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Because every new drug is somewhat different from preexisting ones, unforeseen safety or efficacy issues may arise during the regulatory review.
To avoid downstream disconnect between in vitro activity and in vivo efficacy that may arise when SAR studies are driven by target-based or cell-based assays, a 4-day mouse model using infection with a transgenic T. cruzi luc strain expressing firefly luciferase was used in the early stages of the SAR efforts.
Though the technique is viewed as the "gold standard" [ 5] for its therapeutic safety and efficacy, many complications may arise such as wound issues, vessel injuries and bleeding which require a secondary surgical operation [ 6, 7].
The efficacy of peppermint oil may arise from effects on smooth muscle, again reducing colonic contractility and pain owing to its calcium channel blocking activity.
Furberg & Psaty have discussed the potential problems that may arise through extrapolating proof of efficacy between drugs within a class [ 72].
In addition, these sessions are used to increase self-efficacy of the child by discussing challenges that may arise and how to sustain positive thinking and motivation to stay on track.
"Because of the increasing design complexity and regulatory requirements for these devices, there is a growing demand for Ph.D.-level employees with... problem-solving skills who can address scientific issues that may arise regarding the design, safety, and efficacy of devices," says Ippolito.
The ether anesthetics at MAC may exhibit lower efficacy for some 3-transmembrane receptors, such as NMDA receptors, because immobility may arise primarily through actions at 4-transmembrane receptors, such as GABAA and glycine receptors [ 10], among other putatively relevant targets [ 3].
However, the mechanism of a difference in the efficacy of romiplostim before and after splenectomy is not clear, and this difference may arise from the different durations of disease prior to the start of romiplostim treatment; thus, in this study, the analysis was conducted assuming that the efficacy of romiplostim was the same before and after splenectomy.
Future opportunities may arise to challenge the vaccine with the actual virus to measure vaccine efficacy and provide sound recommendations to protect all public health and health care responders against smallpox (13 ).
The question may arise.
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