Toxicity studies: Acute (single dose)

Study

Toxicology, Acute

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

Models

Canine, Mouse, NHP, Rabbit, Rat

Administration Routes

Dietary, Gavage, Infusion, Intramuscular, Intravenous, Subcutaneous

Regulatory

FIH

Industry Market

Device, Pharma

Phase

Nonclinical

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