pre-clinical studies

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: toxicity (how poisonous it is and what side effects might be expected); bioavailability (how effectively it is taken up into the body and delivered to the tissue where it is needed); pharmacokinetics (how it is metabolised, and therefore how long it stays in the body); and whether it has the desired physiological effect. [CUB]