Sentences with phrase «demonstrating efficacy and safety»

Kiefer said that veterinarians should consider the following before working with companies that offer stem cells: what data they have provided demonstrating the efficacy and safety of their product, whether they rely on publications by other companies or groups and whether their product is an equivalent product.

Home / NEWS & MEDIA / pivotal data demonstrating efficacy and safety of apoquel ® published in veterinary dermatology

«This investigational single tablet regimen brings together the potency of an integrase inhibitor, bictegravir, with the demonstrated efficacy and safety profile of the FTC / TAF backbone,» said Norbert Bischofberger, executive vice president, research and development and chief scientific officer, Gilead Sciences.

Additionally, La Roche - Posay products undergo stringent clinical testing to demonstrate efficacy and safety, even on sensitive skin.

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.

The technology's safety and efficacy must also be demonstrated.

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.

With the initial contract of $ 24.9 million over the next 18 months, Mapp Pharmaceutical will manufacture a small amount of the drug for early - stage clinical studies to demonstrate its safety and efficacy in people.

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.

More studies are needed to demonstrate safety, efficacy and oral bioavailability.

«While we have a long way to go in demonstrating the safety and efficacy of this technique, this case represents a significant first step,» said Christopher J. Hartnick, M.D., lead investigator of the study and director of the pediatric otolaryngology division at Mass..

To get through the FDA's demanding approval process, drug companies must demonstrate their product's safety and efficacy in costly randomized clinical trials.

In this trial, we demonstrated the safety and efficacy of a medication that will allow children with severe hemophilia A to be treated with a safe and effective medicine but with a reduced burden of the treatment.»

«To preserve patient access to this treatment option, and given the scale that we've reached, demonstrating the safety and efficacy of fecal transplantation through adequate and well - controlled clinical trials is the right thing to do,» explained Carolyn Edelstein, OpenBiome's director of Outreach and Public Affairs, in an op - ed published earlier today with the Fecal Transplant Foundation.

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.

They demonstrate the safety and efficacy of this strategy, towards clinical implementation [7].

The same year, the FDA approved the start of the first human clinical trial of this vaccine that demonstrated its safety and efficacy at inducing an immune response against the virus.

According to Lise Alschuler, author of the Definitive Guide To Cancer: An Integrative Approach to Prevention, Treatment, and Healing, studies on flax lignans demonstrate safety and efficacy in their use against breast cancer, «inhibiting the growth of human estrogen - dependent breast cancer cells in mice and strengthening the tumor - inhibitory effect of tamoxifen».

Purpose of Study: Recent studies in dogs with lymphoid cell neoplasia have demonstrated the safety and efficacy of Tanovea - CA1 ™ and have led to its conditional FDA approval.

In early studies, we have demonstrated the safety and efficacy of the CT pneumocolonography procedure in normal dogs, but it is important that we learn to accurately interpret the imaging findings for a wide variety of disease processes in clinical patients so that our CT diagnoses are accurate.

Although studies in dogs with lymphoma have demonstrated the safety and efficacy of Rabacfosadine (VC - 007), a limited number of dogs have been treated once every three weeks.

Introducing VANGUARD ® CIV H3N2 / H3N8, a bivalent canine flu vaccine with demonstrated safety and efficacy for protection against both highly contagious H3N2 and H3N8 strains of canine influenza virus (CIV).

Results from the clinical trial recently appeared in the journal Stem Cells Translational Medicine and are the first to demonstrate the safety and efficacy of treating a naturally occurring, chronic inflammatory disease in cats with their own fresh, fat - derived stem cells.

To receive the conditional license, the vaccine was shown to be safe in a field safety study, and a reasonable expectation of efficacy was demonstrated.

After all, the best way to help protect horses against EIV is to vaccinate before exposure to this highly contagious respiratory disease.8 And that's why horse owners can depend on the FLUVAC INNOVATOR vaccine line, because it helps offer demonstrated protection against EIV and is backed by the Zoetis commitment to continuously monitor and evaluate the efficacy and safety of its producAnd that's why horse owners can depend on the FLUVAC INNOVATOR vaccine line, because it helps offer demonstrated protection against EIV and is backed by the Zoetis commitment to continuously monitor and evaluate the efficacy and safety of its producand is backed by the Zoetis commitment to continuously monitor and evaluate the efficacy and safety of its producand evaluate the efficacy and safety of its producand safety of its products.

ProHeart 6 demonstrated predictable safety and efficacy that remained consistent while its usage levels increased dramatically.

In two large clinical studies, SIMBADOL (buprenorphine injection) was well tolerated and demonstrated safety and efficacy for post operative pain control in cats.2

There is a large body of experimental data demonstrating the safety and efficacy of BMDMSC from another individual of the same species, referred to as cell allografts.

The vaccines we use come from several manufacturers and have been carefully selected because of their demonstrated safety and efficacy.