Glossary Element  pre-clinical studies

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English term pre-clinical studies
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English definition the various tests conducted in whole animals and other test systems, such as cell cultures, to determine the relative toxicity of a compound to living systems. These are referred to as pre-clinical studies - tests conducted and evaluated prior to the first administration of the compound to humans. Also included in this category are two-year carcinogenicity assays which typically overlap with the chemical testing phase. Pre-clinical tests include: <b>toxicity</b> (how poisonous it is and what side effects might be expected); <b>bioavailability</b> (how effectively it is taken up into the body and delivered to the tissue where it is needed); <b>pharmacokinetics</b> (how it is metabolised, and therefore how long it stays in the body); and whether it has the desired physiological effect. [CUB]
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