non-small-cell lung cancer (NSCLC). …”
Publicado 2019
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2992“…Recent International Conference on Harmonization (ICH) guidelines provide pharmaceutical companies with regulatory justifications to pursue various global drug‐development pathways, in some of which “local” dose‐ranging and/or pivotal phase III studies are skipped. …”
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2993por Milevoj Kopcinovic, Lara, Culej, Jelena, Jokic, Anja, Bozovic, Marija, Kocijan, Irena“…Its main goal is to assist in the attainment of national harmonization of serous fluid analysis and ultimately improve patient safety and healthcare outcomes. …”
Publicado 2019
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2994por Janik, Miroslaw, Tokonami, Shinji, Iwaoka, Kazuki, Karunakara, Naregundi, Trilochana, Shetty, Mohan, Mandya Purushotham, Kumara, Sudeep, Yashodhara, Indaje, Zhuo, Weihai, Zhao, Chao, Tang, Fangdong, He, Linfeng, Chanyotha, Supitcha, Kranrod, Chutima, Al-Azmi, Darwish, Kurihara, Osamu“…Due to the future legal regulations regarding radon levels in the air, maintaining the system quality and harmonization of results as well as validation of radon and thoron measuring systems is important. …”
Publicado 2019
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2995“…Continued surveillance of migration and TB rates is essential, and there is a need for harmonization of case definitions and reporting standards to optimize TB control programs within Europe.…”
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2996“…In this study, a sensitive and reliable liquid chromatography-tandem mass spectrometry method was developed and validated for the quantitative analysis of six PGIs in DMBZ according to the guidelines of the International Council for Harmonization (ICH). The calibration curves showed good linearity within the studied range, and the correlation coefficient of fitting exceeded 0.998 for each impurity. …”
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2997por Barbieri, Sara, Brkić Bubola, Karolina, Bendini, Alessandra, Bučar-Miklavčič, Milena, Lacoste, Florence, Tibet, Ummuhan, Winkelmann, Ole, García-González, Diego Luis, Gallina Toschi, Tullia“…After revision of the IOC guidelines in 2018, this work represents the first published attempt to verify some of the recommended quality control tools to increase harmonization among panels. Specifically, a new “decision tree” scheme was developed, and some IOC quality control procedures were applied. …”
Publicado 2020
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2998por Ball, Greg, Kurek, Raffael, Hendrickson, Barbara A., Buchanan, James, Wang, William W., Duke, Susan P., Bhattacharyya, Amit, Li, Mengchun, O’Brien, Dennis, Weigel, Judith, Wang, Wenquan, Jiang, Qi, Ahmad, Faiz, Seltzer, Jonathan H., Herrero-Martinez, Esteban, Tremmel, Lothar“…Notwithstanding successful harmonization efforts, the global regulatory framework governing product safety is complex and continually evolving, as evidenced by additional regional guidance and regulations. …”
Publicado 2020
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2999por Synaridou, Maria S., Andriotis, Eleftherios G., Zacharis, Constantinos K., Fatouros, Dimitrios G., Markopoulou, Catherine K.“…The developed chromatographic method was validated based on the International Conference on Harmonization (ICH) guidelines (%Mean Recovery = 99.4% and %Relative Standard Deviation, RSD = 0.43%). …”
Publicado 2020
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3000por Jones, Ella F., Buatti, John M., Shu, Hui-Kuo, Wahl, Richard L., Kurland, Brenda F., Linden, Hannah M., Mankoff, David A., Rubin, Daniel L., Tata, Darrell, Nordstrom, Robert J., Hadjiyski, Lubomir, Holdhoff, Matthias, Schwartz, Lawrence H.“…The Clinical Trial Design and Development Working Group within the Quantitative Imaging Network focuses on providing support for the development, validation, and harmonization of quantitative imaging (QI) methods and tools for use in cancer clinical trials. …”
Publicado 2020
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