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Sökning: WFRF:(Hemmings S)

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11.
  • Chandler, Jennifer A., et al. (författare)
  • International Legal Approaches to Neurosurgery for Psychiatric Disorders
  • 2021
  • Ingår i: Frontiers in Human Neuroscience. - : Frontiers Media S.A.. - 1662-5161. ; 14
  • Forskningsöversikt (refereegranskat)abstract
    • Neurosurgery for psychiatric disorders (NPD), also sometimes referred to as psychosurgery, is rapidly evolving, with new techniques and indications being investigated actively. Many within the field have suggested that some form of guidelines or regulations are needed to help ensure that a promising field develops safely. Multiple countries have enacted specific laws regulating NPD. This article reviews NPD-specific laws drawn from North and South America, Asia and Europe, in order to identify the typical form and contents of these laws and to set the groundwork for the design of an optimal regulation for the field. 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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12.
  • Marshall, S F, et al. (författare)
  • Modeling and simulation to optimize the design and analysis of confirmatory trials, characterize risk-benefit, and support label claims
  • 2013
  • Ingår i: CPT. - : Wiley. - 2163-8306. ; 2, s. e27-
  • Tidskriftsartikel (refereegranskat)abstract
    • The role of modeling and simulation (M&S) in the design and interpretation of phase III studies, from break out session 4 of the European Medicines Agency (EMA)/European Federation of Pharmaceutical Industries and Associations (EFPIA) M&S workshop, was divided into themes illustrated with case studies (Table 1): (1) M&S being conducted to support the design of confirmatory trials; (2) longitudinal model-based test as primary inferential analysis (biosimilarity and disease progression trials); (3) assessment of benefit–risk ratio, approval and labeling of an unstudied dose or dosing regimen, and development of future regulatory guidance.
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  • Resultat 11-12 av 12

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