Sentences with phrase «efficacy testing of»

This model offers unique capabilities for preclinical assessment of thrombosis risk in a patient - specific manner, including efficacy testing of anti-thrombotic agents, elucidation of mechanism of action, and, potentially, biomarker identification, all providing a much - needed platform for drug discovery and development.

But the three - drug approach has since been fast - tracked for approval, assuming a large - scale efficacy test of 10,000 people confirms positive results at the end of May.

This brief report describes results from an efficacy test of Adolescent ParentWays program, an intervention developed for parents of adolescents ages 13 — 16 years who have symptoms of behavioral problems and social difficulties.

Not exact matches

Theranos is not required to do this, and Holmes describes FDA approval as the «gold standard» for determining efficacy and the proper use of a test.

The FDA, which is the ultimate arbiter of safety and efficacy — of high quality tests that are proven to work — is the gold standard, and Theranos wants its tests to be the best and safest for its patients.

Yes, he'd understood the science of DNA testing was incomplete, and that there was vigorous debate over the efficacy (and even potential downside) of population screening, and that it still wasn't clear if the process had reached the point where two different testing companies would even arrive at the same results.

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

The treatment was approved for the devastating rare disease Duchenne muscular dystrophy but created major divisions within the FDA because it simply hadn't demonstrated a whole lot of efficacy, meaning the pricey therapy is essentially being subjected to a real - world clinical test.

You can also A / B split - test to determine the efficacy of different colors and images.

Imagine two scenarios as a potential investor who is entirely unfamiliar with security crowdfunding: (i) encountering different content, of varying quality across each funding portal you visit; (ii) encountering the same content, tested an optimized to ensure the highest quality and efficacy, across all platforms.

Where were the preliminary animal testing and computer models establishing some parameters of safety and efficacy for these experiments?

Those who make the effect of prayer on material conditions the test of its efficacy have little rootage for their ideas in New Testament soil.

Neither agreement with «reality» nor inner consistency is, in this theory, the test of the truth and the adequacy of the resulting picture; the criterion is its efficacy in stimulating and directing the power of our imagination.

Though many of these rewetting drops are available over the counter, many were known to cause only temporary relief from signs and symptoms or may not even be an effective treatment and some of these rewetting agents have not been tested for its efficacy scientifically.

We have tested the efficacy of combining higher protein main meals with breakfast and lunch meal replacements in the form of shakes in the early stages of weight loss.

Surely its a goal worthy enough to accurately test the efficacy of food labels before deciding that labels don't work based on the misinterpretation of one study.

As the Pound Report states, «The objective is to improve the efficacy of testing procedures and other anti-doping activities, not merely to rely on having performed a certain number of tests.»

We can't test the efficacy of the flu vaccine because everyone knows it's effective.

Clean Label Project ™ had the top - selling laundry detergents, dish soap, all - purpose sprays, and all - purpose wipes tested and reviewed by a third party analytical chemistry laboratory for chemicals of concern and product efficacy.

«So it's making sure the efficacy of these products is tested — that people know what's gone into them, know how to prepare it safely and that these new tricks companies are producing are actually tested.»

The trial was designed to test the safety and efficacy of omega - 3 — fortified formulas compared with unfortified formulas or breast milk in 288 premature infants.

«This phase III trial will be noteworthy for being the first prostate cancer trial to assess a biomarker, namely AR - V7 in circulating tumour cells, as a predictor of response at the same time as testing the efficacy of the drug,» Prof Taplin will conclude.

The trial needs to involve at least 50 people with OCD and a credible control treatment to really test the efficacy of this idea, says Jon Abramowitz, a clinical psychologist at the University of North Carolina at Chapel Hill.

The only remaining need for the live virus was to test the efficacy of drugs in vitro, it said.

The time it takes for a new drug to go from bench to prescription pad can be staggering — typically three to six years are needed for development before it's even ready for safety and efficacy testing, according to the Pharmaceutical Research and Manufacturers of America.

In 2014 the agency released proposed guidelines that will subject the measures, for the first time, to federal oversight — including having to submit evidence of efficacy to it before the tests may be marketed.

The company plans in October to conduct a separate test specifically to study the seasonal flu vaccine's effectiveness among 480 elderly participants (a demographic often encouraged to get seasonal flu shots), and Phase III efficacy trials across a larger set of demographics are scheduled to begin early next year.

Dr. Rassool says that a clinical trial is planned to test whether low doses of a DNMT inhibitor, decitabine, and an investigational PARP inhibitor, talazoparib, can be safely combined and whether this therapy shows efficacy for AML patients, especially those who can not receive intensive chemotherapy, whose leukemia is resistant to treatment, or who have experienced a relapse after treatment.

The investigation first tested anti-CTLA4 and anti-PD1 checkpoint blockades in combination, but found only «modest efficacy,» said the paper's first author Xin Lu, Ph.D., formerly a DePinho trainee, now an independent investigator at the University of Notre Dame.

The organs - on - chips can then be used to test the efficacy of drug treatments on a particular organ.

Chimeras can provide better ways to test the efficacy of drugs and vaccines than existing methods, says Carrie Wolinetz, an NIH policy official.

The research team, Heller says, has already begun experiments to further explore the implications of these results, which include looking at differences in this pathway between cells taken from allergic and healthy individuals, and testing the efficacy of an inhalable drug that mimics the function of GRB1 and p70S6K to shut off the development of M2 macrophages in the lungs of mice.

The efficacy of the dsRNAs as an insecticide was tested at the Max Planck Institute for Chemical Ecology in Jena.

Following the success of this preliminary safety and feasibility study, more patients are being recruited for a larger clinical trial of the procedure to test the efficacy and durability of the procedure.

The company hopes to launch a second study in mid-2015 to determine the appropriate dose before moving on to test the efficacy of the treatment.

However, he emphasizes that «instead of moving too quickly, South Korea needs to adopt the stricter regulations from other countries to test safety and efficacy.»

Stage 3 testing by an international team of researchers led by Belgian gastroenterologist Jan Tack (University Hospitals Leuven) confirms the drug's efficacy.

Despite a lack of rigorous clinical trials to test safety or efficacy, a ban of the treatment by health authorities, and a lack of peer review by the scientific community, the privately funded Stamina Foundation has been using cultured mesenchymal stem cells that have been exposed to putative conditions that favour neuronal differentiation to treat different diseases in severely or terminally ill patients.

The five types of cancers analyzed in this study have screening methods that allow for detection at an early stage, though in some instances, debate remains over efficacy and appropriate use: mammography for breast cancer, colonoscopy for colorectal cancer, Pap smear and / or HPV test for cervical cancer, spiral computed tomography or CT for lung cancer, and PSA test for prostate cancer.

The study involved 23 fertility centres in the Netherlands and was the first robust study to test the efficacy of lifestyle modification in obese subfertile women trying to get pregnant.

There is no evidence that patients have suffered harm from these drugs; the FDA says it has detected no increase in reports of side effects or lack of efficacy among Cetero - tested medications.

How could the study test the efficacy of herbicide rotation if no herbicides were sprayed?

In addition to testing the overall efficacy of the solution, the 13 - week pilot clinical trial focused on the roles of psychological traits called locomotion (think of «just do it») and assessment («do it right»).

Exploiting the same pre-clinical model used for their studies, the researchers are testing the efficacy of this kind of drug candidates against cancer stem cells, and the possibility of identifying combination regimens with standard chemotherapies with minimized toxic effects, with the perspective of their possible application for the treatment of human breast cancer.

In a phase 1b clinical trial with 21 patients, researchers tested the safety and efficacy of combining the immunotherapy drug pembrolizumab with an oncolytic virus called T - VEC.

At present invasive testing is required for definitive prenatal diagnosis of these disorders, but our experience with CAH leads us to believe that NIPD will have the same diagnostic efficacy in other AR disorders.»

The clinical trials will test the safety and efficacy of the procedure.

«First, it would allow us to understand what DUX4 does in muscle to cause muscle loss, and second, it would provide a system in which efficacy of potential therapies could be evaluated before they are tested in humans.»

These models can be used to explore the cellular role of PCSK9 in vitro and to test the efficacy of cholesterol - lowering agents.

«Our work and that of our colleagues on stress and CRF have been mechanistically implicated in Alzheimer's disease, but agents that impact CRF signaling have not been carefully tested for therapeutic efficacy or long - term safety in animal models,» said the study's principal investigator and corresponding author Robert Rissman, PhD, assistant professor in the Department of Neurosciences and Biomarker Core Director for the Alzheimer's Disease Cooperative Study (ADCS).