Sentences with phrase «about safety and efficacy»

Overall, a great deal remains to be learned about the safety and efficacy of pharmacotherapy in this age group.

Have you ever wondered about the safety and efficacy of Pedialyte for dogs?

There's still a lot more to learn about their safety and efficacy, but so far it looks promising.

While we know that sunscreens prevent sunburns, beyond that simple fact surprisingly little is known about their safety and efficacy.

By considering patient experiences and feedback, researchers and advocates alike can learn more about the safety and efficacy of potential stem cell therapies.

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.

Alice Klein notes some clinicians» concerns about the safety and efficacy of biosimilar versions of biological drugs compared with the...

Some have raised concerns about the safety and efficacy of the procedure, saying the team should have tested the approach in animals first.

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.

The petitioners» goal is to demonstrate to the public that there is consensus within their scientific community about the safety and efficacy of using genetic modification technology in agriculture.

The drug was voluntarily withdrawn in 2010 following questions about its safety and efficacy.

The U.S. Food and Drug Administration recently banned TCC from soaps because of questions about its safety and efficacy.

Women should also understand that there is uncertainty about the safety and efficacy of planned VBAC in pregnancies that go beyond 42 weeks of pregnancy, or those with twins or especially large babies.

Many parents have concerns about the safety and efficacy of flu shots for children.

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.

Not exact matches

Boehringer Ingelheim stepped away from flibanserin after the FDA rejected the drug due to concerns about its efficacy and safety; Goldstein persuaded the Whiteheads to step in.

We do this by conducting clinical trials in which we collect safety and efficacy data about our experimental drugs with the goal of submitting those data to regulatory authorities, like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), so that these experimental drugs can be approved for use by patients.

My patients often ask me about the efficacy and safety of the supplements that claim to increase your milk supply.

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.

About Hops: From http://www.drugs.com/npp/hops.html «Pregnancy / Lactation Information regarding safety and efficacy in pregnancy and lactation is lacking».

Such tests would come under the greatest inspection, information about them would need to be entered in a national database, and manufacturers would have to prove their safety and efficacy to the FDA before they could be sold.

It's about determining efficacy (how well it works and how much is needed) and safety (at what level might the compound produce adverse effects), a risk - benefit curve.

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 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.

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.

Researchers also noted that little is known about the efficacy and safety of off - label use of naloxone for treating overdoses related to newly emerging illicit uses of more powerful opioids such as fentanyl and fentanyl derivatives.

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.

PD01A: Promising Animal Efficacy; Initial Human Safety and Hints of Disease Modification At the time of our last post on α - synuclein vaccines, AFFiRiS had published several papers about the AFFITOME immnotherapy discovery platform [8 - 11] and had even begun their first Phase I trial of PD01A, but had kept nearly silent on many of the most elementary aspects of the vaccine.

«We have been very concerned about reports of patients using unproven medical therapies whose safety and efficacy have not been tested in systematic clinical trials,» he said.

In fact, of the more than 54,000 dietary supplements comprising the Natural Medicines Comprehensive Database (an online encyclopedia of natural supplements), only about a third reportedly have research backing up their safety and efficacy.

[107] Establishing guidelines to assess safety and efficacy of botanical supplement products, the European Medicines Agency provided criteria for evaluating and grading the quality of clinical research in preparing monographs about herbal supplements.

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.

One of the most disturbing aspects of this scenario is that it was created due to the carelessness of conventional medical practice, which dictated — without good supporting evidence of safety and efficacy — that any woman over 50 complaining about anything remotely related to menopause, be put on HRT.

For more information on these products, consult your veterinarian, as different vets have different opinions about various flea prevention products based on experience with efficacy and safety.

About the Study The study, «Efficacy and safety of oclacitinib for the control of pruritus and associated skin lesions in dogs with canine allergic dermatitis,» was conducted as a double - masked, placebo - controlled clinical trial aimed to evaluate the safety and efficacy of APOQUEL compared with Efficacy and safety of oclacitinib for the control of pruritus and associated skin lesions in dogs with canine allergic dermatitis,» was conducted as a double - masked, placebo - controlled clinical trial aimed to evaluate the safety and efficacy of APOQUEL compared with efficacy of APOQUEL compared with placebo.

Merck's website states about its H3N2 vaccine: «This vaccine has a reasonable expectation of efficacy and safety.»

What that means is that studies of the vaccines are still in process, so we don't have any data about the efficacy and safety of these shots.

The trial is usually doubled - blinded, intent to treat, an external data safety monitoring board is set up (they are also blinded, but have the power to break the blind if there is concern about safety or overwhelming efficacy), and a randomization code is generated, amongst other things.

A paper reporting a «rigorous double blind» study — the VIGOR trial — was submitted to NEJM in 1998, got through peer review at one of the most up - tight journals in the world of medicine, and — by way of cherry - picking the data submitted (selecting out some study subjects whose adverse events histories which, if considered, would've significantly affected the safety profile for rofecoxib and revealed something that Merck really didn't want us prescribers to learn about their «blockbuster» product — was published to be touted by Merck's marketing weevils as solid proofs of Vioxx's tolerability, efficacy, and safety.

While many of the participants raised concerns about the efficacy and safety of large - scale iron fertilization, others seemed to acknowledge that the urgency of the climate crisis warranted the continuation of carefully designed experiments — pointing out that, if done appropriately, they could provide a win - win for both scientists and businesses interested in selling carbon offsets.

Charted and recorded information in client files.Tracked client movement on and off the unit by documenting times and destinations of clients.Checked facility for open windows, locked doors, malfunctioning smoke detectors and other safety hazards.Quickly responded to crisis situations when severe mental health and behavioral issues arose.Efficiently gathered information from families and social services agencies to inform development of treatment plans.Documented all patient information including service plans, treatment reports and progress notes.Collaborated closely with treatment team to appropriately coordinate client care services.Developed comprehensive treatment plans that focused on accurate diagnosis and behavioral treatment of problems.Consulted with psychiatrists about client medication changes, issues with medicine compliance and efficacy of medications.Organized treatment projects that focused on problem solving skills and creative thinking.Referred clients to other programs and community agencies to enhance treatment processes.Created and reviewed master treatment and discharge plans for each client.Guided clients in understanding illnesses and treatment plans.Developed appropriate policies for the identification of medically - related social and emotional needs of clients.Assisted clients in scheduling home visits and phone calls and monitored effectiveness of these activities.Evaluated patients for psychiatric services and psychotropic medications.Monitored patients prescribed psychotropic medications to assess the medications» effectiveness and side effects.Evaluated patients to determine potential need to transfer to specialized inpatient mental health facilities.Administered medication to patients presenting serious risk of danger to themselves and others.Conducted psychiatric evaluations and executed medication management for both inpatient and outpatient facilities.Led patients in individual, family, group and marital therapy sessions.Diagnosed mental health, emotional and substance abuse disorders.Recorded comprehensive patient histories and coordinated treatment plans with multi-disciplinary team members.Consulted with and developed appropriate treatment and rehabilitation plans for dually diagnosed patients.Referenced and used various therapy techniques, including psychodynamic, family systems, cognitive behavioral and lifespan integration psychotherapy.

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?