Sentences with phrase «trial design so»

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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.

And so, over years of design, testing, trials, redesigns, and a whole lot of baby snuggles, the LÍLLÉbaby COMPLETE was born.

So Szmulewitz and colleague Mark Ratain, MD, the Leon O. Jacobson professor of medicine and director of the Center for Personalized Therapeutics at the University of Chicago Medicine, designed a randomized clinical trial to see if the drug could be used more efficiently and at less expense.

«The trial was designed to have equal late toxicity, so although there were some differences in shorter - term side effects, the results for long - term toxicity were precisely what we hoped to find,» said Dr. Widmark.

But the trial — following strict guidelines in its design — provides more robust evidence than the studies carried out so far.

Ferguson's team is calling for trials of Zika treatments and vaccines to be designed so that even if the epidemic burns out, they are ready to kick in quickly should Zika roar back again.

They will have been involved in the design of the drug trial so they can shape the way the results are analysed.

«The immune response and the safety so far have put these out there further than the other candidates we have,» says infectious disease specialist Scott Hammer of Columbia University, part of the team designing the VRC vaccine trial.

«The mouse work is promising enough to adapt these technologies for real time analysis of patient materials so that clinical trials can be designed to test this new diagnostic and drug selection approach,» he said.

The new commissioner, who has been a proponent of so - called pragmatic clinical trials, designed to gather more useful data by observing broad populations in real - world settings, said in his November 2015 confirmation hearing that streamlining clinical trials would be among his priorities.

On the other hand, first clinical trials with drugs designed to target cancer stem cells are now under way, so far yielding moderately positive results.

So, even if (as I suspect will be the case), better designed double - blind and controlled trials eventually show no specific benefits from this training, at least the participants will have had fun taking part.»

In July 2015, the most exciting drug trial so far in Huntington's disease began - one in which an ASO designed to reduce production of huntingtin protein was actually delivered to people with HD.

He wanted to find out, so he designed a trials that included a placebo group.

The trial was designed to find a way to inject kangaroos by dart, so they.

«Trials Evolution is not only one of the best downloadable games of the year so far, it's one of the best games on any platform so far this year,» noted Peter,» It's a masterclass in perfectly tuned level design.»

In addition to normal randomized - controlled - trial design, we also administered the assessments to second graders in a high - socioeconomic - status (SES) school district that did not use our units, so that we could compare the PBL group not only to a comparable control group but also to a high - SES benchmark.

This is designed so that students can use an Excel spreadsheet to complete trial and improvement.

1946 H.R.G. Aerodynamic — This interesting but not very successful sporting car is assessed by H.R.G. expert Ian Dussek / Registration records, Part 6 — David Hales continues his series of articles explaining what records survive and where / 1932 Singer Junior restored — David Hawtin talked to the owner of this splendily restored family saloon and discovered why it was an advanced design for its day / Origins of the small car — The development of the early voiturette is traced for us by Bryan Goodman / Car badges — In Part I of this article Michael Worthington - Williams illustrates well - known and not - so - well known examples / 1934 TT Ford V8 — The Editor describes this inexpensive but capable performer that excelled in road racing trials and sprints / Brooklands 200 - mile race — The last race using the outer circuit was run in 1924.

Mick Walsh gets behind the wheel of an historic Alfa Romeo 8C 2300 and in, Potent Perfection, reveals what makes this famous model so special / Doug Nye shares some marvellous glass - plate negatives from the early days of motor sport in Europe and describes the men and machines shown in The motor racing photography of Maurice - Louis Branger / Famous furniture designer Ambrose Heal bought a Sunbeam Twenty new in 1930 and drove it extensively across Europe / This much - loved car is still in the family today, as Matthew Bell discovers in Family Business / Designed and built by Ken Delingpole and Ron Lowe, the Ford - powered Dellows were among the most successful postwar trials cars.

It was designed to be waterproof, so it should be able to deal with the daily trials and tribulations.

AKC Earthdog Trials are designed to simulate this activity, so Scotties are well suited for this event and usually enjoy the experience.

The pet food industry found the feeding trials too restrictive and expensive, so AAFCO designed a procedure permitting nutritional claims based by chemically analysing the food for compliance with «Nutrient Profiles.»

He is, shall we say, an empirical learner, so it's possible he got to Van der Ryn's design through trial and error, though someone might have slipped him a suggestion or two while he wasn't paying attention.

[36] The Rules of Court are designed to permit parties to obtain full disclosure of relevant materials far in advance of trial so as to avoid unnecessary litigation, to make or seek admissions, and to settle claims that ought to be settled.

So, Totten, a litigator specializing in complex civil cases and co-chair of the group's construction and design team, started sitting in on the trial at the federal courthouse, conveniently located across the street from the firm's Chicago office.

So there you have it — a comprehensive list of litigation apps, many designed by lawyers, with the work flow and needs of trial attorneys in mind.

More recently a contractual ADR / mediation scheme was established in the jurisdiction designed to persuade the parties to reach settlements before the cases reach trial, and so as to avoid the costs of litigation.

Alternatively, online company Sleeping Duck has designed mattresses to support everyone who has difficulty sleeping and offers a 100 - night trial, so you can adjust the comfort level of your mattress and ensure it's right for you.

There are 11 high resolution images again to check, so do not miss to see Glamorous images all in Studio Apartment Design Ideas for Independent Living Trial article galleries for your next inspiration by clicking the thumbnail below.