Sentences with phrase «for efficacy testing»

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.

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.

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.

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.

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.

Myth: The FDA puts infant formulas through rigorous testing to ensure safety and efficacy before it is released for use by 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 only remaining need for the live virus was to test the efficacy of drugs in vitro, it said.

Although gene therapy research has made great strides in recent years, it has yet to be widely deployed, and no CRISPR - edited genes have yet been tested for safety or efficacy in human clinical trials.

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.

Clinical trials that specifically test ADAR1 - targeted therapeutics for their safety and efficacy against multiple myeloma are still necessary before this approach could become available to patients.

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.

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 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 that early next year it will initiate clinical trials on product safety, which will pave the way for human efficacy testing that could be completed by 2011.

Qin says subsequent experiments for testing vaccine or antiviral drug efficacy should use contemporary strains with the S139N mutation.

This analysis shows that PSC shares many genetic risk loci with other immune - mediated diseases and opens up the possibility for testing drugs known to be effective in genetically similar diseases for efficacy in PSC.

Stem cell models, derived from healthy or diseased cells, are also being developed for use in drug efficacy and toxicity testing.

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.

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.

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.»

You can look for efficacy in cell cultures, but that tells you almost nothing about what's going to happen when you test in a mouse or a human.

The blood vessels being reported Feb. 18 in Nature Scientific Reports are also miniaturized to enable 3D microscale artificial organ platforms to test drugs for efficacy and side effects.

Initial versions are currently being tested for efficacy.

«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).

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.

In addition, alternatives to repeated Pap testing, such as cytologic reprocessing of inadequate samples or primary HPV DNA screening should be studied for efficacy and acceptability among FTM patients.

This compound has been recently designated for phase III clinical trials to test its efficacy for treating epilepsy and providing relief of neuropathic pain.

If these preclinical studies are successful, the researchers plan to further develop their CAR T cell therapy and test its safety and efficacy for different types of metastatic cancer in upcoming clinical trials.

They chose schools that were both above and below average when it came to student test scores and collective efficacy for teachers.

Improved diagnostic tests are on the horizon, but we need huge efforts to increase their accuracy, use them for active case finding in the community, and eventually make them available in low income countries so as to inform treatment decisions and preserve the efficacy of any new antibiotic drugs for TB,» says lead author of the Commission Professor Keertan Dheda, University of Cape Town.

It costs millions of dollars to develop drugs and get them tested in animals before they can ever be used in clinical trials for safety and efficacy in humans.

Following the end of the first trial, there will be two more — to test the treatment's efficacy — before it can be approved for commercial use on the market.

If no serious problems are detected, the drug is tested for efficacy in a Phase III trial.

A brain plaque inhibitor developed by Merck is now being tested in larger studies for efficacy against the still unstoppable neurodegenerative disease

In the study, the researchers tested the efficacy of the vaccine for the bacterial pathogen Piscirickettsia salmonis by comparing the reaction of vaccinated and non-vaccinated Atlantic salmon when exposed to the sea louse Caligus rogercresseyi in the lab.

J&J announced Monday that it, too, is seeking an EUAL designation for its Ebola Zaire vaccine, which has completed Phase 1 testing, but was not tested for efficacy because the West African outbreak ended before that work could be done.

Future federal clinical trials of cognitive treatments for schizophrenia will use the tests developed by the MATRICS committee, based upon the above seven domains, for a more standardized measure of efficacy.

The HVTN is an international collaboration that conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy.

Testing the efficacy of your gRNAs is then a simple matter of transfecting HEK293T cells with your modified pCAG - EGXXFP plasmid along with the individual gRNAs in their PX330 plasmids (or similar plasmids for gRNA expression), one gRNA at a time.

The researchers are now testing the efficacy of the technique in animal models to verify its potential for therapeutic use.

Sanofi - Aventis tested safety and efficacy of naked DNA plasmid that includes the gene encoding for human FGF1.

We have used a variety of cell models to test toxicity, cell penetration, and efficacy of furin inhibitors, and have identified small molecule inhibitors selective for cell surface furin action as well as inhibitors which also work intracellularly.

These mice are ideal for testing the efficacy of anti-human TNF therapeutics in a variety of induced inflammatory models.

TghIL17A mice in combination with induced psoriasis protocols form a drug efficacy evaluation platform for testing anti-huIL17A therapeutics.

We should guard against raising expectations of miracle cures for thousands of patients in the near future however as the current trial will require extensive tests for efficacy and safety.