Sentences with phrase «on efficacy and safety»

They focused on the efficacy and safety of tPA treatment and also looked for any factors or patient subgroups that might affect treatment outcome.

We do not choose vaccines based on price, but on efficacy and safety data that we review regularly.

I sincerely hope this blog post doesn't deteriorate into a debate on the efficacy and safety... [Read more...]

Gabapentin may play a role in chronic pain management in pets; however further research and studies need to be done on efficacy and safety.

There are mixed results on the efficacy and safety of using H2O2 as an emetic.

By taking the opportunity of personal service to educate their customers on the efficacy and safety of products that are proven to be effective, [pet specialty retailers] can garner sales at a higher value and have a happy customer.»

The drug was approved based on efficacy and safety results from a phase III trial presented earlier this year at the 2015 American Society of Clinical Oncology Annual Meeting.

Medical schools have resisted the introduction of a specific phytotherapy curriculum, preferring to wait for more data on efficacy and safety.

After hearing about his work, several other companies, including Pfizer, Bayer, and Eli Lily, decided to examine the effects of different genetic variants on the efficacy and safety of drugs they had in development.

Not exact matches

FDA panels (and the agency itself) judges experimental treatments on their safety and efficacy.

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.

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.

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).

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.

RxAdvance's staff of experienced pharmacists and care managers provide plan sponsors with clinically - driven services focused on safety, efficacy, and cost containment.

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).

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.

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.

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 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

Theadequatemother is an anesthesiologist who has done some very helpful posts on the safety and efficacy of epidural anesthetic.

The workshop, which took place on the August 28 - 29, 2017, was aimed at educating the Herbal Manufacturers on «Specifications for Herbal Products» with the aim of improving the overall quality, efficacy and product safety on the market.

«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».

Follow - up data on safety and efficacy has been assessed at up to six years in women age 15 - 26 and the current team of investigators also looked at data on the large cohort of young people two years ago.

The CO-STAR (Hepatitis C Patients on Opioid Substitution Therapy Antiviral Response) trial sought to evaluate the efficacy and safety of elbasvir - grazoprevir for injection drug users.

It helps to clarify the pre-existing evidence on the effectiveness of these approaches and their side effects in the short term, as well as introducing longer term evidence of efficacy and safety.

Respondents in this year's survey pointed to five main causes of the field's less than favorable reputation: drug and product recalls such as the withdrawal of Avandia; safety issues such as the discovery of problems with raw material from China used in medical products; scandals, including evidence that pharmaceutical companies have failed to release data from trials whose results cast doubts on their drugs» safety and efficacy; lawsuits brought against companies that failed to warn patients of problems with their products; and ethical issues such as kickbacks for physicians promoting specific medications.

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.

Rwanda will present safety and efficacy data on 50 patients at the American Urology Association in May 2011, and a randomized, controlled trial with 150 participants, designed to compare PrePex with the conventional surgical method is currently ongoing.

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.

Previous clinical trials have evaluated the efficacy, safety and tolerability of CIP on human patients.

In January 2013, the American Society for Reproductive Medicine declared the technique of oocyte cryopreservation (egg freezing) no longer experimental, although it called for «more widespread clinic - specific data on the safety and efficacy of oocyte cryopreservation... before universal donor oocyte banking can be recommended.»

To this point, there has been little definitive evidence to guide surgeons about the safety and efficacy of laparoscopic versus open resection on pathological outcomes in rectal cancer.

Scientists poured scorn on the decision, contending it puts patients at risk and undermines the authority of the Brazilian Health Surveillance Agency (the equivalent of the U.S. Food and Drug Administration) to regulate research and approval of new drugs based on internationally accepted safety and efficacy protocols.

«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).

Additionally, the proportion of patients in the United States who are prescribed opioids for non-cancer pain has almost doubled over the past decade, indicating the need to do a more focused examination on the safety and efficacy of these and other treatment options.

Two new phase III clinical trials investigating the efficacy and safety of bitopertin, a glycine uptake inhibitor considered to be a promising new add - on therapy for treating negative symptoms in schizophrenia, failed to show a benefit of the drug over placebo.

This has in turn spurred research on two fronts: standardizing the plant material to allow its use in natura and validating its medicinal efficacy and safety.

An HFEA spokesperson says that the agency is waiting for further experiments on the safety and efficacy of mitochondrial replacement (including data from Herbert's team) before approving what could be the world's first mitochondrial replacement in humans.

The Rao report says that generally, «endorsement or opposition to a generic technology is scientifically not rational,» and argues instead that «safety and efficacy must be judged on product basis.»

The first report on the safety and efficacy of this therapy in children under 12 years old — led by Guy Young, MD, director of the Hemostasis and Thrombosis Center of Children's Hospital Los Angeles — has been published in the Journal of Thrombosis and Haemostasis.

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.

On «the lack of quality controls on cells,» which makes the treatment hard to replicate, thus not guaranteeing safety and efficacy of the produOn «the lack of quality controls on cells,» which makes the treatment hard to replicate, thus not guaranteeing safety and efficacy of the produon cells,» which makes the treatment hard to replicate, thus not guaranteeing safety and efficacy of the product

If their phase I clinical trial to test the safety and preliminary efficacy of this therapy gains approval, University of Pittsburgh researchers will test the therapy on 10 patients who suffer from chronic ischemic stroke — the most common form, in which clots block blood flow.

To address these issues, «the committee recommends that any initial MRT clinical investigations focus on minimizing the future child's exposure to risk while ascertaining the safety and efficacy of the techniques.»

Early results from a phase I, first in - human study indicate that a potential new class of drugs, RNA interference (RNAi) drugs, can be safely administered in humans, according to a researcher who presented data on the safety and preliminary efficacy of TKM - 080301 at the AACR Annual Meeting 2013, held in Washington, D.C., April 6 - 10.

But «overall, I wish more attention was paid to the fact that this small trial was to examine safety and efficacy and that much more needs to be done to make statements regarding clinically meaningful impact on disease,» Vandross said.

Medical professional societies and clinical researchers advocated for the policy based on the available literature on FMT's safety and efficacy and the lack of treatment alternatives for this patient population.