Single Dose Toxicity

A single dose toxicity study (SDS) is narrowly conceptualized as an examination of the acute toxicity response that results from a single administration of a subject. A single dose toxicity study, in the broader sense, can be used to obtain information on the acute toxicity of a drug in a single dose or in multiple doses within a 24-hour period. Single-dose toxicity testing is usually required for drugs intended for use in humans. The single dose toxicity test is important for the initial elucidation of the toxic effects of a drug and for the understanding of its target organ of toxicity. The information obtained from single-dose toxicity tests is important for the dose design of repeated-dose toxicity tests and for the selection of starting doses for clinical trials of certain drugs, and can provide information relevant to acute toxicity due to drug overdose in humans.