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Toxicity studies: Acute (single dose)

Toxicity studies: Acute (single dose)

Acute toxicity is produced by an active ingredient when administered in one or more doses during a maximum period of 24 hours. The test uses two mammalian species, including one nonrodent.

The objective is to identify doses causing no adverse effect and doses causing major, life-threatening toxicity. 

Information obtained from single-dose studies is useful in choosing doses for repeat-dose studies, providing preliminary identification of target organs of toxicity. 

Acute toxicity studies may also aid in the selection of starting doses for Phase I human studies and provide information relevant to acute overdosing in humans.

Molecule or Product Type

Small Molecule

Regulatory

FIH

Industry Market

Pharma, Device

Phase

Nonclinical