Sentences with phrase «efficacy standards for»

«Expedited approaches can be used without compromising efficacy standards for drugs that demonstrate breakthrough therapy potential.»

Not exact matches

Theranos is not required to do this, and Holmes describes FDA approval as the «gold standard» for determining efficacy and the proper use of a test.

The FDA, which is the ultimate arbiter of safety and efficacy — of high quality tests that are proven to work — is the gold standard, and Theranos wants its tests to be the best and safest for its patients.

Not only should clinicians consider the lack of evidence supporting the efficacy of rACTH, but its story should cause us to reexamine and strengthen our standards for FDA approval, Medicare and private insurance coverage, and professional use patterns.»

For the same reason, it is not easy to prove treatment efficacy by means of controlled, randomized studies, the «gold standard» for evaluating new therapiFor the same reason, it is not easy to prove treatment efficacy by means of controlled, randomized studies, the «gold standard» for evaluating new therapifor evaluating new therapies.

Meta - analyses of this expanded research base confirm the model's impacts on a range of risk and protective factors associated with child maltreatment.7, 8,9 In addition, all of the major home visitation models in the U.S. are currently engaged in a variety of research activities, many of which are resulting in better defined models and more rigorous attention to the key issue of participant enrolment and retention, staff training and quality assurance standards.10 For example, recent findings emerging from the initial two - year follow - up of the Early Head Start National Demonstration Project confirm the efficacy of home visitation programs with new parents.

In contrast to the stated modernising goals of his first two presidencies — the achievement of greater state efficacy and the improvement of living standards and prosperity for ordinary Russian citizens — Putin has been recast as the saviour of the Russian nation.

Exploiting the same pre-clinical model used for their studies, the researchers are testing the efficacy of this kind of drug candidates against cancer stem cells, and the possibility of identifying combination regimens with standard chemotherapies with minimized toxic effects, with the perspective of their possible application for the treatment of human breast cancer.

«All endpoints of efficacy and tolerability favoured treatment with pembrolizumab, suggesting it should become one standard of care for first line treatment of patients with advanced NSCLC and high PD - L1 expression.

Researchers in New Zealand studied 206 OA patients for two years to measure the efficacy of adding regular physical exercise, manual therapy, or a combination of both therapies to standard care, versus continuing usual medical care for OA alone.

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.

«It's not feminist to accept a lower standard of drug efficacy and safety for women than for men,» she says.

Nor did the article give a hint of the ferocious battle among doctors about the safety and efficacy of tPA: While a number of professional associations endorsed the drug, many others, such as the American Academy of Emergency Medicine, said it should not be considered the standard of care for acute stroke.

For influenza we offer the ferret model, the «gold standard» for infections with human influenza viruses, which will be used to assess the efficacy of vaccine candidatFor influenza we offer the ferret model, the «gold standard» for infections with human influenza viruses, which will be used to assess the efficacy of vaccine candidatfor infections with human influenza viruses, which will be used to assess the efficacy of vaccine candidates.

To compare the efficacy of the rainbow and standard mechanisms, we determined the fluence of the single laser pulse that provided the same lifetime of the PNB around a mono - NP cluster as was achieved for the rainbow PNB.

Model F: Standard immune competent mouse model for protective efficacy Model G: GMP, adjuvant and formulation studies Model H: Comparative phase 1 clinical trial

If this national standards endeavor were a new drug for fighting swine flu or breast cancer, the FDA would subject it to rigorous long - term «field trials» to determine both its safety and its efficacy before releasing it for widespread use.

Topics of discussion will include: • Setting goals and identifying criteria to evaluate programs for efficacy, standards - alignment, and student growth • How to build teacher capacity using data - informed instruction and intentional organizational support structures • Scaling beyond intervention; increasing district - wide adoption and usage of personalized learning programs All K - 12 administrators and educators are encouraged to attend.

Our experienced consultants have helped schools and districts, including First Nation schools, create culturally relevant, engaging, standards - based curricula that motivates learning, boosts academic achievement, and increases student efficacy, creating a foundation for a high - quality education for all students.

A comprehensive assessment system measures growth toward mastery of state standards and a student's capacity to: transfer and adapt learning, from application in one situation to new situations; analyze and synthesize standards related content; evaluate standards related to content for utility and efficacy; and create new content beyond standards - based materials.

If this latter hypothesis should ever be proven correct, it would testify to the efficacy of a standards - based strategy for raising student achievement.

Research comparing the efficacy of full - day to part - day is limited and some was conducted prior to the Common Core State Standards and other measures holding all students accountable for achieving the same standards regardless of time - in - school models.

«Only programs that meet the highest degree of efficacy standards will qualify for ESSA funding, and because of its proven success, Achieve3000 is at the top of that list.»

The Efficacy Institute approach is built on three elements: building consensus on clear targets for academic proficiency; building belief among teachers, parents, and children themselves that proficiency standards can be achieved; and then building a continuous stream of feedback from student assessments to drive changes in curriculum and instructional strategy.

Efficacy of low - dose (2 millicurie) versus standard - dose (4 millicurie) radioiodine treatment for cats with mild - to - moderate hyperthyroidism.

Lucy, J, Peterson ME, Randolph J, Scrivani P, Thompson M, Davignon D, Scarlett J. Efficacy of low - dose (2 millicurie) versus standard - dose (4 millicurie) radioiodine (131I) treatment for cats with mild - to - moderate hyperthyroidism.

Requires the Administrator of the Environmental Protection Agency to: (1) promulgate performance standards (limiting emissions of sulfur dioxide, nitrogen oxides, particulate matter, and mercury) for new boilers, integrated gasification combined cycle plants, and combustion turbines; and (2) conduct a comprehensive research and environmental assessment program to enhance understanding of health and environmental effects of particulate matter and mercury and to demonstrate the efficacy of emission reductions under this Act.

In order to compare radiative forcings, one also needs to adjust for the efficacy of the forcing relative to some standard, usually the response to increasing CO2.

However, estimating a long - run relationship for motor fuel use per capita was difficult because of the efficacy of the CAFE standards to influence fleet fuel economy.

That requires the Department of Justice to inspect the procedures for creating such national standards, and the efficacy of such phrases in the records provisions of the Canada Evidence Act.

Summary: (To include comparison groups, outcomes, measures, notable limitations) This study compared the efficacy of a manualized cognitive behavior therapy that addresses both posttraumatic stress disorder (PTSD) and substance abuse (Seeking Safety (SS)-RRB- with a manualized cognitive behavior therapy that addresses only substance abuse (Relapse Prevention) and with standard community care for the treatment of comorbid posttraumatic stress disorder (PTSD) and substance use disorder.

The treatment tested in this study combines 3 interventions that have shown some efficacy individually: early detection of prodromal symptoms, 4 enhancement of treatment compliance, 12 and induction of lifestyle regularity, 13 in a structured group intervention for euthymic bipolar outpatients receiving standard pharmacologic treatment.

Integrated Mental Health Treatment and HIV Prevention for Court - Involved Youth The purpose of this study is to compare the relative efficacy of an integrated mental health treatment and HIV prevention program to standard - of - care mental health treatment for 200 youth receiving mental health evaluations through the RI Family Court, Juvenile Mental Health Clinic.

The purpose of the trial is to evaluate the efficacy of using a family - based treatment program (Behaviour Exchange Systems Training; BEST Plus) versus a standard cognitive - behavioural individual treatment program for the youth, (Self Help for Alcohol / Other Drug problems and DEpression — Youth; SHADEY CBT), versus receiving both the family and the CBT intervention (COMBINED condition).

The Clinic works to the standards established by key experts in the field and undertakes research and evaluation to determine the efficacy of outcomes for children.

Randomised controlled trials (RCTs) are the gold standard for determining the efficacy of interventions; however, such evidence for early childhood interventions is often not available.

Summary: (To include comparison groups, outcomes, measures, notable limitations) This study examined the efficacy of standard Level 4 Triple P online, an eight - module intensive online positive parenting program for parents of children with early - onset disruptive behavior problems, compared with an «internet use as usual» group.

Relative Efficacy of Mindfulness - Based Relapse Prevention, Standard Relapse Prevention, and Treatment as Usual for Substance Use Disorders: A Randomized Trail