Sentences with phrase «study drug administration»

Participation involves study drug administration, scheduled blood tests, biopsies and swabs, and necessary medical imaging — such as PET and CT scans — which are part of standard follow - up.

Inclusion Criteria: • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 • Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC)(Stage IIIb or greater) • Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 • Known PD - L1 tumor status as determined by an immunohistochemistry (IHC) assay performed by the central laboratory on tissue obtained at Screening • A woman of childbearing potential must have a negative highly sensitive serum (beta - human chorionic gonadotropin [beta - hCG]-RRB- at Screening within 14 days prior to study drug administration Inclusion Criteria for Crossover: • Participants must have been randomized to Arm A of the study and had radiographic disease progression according to RECIST 1.1 • Participants must have a mandatory biopsy at the time of disease progression according to RECIST 1.1 prior to crossing over.

And, if heterosexually active, agree to consistently use highly effective contraception per locally accepted standards in addition to a barrier method starting at Screening and throughout the study period and for 180 days after the final study drug administration.

• Female subject must agree not to breastfeed at Screening and throughout the study period and for 60 days after the final study drug administration.

• Female subject must not donate ova starting at Screening and throughout the study period and for 180 days after the final study drug administration.

A total of 409 patients (median age, 66 years) were included in the study, with a median time to study drug administration of 3.5 hours after diagnosis of shock.

Not exact matches

Speaking of checkpoint inhibitor drugs... Merck's star cancer immunotherapy treatment Keytruda is facing some troubling clinical trial incidents which have now compelled the Food and Drug Administration (FDA) to halt three studies of the drug in multiple myeloma, a rare blood cancer, after a number of patient deaDrug Administration (FDA) to halt three studies of the drug in multiple myeloma, a rare blood cancer, after a number of patient deadrug in multiple myeloma, a rare blood cancer, after a number of patient deaths.

According to a 2015 research study in the Journal of American Medical Association, many new drugs approved by the Food and Drug Administration don't improve overall survival.

The company is chasing an at least $ 80 million IPO to help fund the phase 3 studies that would be necessary for the Food and Drug Administration (FDA) to clear the treatment (the company has made modifications to the experimental, once - a-day pill that fights brain plaque buildup associated with Alzheimer's).

The Food and Drug Administration (FDA) has given Alnylam Pharmaceuticals the green light to relaunch clinical trials of its treatment for the bleeding disorder hemophilia after pausing the studies after a patient death.

The IMvigor211 study had been meant to confirm a previous trial, called IMvigor210, that was central to the U.S. Food and Drug Administration's accelerated approval last year of Tecentriq against bladder cancer.

Lilly outlined in July a likely multi-year delay for its experimental rheumatoid arthritis drug baricitinib, after the U.S. Food and Drug Administration declined to approve the drug, calling for an additional clinical stdrug baricitinib, after the U.S. Food and Drug Administration declined to approve the drug, calling for an additional clinical stDrug Administration declined to approve the drug, calling for an additional clinical stdrug, calling for an additional clinical study.

The dust jacket of Michael Massing's study of U.S. drug policy offers a summary of his thesis in bold red letters: «Under the Nixon Administration, America Had an Effective Drug Poldrug policy offers a summary of his thesis in bold red letters: «Under the Nixon Administration, America Had an Effective Drug PolDrug Policy.

As recently as February researchers with the US Food and Drug Administration ran a study that mimicked the small doses of BPA that people may come into contact with.

While the Food and Drug Administration (FDA) did not require approval of cryotherapy because it is a non-invasive procedure, the company believes that additional studies can help business with the added confirmation and explanation of benefits, as well as increase exposure of cryotherapy to the mainstream.

Alarmed by DMSO's sudden popularity and worried about misuse of it, the U.S. Food and Drug Administration banned the substance for medical use in 1965, citing a study that suggested it caused eye damage in laboratory rats.

While the US Food and Drug Administration (FDA) had earlier stated that BPA — the chemical that hardens plastics in products like bottles and cups, and is used in linings of metal cans — is safe; the agency announced last month that a few new studies have underlined «some concerns» about BPA's possibility of potentially damaging the brain of fetuses, infants and children.

Funding / Support: The Infant Feeding Practices Study II was funded by the Food and Drug Administration, Centers for Disease Control and Prevention, Office of Women's Health, National Institutes of Health, and Maternal and Child Health Bureau in the US Department of Health and Human Services.

The Infant Feeding Practices Study II is a longitudinal study of new mothers and their infants conducted by the Food and Drug Administration and the Centers for Disease Control and Prevention from May 2005 to June Study II is a longitudinal study of new mothers and their infants conducted by the Food and Drug Administration and the Centers for Disease Control and Prevention from May 2005 to June study of new mothers and their infants conducted by the Food and Drug Administration and the Centers for Disease Control and Prevention from May 2005 to June 2007.

We have posted the raw data on our website in the same manner that the Food and Drug Administration (FDA) does as part of their FDA Total Diet study.

The Food and Drug Administration has long permitted its use, but in recent years concerns about the chemical have grown as studies have indicated low doses of the substance can disrupt hormone systems in laboratory animals and possibly increase the risk of cancer or other serious illness.

And while the science may be disputed, depending on who is funding the study, as to whether commonly used food dyes such as Yellow 5, Red 40 and 6 others made from petroleum pose a «rainbow of risks» that include hyperactivity in children, cancer (in animal studies), and allergic reactions, because of the problem of hyperactivity, the Center for Science in the Public Interest petitioned the Food and Drug Administration to ban the use of these dyes given that the British government and European Unionhave taken actions that are virtually ending their use of dyes throughout Europe.

PFC was one of the initial study sites for FDA approval of the Follistim Pen, an FSH medication delivery device that today has made fertility drug administration much easier and comfortable for patients and is now widely used for ovarian stimulation.

«According to the US Food and Drug Administration, the scientific evidence is «mixed» over the benefits of adding ARA and DHA to baby formula, with no currently available published studies on the long - term impact.

After much petitioning by the Center for Science in the Public Interest (CSPI), The Food and Drug Administration (FDA) has announced plans to form an advisory committee meeting which will review clinical studies conducted on common food dyes including Yellow 5 and Red 40 and the link connecting them to adverse behavior issues in children.

President Obama is not so sure, thus the Food and Drug Administration (FDA) will conduct a $ 30 million study on the health effects of BPA.

Two puffed grain rice snacks were tested by the US Food and Drug Administration; the banana flavor had a total As concentration of 109 ng / g (46 ng / g inorganic), and the blueberry flavor was below the limit of quantitation of 3 ng / g.45 In the study by Signes - Pastor et al, 10 As concentrations in 97 rice crackers from 15 different brands ranged from 19 to 246 ng / g, with inorganic As ranging from 19 to 212 ng / g.

But critics argue that the study has not been peer reviewed or published in a scientific journal, and the U.S. Food and Drug Administration has said that food coming in contact with the chemical is safe, even in baby feeding bottles.

Since then an advisory committee to the US Food and Drug Administration has been studying whether the process is safe, after a Portland researcher said he had conducted the technique successfully on monkeys - and now wanted to begin trying it on humans.

However, the US Food and Drug Administration says that, currently, «all approved high - intensity sweeteners have been thoroughly studied and have a reasonable certainty of no harm to consumers under their approved conditions of use».

On the question of health effects, Mitch Zeller, the U.S. Food and Drug Administration's director of the Center for Tobacco Products, said that his agency is funding «dozens» of studies assessing the potential dangers of the devices.

In a statement sent to reporters last night, Sen. Barbara Boxer, chair of the Environment and Public Works committee, said the study prompted her to ask the Food and Drug Administration to inform the public «how best to protect children from perchlorate.»

The company has shown in pilot studies that the technology works, and it is on track to begin filing for approval with the U.S. Food and Drug Administration in July.

Clinical studies face additional hurdles because the plant is listed on Schedule I, the U.S. Drug Enforcement Administration's (DEA's) list of the most dangerous drugs.

PreScience Labs, a U.S. company founded by Geschwind, received approval for a phase I study from the U.S. Food and Drug Administration in 2013.

A study of Food and Drug Administration data for several million pacemakers and defibrillators implanted in 1990 - 2002 found that about one in 150 failed, about one quarter of these failures were battery / capacitor abnormalities, and 61 people died due to device malfunctions.

In fact, based on previous studies, the US Food and Drug Administration concluded in 2003 that eating 1.5 ounces per day of most nuts «may reduce the risk of heart disease.»

Although the trial first received the go - ahead in January last year, it was put on hold the following August by the US Food and Drug Administration, which demanded further evidence that the treatment wouldn't cause cysts like those seen in some animal studies.

The study was sponsored by the U.S. Centers for Disease Control and Prevention, U.S. Food and Drug Administration, National Institutes of Health, President's Emergency Plan for AIDS Relief, U.S. Agency for International Development, Rockefeller Foundation, Medtronic, Merck Foundation, and BD (Becton, Dickinson and Company).

For example, a study just out in The Lancet, funded by the U.S. Food and Drug Administration and focused on Medicare patients, found that the high - dose vaccine was 22 percent more effective at preventing flu - related hospital admissions.

The U.S. Food and Drug Administration has approved few of these medications for the preschool age group, yet previous studies documented two to threefold increases in psychotropic prescriptions for preschool children between 1991 and 2001.

Even with promising drug candidates, there are often studies that show negative effects, for instance if the dose was too low or the timing of the drug's administration wasn't ideal.

The U.S. Environmental Protection Agency, the Food and Drug Administration, the U.S. Department of Agriculture, and other agencies involved in regulating biotechnology products should increase their scientific capabilities, tools, and expertise in key areas of expected growth, said the committee that conducted the study and wrote the report.

Although the U.S. Food and Drug Administration is currently barred from granting approval to anyone hoping to use this technology in pregnancies, the Nature study suggests such work could be possible, says Jennifer Doudna of the University of California, Berkeley, a biochemist and CRISPR expert.

Three studies presented at the American Epilepsy Society's 69th Annual Meeting in Philadelphia highlight emerging efficacy and safety data of Epidiolex, a pharmaceutical liquid formulation of cannabidiol, which is currently undergoing U.S. Food and Drug Administration (FDA) authorized Phase 3 pivotal clinical trials in the United States and across the globe by GW Pharmaceuticals.

A new study shows that analyzing the queries made to Google and other search engines can reveal possibly dangerous drug interactions faster than the Food and Drug Administration can track tdrug interactions faster than the Food and Drug Administration can track tDrug Administration can track them.

As reported in 2015, the study met its primary endpoint after a median follow up of 2.3 years, with ipilimumab significantly improving recurrence - free survival.2 The drug was subsequently approved by the US Food and Drug Administration as adjuvant therapy for stage III melandrug was subsequently approved by the US Food and Drug Administration as adjuvant therapy for stage III melanDrug Administration as adjuvant therapy for stage III melanoma.

Many patients and physicians assume that the safety and effectiveness of newly approved drugs is well understood by the federal Food and Drug Administration (FDA)-- but a new study by researchers at Yale School of Medicine shows that the clinical trials used by the FDA to approve new drugs between 2005 and 2012 vary widely in their thoroughness.

That study — called an ICV trial for «intracerebroventricular» drug administration — is back in the limelight because a mother of two children afflicted with NPC recently asked for a correction in an article that appeared in the journal Current Topics in Medicinal Chemistry.

In April, a Clinical Center employee had noticed what appeared to be a fungal contamination in a vial of albumin — used in the administration of the drug interleukin in experimental studies — after being unable to draw the liquid out of the vial.