Sentences with phrase «efficacy data on»

To date, efficacy data on psychotherapy derive mainly from two types of studies recognized for their scientific validity: so - called efficacy studies1 and effectiveness studies2.

We have commenced a series of clinical trials designed to obtain safety and efficacy data on Epidiolex to provide to the FDA and other regulatory authorities around the world, which is necessary to be considered for approval as a prescription medicine.

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.

Not exact matches

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

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.

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).

This account of awareness is empirical because it is based on the immediate experience of the causal efficacy of the physical world; it is radically empirical because it claims to sense, in addition to the data for the five senses, the objective embodiments of values, and it senses these values «intuitively» — that is, physically by, for example, a sense of aversion or a sense of attraction.

Sometimes, especially when he is speaking pre-systematically and citing examples from ordinary experience, Whitehead seems to claim that causal efficacy merely discloses relations among the data of presentational immediacy and to indicate that «something is going on in nature and some things are affecting other things.»

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.

And New York State Senator Brad Hoylman announced there would be a public forum on June 14 at the Senate Hearing Room «to assess the efficacy of New York State's Hate Crimes Law, how state and local government agencies are implementing and enforcing the Law, and whether amendments should be considered to expand the data collection, statistical reporting, law enforcement training requirements and / or otherwise further the Law's goals.»

Thomas Smith, who studies the epidemiology of malaria at the Swiss Tropical Institute in Basel, says it may be premature to say exactly what the efficacy is based on this early data from the trial, which is still ongoing.

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.

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.

Gaff, who calls herself a mathematical ecoepidemiologist, at Old Dominion University in Norfolk, Va., is one of the few people collecting real field data on the efficacy of tick - slaying robots...

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.

Shadi Yaghi, M.D., of Brown University, Providence, R.I., and colleagues analyzed data from 10 stroke centers across the United States to understand the natural history of thrombolysis - related sICH and to focus on the efficacy of various treatments used.

The authors performed a systematic literature search for data on e-cigarettes» mechanism of action, their emissions, how they are seen by groups of potential users, their efficacy in smoking cessation, and their addiction potential.

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.»

What's really necessary, Dr. Gaillard says, is real data on efficacy for each of the medications commonly prescribed to pediatric epilepsy patients — a marked vacuum in research that prevents doctors from using evidence - based reasoning when making medication choices.

Long - term ETV or TDF therapy is the most common treatment option in CHB of any severity, but efficacy data have been mainly based upon on - therapy virological remission rates.

But more data on the efficacy of the lower dose need to be collected, especially because an African population may react differently to those studied in the trials.

Because MVA was never tested in a real outbreak, data on its efficacy will have to come from animal studies.

What we have done, however, is to unleash drugs with well - documented toxicities onto the market, without obtaining rigorous data on their clinical efficacy.»

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

Only four provided data for positive outcomes or adverse effects, and none provided any data on efficacy beyond the end of treatment.

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.

NeuroPhage has accumulated extensive preclinical data on this candidate, demonstrating its efficacy across disease models of Alzheimer's and Parkinson's disease, tauopathies and other related diseases characterized by aggregation of amyloid beta, tau, and alpha - synuclein proteins.

«The ASGCT decision to include a presentation on AST - OPC1 in its Presidential Symposium signifies the ground - breaking nature of our program, and reflects the encouraging efficacy and safety data we have seen to date in patients with severe spinal cord injuries that have been treated with AST - OPC1,» commented Steve Cartt, President and Chief Executive Officer of Asterias.

«It is exciting to be directly involved in creating an innovative clinical trial infrastructure that will yield important efficacy and safety data on novel asthma interventions,» says Dr. Jain, «I look forward to participating in this work and seeing how it directly impacts asthma patients.»

This data suggests a different effect of ketosis on glucose homeostasis in diabetic and non-diabetic individuals.21 Other studies support the long - term efficacy of ketogenic diets in managing complications of T2D.36, 37 Although significant reductions in fat mass often results when individuals restrict carbohydrate, the improvements in glycaemic control, haemoglobin A1c and lipid markers, as well as reduced use or withdrawal of insulin and other medications in many cases, occurs before significant weight loss occurs.

Local outcome data will drive this decisionmaking, says Kane, and to deliver on these new requirements, he imagines a future in which a collection of «efficacy networks» provide local capacity to measure, evaluate, and share the impact of local interventions.

It is worth pausing to dwell on this fact: there are virtually no data with which to evaluate the efficacy of this program, yet the program has been embraced by two states and by the largest city in the United States.

Along with academic proficiency data, schools also receive fascinating and useful survey data about their views and attitudes on classroom discipline, relationships with teachers, self - efficacy, and motivation.

Because it began as a research collaboration, the emphasis of ATC21S ™ has always been on gathering data to analyse the efficacy of the tool and develop and improve it based upon that data.

has always been on gathering data to analyse the efficacy of the tool and develop and improve it based upon that data.

Responding to Whitehurst and Chingos» call for more research on textbook efficacy, we have recently undertaken a project [vii] using data from California to investigate the impact of textbooks on student achievement.

However, an analysis of data - use effects reported in Section 2.5, which did not use principal efficacy as a moderating variable, also reported significant data use effects on students, but only in elementary schools.

Additionally, LEAP will conduct rigorous research to aggregate and analyze data on teacher practice, student outcomes and product efficacy.

The act goes on to stress the importance of using student data to evaluate the efficacy of classroom technology and urges districts to invest in data - based edtech tools.

The Achieve3000 platform is powered by built - in blended learning, actionable data, and proven efficacy, ensuring equity of access to core instruction while accelerating student learning, improving performance on high - stakes assessments, and preparing all students for college and career success.

Culture and Collaboration Collaborate effectively and meet frequently with the MWA Division Directors, Associate School Directors, Deans of Students, Lead Teachers, Content Leads, the other divisional DCI, and MWAS team members to successfully build capacity of Teaching Faculty and Teacher Interns Work with the Data and Assessment team to compile, analyze, and respond to data on the school's schoolwide data management and assessment systems, including oversight and implementation of the schoolwide Benchmark Assessment system Through informal observations, formal observations, and other qualitative measures, utilize approved tools and matrices to assess faculty adherence and fidelity to efficacy and growth mindset instructional practices, data - informed instructional lesson planning and practices, and cultural competence practices in working with students, faculty and families Work closely with the Director of Teacher Residency to support and inform MWA Teacher Residents with the necessary entry - level skills expected of MWA teachers; this includes working with and supporting the Mentor Teachers assigned to Teacher Residents Supervise and support New Teacher Induction Program Mentor teachers towards helping new - to - the - profession teachers in «clearing» their credential and meeting state mandates for certification; this includes support for all intern teachers Develop and maintain positive relationships with various internal & external stakeholders including administrative colleagues, parents, students, teaching faculty, support and intervention staff members, and board memData and Assessment team to compile, analyze, and respond to data on the school's schoolwide data management and assessment systems, including oversight and implementation of the schoolwide Benchmark Assessment system Through informal observations, formal observations, and other qualitative measures, utilize approved tools and matrices to assess faculty adherence and fidelity to efficacy and growth mindset instructional practices, data - informed instructional lesson planning and practices, and cultural competence practices in working with students, faculty and families Work closely with the Director of Teacher Residency to support and inform MWA Teacher Residents with the necessary entry - level skills expected of MWA teachers; this includes working with and supporting the Mentor Teachers assigned to Teacher Residents Supervise and support New Teacher Induction Program Mentor teachers towards helping new - to - the - profession teachers in «clearing» their credential and meeting state mandates for certification; this includes support for all intern teachers Develop and maintain positive relationships with various internal & external stakeholders including administrative colleagues, parents, students, teaching faculty, support and intervention staff members, and board memdata on the school's schoolwide data management and assessment systems, including oversight and implementation of the schoolwide Benchmark Assessment system Through informal observations, formal observations, and other qualitative measures, utilize approved tools and matrices to assess faculty adherence and fidelity to efficacy and growth mindset instructional practices, data - informed instructional lesson planning and practices, and cultural competence practices in working with students, faculty and families Work closely with the Director of Teacher Residency to support and inform MWA Teacher Residents with the necessary entry - level skills expected of MWA teachers; this includes working with and supporting the Mentor Teachers assigned to Teacher Residents Supervise and support New Teacher Induction Program Mentor teachers towards helping new - to - the - profession teachers in «clearing» their credential and meeting state mandates for certification; this includes support for all intern teachers Develop and maintain positive relationships with various internal & external stakeholders including administrative colleagues, parents, students, teaching faculty, support and intervention staff members, and board memdata management and assessment systems, including oversight and implementation of the schoolwide Benchmark Assessment system Through informal observations, formal observations, and other qualitative measures, utilize approved tools and matrices to assess faculty adherence and fidelity to efficacy and growth mindset instructional practices, data - informed instructional lesson planning and practices, and cultural competence practices in working with students, faculty and families Work closely with the Director of Teacher Residency to support and inform MWA Teacher Residents with the necessary entry - level skills expected of MWA teachers; this includes working with and supporting the Mentor Teachers assigned to Teacher Residents Supervise and support New Teacher Induction Program Mentor teachers towards helping new - to - the - profession teachers in «clearing» their credential and meeting state mandates for certification; this includes support for all intern teachers Develop and maintain positive relationships with various internal & external stakeholders including administrative colleagues, parents, students, teaching faculty, support and intervention staff members, and board memdata - informed instructional lesson planning and practices, and cultural competence practices in working with students, faculty and families Work closely with the Director of Teacher Residency to support and inform MWA Teacher Residents with the necessary entry - level skills expected of MWA teachers; this includes working with and supporting the Mentor Teachers assigned to Teacher Residents Supervise and support New Teacher Induction Program Mentor teachers towards helping new - to - the - profession teachers in «clearing» their credential and meeting state mandates for certification; this includes support for all intern teachers Develop and maintain positive relationships with various internal & external stakeholders including administrative colleagues, parents, students, teaching faculty, support and intervention staff members, and board members

We haven't got a single piece of data to inform us on CCSS's efficacy, but your sources have already decided it is winner.

You will be immersed in full - day workshops focused on strategies to effectively use data to target interventions, personalize learning, and evaluate instructional efficacy with our proprietary ITS Model.

However, the law requires districts to include certain practices, such as relying on multiple objective measures in placement decisions, using student performance data to ensure equity and efficacy, and ensuring the consistency of placement policies between elementary and high school districts.

Tennessee will use its data system to measure and publicly report on the efficacy of professional development activities, mapping participants improvement back to the source of their training and only funding or recommending those activities and programs that demonstrate results.

That is to say if passed, this bill would limit how much weight students» academic success will have on a school's overall rating and will limit how schools use assessment data to measure a school's efficacy.