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en The large number of safety studies indicates that this issue has received a great amount of attention. Unfortunately, many of these studies involve more advocacy than science. It's not that these studies aren't valuable, but they have problems with methodology, statistical analysis and even simple understanding of important terms, such as 'speeding.' In accident data, speeding is defined as both 'traveling faster than the posted limit' and 'traveling too fast for conditions.' Studies often do not differentiate between these definitions.
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en Before beginning any human trials, the sponsor must perform extensive animal toxicity studies. Animal studies provide guidance on initial dosing and point to areas of safety needing special attention during human studies.
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en I'm really enthusiastic about the colleagues that I'll gain in [history and American studies], and film studies, gender and lesbian and gay studies, and around the University. And then, of course, there are amazing students at Yale, and I look forward to working with them.
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en We have over 50 studies, and there is no clear-cut answer, ... We have positive studies. We have negative studies. I think the state of the art was beautifully illustrated in 1995 when we had reports from (two) respected teams of epidemiologists with opposite conclusions, two weeks apart.
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en The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion.
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en The underlying problems is that the FDA has little ability to enforce these commitments, short of withdrawing approval for the drug - an outcome that may not serve the public health well. The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion.
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en There are a number of studies published that report on varying degrees of effectiveness. But there are also a lot of studies that point to the fact that the vaccines are effective in preventing the serious complications that lead to hospitalizations and death, and that's an important note that we should never lose sight of.
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en Studies such as the one by Mangano and colleagues point the way to the prospective design of studies to assess drug safety and to the collection of as much information as necessary to provide answers of the highest quality.
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en To me, the traffic studies were kind of a sham, because they never defined the criteria for the evaluation. The studies said the roads are adequate, but they don't state what would be too much traffic.
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en The underlying problem is that the FDA has little ability to enforce these commitments, short of withdrawing approval for the drug - an outcome that may not serve the public health well. The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion.
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en The underlying problem is that the FDA has little ability to enforce these commitments, short of withdrawing approval for the drug _ an outcome that may not serve the public health well. The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion.
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en The underlying problem is that the FDA has little ability to enforce these commitments, short of withdrawing approval for the drug -- an outcome that may not serve the public health well. The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion.
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en The underlying problem is that the FDA has little ability to enforce these commitments, short of withdrawing approval for the drug — an outcome that may not serve the public health well. The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion.
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en It's no mystery to doctors that the over-the-counter preparations may not do much for the cough but the guidelines are stating the fact that there are very few well-done scientific studies to support their use. That's not to say that some of these products may not be helpful for some people to some degree, but those studies just aren't out there.
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en Phase 2 studies are typically well controlled and closely monitored and may involve up to several hundred patients. At the conclusion of these studies, FDA (Food and Drug Administration) and the sponsor usually meet to determine how the drug's development should be studied in Phase 3 and how to design and conduct further trials.
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Denna sidan visar ordspråk som liknar "The large number of safety studies indicates that this issue has received a great amount of attention. Unfortunately, many of these studies involve more advocacy than science. It's not that these studies aren't valuable, but they have problems with methodology, statistical analysis and even simple understanding of important terms, such as 'speeding.' In accident data, speeding is defined as both 'traveling faster than the posted limit' and 'traveling too fast for conditions.' Studies often do not differentiate between these definitions.".