Table of Contents
What is subacute toxicity testing?
Subacute toxicity studies are conducted to evaluate a new drug’s potential adverse effects following a treatment period of 2–4 weeks’ duration. Subacute toxicity studies are conducted as range-finding studies in order to choose dosage levels to be used in subsequent subchronic and chronic toxicity studies.
What is toxicity testing methods?
Toxicity Tests. A test method is a definitive procedure that produces a test result. A toxicity test, by extension, is designed to generate data concerning the adverse effects of a substance on human or animal health, or the environment.
What are different types of toxicity studies?
Types of Toxicology Studies
- Systemic toxicology studies. Single-dose studies. Repeated-dose studies.
- Reproductive toxicology studies. Male fertility studies. Female reproduction and developmental toxicology studies.
- Local toxicology studies.
- Hypersensitivity studies.
- Genotoxicity studies.
- Carcinogenicity studies.
What does subacute exposure mean?
Multiple or continuous exposures occurring for approximately 10% of a species lifetime, usually over 3 months.
What is preclinical toxicology?
Non-clinical (or preclinical) toxicology studies are required to establish the toxicological profiles of new drug candidates prior to administration to humans and extend the known profiles of existing drugs (e.g., new indications, new formulations, new routes of administration, etc.).
What is LC50 and LD50?
LD50 is the abbreviation used for the dose which kills 50% of the test population. LC50 is the abbreviation used for the exposure concentration of a toxic substance lethal to half of the test animals. LD50 is expressed in milligrams per kilogram of body weight of the test animal (which must be mentioned).
What are the 3 types of toxicity?
Types of toxicity There are generally three types of toxic entities; chemical, biological, and physical. Chemicals include inorganic substances such as lead, hydrofluoric acid, and chlorine gas, organic compounds such as methyl alcohol, most medications, and poisons from living things.
What is subacute toxicity examples?
Subacute toxicity (repeat dose toxicity) focuses on adverse effects occurring after administration of a single dose or multiple doses of a test sample per day given during a period of from 14 to 28 days.
What are preclinical tests?
Preclinical testing is the link between drug discovery and availability to the patient. It takes at least 12–15 years for a drug to get from the lab to clinical use. Chemical agents are synthesized or obtained by other high-throughput methods.
What does preclinical testing involve?
Preclinical studies refer to the testing of a drug, procedure or other medical treatment in animals before trials may be carried out in humans. During preclinical drug development, the drug’s toxic and pharmacological effects need to be evaluated through in vitro and in vivo laboratory animal testing.
What is the purpose of LC50?
Acute lethal dose/concentration estimates are the most widely used measure of toxicity and these data often are used in ecological risk assessment. However, the value of the lethal concentration (LC50) as a toxicological endpoint for use in ecological risk assessment recently has been criticized.
What is the difference between LC50 and ec50?
4.1 EC 50 and LC 50. An EC 50 is a statistical estimate of the concentration of a toxicant in the ambient medium necessary to produce a particular effect in 50% of a very large population under specified conditions. An LC 50 is a special case of the EC 50 in which the effect recorded is death.
How do you test for subacute toxicity?
Subacute toxicity. The Draize Test acute toxicity testThe procedure involves applying 0.5mL or 0.5gof a test substance to the eye or skin of arestrained, conscious animal, and leaving it for4HRS.The animals are observed for up to 14 days, forsigns of erythema and edema in the skin test, andredness, swelling, discharge, ulceration,hemorrhaging,…
What does subacute and subchronic toxicity mean?
Subacute & Subchronic Toxicity. The Biocompatibility Subacute and Subchronic Toxicity test is used to discover the effects a material with repeat exposure would have on a patient, including any compound toxicity effects. It determines the systemic effect of repeated doses of materials or their extracts for no less than 24 hours…
What is the duration of subacute toxicity studies?
Sub acute toxicity studies Duration 14 days to 90 days Test System/Animal System 2 species required. Mice, rats, rabbits, guinea pigs, dogs. Dose Administration 3 to 4 doses given by the same routes as previous toxicity
What is acute toxicity testing?
,• Acute toxicity testing- study the effect of a single dose on a particular animal species. • Acute toxicity testing be carried out with two different animal species (one rodent and one non-rodent). • In acute toxicological testing, the investigational product is administered at different dose levels, and the effect is observed for 14 days.