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The role of the benchmark dose in a regulatory context.

Travis KZ, Pate I, Welsh ZK

Syngenta CTL, Alderley Park, Macclesfield, Cheshire, SK10 4TJ, UK. Kim.Travis@Syngenta.com

The use of no observed adverse effect levels (NOAELs) as a way of interpreting toxicology studies carries a number of problems, and the benchmark dose (BMD), or its lower confidence limit have been proposed as potential replacements. In practice, the theoretical advantages of the BMD approach are often outweighed by the practical disadvantages posed in a regulatory context. Attempts to seek consensus for the routine use of BMD methodology tend to involve diluting its potential advantages as much as they address the disadvantages, resulting in a relatively complex interpolation tool that delivers little more than the NOAEL. It is time to recognise that the BMD will never entirely replace the NOAEL. The two methods can have complementary roles. The NOAEL is well suited as a routine simple summary of effects in toxicology studies, whilst the BMD can be a higher tier approach for the interpretation of the most critical studies in a regulatory data package.

Published 15 November 2005 in Regul Toxicol Pharmacol, 43(3): 280-91.
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