Exact(5)
If there is a risk, those that will make a profit should encourage thourough independent research that demonstrates safety.
The IDMC has the mandate to recommend discontinuation of the clinical trial, or part thereof, as it deems fit on the following basis: 1) if the new treatment demonstrates significant effectiveness, 2) if the new treatment demonstrates safety concerns or harm to the participants; or 3) if it is clear that efficacy will not be demonstrated (futility) [1] [3].
This study demonstrates safety and tolerability of reverse iontophoresis (using a current of 250 μA) in healthy controls and patients with CKD for up to 5 h.
This prospective, open-label, nonrandomized, noncontrolled multicenter clinical study with 200 chronic tinnitus patients demonstrates safety and good applicability, that is, good patient compliance and low drop-out rate, of acoustic CR Neuromodulation.
Oral delivery of escalating-dose Salmonella Typhi (Quailes strain) using sodium bicarbonate buffer solution in an outpatient, ambulant-design human infection study demonstrates safety, requires a lower challenge inoculum than that used in historical studies, and offers a unique insight into host pathogen interactions.
Similar(55)
There were also 75 safety exhibits demonstrating safety devices.
"We're not going to launch until we can demonstrate safety, and that's what this programme is going to do," she continued.
Mr. Troy, arguing for the F.D.A., said that if pharmacies were allowed to do so they would essentially be selling prescription drugs without demonstrating safety and efficacy.
(The F.D.A.'s powers to require new drugs to demonstrate safety before being marketed came in 1938 with passage of the Food, Drug and Cosmetic Act).
His siblings include Abdi Yussuf Ali Adan, alias Abdi Mulla, an al-Shabaab leader who accidentally shot himself with his own pistol while demonstrating safety precaution techniques to new recruits in Kismayu.
"If we can demonstrate safety and strong immune responses in phase one or two, we could then enter a partnership or merger with a large pharmaceutical company and obtain long-term financing".
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com