Sentences with phrase «safety and efficacy in»

«But having it approved in dogs gives us a level of confidence regarding safety and efficacy in that species.»

For prevention or treatment of fleas, we recommend you talk to your veterinarian and obtain a recommendation for a product that has been extensively tested for safety and efficacy in cats.

According to Lise Alschuler, author of the Definitive Guide To Cancer: An Integrative Approach to Prevention, Treatment, and Healing, studies on flax lignans demonstrate safety and efficacy in their use against breast cancer, «inhibiting the growth of human estrogen - dependent breast cancer cells in mice and strengthening the tumor - inhibitory effect of tamoxifen».

Much more needs to be understood about their long - term use and combination with the diet before giving a definitive answer on their safety and efficacy in humans.

However, the safety and efficacy in pediatric patients less than 12 months of age has not been established.

Few herbal products have been widely tested for safety and efficacy in randomized, placebo - controlled trials, as the U.S. Food and Drug Administration (FDA) requires of prescriptions drugs.

Given that drugs derived from JQ1 are already being tested in cancer clinical trials, their safety and efficacy in humans are already being defined.

He also oversees the design and execution of GLP toxicity studies, a critical final step before IDRI's vaccines can be tested for safety and efficacy in humans.

The company's lead proprietary compound, LMTX ®, has recently completed three Phase 3 clinical trials to evaluate its safety and efficacy in the treatment of Alzheimer's disease and behavioural - variant frontotemporal dementia.

It is currently being evaluated for safety and efficacy in preclinical models with a Phase I trial expected to begin in 2019.

EOS100850 is currently being evaluated for safety and efficacy in preclinical models.

«Since these molecules come from species other than humans, many studies must be done to evaluate their safety and efficacy in the context of treatment,» he says.

On a more pragmatic level, the researchers hope to soon be able to translate the findings into clinical trials to test safety and efficacy in people.

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.

At Merck Frosst Canada, I have been an integral part of the discovery of a new molecule, the testing of its mechanism of action, the validation of its safety and efficacy in Phase IIb and III clinical trials, the market approval of the resulting product, and the subsequent management of patients and their disease.

To get through the FDA's demanding approval process, drug companies must demonstrate their product's safety and efficacy in costly randomized clinical trials.

«The next steps are to develop tau - lowering therapeutics that could be used in humans and to evaluate their safety and efficacy in preclinical studies,» said Dr. Mucke, «objectives we are pursuing actively.»

With the initial contract of $ 24.9 million over the next 18 months, Mapp Pharmaceutical will manufacture a small amount of the drug for early - stage clinical studies to demonstrate its safety and efficacy in people.

«So we bought the rights to the drug and started working with Professor Gabay to assess its safety and efficacy in a clinical trial,» explains Andrew Sleight, CEO of AB2 Bio Ltd., the Lake Geneva startup that has the World Wide license of the drug.

About Hops: From http://www.drugs.com/npp/hops.html «Pregnancy / Lactation Information regarding safety and efficacy in pregnancy and lactation is lacking».

There are two things, safety and efficacy — you do not talk about safety and efficacy in food, you only talk about these in terms of drugs.

A stroke drug invented at The Scripps Research Institute has shown signs of safety and efficacy in a mid-stage clinical trial.

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.

Not exact matches

We are very confident in the safety and efficacy of EpiPen products being produced at the site.»

Although the FDA can't dictate prices or reject therapies over pricing concerns (they can only focus on safety and efficacy), the agency can encourage more competition through moves like this (as well as speedier approval pathways) which could spur drug makers to produce products that ultimately lower costs for patients — a goal cited by FDA Commissioner Scott Gottlieb in announcing the list.

Boehringer Ingelheim stepped away from flibanserin after the FDA rejected the drug due to concerns about its efficacy and safety; Goldstein persuaded the Whiteheads to step in.

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).

Announced a clinical trial collaboration with Pfizer, Inc. (Pfizer) to evaluate the safety and efficacy of the investigational combination of Yescarta and Pfizer's utomilumab, a fully humanized 4 - 1BB agonist monoclonal antibody, in patients with refractory large B - cell lymphoma.

Our forecast for bictegravir starts later than this implied timeline (Q3 2018) but ramps to more than $ 10bn in global sales based on the product's convenience, safety and tolerability and efficacy.

We do this by conducting clinical trials in which we collect safety and efficacy data about our experimental drugs with the goal of submitting those data to regulatory authorities, like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), so that these experimental drugs can be approved for use by patients.

In a March 16 research note, Andrew Fein, an analyst at H.C. Wainwright & Co., reported that OvaScience (OVAS: NASDAQ) shifted its focus back to research and development, after interim data from the first 20 patients in its Phase 1 trial of OvaPrime showed no signs of efficacy despite indicating safety and tolerabilitIn a March 16 research note, Andrew Fein, an analyst at H.C. Wainwright & Co., reported that OvaScience (OVAS: NASDAQ) shifted its focus back to research and development, after interim data from the first 20 patients in its Phase 1 trial of OvaPrime showed no signs of efficacy despite indicating safety and tolerabilitin its Phase 1 trial of OvaPrime showed no signs of efficacy despite indicating safety and tolerability.

But oliceridine's value proposition actually depends on how well it stacks up against morphine from both a safety and efficacy standpoint, which is the secondary endpoint in each trial.

But for those new parents who have been bombarded with misinformation and hearsay regarding the safety and efficacy of sleep training, it's yet another assurance that you can feel confident in the fact that getting your child to sleep through the night is important, safe, and beneficial to your entire family.

They have a vested interest in publishing studies that promote the use of their medications and failing to publish study results that call the efficacy or safety of their drugs into question.

The aim of this trial is to evaluate the safety and efficacy of continuous KMC initiated immediately after birth compared to the current recommendation of initiating continuous KMC after stabilization, in improving survival of neonates with birth weight from 1.0 to < 1.8 kg.

The brief includes the analysis of survey data from program participants on child safety in the home, observed parenting practices, parental stress and parenting efficacy, self - reported parenting practices, and rates of child maltreatment.

The DAME trial was a multi-site, randomised controlled trial of antenatal expression of colostrum in late pregnancy for women with diabetes in pregnancy to explore the safety and efficacy for mother, foetus and infant.

• «The Magic Number» teaching concept to help mothers maintain their milk supplies while pumping • Breast massage and compression to help mothers increase breast milk yields and overcome breastfeeding difficulties • New, more - conservative guidelines on the use of galactogogues • Fenugreek, milk volume, and prolactin levels in mothers of preterm infants • The safety and efficacy of placenta consumption as a galactogogue • Preparation, cleaning, and sterilization of breast pump parts • Appropriate use of nipple shields to improve breastfeeding outcomes • The importance of the mother - infant relationship in babies» growth and development

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.

Safety and efficacy of antenatal milk expressing for women with diabetes in pregnancy: protocol for a randomised controlled trial.

ObjectiveTo evaluate the efficacy and safety of magnesium sulfate in the resolution of vaginal bleeding and contractions in nonsevere placental abruption.

Suksomboon N, Poolsup N, Yuwanakorn A. Systematic review and meta ‐ analysis of the efficacy and safety of chromium supplementation in diabetes.

Women should also understand that there is uncertainty about the safety and efficacy of planned VBAC in pregnancies that go beyond 42 weeks of pregnancy, or those with twins or especially large babies.

«Until we have further evidence on the efficacy of medical cannabis for the treatment of sleep apnea, and until its safety profile is established, patients should discuss proven treatment options with a licensed medical provider at an accredited sleep facility,» said lead author Dr. Kannan Ramar, professor of medicine in the division of pulmonary and critical care medicine at Mayo Clinic in Rochester, Minnesota.

In October, a UNESCO bioethics panel recommended a temporary ban on «engineering of the human germline, at least as long as the safety and efficacy of the procedures are not adequately proven».

Further studies in animal models and patients (with altered TRPM7 channel function) have been initiated, in order to evaluate the efficacy and safety of magnesium as a therapeutic for this disease.

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.

«I believe in the 21st century, the classic public health measures that are critical can be complemented by the addition of rapid diagnostics; by the development of vaccines, assessment of safety and efficacy and then deployment; and by the development of drugs.

This open label, multicentre, phase 1B trial investigated the safety and efficacy of omaveloxolone in combination with the checkpoint inhibitors ipilimumab or nivolumab.