Safety Terms Links

In most cases, limited information is available regarding the toxic effects of chemicals. Empirical guidelines are then used in an attempt to protect most of the aquatic ecosystem s biota. The regulation of chemicals, for instance, generally uses safety factors from 10 to 1000 depending on the number of species tested. Mesocosm studies or comparisons with real field situations are accepted with lower safety factors on a case by case basis, since these studies reduce the uncertainty linked to the relevance of laboratory models in terms of site-specific data. 

Although BA studies have many pharmacokinetic objectives beyond formulation performance as described above, it should be noted that subsequent sections of this guidance focus on using relative BA (referred to as product quality BA) and, in particular, BE studies as a means to document product quality. In vivo performance, in terms of BA/BE, may be considered to be one aspect of product quality that provides a link to the performance of the drug product used in clinical trials and to the database containing evidence of safety and efficacy. 

A survey in 2000, carried out in Los Angeles by a group at the University of Southern California School of Medicine, found a link with bladder cancer. It involved 1541 people with this condition and they were compared to 897 people who were not so afflicted. Adjustments were made to take into account smokers, who are liable to be more at risk of this disease in any case, and it found that those who used permanent hair dyes every month had a slightly higher risk of bladder cancer, especially if they had used hair dyes continuously for 15 or more years. Hairdressers had an even higher risk. This revelation prompted the Scientific Committee on Cosmetic Products and Non-Food Products ofthe EU (SCCNFP) to issue a discussion paper in February 2002. This was followed in December that year by a requirement that manufacturers must submit by July 2005 all their data on hair dyes together with studies to assess their safety in terms of cancer and toxicity. The outcome of this has yet to be published, but it will take the form of an approved list of hair dyes which will be issued in 2007. 

R D success has been clearly linked to the development and creation of billion-dollar human medication. Current regulations favor fast-track approval of lifesaving medication and long-term safety and efficacy data for chronic diseases. The blockbuster drugs are the main driver of industrial R D and contribute a major share of the total pharmaceutical sales, profits, and market value of the successful companies. The criteria for blockbuster drugs are defined, and output of blockbuster... 

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