Toxicity studies: Acute (single dose)
Record Type: Study
Disease: Asthma & Allergy, Autoimmune & Inflammatory, Cardiology, CNS, Dermatology, Gastroenterology, General Medicine, Hematology, Infectious Disease, Metabolic Endocrine, Musculoskeletal, NASH, Nephrology, Oncology, Ophthalmology, Pediatrics, Pulmonary Respiratory, Rare Disease, Renal Hepatic, Reproductive Health, Rheumatology, Urology
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.