Sentences with phrase «safety studies in»

The results of long - term safety studies in mice were previously submitted to the Food and Drug Administration to gain permission for a Phase 1 clinical trial under an Investigational New Drug (IND) application.

If all goes well, he and his colleagues hope to conduct human safety studies in three to five years.

Standard definitions are needed for measuring outcomes when evaluating vaccine safety studies in pregnant women, a problem recently highlighted by the World Health Organization.

It is not unreasonable to expect different safety concerns in adult women compared with young girls, and our study is an important supplement to the safety studies in young girls,» said lead author Dr. Anders Hviid, of the Statens Serum Institut, in Denmark.

He worries that, without the proper safety studies in place, the treatments could «lead to serious complications like cancer and autoimmune disease».

«We did extensive safety studies in monkeys,» says Fritz Scheiflinger, vice-president of research and innovation at Baxter BioScience in Vienna.

Those assets included a therapy designed to inhibit TFPI that had already entered a safety study in the United Kingdom.

The move could also spell relief for Amicus Therapeutics and CEO John Crowley, who personally lobbied the president on the FDA's decision to delay any final decision on their drug for Fabry disease so they could see the results of a safety study in 2019.

His team is winding up a safety study in which 40 patients breathed in a single dose of a lipid - CFTR DNA mixture.

The first clinical trial was a safety study in Australia, followed by an ongoing efficacy study in Peru to evaluate the ability to treat patients with malaria.

A safety study in dogs demonstrated no adverse effects of Cosequin administration on blood work parameters, including complete blood count, biochemical, and clotting values.

Cosequin ASU has been evaluated in a safety study in horses, and no adverse effects were noted from administration.

In a clinical study, Vanguard ® Rapid Resp vaccines were shown to reduce the duration of coughing in dogs by 84.4 % following Bb challenge, and also to reduce other clinical signs, such as nasal discharge and retching.1 A field safety study in 614 client - owned dogs showed that Vanguard ® Rapid Resp is safe and well - tolerated, with no abnormal health events or reactions reported in the immediate post-vaccination period.

Not exact matches

A recent study from ConsumerAffairs looks at the safety of Uber, Lyft and taxi cars in cities around the U.S.

In a safety vest, equipped with a pen light, the engineer studied the place, noting with morbid fascination how it had survived the explosion despite frequent departures from code — deviations he said did not make sense.

Despite the safety concerns many people have about riding in cars with strangers, a new study claims that Uber makes the streets safer.

His studies found a direct correlation between more time spent online and feelings of loneliness, where more time offline with family and close friends in face - to - face meetings correlated with feelings of safety, security and improved mental function.

In a pilot study, researchers will compare the skills, safety records, and performance of two groups of new drivers: those using virtual reality and those trained by traditional means.

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.

Celebrated NFL safety Troy Polamalu began studying at the University of Southern California in 1999.

And in the recent randomized study — which was designed to assess the safety and tolerability of various doses in volunteers from Canada, Germany, and the UK — IONIS - HTTRx appeared to substantially block the gene's pernicious message from getting through.

For example, the anxious group read sentences like «safety is not guaranteed in our neighborhoods nor in our own homes,» which was intended to highlight the «lack of control over negative circumstances that may happen in life and an uncertain future,» according to the study.

I think they have 85 plus percent, it was the latest study of ad dollars, so how do you view the duopoly and also in things like Google in particular, they're not — they can't escape this brand safety issue either, they have a lot of issues with YouTube as well.

CM4620 arose from CalciMedica's internal R&D, is patent protected, and in Phase 1 safety studies has been shown to be safe and well tolerated.

In one study, people watched a silent film about an accident at an industrial site that occurred because of poor safety practices.

Detailed 48 - week results from a Phase 3 study evaluating the efficacy and safety of switching from a regimen containing abacavir, dolutegravir and lamivudine (600 / 50/300 mg)(ABC / DTG / 3TC) to Biktarvy, a once - daily single tablet regimen, in virologically suppressed adults with HIV.

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

When companies scored a second or third time with a qualifying value, that is, above 175 in health and wellness and 350 in safety, the portfolio doubled or tripled its investment in them and maintained that «over-weighting» for the remainder of the study.

Thirdly, it cites a study that the safety net has shifted to in - work families from out - of - work families.

Alnylam, which has been weighed down in the past by drug safety concerns, said it plans to initiate a program targeting cardiomyopathy - another symptom of the disease - alongside polyneuropathy in a late - stage study next year.

Keep in mind that while the study was performed using a safety razor (disposable and cartridge razors hadn't been invented yet), most of the findings pertain to shaving in general — no matter what type of razor you use.

Their study found that Americans waste 160 billion pounds of food each year — often because of simple misunderstandings about expiration dates: Many Americans refuse to consume food after the dates on packaging passes, even though in many cases, the dates have nothing to do with food safety.

recent study identified and provided industry guidance in determining the safety of oats and other whole grains for the gluten - free market.

The new gluten threshold and sampling plan outlined in the study provides valuable guidance to processors and enhances the safety of whole grain products certified by GFCO for consumers.

The purpose of the GFCO study was to identify and provide industry guidance in determining the safety of oats and other whole grains for the gluten - free market.

In addition to these studies, they are poorly regulated and have not been tested for safety by the FDA or by the biotech companies that produce them, like monsanto.

In addition, the LEAP study design excluded 9.1 % of the infants who were screened (76 of 834) because large wheals (greater than 4 mm in diameter) developed after the skin - prick test21 that were probably associated with peanut allergy; the safety and effectiveness of early peanut consumption in that population remain unknowIn addition, the LEAP study design excluded 9.1 % of the infants who were screened (76 of 834) because large wheals (greater than 4 mm in diameter) developed after the skin - prick test21 that were probably associated with peanut allergy; the safety and effectiveness of early peanut consumption in that population remain unknowin diameter) developed after the skin - prick test21 that were probably associated with peanut allergy; the safety and effectiveness of early peanut consumption in that population remain unknowin that population remain unknown.

A Texas Workforce Commission study on the technology's impact produced statistics that showed considerable improvements in safety — and to the bottom line.

Yet in a 2006 study published by Food Protection Trends on the rankings of safety problems across all food sectors, 94 percent of study respondents identified «deficient employee training» as the biggest safety issue.

Although the cancer study has been challenged by the European Food Safety Agency (a group that has strong food industry ties), I will side with the unbiased Center for Science in the Public Interest on this one.

Yet in a 2006 study published by Food Protection Trends on the rankings of safety problems across all food sectors, 94 percent of study respon dents identified «deficient employee training» as the biggest safety issue.

To help you with your exam, you may take the Learn2Serve Food Safety Management Principles course that provides a basic study overview of the topics that will be covered in the Food Protection Manager Certification Exam.

Low - calorie sweeteners are some of the most studied and reviewed ingredients in the food supply today and have passed rigorous safety assessments.

But it is important to note that the Tufts study wasn't a safety trial, because existing research was already available that showed that beta - carotene in Golden Rice was as safe as beta - carotene in other foods.

THE SAFETY OF CAFFEINE Caffeine is a comprehensively studied ingredient in the food supply, with centuries of safe use.

Many of our industry's leading food manufacturers and retailers, as well as international food safety and quality standards now require that their suppliers undertake a detailed study of their supply chain in accordance with GFSI guidance on food supply chain vulnerability.

«Energy drinks have been safely consumed by people around the world for more than 25 years and nothing in this study of just 18 people refutes the safety of these products or their ingredients.

While the produce industry and the federal government have made great strides in protecting the nation's food supply with steps like the Produce Traceability Initiative and the Food Safety Modernization Act, a new study from the University of California - Davis suggests reusable plastic containers may represent a backdoor for contamination.

The threshold and sampling plan provided in the study will help consumers of GFCO certified products by enhancing the safety of whole grain foods.

Out of concern for our customers and our concern for safety as a whole, we had a toxicity study performed based on the highest levels of tungsten found in our rice protein drinks.