Sentences with phrase «term safety and efficacy»

Although vaccinations are available for canine diseases such as leptospirosis, Lyme Disease, Bordatella, and influenza, the long - term safety and efficacy of these vaccinations is questionable, so their use in clinical practice is not routinely recommended.

Long - term safety and efficacy of a cholesterol - lowering diet in children with elevated low - density lipoprotein cholesterol: seven - year results of the Dietary Intervention Study in Children (DISC)

«It is possible that the high fat content of a low - carbohydrate diet exerts detrimental effects on endothelial function, which raises concerns regarding the long - term safety and efficacy of low - carbohydrate diets... Currently, supported by evidence from long - term trials, we believe that a low - fat diet should remain the preferred diet for diabetes prevention.»

Looking at the published science, and particularly the long - term safety and efficacy of fasting, there are a number of reasons to be concerned with this approach to weight loss and metabolic health.

Looking at the published science, and particularly the long - term safety and efficacy of fasting, there are a number of reasons to be concerned with this fad approach to weight loss and metabolic health.

Long - term safety and efficacy following systemic administration of self - complementary AAV vector encoding human FIX pseudotyped with serotype 5 and 8 capsid proteins.

A Phase 2b Open - Label Extension Study to Evaluate the Long - term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001 - 201 (PRONTO)

He will continue evaluating the long - term safety and efficacy of Ins - PBA - F.

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).

Not exact matches

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.

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.

«We also needed to look at long - term efficacy, safety and immunogenicity,» he says.

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.

«The combined results of ERASURE, along with the FIXTURE trial, are very exciting in terms of the efficacy and safety of secukinumab,» Elewski, co-lead author, said.

These encouraging results in terms of safety and efficacy are paving the way for a new kind of treatment, not only for Still's disease, but other rare inflammatory diseases, too.

In broad terms, a regulatory writer assists in the production of the clinical documentation required by these national regulatory agencies when assessing the safety and efficacy of drugs.

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.

«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).

They also recommend stringent FDA oversight, the conditional approval of biologic licensing applications, clinic - specific licensing, possible sunset contingency provisions, and long - term intergenerational follow - up of the children of mothers who undergo mitochondrial replacement to determine the continuing safety and efficacy of the intervention.

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.

After participating in an 8 - week baseline period followed by 12 weeks of brivaracetam treatment, patients became eligible for long - term follow - up to monitor the drug's efficacy and safety.

«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.

In 2009, the UK Medical Research Council and National Institute of Health Research, through the Efficacy and Mechanism Evaluation Programme, funded the Robotic vs Laparoscopic Resection for Rectal Cancer (ROLARR) trial to undertake an evaluation of the safety, efficacy, and short - and long - term outcomes of robotic - assisted vs conventional laparoscopic rectal cancer Efficacy and Mechanism Evaluation Programme, funded the Robotic vs Laparoscopic Resection for Rectal Cancer (ROLARR) trial to undertake an evaluation of the safety, efficacy, and short - and long - term outcomes of robotic - assisted vs conventional laparoscopic rectal cancer efficacy, and short - and long - term outcomes of robotic - assisted vs conventional laparoscopic rectal cancer surgery.

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.

A biosimilar biotherapeutic product is similar (but not identical) in terms of quality, safety, and efficacy to an already licensed reference product.

This brings about needs for optimization of the antibodies in terms of efficacy and safety, as well as of genetic recombination procedures for creating them.

This partnership allows rigorous testing of efficacy, safety and long - term reliability of neurotechnology that would not be otherwise possible within the traditional «silos» of academic, industry, regulatory and clinical communities.

Most therapeutic research involving the testing of new drugs is conducted in highly regulated phases that study dosage, safety, efficacy and long - term side effects:

When it comes to supplements, you might having trouble choosing what's most adequate for your goals, given the great number of choices with different price ranges we have today, but the best idea is to stick with those supported by science in terms of efficacy and safety.

Sidney Wolfe, MD, director of the Health Research Group at the consumer advocacy group Public Citizen, notes that weight - loss products have a dismal history in terms of safety and efficacy.

Whilst initial findings are promising, the long - term efficacy, safety, and whether these metabolic improvements can be maintained during weight - stabilization, remain unknown.

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 much more clinical work and human studies are still needed in order to fully understand it's mechanisms, long - term safety and overall efficacy.

Short - term safety, tolerability and efficacy of a very low - calorie - ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus.

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.

Long - term compassionate use of oclacitinib in dogs with atopic and allergic skin disease: safety, efficacy and quality of life.

2Autefage A, Gossellin J. Efficacy and safety of long - term oral administration of carprofen in the treatment of osteoarthritis in dogs.

What evidence is available about the long - term efficacy and safety of psychosocial interventions (behavioral modification) for the treatment of ADHD for children, and specifically, what information is available about the efficacy and safety of these interventions in preschool - aged and adolescent patients?

Although there is currently no universally - accepted definition of the term «evidence - based», the general understanding of this concept involves support of the safety and efficacy of an intervention by empirical research following specific rules of data collection, analysis, and reporting.