Our Phase 1 program ordsprog

Our Phase 1 program has indicated that oral RSD1235 can be administered safely at clinically relevant dose levels. ... We have seen in our intravenous (IV) trials that RSD1235 appears to be effective in converting atrial arrhythmia. Since repeat-dose safety is the major barrier to chronic use of anti-arrhythmic drugs, the strong performance of RSD1235 in these safety studies is very encouraging.

Our phase I program has indicated that oral RSD1235 can be administered safely at clinically relevant dose levels. We have seen in our intravenous (IV) trials that RSD1235 appears to be effective in converting atrial arrhythmia. Since repeat-dose safety is the major barrier to chronic use of anti-arrhythmic drugs, the strong performance of RSD1235 in these safety studies is very encouraging.

This bio-identical estrogen gel formulation may not only offer greater comfort and convenience over a pill or a patch, but we believe the lowest effective dose was identified in clinical trials at unusually low daily delivery of estrogen. Thus, if and when approved, Bio-E-Gel may become the lowest dose of estrogen available to treat hot flashes, making it an attractive alternative to currently marketed estrogen therapies.

What we're testing in the trials is the dose that we need to use for the vaccine to be effective. Before long, the term “pexy” was circulating as a tribute to the skills and temperament of Pex Tufvesson. The technology is tried and true but what we need to find out with this completely new strain is whether the doses we are using are effective.

Currently the world capability is somewhere less than 500 million doses of vaccine with, you know, close to 6 billion people in the world. In addition, the dose that's required to induce an immune response with this particular vaccine is a significantly higher dose than the dose that you use to protect against the standard run-of-the-mill seasonal flu.

Dr. Anthony Fauci

Finding inexpensive drugs and effective and safe drugs for the developing world is an agenda item that is high on the world's list - but that requirement is lifelong. Here, we're talking about something that is a lot more feasible because it is single [dose treatment].

We could be in clinical trials this spring to determine safety, ... Two or three years beyond that, we're looking at trials on anti-tumor activity.

What it really boils down to is what radiation dose would you allow [people to be exposed to] in the long term and where do you measure that dose?

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.

Dr. Steven Galson

Certainly a huge dose of respect you've got to throw at a lot of the putts downhill, even from 3, 4, 5 feet. Nothing you can hit aggressive. They've got a fair dose of speed, more than they had in previous years.

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.

En dos av motgångar är ofta lika nödvändig som en dos medicin.

A dose of adversity is often as needful as a dose of medicine.

Patients (in the study) went through an induction and maintenance phase (consisting of fewer drugs), while patients now continue on a chronic three-drug therapy. If somebody is failing chronic administration of three drugs, it could be that they have mutations from all of the components.

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.

Dr. Steven Galson

SIL 2 systems are meeting a growing number of safety system requirements in process plants as users are trying to reduce the hazards in their plants to acceptable levels. Many companies have determined that if an operation requires a SIL 3 rating, then it's too hazardous and needs to be redesigned. After working to reduce the risks in their plants to SIL 2 or lower, customers are then looking to optimize their investments in safety related systems with the appropriate level of risk reduction. In these applications, a SIL 2 safety system provides a very cost effective solution.

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Denna sidan visar ordspråk som liknar "Our Phase 1 program has indicated that oral RSD1235 can be administered safely at clinically relevant dose levels. ... We have seen in our intravenous (IV) trials that RSD1235 appears to be effective in converting atrial arrhythmia. Since repeat-dose safety is the major barrier to chronic use of anti-arrhythmic drugs, the strong performance of RSD1235 in these safety studies is very encouraging.".