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Human Risk Assessment

Human Risk Assessment - the problem with traditional studies

The assessment of the risk that chemicals pose to human health is still dependent on traditional 'safety assessment' in non human species. The problem however is that the non-human species routinely used (ie rodents) do not accurately reflect the human biological response to chemicals and compounds. Inaccurate extrapolation to man is routinely applied to 'determine' whether there is a health risk to man, and even what the exposure limit or acceptable dose is. This has led to chemicals failing these required safety tests on uncertain grounds, and is responsible for many 'safe' chemicals being abandoned.

This problem is likely to get worse as recent legislation has now introduced tighter regulations that demand that traditional safety tests are more frequently performed across a wider range of chemicals than ever before.

The same is true for compounds being developed as therapeutics, as many drug candidates have also failed safety assessment in toxicity tests using rodents due to reasons that are not relevant to man. This has contributed to the unacceptably high attrition rates in late stage drug development.

CXR Biosciences Human Risk Assessment Solutions

The key to determining the true health risk of chemicals and compounds is by understanding their mechanism(s) of toxicity.  Armed with decades of toxicological experience, CXR apply a range of molecular biological, and post genomic techniques to understand the biological mechanisms underlying a toxic event in safety or preclinical animal studies and determine whether this is relevant to man.

 

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