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Notably, these confounding factors preclude the interpretation of safety.
Interpretation of safety data was further complicated by heterogeneity or lack of information of use of concomitant drugs, mode of collection of safety information, use of blinding, and other study design parameters.
These judgments are not always straightforward, and they profoundly influence interpretation of safety data.
Interpretation of safety results should take into account the 3 1 randomization scheme of the trial.
The interpretation of safety and tolerability data from the LDX clinical trial program requires that several limitations be considered.
Concern has been expressed by different authors about the interpretation of safety data by the pharmaceutical industry in relation to new products.
Similar(47)
Moreover, we acknowledge that this particular group of GPs may not be considered 'experts' and therefore the possibility of 'unconscious incompetence' exists, with GPES having differing interpretations of safety and a potential lack of knowledge/insight of safety systems and their role in individual errors when compared to patient safety 'experts'experts
The combination of the safety database size and trial design limits the interpretation of the safety profile of this molecule; however, a larger study (N=161) that characterises the safety profile of sifalimumab in SLE has recently been accepted.
And scores of the most connected and kinetic of the fashion industry from both sides of the Atlantic were due at the museum on Monday night for the Costume Institute ball where they were set to gape not just at each other's interpretations of safety-pin couture but also at the terrifying 15,000-razor blade chandelier specially hung in the main hall.
International harmonization of the approach to these four topics would have many advantages, including reduced discrepancies in the interpretation of liver safety data and facilitation of precompetitive sharing of liver safety data and relevant biospecimens.
But federal regulators contend the latest strategy — which relies on a creative interpretation of drug safety laws — is illegal.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com