Sentences with phrase «efficacy and safety as»

For example, the Human Rights Tribunal of Ontario has dismissed claims of discrimination against the Ontario Drug Benefit Program on the basis that there was no Code - related reason for denying coverage, but rather a dispute over its efficacy and safety as a medical treatment (e.g. Kueber v. Ontario (Attorney General), 2014 HRTO 769).

In 1995, Brazilian pharmaceutical companies were legally required to document pharmacological efficacy and safety as well as the predictive toxicology of phytoremedies just as for as any other pharmaceutical product.

Not exact matches

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.

To ensure the strength and efficacy of our environmental guidelines, policies and controls, we have established an environmental management system (EMS) within our manufacturing operations as part of our overarching environmental, health and safety (EHS) function.

Our Bloomingdale facility is at the heart of our manufacturing and distribution network and strongly supports our ability to achieve consistent levels of product quality, efficacy, and safety, as well as our ability to meet increasing consumer demand.

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 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

Diphenhydramine does have a long track record of safety and efficacy as an antihistamine, but it's not recommended for children under two.

If a food was being marketed as a drug, it needed to prove safety and efficacy, something no food maker wanted to do.

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».

Furthermore, there have been no studies of the safety and efficacy of other delivery methods such as vaping or liquid formulation.

Further studies in animal models and patients (with altered TRPM7 channel function) have been initiated, in order to evaluate the efficacy and safety of magnesium as a therapeutic for this disease.

«If nanoparticles are carrying a drug to deliver, different uptake could mean different therapeutic efficacy and other important differences, such as safety, in clinical data.»

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 FDA doesn't evaluate foods intended to aid general life conditions, such as mood and mental sharpness, so ginkgo biloba need not be certified for safety or efficacy.

Regulations already in place in the European Union insist that stem cell therapies follow the same safety and efficacy rules as pharmaceuticals.

Intervention from wealthy non-scientists such as the philanthropist Mary Lasker drove even deeper investment into animal - based vaccines despite growing evidence of their lack of safety and efficacy.

Apart from patient testimonials and a few preliminary studies in tumor cell lines and in mice, critics say, there is no evidence of the safety or efficacy of the compound, popularly known as the «cancer pill» or «fosfo.»

Goldman says the IMI also provides a platform for agencies such as the U.S. Food and Drug Administration and the European Medicines Agency to discuss novel regulatory approaches to getting drugs to patients quickly while ensuring safety and efficacy.

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.

1) Facilitate safe off - label use of existing vaccines — Support collaboration between the zoological community and conservationists in the field to determine the safety as well as efficacy of existing distemper vaccines that could be, at a minimum, administered opportunistically to endangered wild carnivores whenever they are being handled (e.g. during radio - collaring exercises or when being translocated to mitigate human - wildlife conflict).

The goals of Cohort B, for which survival data are not yet complete, were, primarily, to prove pembrolizumab's safety and, secondarily, to explore its efficacy as a first - line treatment.

Susan Gould Fogerite, director of research for the Institute for Complementary and Alternative Medicine in the School of Health Related Professions, said that although there is widespread evidence that yoga is being used as a form of exercise by those with MS, much of the feedback has been anecdotal and there isn't much empirical data regarding its safety and efficacy.

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.

Dr. Timmerman, who holds the Effie Marie Cain Distinguished Chair in Cancer Therapy Research, has championed the use of SABR globally and has served as the lead investigator in several national trials designed to evaluate the efficacy and safety of SABR to treat cancer in the lung, liver, spine, and prostate.

A total of 347 patients (155 treated with vitamin E, 192 not treated with vitamin E) were included in the analysis which compared data from three clinical trials that investigated the efficacy and safety of vitamin E as a treatment for NASH: the PIVENS, TONIC and FLINT trials.

The ENGOT - OV16 / NOVA trial evaluated the efficacy and safety of the PARP inhibitor niraparib as maintenance therapy in patients with recurrent ovarian cancer who respond to platinum - based chemotherapy.

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.

For very rare diseases such as WAS, multicenter clinical trials are the only effective way of proving the safety and efficacy of gene therapy and having it rapidly approuved and made available to all patients.

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.

As an aid to clinical decision making, they conducted an in - depth review of the safety and efficacy of proposed treatments for PMDD.

As a first step in evaluating the safety and efficacy of the X4 - ZFNs in vivo, we employed a NSG humanized mouse model.

SEATTLE, WA and DURHAM, NC — The HIV Vaccine Trials Network (HVTN) and the HIV Prevention Trials Network (HPTN) today announced the initiation of HVTN 704 / HPTN 085, also known as Antibody Mediated Prevention (AMP) or the AMP Study, a Phase 2b clinical trial to evaluate the safety and efficacy of VRC01, a broadly neutralizing monoclonal antibody (bnAb).

A Randomized, Phase III Trial to Evaluate The Efficacy and Safety of MK - 3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor - Negative Breast Cancer with ≥ 1 cm Residual Invasive Cancer or Positive Lymph Nodes (yPN +) After Neoadjuvant Chemotherapy

The HVTN's mission is to fully characterize the safety, immunogenicity, and efficacy of HIV vaccine candidates with the goal of developing a safe, effective vaccine as rapidly as possible for prevention of HIV infections globally.

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.

We should guard against raising expectations of miracle cures for thousands of patients in the near future however as the current trial will require extensive tests for efficacy and safety.

In this presentation, we discuss data from studies conducted with academic, clinical, and industry collaborators that demonstrates the utility of the system as a more predictive, human - relevant alternative for efficacy and safety testing of new chemical entitites.

«Successful antagonists, following clinical trials for safety and efficacy, could be incorporated into the seasonal vaccine as a way of enhancing responses.

The funding will help support our current clinical trial evaluating the safety and efficacy of ViaCyte's PEC - Direct product candidate, which is in development as a potential cure for patients with high - risk type 1 diabetes.

From Emulate, our President and Chief Scientific Officer Geraldine A. Hamilton will discuss how our Human Emulation System can act as a platform for efficacy and safety testing in drug discovery and development.

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.

With these technologies, we are creating heart cells from skin samples of patients with many cardiovascular diseases, such as heart failure, to test the safety and efficacy of new or existing drugs that treat or prevent the condition.

But, he notes that it will be necessary to perform well - designed clinical trials that test the safety and efficacy of high - grade NMN in humans before making the leap to using NMN (or perhaps its analogs) as pharmacotherapeutic agents.

Monies have gone to fund such projects as a postdoctoral fellow studying familial hypercholesterolemia, evaluating the efficacy and safety of a new drug for congenital hyperinsulinism, and identifying molecular targets for Pitt - Hopkins Syndrome treatments.

U.S. Phase 1 Trial in SMA Type 2 (STRONG) The open - label, dose - comparison, multi-center Phase 1 trial — known as STRONG — is designed to evaluate the safety, optimal dosing, and proof of concept for efficacy of AVXS - 101 in two distinct age groups of patients with SMA Type 2, utilizing a one - time IT route of administration.

Overall, SR - Tiget represents a multi-disciplinary research environment, which provides a unique blend of scientific expertise in the development of innovative gene and cell therapy strategies, access to relevant preclinical models to evaluate their efficacy and safety, as well as competence in conducting early phase clinical trials.

Immune Design entered into clinical collaboration agreements with Merck, known as MSD outside the U.S. and Canada, to evaluate the safety and efficacy of two Immune Design immuno - oncology investigative agents, G100 and LV305, separately combined with KEYTRUDA ® (pembrolizumab), Merck's anti-PD-1 therapy, in Phase 1 trials in patients with non-Hodgkin's lymphoma (NHL) and melanoma, respectively.