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2961“…Different analytical performance parameters such as linearity, precision, accuracy, limit of detection, limit of quantitation and robustness were determined according to International Conference on Harmonization ICH Q2B guidelines. Results of analysis of the developed method were compared by performing ANOVA.…”
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2962“…The developed RP-UPLC method is validated as per International Conference on Harmonization (ICH) guidelines with respect to system suitability, specificity, precision, accuracy, linearity, robustness and filter compatibility.…”
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2963“…Thus, there is an urgent need for the development of international co-ordination to promote and develop NHPs, including their assessment, perspectives, pharmacovigilance, and potential harmonization of regulation, quality control and clinical uses.…”
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2964“…Given the tensions being created by the apparent vulnerability of the health systems strengthening agenda, and the increasing rhetoric around the need for greater harmonization in development assistance, an examination of the positioning of the World Bank in this context is vital.…”
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2965“…However, due to the lack of harmonization of laboratory techniques, the heterogeneity of disease progression, and the small number of recruited patients in most of those studies, there has been a poor translation of basic research into clinical practice. …”
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2966“…Complete validation for the method was carried out according to Internation Conference on Harmonization guidelines. Linearity was achieved in the range 10-50 μg/ml with a correlation coefficient (r) 0.9998. …”
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2967por Meroni, Pier Luigi, Bizzaro, Nicola, Cavazzana, Ilaria, Borghi, Maria Orietta, Tincani, Angela“…Automated ANA reading systems have recently been developed, which offer the advantage of faster and much easier performance as well as better harmonization in the interpretation of the results. Preliminary validation studies of these systems have given promising results in terms of analytical specificity and reproducibility. …”
Publicado 2014
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2968por Van Buskirk, Glenn A., Asotra, Satish, Balducci, Christopher, Basu, Prabir, DiDonato, Gerald, Dorantes, Angelica, Eickhoff, W. Mark, Ghosh, Tapash, González, Mario A., Henry, Theresa, Howard, Matthew, Kamm, Jason, Laurenz, Steven, MacKenzie, Ryan, Mannion, Richard, Noonan, Patrick K., Ocheltree, Terrance, Pai, Umesh, Poska, Richard P., Putnam, Michael L., Raghavan, Ramani R., Ruegger, Colleen, Sánchez, Eric, Shah, Vinod P., Shao, Zezhi Jesse, Somma, Russell, Tammara, Vijay, Thombre, Avinash G., Thompson, Bruce, Timko, Robert J., Upadrashta, Satyam, Vaithiyalingam, Sivakumar“…Important topics reviewed include International Conference on Harmonization, in vitro–in vivo correlation considerations, quality-by-design approaches, process analytical technologies and current scale-up, and process control and validation practices. …”
Publicado 2014
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2969“…All acceptance criteria of the International Conference on Harmonization guidelines for validation were covered in the method validation. …”
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2970“…The methods were validated according to the International Conference on Harmonization (ICH) guidelines. The selectivity of the proposed methods was tested using laboratory-prepared mixtures. …”
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2971“…Furthermore, we discuss a number of local educational provisions that can be implemented on university level to help in facilitating the process of harmonization.…”
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2972“…In response to Ca(2+) influx, a synapse needs to release neurotransmitters quickly while immediately preparing for repeat firing. How this harmonization is achieved is not known. In this study, we found that the Ca(2+) sensor synaptotagmin 1 orchestrates the membrane association/disassociation cycle of Rab3, which functions in activity-dependent recruitment of synaptic vesicles. …”
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2973“…Nine themes or factors that impact integration were identified: data availability, accessibility, harmonization, stakeholder collaboration, policy and strategic alignment, resource adequacy, environmental health indicators, and data exchange networks. …”
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2974“…Expert opinion: Despite the incentives provided by recent regulatory modifications and the efforts of formulation scientists, there is still a need for implementation of pharmaceutical technologies that enable the manufacture of licensed age-appropriate formulations. Harmonization of endeavors from regulators, industry and academia by sharing learning associated with data obtained from pediatric investigation plans, product development pathways and scientific projects would be the way forward to speed up bench-to-market age appropriate formulation development. …”
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2975“…The drugs in combination were subjected to various stress degradation studies as per the International Conference Harmonization (ICH) guidelines. Results obtained from the stress degradation studies revealed that the developed method is applicable for stability studies.…”
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2976por Anumolu, P. D., Satyanarayana, M., Gayatri, T., Praveena, M., Sunitha, G., Subrahmanyam, C.V.S.“…The proposed method was validated for linearity, range, accuracy, precision, limit of detection and quantification according to International Conference on Harmonization guidelines. Statistical analysis of the results revealed high accuracy and good precision. …”
Publicado 2016
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2977por Moncarz, Howard T.“…Third is the application to show the coverage of interoperability standards to enable industry to make decisions on standards development and harmonization efforts. A prototype system has been implemented to demonstrate the principles involved in the approach.…”
Publicado 2002
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2978por Berridge, Brian R., Mowat, Vasanthi, Nagai, Hirofumi, Nyska, Abraham, Okazaki, Yoshimasa, Clements, Peter J., Rinke, Matthias, Snyder, Paul W., Boyle, Michael C., Wells, Monique Y.“…The INHAND Project (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice) is a joint initiative of the Societies of Toxicologic Pathology from Japan (JSTP), Europe (ESTP), Great Britain (BSTP) and North America (STP) to develop an internationally-accepted nomenclature for proliferative and non-proliferative lesions in laboratory animals. …”
Publicado 2016
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2979por Gallagher, Bernard, Berman, Anne H., Bieganski, Justyna, Jones, Adele D., Foca, Liliana, Raikes, Ben, Schiratzki, Johanna, Urban, Mirjam, Ullman, Sara“…Differences in NHREs have implications particularly in terms of harmonization but also for ethical philosophy and practice and for research integrity.…”
Publicado 2016
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2980“…Despite the obstacles we are faced to, EQA at national level is useful tool regarding standardization and harmonization aspects in total testing process within the country. …”
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