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  1. 4961
    “…There are approximately 30 national and international guidelines on biosimilar development and this number is growing. The European Union's guidance describes an approach that enables biosimilars to enter clinical trials based on robust in vitro data alone; in contrast, the World Health Organization's guidance is interpreted globally to mean in vivo toxicity studies are mandatory. …”
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    Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges
  2. 4962
    por Merkiel, Sylwia, Chalcarz, Wojciech
    Publicado 2016
    “…Common regulations worked out for all preschools in the European Union would be a good way to provide adequate nutrition to preschool children.…”
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    Preschool diets in children from Piła, Poland, require urgent intervention as implied by high risk of nutrient inadequacies
  3. 4963
    “…European Legislation, e.g., the European Union's Cosmetic Directive and REACH, demands the use of alternative methods. …”
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    Innovative Strategies to Develop Chemical Categories Using a Combination of Structural and Toxicological Properties
  4. 4964
    “…OBJECTIVES: The annual incidence of hip fracture is 620 000 in the European Union. The cost of this clinical problem has been estimated at 1.75 million disability-adjusted life years lost, equating to 1.4% of the total healthcare burden in established market economies. …”
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    A process evaluation of the WHiTE Two trial comparing total hip arthroplasty with and without dual mobility component in the treatment of displaced intracapsular fractures of the proximal femur: Can a trial investigating total hip arthroplasty for hip fracture be delivered in the NHS?
  5. 4965
    “…Previously, aggregate data were reported to the European Centre for Disease Prevention and Control by European Union/European Economic Area (EU/EEA) countries. …”
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    Improving influenza virological surveillance in Europe: strain-based reporting of antigenic and genetic characterisation data, 11 European countries, influenza season 2013/14
  6. 4966
    “…After preventive vaccination had been approved in the European Union, several countries have introduced vaccination schemes to protect poultry, captive wild birds or exotic birds in zoos against HPAI. …”
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    The response of mute swans (Cygnus olor, Gm. 1789) to vaccination against avian influenza with an inactivated H5N2 vaccine
  7. 4967
    “…METHODS: Analytical (small subset reported here) and nonclinical studies compared the structural, functional, and in vivo nonclinical similarity of PF-06438179 with Remicade sourced from the United States (infliximab-US) and/or European Union (infliximab-EU). RESULTS: The peptide map profiles were superimposable, and peptide masses were the same, indicating identical amino acid sequences. …”
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    Nonclinical Evaluation of PF-06438179: A Potential Biosimilar to Remicade(®) (Infliximab)
  8. 4968
    “…This analysis was limited to patients with schizophrenia who were treated with olanzapine LAI consistent with the approved indication and dosing recommendations of the European Union Summary of Product Characteristics (N=966). …”
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    Clinical outcomes with olanzapine long-acting injection: impact of the 3-hour observation period on patient satisfaction and well-being
  9. 4969
    “…AIMS: To evaluate potential differences between PF‐05280586 and rituximab sourced from the European Union (rituximab‐EU) and USA (rituximab‐US) in clinical response (Disease Activity Score in 28 Joints [DAS28] and American College of Rheumatology [ACR] criteria), as part of the overall biosimilarity assessment of PF‐05280586. …”
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    Comparative assessment of clinical response in patients with rheumatoid arthritis between PF‐05280586, a proposed rituximab biosimilar, and rituximab
  10. 4970
    “…In the U.S., the National Institutes of Health commit 0.025 % of their annual research budget to climate change and health. The European Union Seventh Framework Programme committed 0.08 % of the total budget to climate change and health; the amount committed under Horizon 2020 was 0.04 % of the budget. …”
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    Current medical research funding and frameworks are insufficient to address the health risks of global environmental change
  11. 4971
    “…Food and Drug Administration as well as regulatory considerations in the European Union will be covered. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s40425-016-0179-0) contains supplementary material, which is available to authorized users.…”
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    Validation of biomarkers to predict response to immunotherapy in cancer: Volume II — clinical validation and regulatory considerations
  12. 4972
    “…There is a need for further qualitative research to establish the reasons for less than absolute authentication and detection rates in the hospital environment to improve this technology in preparation for the incumbent European Union regulative deadline.…”
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    Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study
  13. 4973
    “…Our scenario analyses showed that a shift toward more patients on PD (as a first choice) with a corresponding reduction in HD in-center gave a saving over a 5-year period of 32 and 10,623 million EURO, respectively, for Norway and the European Union. CONCLUSIONS: PD was the most cost-effective dialysis alternative and was comparable with HD regarding efficacy outcomes. …”
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    More Use of Peritoneal Dialysis Gives Significant Savings: A Systematic Review and Health Economic Decision Model
  14. 4974
    “…In this context, the European Union Committee on Public Health has declared it essential that preventative measures are taken by centres providing care for women with a multidisciplinary approach. …”
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    Psychoeducational preventive treatment for women at risk of postpartum depression: study protocol for a randomized controlled trial, PROGEA
  15. 4975
    “…METHODS: Since 2011 sulfur hexafluoride (SH, SonoVue(®), Bracco, Italy) is the only ultrasound contrast available in the European Union and its use in children has not been approved. …”
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    Off-label-use of sulfur-hexafluoride in voiding urosonography for diagnosis of vesicoureteral reflux in children: A survey on adverse events
  16. 4976
    “…Monitoring the level of knowledge regarding antibiotics is a part of the European Union Community strategy against antimicrobial resistance. …”
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    Surveys of public knowledge and attitudes with regard to antibiotics in Poland: Did the European Antibiotic Awareness Day campaigns change attitudes?
  17. 4977
    “…It was approved in the European Union in January 2016 and in the US in February 2016 as an adjunctive therapy for the treatment of POS in patients older than 16 years of age. …”
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    New developments in the management of partial-onset epilepsy: role of brivaracetam
  18. 4978
    “…The US Orphan Drug Act of 1983 served as a key milestone in this journey, providing a roadmap for other countries to introduce and implement similar orphan drug legislation; more recently, the European Union (EU) has gone further to encourage the widespread adoption and implementation of rare disease plans or strategies designed to more adequately address the comprehensive needs of patients with rare diseases. …”
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    Review of 11 national policies for rare diseases in the context of key patient needs
  19. 4979
    “…The United Kingdom (UK) has voted to leave the European Union (EU) and there is heightened political discourse around the world about the impact of migration on healthcare services. …”
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    Prevalence of GMC performance assessments in the United Kingdom: a retrospective cohort analysis by country of medical qualification
  20. 4980
    “…By contrast, in the affected eastern European Union (EU) countries where ASF is currently as epidemic, the on-going spread of the disease affects mainly wild boar populations located in restricted areas and, to a much less extent, domestic pigs. …”
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    African swine fever: a global view of the current challenge
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