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3141“…The ability to reference data about best practices facilitates future harmonization, data sharing, and reproducibility, all of which advance this important frontier in developmental science.…”
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3142“…The photostability characterization is ruled by ICH (The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use), which releases details throughout basic protocols of stability tests to be performed on new medicinal products for human use. …”
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3143“…Furthermore, those working in the area of “sonic seasoning” sometimes describe certain sonic compositions as harmonizing crossmodally with specific flavor sensations. …”
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3144por Elberskirch, Linda, Sofranko, Adriana, Liebing, Julia, Riefler, Norbert, Binder, Kunigunde, Bonatto Minella, Christian, Razum, Matthias, Mädler, Lutz, Unfried, Klaus, Schins, Roel P. F., Kraegeloh, Annette, van Thriel, Christoph“…Reliable and comprehensive studies should be performed supported by standards or guidelines, which need to be harmonized and usable for the multidisciplinary field of nanosafety research. …”
Publicado 2022
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3145por Saito, Jumpei, Agrawal, Anjali, Patravale, Vandana, Pandya, Anjali, Orubu, Samuel, Zhao, Min, Andrews, Gavin P., Petit-Turcotte, Caroline, Landry, Hannah, Croker, Alysha, Nakamura, Hidefumi, Yamatani, Akimasa, Salunke, Smita“…More progress on clear safety limits, quantitative information on excipients of concern in the pediatric population, and international harmonization of excipients’ regulatory processes for the pediatric population are required.…”
Publicado 2022
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3146por Santisteban-Espejo, Antonio, Bernal-Florindo, Irene, Perez-Requena, Jose, Atienza-Cuevas, Lidia, Moran-Sanchez, Julia, Fernandez-Valle, María del Carmen, Romero-Garcia, Raquel, Garcia-Rojo, Marcial“…The results of this systematic review should contribute to the interdepartmental harmonization and achievement of a consensus in the current clinical applications of NGS studies of cHL.…”
Publicado 2022
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3147por Bourget, Marie-Hélène, Kamentsky, Lee, Ghosh, Satrajit S., Mazzamuto, Giacomo, Lazari, Alberto, Markiewicz, Christopher J., Oostenveld, Robert, Niso, Guiomar, Halchenko, Yaroslav O., Lipp, Ilona, Takerkart, Sylvain, Toussaint, Paule-Joanne, Khan, Ali R., Nilsonne, Gustav, Castelli, Filippo Maria, Cohen-Adad, Julien“…This extension will facilitate future harmonization efforts in the context of multi-modal, multi-scale imaging such as the characterization of tissue microstructure with qMRI.…”
Publicado 2022
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3148por Massardi, Stefano, Rodriguez-Cianca, David, Pinto-Fernandez, David, Moreno, Juan C., Lancini, Matteo, Torricelli, Diego“…Understanding and identifying the technological ways to assess pHEI is necessary for the future acceptance and large-scale use of these devices. The harmonization of these evaluation processes represents a key factor in building a still missing accepted framework to inform human–device contact safety. …”
Publicado 2022
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3149por Marie, Aya A., Salim, Mohamed M., Kamal, Amira H., Hammad, Sherin F., Elkhoudary, Mahmoud M.“…The newly developed method was validated according to the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines. …”
Publicado 2022
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3150por Alter, Peter, Orszag, Jan, Wouters, Emiel F M, Vogelmeier, Claus F, Jörres, Rudolf A“…It appears undeniable that differences of this magnitude have an impact on clinical interpretation. Thus, device harmonization seems to be required.…”
Publicado 2022
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3151por Nishioka, Kinue, Makimura, Tomomi, Ishiguro, Akihiro, Nonaka, Takahiro, Yamaguchi, Mitsune, Uyama, Yoshiaki“…Based on past experiences, data reliability and appropriateness of the methodology for analysis are the major discussion points in utilizing RWD and RWE for regulatory decision making. International harmonization of regulatory requirements is another important area in utilizing RWD and sharing the RWE globally. …”
Publicado 2021
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3152por Sedbare, Rima, Raudone, Lina, Zvikas, Vaidotas, Viskelis, Jonas, Liaudanskas, Mindaugas, Janulis, Valdimaras“…The developed and optimized UPLC-DAD methodology was validated according to the guidelines of the International Council for Harmonization (ICH), evaluating the following parameters: range, specificity, linearity (R(2) > 0.999), precision, LOD (0.27–1.86 µg/mL), LOQ (0.90–6.18 µg/mL), and recovery (80–110%). …”
Publicado 2022
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3153por Macêdo, Marcos Antônio, Sato, João Ricardo, Bressan, Rodrigo A., Pan, Pedro Mario“…Future studies should consider some level of harmonization for clinical instruments and neuroimaging methods.…”
Publicado 2022
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3154por Emmerich, Ilka Ute“…The new pharmaceutical regulations for veterinary medicinal products introduced in the course of the EU harmonization also have an impact on pharmacotherapy of honey bee colonies in Germany. …”
Publicado 2022
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3155por Suárez-González, Javier, Cáceres-Pérez, Amor R., Oliva, Alexis, Santoveña-Estévez, Ana, Fariña, José B.“…Secondly, we aimed to optimize it through the design of experiments and multi-linear regression based on a central composite design and to validate it according to the guidelines of the International Conference on Harmonization. The application of this tools enabled the identification of the influential factors (flow rate, formic acid, and temperature) and their effects on the studied responses (retention factor and percentage for each drug) as part of the quality by design approach. …”
Publicado 2022
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3156por Constantinescu, Georgiana, Preda, Cristina, Constantinescu, Victor, Siepmann, Timo, Bornstein, Stefan R., Lenders, Jacques W. M., Eisenhofer, Graeme, Pamporaki, Christina“…In the present analysis we provide an overview of the literature and propose standardized terminology in an attempt at harmonization to facilitate scientific communication.…”
Publicado 2022
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3157“…In this review, multi-omics data harmonization methods were introduced, and common approaches to molecular network inference were summarized. …”
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3158“…The purpose of this article is to describe pharmacovigilance systems and processes in high-income countries, particularly those that are also members of the International Conference on Harmonization (ICH). All high-income countries are members of the WHO PIDM. …”
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3159por Alvino, Valeria Vincenza, Mohammed, Khaled Abdelsattar Kassem, Gu, Yue, Madeddu, Paolo“…Therefore, this review is devoted to appraising current methodologies’ pros and cons and proposing standardization and harmonization improvements. We highlight the importance of developing upgraded protocols to create therapeutic pericyte products according to the regulatory guidelines for clinical manufacturing. …”
Publicado 2023
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3160“…Microplastic quantification method validation and harmonization are not yet far developed. For the analysis of small microplastic, approximately <0.5 mm, extraction from organic and inorganic materials is fundamental prior to quantitative and qualitative analysis. …”
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