Search results
Results from the WOW.Com Content Network
Single ascending dose (Phase Ia): In single ascending dose studies, small groups of subjects are given a single dose of the drug while they are observed and tested for a period of time to confirm safety. [8] [14] Typically, a small number of participants, usually three, are entered sequentially at a particular dose. [13]
In a 28-day repeat oral dose toxicity study in dogs and rats, the single- and multiple-dose toxicokinetics of KH176(m) were studied. From Day 1 to Day 28, both species showed a dose-proportional increase in KH176(m) exposure. At any dose level, no significant accumulation of KH176(m) systemic exposure was observed following repeated dosing.
Acute toxicity describes the adverse effects of a substance that result either from a single exposure [1] or from multiple exposures in a short period of time (usually less than 24 hours). [ 2 ] To be described as acute toxicity, the adverse effects should occur within 14 days of the administration of the substance.
U.S. Army Public Health Center Toxicology Lab technician assessing samples. Toxicology testing, also known as safety assessment, or toxicity testing, is the process of determining the degree to which a substance of interest negatively impacts the normal biological functions of an organism, given a certain exposure duration, route of exposure, and substance concentration.
The preclinical toxicity testing on various biological systems reveals the species-, organ- and dose-specific toxic effects of an investigational product. The toxicity of substances can be observed by (a) studying the accidental exposures to a substance (b) in vitro studies using cells/ cell lines (c) in vivo exposure on experimental animals.
Studies have shown significant hepatotoxicity is uncommon in patients who have taken greater than normal doses over 3 to 4 days. [23] In adults, a dose of 6 grams a day over the preceding 48 hours could potentially lead to toxicity, [20] while in children acute doses above 200 mg/kg could potentially cause toxicity. [24]
Repeated Dose 28-day Oral Toxicity Study in Rodents 408: Repeated Dose 90-Day Oral Toxicity Study in Rodents 409: Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents 410: Repeated Dose Dermal Toxicity: 21/28-day Study 411: Subchronic Dermal Toxicity: 90-day Study 412: Subacute Inhalation Toxicity: 28-Day Study 413
Acute toxicity; Other multiple dose toxicity; Specific numeric toxicity values such as LD 50, LC 50, TDLo, and TCLo are noted as well as species studied and the route of administration used. For all data the bibliographic source is listed. The studies are not evaluated in any way.