Sentence examples for approval trial from inspiring English sources
In the Pivotal US approval trial the TAH achieved a BTT rate of >79%.
Moreover, the costs for protocol approval, trial monitoring, and insurance coverage are steadily rising.
Whereas the average 30 day rate for stroke or death was 7.3% in the included trials, the Emboshield and Xact Post Approval Carotid Stent Trial (EX) registry (which included 2145 high risk surgical patients) and the Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events (C2) (which included 4175 patients) showed 30 day rates for stroke or death of only 4.1%and3.4%4%, respectively.
Approval trials were carried out to confirm these results.
In its rejection of the ASA's rescheduling petition in 2011, the DEA cited a 4-year-old Department ofoundlth ano Human Serviconsensus that fonnd no consensus on medical uses for marijuana, but it did not take into account studies showing the medical benefits of marijuana on the grounds the studies did not meet the standard of double-blind FDA approval trials.
A score was determined in accordance with the criteria used in the approval trials for trastuzumab [ 17, 20].
All approval trials for currently used nitrogen-containing bisphosphonates except HIP (risedronate) and HORIZON (zoledronic acid) were designed with primary vertebral fracture endpoints.
The authors should state whether or not there is data from the methylphenidate approval trials that demonstrates suggestion of delayed puberty or delayed development among prepubertal boys taking this medication.
"In the real world, patient outcomes are sometimes not as good as they were in the pre-approval trials," Dr. Berliner said.
The company's software automates the entire clinical development process — from Phase I through regulatory submission, post-approval trials and and more.
However, post-approval trials with extensive patient exposure are needed to generate knowledge of more patient-specific clinical effectiveness and long-term safety, in particular with respect to rare adverse reactions.
