“…The binary combination of drug product was subjected to the different stress conditions such as acid, base, oxidation, heat and photolysis as per the recommendations of international conference on harmonization (Q2). The degradation Product found in stress patterns are well separated among main analyte compounds. …”
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“…These efforts need to be catalysed, promoted and fostered through international collaboration and harmonization.…”
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“…There is a large need for harmonization and increased collaboration between the African nations’ NRAs. …”
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“…SUMMARY: The London Classification is a standardized method and nomenclature for description of alterations in anorectal motor and sensory function using office-based investigations, adoption of which should bring much needed harmonization of practice.…”
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“…MAIN MEASUREMENTS: Following the guidelines of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR): 1) Direct translation. 2) Pilot study based on Delphi methodology with family doctors. 3) Back-translation. 4) Equivalence analysis. 5) Comprehension analysis of versions obtained in Spanish, Catalan and Galician through cognitive debriefing in a sample of patients. 6) Transcultural harmonization. RESULTS: 73 family doctors participated in the Delphi study. …”
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“…This might be due to several reasons including disparities in health expenditure policies; lack of harmonization between countries; and variations in assessment of disease severity, use of disease monitoring tools, or application of treatment targets by physicians. …”
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“…In order to support text mining approaches as well as data description, linking and harmonization in the context of COVID-19, we have developed an ontology representing major novel coronavirus (SARS-CoV-2) entities. …”
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“…These factors include the availability of real‐world data, development of predictive models, experience with the US Food and Drug Administration (FDA)’s pediatric exclusivity program, development of clinical decision software, funding mechanisms like the Prescription Drug Users Fee Act (PDUFA), and harmonization of global regulatory policies. From an examination of these factors, we recommend a relatively simple, efficient expansion of current practices designed to predict, confirm, and continuously improve drug dosing for more patients. …”
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“…Recommendations regarding next steps include the development of new patient-reported outcome tools, focus on psychosocial support, health disparities, and financial implications, and research harmonization and interdisciplinary collaboration.…”
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“…Key challenges for this design that are revealed by the review are how to define the scope of the law (what should be regulated), what types of regulations are required (eligibility criteria, approval procedures, data collection, and oversight mechanisms), and how to approach international harmonization given the potential migration of researchers and patients.…”
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“…CONCLUSION: Monocyte subset analysis is useful in screening for and monitoring CMML. Harmonization of the protocols for monocyte subset analysis is required.…”
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“…This guideline includes the following steps: preparation, forward translation, reconciliation, back translation, back translation review, harmonization, cognitive debriefing, debriefing results review, proofreading and final report. …”
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“…Background and Objectives: The harmonization of recovery of consciousness and muscular function is important in emergence from anesthesia. …”
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“…We further consider promising strategies for the harmonization of high-dimensional, heterogeneous multiomics datasets (panomics) and techniques for nonparametric validation of best-fit models. …”
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“…We also discuss the advances and possible drawbacks that regulatory activity and harmonization process on such industry have achieved at international level in recent years, with a special focus on the European Union. …”
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“…The method was continued and validated in accordance with International Conference on Harmonization Guidelines. Validation study revealed the specificity and reliability of the method. …”
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“…Key lessons learned from these experiences include the benefits of leveraging an established infrastructure, innovations surrounding remote research activities, data harmonization and central safety reviews, and early community engagement and involvement. …”
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“…For this purpose, we first harmonized the differing skeleton joint definitions of the datasets, reducing the biases and systematic test errors in cross-database experiments. …”
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“…Here, we report significant updates of DrugComb, including: (i) manual curation and harmonization of more comprehensive drug combination and monotherapy screening data, not only for cancers but also for other diseases such as malaria and COVID-19; (ii) enhanced algorithms for assessing the sensitivity and synergy of drug combinations; (iii) network modelling tools to visualize the mechanisms of action of drugs or drug combinations for a given cancer sample and (iv) state-of-the-art machine learning models to predict drug combination sensitivity and synergy. …”
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“…The success of SARS-CoV-2 vaccine development should be credited to open science, industry partnerships, harmonization of clinical trials, and the altruism of study participants. …”
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