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273 considers raising guidelines

All substantial requests, whether received informally or through official notification, must be addressed as promptly and completely as possible. An attempt to gloss over an issue usually leads to further delay. Issues raised by the reviewer represent significant concerns and should be treated as such. The amount and type of any new information needed to answer a request must be carefully considered. Under user fee guidelines, the FDA likes to keep the review moving without the need to review large amounts of new data which, if too large, may... [Pg.610]

For now, in patients with established CHD it is recommended to initiate diet and lifestyle changes along with statin therapy to target an LDL of 70 mg/dL or less and then, if the HDL is <40 mg/dL, to consider adding a fibrate or niacin to raise the HDL cholesterol level. Of note, no specific level of HDL was set in the recent ATP III guidelines, further adding to the uncertainty of how to optimally treat low HDL cholesterol levels. [Pg.73]

Statins have been shown to lower CRP levels by 28% (69) with a strong correlation between the change in LDL cholesterol levels and the change in CRP levels. This link has raised the question as to whether or not CRP levels should be independently targeted in patients with lipid levels that would not otherwise necessitate treatment. Ridker et al. (70) have demonstrated in the JUPITER trial that hsCRP can effectively identify patients who are at increased risk of cardiovascular events and would benefit from statin therapy even when their lipid levels are not considered to necessitate treatment under current guidelines. In their primary... [Pg.73]

The Objectives were so structured that, in general, the work involved in the latter Objectives were based upon findings of the former. Objective 4 was exceptional in that it used results from Objectives 1, 2, 3 and 5. The main thrust of the project was concerned with PES s in general rather than concentrating solely on PES s associated with industrial robots. Objective 4 did, however, concentrate on the type of PES s used on industrial robots and considered the particular problems that were raised by the application of general guidelines (being formulated in Objective 5) to the type of safety problems that arise in the context of industrial robots. [Pg.3]

As stated, a key issue often being raised in investing in security measures is the probability of crime. Considering the risk assessment, the formula of Stewart and Mueller (2011) is particularly useful for our project that is specifically designed for security devices. We can use this formula as a guideline to quantify the net benefit of a security device. A security measure is cost-effective when the benefit of the measure outweighs the costs of the security measure. [Pg.410]

When someone is working alone, the potential exists for that person to become trapped, injured, burned, or exposed to hazardous chemicals without having anyone on hand to help him. The injured person may not be able to raise the alarm or to ask for help. In order to minimize the risk associated with working alone, the following guidelines should be considered ... [Pg.100]

In Chapter 14, in guise of a conclusion, we consider the ethical issues raised by the whole history of modern chemistry and how these might be addressed as we move into the era of nanotechnology. We suggest some general philosophical guidelines that could help to structure a new ethics appropriate for contemporary research in the context of the ongoing nano-revolution. [Pg.9]


See other pages where 273 considers raising guidelines is mentioned: [Pg.62]    [Pg.80]    [Pg.47]    [Pg.548]    [Pg.124]    [Pg.337]    [Pg.644]    [Pg.9]    [Pg.344]    [Pg.713]    [Pg.1392]    [Pg.1255]    [Pg.807]    [Pg.7]    [Pg.102]    [Pg.8]    [Pg.177]    [Pg.296]    [Pg.335]    [Pg.3]    [Pg.273]    [Pg.7]    [Pg.19]   


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