Sentences with phrase «conduct safety trials»

Its anti-science to block access to GMO seed to conduct safety trials.

«The biggest hurdle will be conducting safety trials in the most important target population — women who are pregnant or planning pregnancies,» said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and president of the Sabin Vaccine Institute.

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.

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.

Current research includes: co-leading organisational case studies in Birthplace in England, a national study of birth outcomes in home, midwife led, and obstetric led units; investigating the relationship between measures of safety climate and health care quality in A and E and intrapartum care; and conducting nested process evaluations of two trials of obesity in pregnancy behavioural interventions.

As it has been shown that conducting a randomised controlled trial is not possible, the best evidence about the safety of home birth can only come from good quality, routine registrations such as the one we used in our study.

Larger trials with stricter safety measures have demonstrated that with a cautious protocol, breech birth can be conducted safely in appropriately supported obstetrical units.

The trial he conducted tested the safety of a therapy for ornithine transcarbamylase (OTC) deficiency, a rare disorder in which the liver lacks a functional copy of the OTC gene.

Northfield Laboratories, Inc., in Evanston, Ill., has been conducting clinical trials for its oxygen - carrying red blood cell substitute, PolyHeme, but in May said the product failed to meet the primary goals of mortality and safety in an important phase III study.

Omer, Tzannou and their colleagues conducted a clinical trial to determine the safety and effectiveness of pre-prepared virus - specific cells to treat five viral infections simultaneously in patients who had received a hematopoietic stem cells transplant.

To test the potential benefit and safety of targeted hypothermia in donors on delayed organ function rates in the recipients of their kidneys, Niemann and his research team conducted a randomized controlled trial in two large organ donation service areas from March 2012 to October 2013.

Researchers conducted a double - blind, randomized, placebo - controlled clinical trial to evaluate the safety and efficacy of pinaverium.

Wolfe acknowledges, however, that we won't know what the long - term safety issues are until a large - scale human trial is conducted, which researchers hope to begin in the next three years.

Even if the cost is as low as Hayward claims, Sachleben agrees that adoption will likely be the biggest obstacle — pharmaceutical companies might have to conduct safety experiments or even clinical trials, after which they would only be able to add the tags to solid pills and not sprays or liquids to adhere to the FDA guideline.

But many projects come under public and federal scrutiny — the recent fracas over gene therapy trials is a case in point (Science, 24 March, p. 2163), often because the manner in which they were conducted led to concerns over the safety of the recruited participants or the protection of their confidentiality.

This prospective, single - arm, phase II clinical trial was conducted to evaluate the safety, feasibility, and efficacy of induction chemotherapy followed by SABR in 34 patients who had biopsy - proven PDA.

Led by Professors Jorgen Vestbo and Ashley Woodcock from The University of Manchester's School of Biological Sciences, the research team conducted an effectiveness and safety trial of fluticasone furoate - vilanterol to manage COPD.

He and Dr. Fisher urged professional societies and obesity researchers to develop guidelines to design and conduct trials of bariatric surgery and standardize reporting of concerns about effectiveness and safety.

Adding the monoclonal antibody drug trastuzumab — already used to treat certain breast cancers — to the chemotherapy regimen of women with a rare form of uterine cancer lengthens the amount of time their tumors are kept from growing, according to Johns Hopkins Medicine researchers conducting a small phase II trial of the regimen, testing its safety and value.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), helped identify the viral strain used in the ZPIV vaccine, supported the preclinical safety testing, and is sponsoring the conduct of this trial.

Such a model should provide appropriate data regarding the safety and the efficiency of the drug, thus evaluating its benefit / risk ratio, prior to conducting early phases of a therapeutic trial.

Based on proof - of - concept pre-clinical studies indicating robust efficacy and favorable safety profile, the company is now advancing to conduct a clinical trial testing the efficacy of this new treatment.

The HVTN is an international collaboration that conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy.

Dr Brooks will be presenting the results of a single - center, randomized, double - blind, placebo - controlled clnical trial which was conducted to evaluate the safety, tolerability and clinical endpoint responsiveness of a drug called Ibudilast (or MN - 166) in subjects with the neurodegenerative condition, Amyotrophic Lateral Sclerosis (or ALS — also known as motor neuron disease; Click here to read a previous SoPD post about ALS and Click here to learn more about this clinical trial).

When conducting clinical trials, Rutgers Cancer Institute of New Jersey's most important responsibility is to protect patients through well - designed protocols, a dedicated Institutional Review Board (IRB), a careful informed consent process and rigorous monitoring of the safety of the clinical trial.

Again, this was only a basic safety and pharmacokinetics trial, and was conducted in healthy young people without PD.

The shorter - term single - dose trial is recruiting 40 healthy and relatively young (ages 21 - 65 y) subjects for a narrow safety trial, whereas the multiple - dose trial will be conducted in 60 persons suffering with PD (the trial protocol specifies the recruitment of idiopathic PD subjects), and includes subjects that are somewhat older (ages 40 - 80) and with a wider range of severity of disease (Hoehn and Yahr stages I - III) than were used in AFFiRiS» trial of PD01A.

In accordance with the Cancer Center's Data and Safety Monitoring Plan (DSMP), internal compliance audits of interventional cancer trials are performed by the audit staff to ensure the conduct and integrity of the study are of the highest quality and that all trials adhere to regulatory requirements.

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.

These centers specialize in conducting clinical trials to evaluate the safety and effectiveness of new CF therapies.

Glenda Gray, executive director of the Wits Health Consortium's perinatal HIV research unit in South Africa, presented data today at the HIV R4P conference in Cape Town indicating that the prime - boost vaccine candidates initially tested in the RV144 trial in Thailand — the only HIV vaccine trial to date to show any efficacy — induced cross-clade immune responses in a Phase I safety trial conducted in South Africa, with immunogenicity similar to or greater than that of the responses induced in Thai volunteers.

CO2 extracts are still very experimental as few clinical trials have been conducted evaluating their safety and efficacy.

All diabetes medications henceforth were required to conduct large - scale safety trials to safeguard the public interest.

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 placebo.

Dr. Powers completed a clinical drug safety trial for the use of Advantage Multi for Cats (Bayer) in domestic ferrets, and has conducted several other research studies while at Carolina Veterinary Specialists, including an investigation into the metabolism of the anticonvulsant drug phenobarbital in African grey parrots and ongoing studies investigating a newly characterized intestinal parasite of cockatiels, Spironucleus meleagridis.

(Research and trials were conducted in order to ensure the safety and durability of the carpet.)

(7) records or information compiled for law enforcement purposes, but only to the extent that the production of such law enforcement records or information (A) could reasonably be expected to interfere with enforcement proceedings, (B) would deprive a person of a right to a fair trial or to an impartial adjudication, (C) could reasonably be expected to constitute an unwarranted invasion of personal privacy, (D) could reasonably be expected to disclose the identity of a confidential source, including a State, local or foreign agency or authority or any private institution which furnished information on a confidential basis, and, in the case of a record or information compiled by criminal law enforcement authority in the course of a criminal investigation or by an agency conducting a lawful national security intelligence investigation, information furnished by a confidential source, (E) would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law, or (F) could reasonably be expected to endanger the life or physical safety of any individual; [the law enforcement exemption]

• 8 years of experience at various terminals with demonstrated ability to maintain daily logs and handle daily orders effectively • Expertise in monitoring tank gauges, tank cleaning, container flushing and forklift operation • Well versed in data entry, inventory maintenance, shelf stocking, container weighing and pump alignment • Exceptional communication skills and computer proficiency • Substantial knowledge regarding safety guidelines to be followed while loading and unloading containers with hazardous material, chemicals and fuel • Well versed in carrying out product transfer operations and monitoring of the same • Proficient in conducting quality control trials and issuing inspection reports regularly