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The open-label design may have biased safety reporting.
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The 90th percentile NHANES dietary values used by the FDA (2010) therefore cannot be characterized as biased toward safety.
The open design would not have influenced the immunogenicity results, but had the potential to bias the safety, although this bias would most likely be in favor of the control MenACWY polysaccharide vaccine vs. the MenACWY-TT vaccine.
We then show that in the context of our analysis, any trade-offs inferred on the basis of other trade-offs, as is common practice (e.g. inferring a safety vs time trade-off on the basis of monetary valuations for time and safety), produces biased results, suggesting that the assumption of fungibility does not hold.
The study results show that incident reports were strongly biased towards physical patient safety incidents that caused clearly identifiable physical harm.
Dickey characterizes chemical risk assessments as inherently biased "on the side of safety" and is concerned that "unnecessarily conservative risk criteria" could harm human health and society as a whole.
19 20 However, the healthcare workers' reports on quality and safety may be biased for several reasons, and the discrepancy between healthcare workers' assessments and clinical outcomes may be great.
Thus, for benchmarking and comparative analysis approaches, the deployment of broader scale, less biased analytical approaches for GM safety assessment should also embrace the issues of sources and extents of variation [ 67].
The justifications for the FDA's risk criteria (FDA 2010) that Dickey provides in his letter do not reflect the most current scientific understanding of the health risks from polycyclic aromatic hydrocarbons (PAHs)—or the risk assessment process and therefore cannot be characterized as biased "on the side of safety".
Mr. Roberson said community leaders planned to gather today to plan a forum on bias and safety issues and on what gays should do in response to the latest attack.
The DACOBS is 42-item Likert self-rating scale that measures cognitive biases and safety behavior in psychosis.
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