Sentences with phrase «safety and efficacy study»

They are planning to pursue a Phase 1 safety and efficacy study in human volunteers.

Green also noted that additional safety and efficacy studies are needed before the treatment makes its way to the clinic.

Because bazedoxifene has already undergone safety and efficacy studies as a treatment for osteoporosis, it may be a viable near - term option for patients with advanced breast cancer whose tumors have become resistant to other treatment options, Wardell reported.

There, a commercial tablet containing 200 mg malic acid and 50 mg magnesium was undergoing safety and efficacy studies before going to market.

Also, bear in mind that caution is necessary when selecting a neutraceutical product as these are not licensed or regulated in the same way that prescription canine pharmaceuticals are, so choosing a reputable company with safety and efficacy studies to back up their products is essential.

Not exact matches

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.

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).

Presentations will highlight the short and long - term effects of Ingrezza on tardive dyskinesia symptoms by body region, long term safety and efficacy data from the KINECT 4 phase 3 open label study and also from RE-KINECT (real - world screening study of patients with possible TD).

There are hundreds of thousands of studies done proving their efficacy and safety.

If you dig and read studies examining the actual safety and efficacy data about the various vaccines, it is clear that vaccination prevents the development of a strong natural immune system.

Reflecting on the evidence, the study's authors wrote, «Despite the media attention and perceived benefits of these therapies, there are still limited data as to efficacy and long - term safety.

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 limited number of marijuana studies are inconclusive regarding the drug's safety and efficacy.

Furthermore, there have been no studies of the safety and efficacy of other delivery methods such as vaping or liquid formulation.

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.

«The study results elucidate the molecular mechanisms underlying disease progression in multiple sclerosis models, providing a basis for future clinical trials to determine safety and efficacy of these chemical agents in humans with demyelinating disorders,» says Patrizia Casaccia, MD, PhD, Professor of Neuroscience, Genetics and Genomic Sciences at Mount Sinai and senior author of the study.

Boni E. Elewski, M.D., professor of dermatology, is the principal investigator of the Efficacy of Response And Safety of two fixed secUkinumab REgimens in psoriasis (ERASURE) trial, one of two studies in the recent New England Journal of Medicine article «Secukinumab in Plaque Psoriasis — Results of Two Phase 3 Trials.»

«These types of studies go beyond safety and efficacy.

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 brochures contain information about toxicology, pharmacology, and animal safety studies used to determine the potential risk a particular therapy may pose to humans, but they also include efficacy studies done in animal models to demonstrate a therapy's potential benefit.

The main objective of this study was to verify the safety of the drug and to confirm its efficacy on the clinical manifestations of the disease.

The new study was a prospective, randomized, investigator - blinded study that included more than 250 daptomycin - exposed children, ages 1 to 17, to document safety and efficacy of the antibiotic in treating pediatric skin and skin structure infections.

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.

«These data reinforce and support the safety and efficacy we have shared in previous studies.

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.

The largest CBD study presented efficacy and safety data on GW Pharmaceutical's investigational medicine, Epidiolex (cannabidiol) from open - label Expanded Access programs at 16 sites.

The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.

Apart from patient testimonials and a few preliminary studies in tumor cell lines and in mice, critics say, there is no evidence of the safety or efficacy of the compound, popularly known as the «cancer pill» or «fosfo.»

During that time, the FDA granted 22 drugs Accelerated Approval and ordered 38 post-approval studies to confirm the safety and efficacy of these drugs.

All these methods are in early stages of development and would require primate and human studies to prove their safety and efficacy, says Bremner.

Michael O'Connor, Ph.D., a Mayo Clinic scientist and inventor of the MBI technology, calls this latest study a major milestone for both safety and efficacy of the imaging device, largely because of the high detection rates achieved through low radiation exposure.

More studies are needed to demonstrate safety, efficacy and oral bioavailability.

«While we have a long way to go in demonstrating the safety and efficacy of this technique, this case represents a significant first step,» said Christopher J. Hartnick, M.D., lead investigator of the study and director of the pediatric otolaryngology division at Mass..

«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 (Astudy'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 (AStudy (ADCS).

«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.»

The safety and efficacy of these methods have been well established through long - term clinical outcomes studies in the field, with the nasal lining protecting the brain from infection just as the blood brain barrier has done.

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.

The standard pharmaceutical development path for products that target pathogens moves slowly from studying safety, dosing, and biological responses in hundreds of people to an expensive efficacy trial with thousands of participants at high risk of becoming naturally infected.

In a study published online by JAMA Cardiology, Fredrik Björck, M.D., of Umea University, Umea, Sweden and colleagues evaluated the efficacy and safety of well - managed warfarin therapy in patients with nonvalvular atrial fibrillation.

Promising outcomes of preliminary studies in patients in Southeast Asia and parts of Western and Central Africa led the World Health Organization to make the recommendation, but safety and efficacy have not yet been proven in large - scale clinical trials.

We hope to move from the safety study into a full scale efficacy study in the spring, involving more patients in centres around the UK and Europe.

Our study is one of the largest to explore the efficacy and safety of anti-TNF therapy in a large independent cohort of JDM patients.»

«We are at a point in our research where we have validated the efficacy of this combination treatment approach in preclinical animal models, and we now need to define its safety through toxicology and pharmacology studies,» says Fisher, Thelma Newmeyer Corman Endowed Chair in Cancer Research and co-leader of the Cancer Molecular Genetics research program at VCU Massey, chairman of VCU School of Medicine's Department of Human and Molecular Genetics and director of the VCU Institute of Molecular Medicine.

He also believes that additional research — possibly randomized, prospective studies — should be done to compare the safety and efficacy of PAE with other commonly performed BPH treatments.

Strollo led a large study of the new treatment, a yearlong safety and efficacy trial involving 126 people with moderate to severe obstructive apnea.

The study protocol calls for the children to be monitored for 15 years in order to assess the treatment's safety and efficacy.

«We're looking forward to longer - term results to come in the next five years from various ongoing observational studies,» Dr. Arterburn said: The Utah Obesity Study, the Michigan Bariatric Surgery Collaborative, and large cohorts from Veterans Affairs health system and the HMO Research Network (including Group Health) and should yield important long - term information comparing the efficacy, safety, and costs of surgical and non-surgical care for severe obesity.

Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes.

Further studies of ALN - TTR02 are needed to examine the clinical efficacy and safety of long - term transthyretin knockdown in patients with familial amyloidotic polyneuropathy.