Sentences with phrase «provide safety and efficacy»

Their eleven - step process provides evaluation, cleaning, documentation, and pet owner education to provide safety and efficacy.

Not exact matches

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

RxAdvance's staff of experienced pharmacists and care managers provide plan sponsors with clinically - driven services focused on safety, efficacy, and cost containment.

«The study results elucidate the molecular mechanisms underlying disease progression in multiple sclerosis models, providing a basis for future clinical trials to determine safety and efficacy of these chemical agents in humans with demyelinating disorders,» says Patrizia Casaccia, MD, PhD, Professor of Neuroscience, Genetics and Genomic Sciences at Mount Sinai and senior author of the study.

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.

«A successful vaccine requires a fine balance between efficacy and safety — vaccines made from attenuated live viruses generally offer fast and durable immunity, but sometimes with the trade - off of reduced safety, whereas inactivated and subunit viruses often provide enhanced safety but may require several doses initially and periodic boosters.

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.

«Further research is needed to provide definitive evidence of the safety and efficacy of Tdap immunization during pregnancy,» the authors write.

«Results described in this manuscript provide a comprehensive characterization of the efficacy of the PMO antisense platform against Marburg virus in nonhuman primates and its safety profile in humans,» Bavari said.

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.

Its technology is expected to provide major advantages in patient treatment efficacy, safety, and manufacturing costs.

The authors concluded existing regulations governing stem cells «provide an appropriate structure for ensuring the safety and efficacy of the next generation of stem - cell - based products.»

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.

Evidence of Bioidentical Hormone Safety and Efficacy Below are listed some articles that will provide evidence - based medical research on the safety and efficacy of bioidentical horSafety and Efficacy Below are listed some articles that will provide evidence - based medical research on the safety and efficacy of bioidentical hEfficacy Below are listed some articles that will provide evidence - based medical research on the safety and efficacy of bioidentical horsafety and efficacy of bioidentical hefficacy of bioidentical hormones:

Why bother when there are literally thousands of studies in support of the safety and efficacy of a whole food plant based diet supplying what you're trying to supplement AND providing a clear benefit in reduced death and diseaand efficacy of a whole food plant based diet supplying what you're trying to supplement AND providing a clear benefit in reduced death and diseaAND providing a clear benefit in reduced death and diseaand disease.

[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.

This provides greater label transparency to prove the product's safety and efficacy.

Maryland University of Integrative Health's Post-Baccalaureate Certificate in Medical Herbalism provides a foundational knowledge of herbal medicine that emphasizes issues of quality, safety, and efficacy.

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.

Their eleven - step process provides evaluation, cleaning, documentation, and pet owner education to promote safety and efficacy.

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.

Prepare solicitations and provide technical review (including safety and efficacy data) of proposals for avian influenza, classical swine fever, Rift valley fever, and other vaccines.