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The drug has already demonstrated safety in nonhuman primate trials, and the cardiovascular research might even be able to skip ahead to a larger phase II trial based on safety data from the ongoing phase I studies, Leeper suggests.
The dose was chosen based on safety data showing that doses of 300 mg are well-tolerated in healthy volunteers [ 11], and the dose was comparable to that used in a previous post-cardiac arrest trial [ 12].
In October 2009, the FDA issued an Emergency Use Authorization (EUA) for the use of peramivir based on safety data from Phase 1, Phase 2 trials, and limited Phase 3 trial data.
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Based on safety and efficacy data, it seems reasonable to recommend at least 800 1000 units cholecalciferol per day in all adults (Table 4).
Feasibility of dose escalation was determined based on safety, tolerability, and PK data review by the sponsor and an independent, external physician, who did not participate in the study, after all patients within a cohort had completed at least two chemotherapy cycles (one cycle without and one cycle with eltrombopag/placebo) and when all patients finished all treatment cycles.
In a Phase I study, Regorafenib was used as monotherapy in patients with advanced solid tumors, including HCC. 33 Based on safety profile and pharmacological data, the recommended dose from was found to be 160 mg daily for 3 weeks every 4 weeks, with a 1-week gap between the two cycles.
Based on safety-on-treatment data, rivaroxaban was associated with a 0.22 increment in QALYs compared to VKA.
"Our reputation is based on safety".
This paper details implementing a computer program to furnish safety personnel with an empirical basis for designing loss prevention programs based on historical safety data.
If a family is making a choice based on the safety data between an Explorer and a van -- say a Dodge Caravan or Ford Windstar -- it would pick the van, which has lower fatality and rollover rates.
It is possible that a new regulatory category could work in the future if it took into consideration the constraints of the dietary supplement industry regarding scientific proof and did not deny consumers access to products based on insufficient safety data.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com