Sentences with phrase «efficacy of the product in»

A Phase 1/2 trial to assess safety, tolerability, and efficacy of the product in human subjects with diabetes, called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was launched in September 2014, and the first implant was announced in October 2014.

Not exact matches

While larger businesses are stuck in committees debating the efficacy of adding a fad item to their inventory, you've already got the product stocked on your shelves and, soon, flying out the door.

We are very confident in the safety and efficacy of EpiPen products being produced at the site.»

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

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).

The agency ordered the commercial pulled after just a few days because it was «false and misleading,» «overstates the efficacy of the drug product» and «may result in serious consequences, including death.»

It is understandable that the idealistic emphasis on the efficacy of spiritual motives and forces, ideas, and energies in the philosophy and history of the early nineteenth century led to a reaction which urged students of social life and development to concentrate on the opposite viewpoint according to which spiritual developments have to be regarded as products of material conditions (Feuerbach, Marx, Engels, against Hegel).

Specifically formulated for maximal efficacy in various types of applications, these consumer - friendly solutions deliver real added value to your products.

All of our products are manufactured with the highest quality, efficacy, and care in all of our GMP - compliant facilities.

(91) Yes — However, the use of cleaners not listed in tables 7.3 or 7.4 (PSL) is permitted under specific conditions laid out in 8.2.3 (32.310): 1) the efficacy of the alternative cleaning substance is documented; 2) the cleaning materials used are effectively removed from the product contact surfaces, by an acceptable removal event (see 3.59 «removal event» definition) and that process documented; 4) the disposal of the effluent has been neutralized to minimize the environmental impact.

He was referring to Intelligent Nutrients, his line of health and beauty products that meets strict NOP organic standards and focuses on sourcing ingredients in a way that supports the earth, while pushing the envelope with stem - cell science to produce maximum - efficacy products.

Lead Judge David Luttenberger, CPP, global packaging director for the Mintel Group, said, «Helping consumers understand the importance of packaging [is a challenge], whether it's in food, drink, medicine or just giving them economical access to the products that they need every day... to make their lives easier, more convenient, safer and make them feel more confident not only about the products they buy, but the role packaging plays in helping ensure that those products maintain their freshness, their quality and their efficacy.»

As manufacturers of dietary supplements continue to extend the utilization of nutraceutical excipients in improving the efficacy of their products, several market players are expected to offer excipients with higher stabilization properties for controlling a range of bioactive ingredients.

The award program, created fifteen years ago, rewards and recognizes companies that are investing in rigorous and measurable scientific studies to show the efficacy of their proprietary ingredients, products or technologies.

Women can find information about the ingredients in supplements and compare the efficacy of the best best breast enlargement products at TopBreastEnhancements.com.

Michele Simon's report on the Academy of Nutrition and Dietetics is thoroughly researched and expertly points out the different ways in which the nation's leading nutrition organization harms its reputation, efficacy, and members by forming partnerships with food companies that care more about selling products than they do about improving the health of Americans.

«One must bear the organic load of the environment such as blood, in mind, before reaching a conclusion about the Zika virus inactivation efficacy by a particular product.»

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.

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.

The standard pharmaceutical development path for products that target pathogens moves slowly from studying safety, dosing, and biological responses in hundreds of people to an expensive efficacy trial with thousands of participants at high risk of becoming naturally infected.

At the meeting, GlaxoSmithKline (GSK) of Rixensart, Belgium, which has the vaccine furthest in development, spelled out how it might scale up production in parallel with the safety and efficacy trials now under way so that the product could be ready for wider distribution by April if warranted.

At Merck Frosst Canada, I have been an integral part of the discovery of a new molecule, the testing of its mechanism of action, the validation of its safety and efficacy in Phase IIb and III clinical trials, the market approval of the resulting product, and the subsequent management of patients and their disease.

Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes.

A biosimilar biotherapeutic product is similar (but not identical) in terms of quality, safety, and efficacy to an already licensed reference product.

A Phase 1/2 trial called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was launched in September 2014, and the first implant was announced in October 2014.

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.

The efficacy trial, HVTN 702, should start enrolling more than 5,000 volunteers during the second half of 2016 provided all products are ready, agreements are in place, study sites are ready and «go» criteria are met.

The Phase 1/2 trial called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type One Diabetes, is ongoing.

With our anti-TIGIT antibody program, we saw anti-tumor efficacy and reactivation of T - cells in preclinical models which is encouraging for the potential of this product as a monotherapy

The first - in - human STEP ONE * trial is evaluating the safety and efficacy of ViaCyte's PEC - Encap (a.k.a. VC - 01 ™) product candidate, a stem cell - derived, encapsulated cell replacement therapy.

ViaCyte's VC - 01 ™ product candidate, a first - in - class cell replacement therapy for the treatment of type 1 diabetes, is currently being evaluated in a Phase 1/2 trial called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type One Diproduct candidate, a first - in - class cell replacement therapy for the treatment of type 1 diabetes, is currently being evaluated in a Phase 1/2 trial called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type One DiProduct in Type One Diabetes.

The Investigational New Drug application for the Phase 1/2 trial, called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was allowed by the US Food and Drug Administration in August 2014.

Immune Design entered into a clinical trial collaboration with Genentech, a member of the Roche Group, to evaluate the safety and efficacy of its CMB305 cancer immunotherapy product candidate combined with the investigational cancer immunotherapy atezolizumab in a randomized Phase 2 trial in patients with soft tissue sarcoma.

A lot of vitamin C products are formulated or bottled in a way that leads to rapid oxidation, which can decrease its efficacy.

Few herbal products have been widely tested for safety and efficacy in randomized, placebo - controlled trials, as the U.S. Food and Drug Administration (FDA) requires of prescriptions drugs.

«People who are using four to five layers of skin care are adding so many ingredients that a) it's hard to know what's working, b) it's impossible to know what isn't, and c) the skin can only absorb so much in one sitting so it may limit the efficacy of all products,» said Sarah Villafranco, M.D., founder of Osmia Organics who also happens to have incredible skin.

Sidney Wolfe, MD, director of the Health Research Group at the consumer advocacy group Public Citizen, notes that weight - loss products have a dismal history in terms of safety and efficacy.

Look for: Some powders may also have added ingredients that claim to aid fat burning and support metabolism — think green tea and acai, although it's difficult to gauge whether ingredients shown to be effective in isolation increase the efficacy of host products.

Prior research had developed a number of new compounds making use of a novel drug discovery paradigm which begins with natural products extracted from plants; it then entails selecting synthetic derivatives which demonstrate efficacy in multiple assays testing protection against different factors of the nerve cell damage and death which take place in brain injuries and in age - associated neurodegenerative conditions.

Stress resistance has not been assessed however and so the biological relevance of this finding is currently unknown.32 Several IER trials (75 - 85 % ER on restricted days) in overweight / obese populations have reported reductions in various markers of oxidative stress 37, 41, which in one study was accompanied by a complementary increase in the anti-oxidant uric acid.37 In a direct comparison of IER (75 % ER for two days / week) and CER, both ER strategies displayed equal efficacy in reducing levels of fast - acting advanced oxidation protein products (AOPP) after six months, which displayed a tendency to occur earlier (i.e. at three months) in the IER group.41 Levels of slow - acting (i.e. long term) AOPP tended to decrease in the IER group and increase in the CER group which the authors proposed may have resulted from IER - induced activation of autophagy, a key homeostatic cellular process in which dysfunctional or unnecessary cellular proteins are degraded and recycled.41 On the other hand, a follow - up study using similar IER / CER protocols demonstrated comparable reductions in AOPP in both groups after three months.48 Summary and Future Research Directioin overweight / obese populations have reported reductions in various markers of oxidative stress 37, 41, which in one study was accompanied by a complementary increase in the anti-oxidant uric acid.37 In a direct comparison of IER (75 % ER for two days / week) and CER, both ER strategies displayed equal efficacy in reducing levels of fast - acting advanced oxidation protein products (AOPP) after six months, which displayed a tendency to occur earlier (i.e. at three months) in the IER group.41 Levels of slow - acting (i.e. long term) AOPP tended to decrease in the IER group and increase in the CER group which the authors proposed may have resulted from IER - induced activation of autophagy, a key homeostatic cellular process in which dysfunctional or unnecessary cellular proteins are degraded and recycled.41 On the other hand, a follow - up study using similar IER / CER protocols demonstrated comparable reductions in AOPP in both groups after three months.48 Summary and Future Research Directioin various markers of oxidative stress 37, 41, which in one study was accompanied by a complementary increase in the anti-oxidant uric acid.37 In a direct comparison of IER (75 % ER for two days / week) and CER, both ER strategies displayed equal efficacy in reducing levels of fast - acting advanced oxidation protein products (AOPP) after six months, which displayed a tendency to occur earlier (i.e. at three months) in the IER group.41 Levels of slow - acting (i.e. long term) AOPP tended to decrease in the IER group and increase in the CER group which the authors proposed may have resulted from IER - induced activation of autophagy, a key homeostatic cellular process in which dysfunctional or unnecessary cellular proteins are degraded and recycled.41 On the other hand, a follow - up study using similar IER / CER protocols demonstrated comparable reductions in AOPP in both groups after three months.48 Summary and Future Research Directioin one study was accompanied by a complementary increase in the anti-oxidant uric acid.37 In a direct comparison of IER (75 % ER for two days / week) and CER, both ER strategies displayed equal efficacy in reducing levels of fast - acting advanced oxidation protein products (AOPP) after six months, which displayed a tendency to occur earlier (i.e. at three months) in the IER group.41 Levels of slow - acting (i.e. long term) AOPP tended to decrease in the IER group and increase in the CER group which the authors proposed may have resulted from IER - induced activation of autophagy, a key homeostatic cellular process in which dysfunctional or unnecessary cellular proteins are degraded and recycled.41 On the other hand, a follow - up study using similar IER / CER protocols demonstrated comparable reductions in AOPP in both groups after three months.48 Summary and Future Research Directioin the anti-oxidant uric acid.37 In a direct comparison of IER (75 % ER for two days / week) and CER, both ER strategies displayed equal efficacy in reducing levels of fast - acting advanced oxidation protein products (AOPP) after six months, which displayed a tendency to occur earlier (i.e. at three months) in the IER group.41 Levels of slow - acting (i.e. long term) AOPP tended to decrease in the IER group and increase in the CER group which the authors proposed may have resulted from IER - induced activation of autophagy, a key homeostatic cellular process in which dysfunctional or unnecessary cellular proteins are degraded and recycled.41 On the other hand, a follow - up study using similar IER / CER protocols demonstrated comparable reductions in AOPP in both groups after three months.48 Summary and Future Research DirectioIn a direct comparison of IER (75 % ER for two days / week) and CER, both ER strategies displayed equal efficacy in reducing levels of fast - acting advanced oxidation protein products (AOPP) after six months, which displayed a tendency to occur earlier (i.e. at three months) in the IER group.41 Levels of slow - acting (i.e. long term) AOPP tended to decrease in the IER group and increase in the CER group which the authors proposed may have resulted from IER - induced activation of autophagy, a key homeostatic cellular process in which dysfunctional or unnecessary cellular proteins are degraded and recycled.41 On the other hand, a follow - up study using similar IER / CER protocols demonstrated comparable reductions in AOPP in both groups after three months.48 Summary and Future Research Directioin reducing levels of fast - acting advanced oxidation protein products (AOPP) after six months, which displayed a tendency to occur earlier (i.e. at three months) in the IER group.41 Levels of slow - acting (i.e. long term) AOPP tended to decrease in the IER group and increase in the CER group which the authors proposed may have resulted from IER - induced activation of autophagy, a key homeostatic cellular process in which dysfunctional or unnecessary cellular proteins are degraded and recycled.41 On the other hand, a follow - up study using similar IER / CER protocols demonstrated comparable reductions in AOPP in both groups after three months.48 Summary and Future Research Directioin the IER group.41 Levels of slow - acting (i.e. long term) AOPP tended to decrease in the IER group and increase in the CER group which the authors proposed may have resulted from IER - induced activation of autophagy, a key homeostatic cellular process in which dysfunctional or unnecessary cellular proteins are degraded and recycled.41 On the other hand, a follow - up study using similar IER / CER protocols demonstrated comparable reductions in AOPP in both groups after three months.48 Summary and Future Research Directioin the IER group and increase in the CER group which the authors proposed may have resulted from IER - induced activation of autophagy, a key homeostatic cellular process in which dysfunctional or unnecessary cellular proteins are degraded and recycled.41 On the other hand, a follow - up study using similar IER / CER protocols demonstrated comparable reductions in AOPP in both groups after three months.48 Summary and Future Research Directioin the CER group which the authors proposed may have resulted from IER - induced activation of autophagy, a key homeostatic cellular process in which dysfunctional or unnecessary cellular proteins are degraded and recycled.41 On the other hand, a follow - up study using similar IER / CER protocols demonstrated comparable reductions in AOPP in both groups after three months.48 Summary and Future Research Directioin which dysfunctional or unnecessary cellular proteins are degraded and recycled.41 On the other hand, a follow - up study using similar IER / CER protocols demonstrated comparable reductions in AOPP in both groups after three months.48 Summary and Future Research Directioin AOPP in both groups after three months.48 Summary and Future Research Directioin both groups after three months.48 Summary and Future Research Directions

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They could not come up with consistent data to proof the efficacy of their products, a reason being they were all manufacturing all sorts of nanoparticles of silver which in turn meant not having a well regulated product when it came to its manufacturing and characteristics.

100 % MONEY - BACK GUARANTEE - We're so confident in the efficacy and potency of our products that we back them all under our 60 - DAY moneyback guarantee - completely hassle - free.

There are a lot of anabolic steroids that we can find in the market today but we must put at top priority the safety and efficacy of the product.

It's very light and refreshing, feels very soothing and Aleavia has done quite a bit of testing of this product to ensure its efficacy, which is very important to me in making a recommendation to you.

[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.

Students will deepen their knowledge of Materia Medica, and learn to evaluate the safety and efficacy of herbal products they see in their patients using.

While it may seem that the 400 mg of reishi extract originally in our reishi products has decreased to 200 mg, the efficacy (strength!)

First off, this retinol serum is packaged in an opaque, airtight pump bottle which is not only convenient to use but also ensures the stability and efficacy of the formula.The product is recommended as a night - time treatment to be applied on clean skin before moisturizing (or use alone).

At FLVS, we invested in a series of external efficacy studies of key courses to inform leadership and show a transparent evaluation of the product to the public.