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2861por Duda, Heike, Hesse, Janina, Haschberger, Birgit, Hilger, Anneliese, Keipert, Christine“…Consequently, a core dataset for the dhr was defined by harmonization with regulatory guidelines as well as other hemophilia registries and by heeding the needs of different stakeholders (patients, clinicians, regulators, and scientists). …”
Publicado 2020
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2862“…The calibration of the reading systems and the automated image interpretation are essential prerequisites for obtaining reproducible and harmonized IIF test results and form the basis for standardization, regardless of the computer algorithms used in the different systems. …”
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2863por Lester, Robert M.“…For nearly 2 decades, regulators have adopted a harmonized approach to drug development, which has succeeded in bringing new pharmaceuticals to market without significant cardiac liability. …”
Publicado 2021
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2864“…This included the use of evidence-based approaches for the harmonization and standardization of public health strategies, using a network of polio laboratories and emergency operation centres and actively pursuing underserved populations. …”
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2865“…The formulation of an ideal vaginal drug delivery system (DDS), with the requisite properties, with respect to safety, efficacy, patient compliance, aesthetics, harmonization with the regulatory requirements, and cost, requires a meticulous selection of the active ingredients and the excipients used. …”
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2866por Fernández-Escobar, Mercedes, Schares, Gereon, Maksimov, Pavlo, Joeres, Maike, Ortega-Mora, Luis Miguel, Calero-Bernal, Rafael“…There is consensus on type II T. gondii genotypes prevailing in Europe, but the absence of harmonization in the use of typing methods limits detailed knowledge. …”
Publicado 2022
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2867por Faerron Guzmán, Carlos A.“…Complexity theory tenets such as non-linearity, transdisciplinarity, open-system analysis, and global-local phenomenology can provide a theoretical basis for a substantive understanding of global health phenomena and a richer instrumental approach to global health challenges. Harmonization between complexity theory and global health may provide the foundation to close the health equity gap put forth by the global health agenda.…”
Publicado 2022
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2868por Batista, Patrícia, Penas, Maria Rodrigues, Pintado, Manuela, Oliveira-Silva, Patrícia“…Legislative efforts about these products remain confusing and without global harmonization. This natural product has been developed to improve or promote physical and mental health. …”
Publicado 2022
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2869“…Validation of the method was performed according to the guidelines of the International Conference on Harmonization. A very good linear dependence of the absorbance on concentration (r(2) = 0.9999) was obtained in a citrate concentration range of 0.5–5.0 mmol/L. …”
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2870por Jiang, Shan“…Evidence from this review supports harmonization of guidelines across countries to promote broad international collaborations on genomics and to benefit precision medicine. …”
Publicado 2022
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2871“…There is an urgent need for global harmonization (e.g., at the Codex Alimentarius level) of the definitions from a commercial perspective and also to have common nomenclature for science and for consumer information.…”
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2872por Kukkola, Anna, Krause, Stefan, Yonan, Yasmin, Kelleher, Liam, Schneidewind, Uwe, Smith, Gregory H. Sambrook, Nel, Holly, Lynch, Iseult“…This approach may reduce subjectivity in microplastic identification and counting and enhances transparency, repeatability and harmonization within microplastic research community. • Instructions for calibration of detection limits for microplastics on fluorescence microscope systems described; • Microplastic identification key developed and tested to reduce false positive detection; • Lower subjectivity for microplastic identification obtained using the detection limits & identification key.…”
Publicado 2023
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2873por Flaus, Anthime, Philippe, Remi, Thobois, Stephane, Janier, Marc, Scheiber, Christian“…The proposed post-reconstruction harmonization method can also facilitate the use of semi-quantitative analysis. …”
Publicado 2023
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2874por Röhr, Susanne, Pabst, Alexander, Riedel-Heller, Steffi G., Jessen, Frank, Turana, Yuda, Handajani, Yvonne S., Brayne, Carol, Matthews, Fiona E., Stephan, Blossom C. M., Lipton, Richard B., Katz, Mindy J., Wang, Cuiling, Guerchet, Maëlenn, Preux, Pierre-Marie, Mbelesso, Pascal, Ritchie, Karen, Ancelin, Marie-Laure, Carrière, Isabelle, Guaita, Antonio, Davin, Annalisa, Vaccaro, Roberta, Kim, Ki Woong, Han, Ji Won, Suh, Seung Wan, Shahar, Suzana, Din, Normah C., Vanoh, Divya, van Boxtel, Martin, Köhler, Sebastian, Ganguli, Mary, Jacobsen, Erin P., Snitz, Beth E., Anstey, Kaarin J., Cherbuin, Nicolas, Kumagai, Shuzo, Chen, Sanmei, Narazaki, Kenji, Ng, Tze Pin, Gao, Qi, Gwee, Xinyi, Brodaty, Henry, Kochan, Nicole A., Trollor, Julian, Lobo, Antonio, López-Antón, Raúl, Santabárbara, Javier, Crawford, John D., Lipnicki, Darren M., Sachdev, Perminder S.“…METHODS: We combined individual participant data for 16 cohorts from 15 countries (members of the COSMIC consortium) and used qualitative and quantitative (Item Response Theory/IRT) harmonization techniques to estimate SCD prevalence. …”
Publicado 2020
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2875por Lee, Sangnim, Ishizuka, Aya, Tachimori, Hisateru, Uechi, Manami, Akashi, Hidechika, Hinoshita, Eiji, Miyata, Hiroaki, Shibuya, Kenji“…No synergetic effects of potential collaboration or harmonization among Japanese funded projects were captured. …”
Publicado 2021
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2876por Karas, Marta, Muschelli, John, Leroux, Andrew, Urbanek, Jacek K, Wanigatunga, Amal A, Bai, Jiawei, Crainiceanu, Ciprian M, Schrack, Jennifer A“…Each measures pair was harmonized using nonparametric regression of minute-level data. …”
Publicado 2022
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2877“…For example, some methods can already be used for international monitoring, yet limitations including target plastic types and sizes, sampling strategy, available infrastructure and analytical capacity, and harmonization of generated data remain. Time and resources to advance scientific understanding must be balanced against the need to answer pressing policy issues.…”
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2878por Al-Rifai, Nafisah, Alshishani, Anas, Darras, Fouad, Taha, Ola, Abu-Jalloud, Shereen, Shaghlil, Lena, Al-Ebini, Yousef“…Moreover, we developed and validated a prompt impurity analysis method based on ultrahigh-performance liquid chromatography with UV detection, revealing that its selectivity, linearity, accuracy, precision, and quantitation limit meet the acceptance criteria of method validation stipulated by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. …”
Publicado 2023
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2879“…Collaborative efforts from all relevant professionals and organizations will be of great importance to overcome substantial challenges in clinical development and post-launch evidence collection of cellular therapies. Harmonization among decision-makers also plays a critical role in reinforcing consistency and improving efficiencies of the regulatory and health technology assessment process. …”
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2880por Green, Jonathan M., Goodman, Polly, Kirby, Aaron, Cobb, Nichelle, Bierer, Barbara E.“…Addressing these problems will require providing additional resources and training to research teams, the commitment of institutional leaders to harmonize practice, and policymakers to critically evaluate the requirement and provide flexibility in applicability.…”
Publicado 2023
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