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  1. 3481
    “…While proof of concept studies have been conducted that provide evidence of their value, challenges with standardization and harmonization still need to be overcome before these methods are used routinely.…”
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    Systems Biology and Biomarkers of Early Effects for Occupational Exposure Limit Setting
  2. 3482
    “…The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection and limit of quantification, precision, linearity, accuracy, and robustness. …”
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    Development of a Stability-Indicating Stereoselective Method for Quantification of the Enantiomer in the Drug Substance and Pharmaceutical Dosage Form of Rosuvastatin Calcium by an Enhanced Approach
  3. 3483
    “…Introduction: Clinical, biodiversity, and environmental biobanks share many data standards, but there is a lack of harmonization on how data are defined and used among biobank fields. …”
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    “Life in Data”—Outcome of a Multi-Disciplinary, Interactive Biobanking Conference Session on Sample Data
  4. 3484
    “…To enable earlier identification of drug-related cardiac effects, the International Conference on Harmonization (ICH) adopted the ICH E14 Guidelines for evaluating the potential for QT/corrected QT (QTc) interval prolongation and proarrhythmic potential for nonantiarrhythmic drugs. …”
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    Electrocardiographic Characterization of Ramucirumab on the Corrected QT Interval in a Phase II Study of Patients With Advanced Solid Tumors
  5. 3485
    “…Here we demonstrate that harmonization of ChIP-seq workflows across cell types and conditions is possible when obtaining chromatin from properly isolated nuclei. …”
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    Standardizing chromatin research: a simple and universal method for ChIP-seq
  6. 3486
    “…METHODS: The Uniform Neuro-Imaging of Virchow-Robin Spaces Enlargement (UNIVRSE) consortium was established with primary aims to harmonize rating and analysis (www.uconsortium.org). …”
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    A priori collaboration in population imaging: The Uniform Neuro-Imaging of Virchow-Robin Spaces Enlargement consortium
  7. 3487
    “…We believe regulatory agencies should use both non-GLP and GLP studies, that GLP requirements assure fundamental tenets of study integrity not typically addressed by journal peer-review, and that use of standardized test guidelines and GLP promotes consistency, reliability, comparability, and harmonization of various types of studies used by regulatory agencies worldwide. …”
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    Does GLP enhance the quality of toxicological evidence for regulatory decisions?
  8. 3488
    “…Objective The objective of openFDA is to facilitate access and use of big important Food and Drug Administration public datasets by developers, researchers, and the public through harmonization of data across disparate FDA datasets provided via application programming interfaces (APIs). …”
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    OpenFDA: an innovative platform providing access to a wealth of FDA’s publicly available data
  9. 3489
    “…The significant bias among the different methods seems mostly attributable to the lack of standardization and calls for additional efforts for improving harmonization of 25OH-D immunoassays.…”
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    Multicenter Comparison of Seven 25OH Vitamin D Automated Immunoassays
  10. 3490
    “…Building on the best practice guidelines for amplification-based PGD established by ESHRE (European Society of Human Reproduction and Embryology), the goal of this meeting was to formulate specific guidelines for CF-PGD in order to contribute to a better harmonization of practices across Europe. Different topics were covered including variant nomenclature, inclusion criteria, genetic counseling, PGD strategy and reporting of results. …”
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    The improvement of the best practice guidelines for preimplantation genetic diagnosis of cystic fibrosis: toward an international consensus
  11. 3491
    “…Out of pocket spending is still a popular method of financing. Harmonization of fee exemption policies can improve access to maternal healthcare.…”
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    Costs and Patterns of Financing Maternal Health Care Services in Rural Communities in Northern Nigeria: Evidence for Designing National Fee Exemption Policy
  12. 3492
    “…We propose development of a new application tool easily adaptable to new occurrences, regular data harmonization meetings between national and district data management teams, and establishment of a data quality audit system to assure good quality data as ways to improve EVD data management during future outbreaks.…”
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    Epidemiological Data Management during an Outbreak of Ebola Virus Disease: Key Issues and Observations from Sierra Leone
  13. 3493
    “…To overcome this challenge, we propose a ‘Safe Harbor Framework for International Ethics Equivalency’ that facilitates the harmonization of ethics review of specific types of data-driven international research projects while respecting globally transposable research ethics norms and principles. …”
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    Towards an ethics safe harbor for global biomedical research
  14. 3494
    “…Further progress identifying genetic and epigenetic susceptibility of paediatric IBD will require international collaboration, population diversity and harmonization of protocols.…”
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    Systematic meta-analyses and field synopsis of genetic and epigenetic studies in paediatric inflammatory bowel disease
  15. 3495
    “…CONCLUSIONS: We conclude that the CRED evaluation method is a suitable replacement for the Klimisch method, and that its use may contribute to an improved harmonization of hazard and risk assessments of chemicals across different regulatory frameworks. …”
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    Criteria for Reporting and Evaluating ecotoxicity Data (CRED): comparison and perception of the Klimisch and CRED methods for evaluating reliability and relevance of ecotoxicity studies
  16. 3496
    “…The US National institutes of Health-Centers of Excellence for Influenza Research and Surveillance is a research consortium that funds numerous labs worldwide to conduct influenza A surveillance in diverse animal species. There is no harmonization of testing procedures among these labs; therefore an external quality assurance (EQA) program was implemented to evaluate testing accuracy among labs in the program in 2012. …”
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    Successes and Short Comings in Four Years of an International External Quality Assurance Program for Animal Influenza Surveillance
  17. 3497
    “…Five key issues for improvement were identified: (1) coherence, coordination and sustainability; (2) data harmonization, collection, processing and reporting; (3) comparison and benchmarking; (4) knowledge sharing and capacity building; and (5) transferability of health information into evidence-based policy making. …”
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    An integrated and sustainable EU health information system: national public health institutes’ needs and possible benefits
  18. 3498
    “…The test was successfully validated according to International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guidelines and thus is suitable for use as part of a commercial manufacturing process. …”
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    A method to measure thrombin activity in a mixture of fibrinogen and thrombin powders
  19. 3499
    “…This is followed by an analysis of the terminologies and of the methods of measurements of the variables, indicating the need for harmonization and standardization. The final section reviews the linguistic domains affected by each different neurodegenerative disease, indicating the variables most consistently impaired at each level and suggesting the key variables helping in the differential diagnosis among diseases. …”
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    Connected Speech in Neurodegenerative Language Disorders: A Review
  20. 3500
    “…Metabolic syndrome was diagnosed based on the Harmonization criteria. Participants completed self-reported questionnaires that assessed alcohol intake, sleep duration, smoking, physical activity, and fruit and vegetable consumption. …”
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    Metabolic syndrome among non-obese adults in the teaching profession in Melaka, Malaysia
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