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Pharmacology Ch.2

Romich 2nd edition "Veterinary Drug Development and Control"

Carcinogenicity the ability or tendency to produce cancer Outline the stages of drug development in the United States -Synthesis/ discovery of a new drug compound -Safety/effectiveness evaluation -Submission and review of the New Animal Drug Application (NADA) -Postmarketing Surveillance
Chronic Studies Long-term toxicity tests that run from 3 months to 24 years to prevent disastrous consequences of a drug therapy Differentiate between effective dose and lethal dose a dose can only be effective/lethal if 50% of the animals that receive have a defined reaction
Clinical Trials conducted in the target species and are done to evaluate the drug's safety and effectiveness in that species Defines margin of safety, calculate it, and understand how it relates to the appearance of toxicity signs Drug A LD50 / ED50 = Margin of Safety A wide or greater therapeutic index or margin of safety means that the drug can produce its desired effect without approaching toxicity
Effective Dose-50 the amount of the test drug causes a defined effect in 50 percent of the animals that receive it Describe how side effects related to reproduction are monitored. Reproductive tests evaluate the drug's effect on conception, fertilization, and pregnancy.
Lethal Dose-50 dose of a test drug that kills 50 percent of the animals that receive it Describe how side effects related to carcinogenicity are monitored. Carcinogenicity tests check to see if the drug causes cancerous tumors in such soft tissues as the urinary bladder or brain.
Long-Term Tests repeat of dosing and check of various organ systems for 3 to 24 months Describe how side effects related to teratogenicity are monitored. Teratogenic tests check for development of fetal defects in pregnant test animals
Long Term Toxicity Tests chronic studies
Margin of Safety therapeutic index
Parameter intensity of effect measured on a subjective scale of either 1 through 3 or through 10
Preclinical Studies a series of tests performed on laboratory animals to determine safety and effectiveness of the drug
Preliminary Studies determine if the drug produces the intended effect(s) and whether it has toxic properties
Shelf Life how long a drug remains stable and effective for use
Short-term Tests check for adverse reactions such as (seizures, paralysis, depressed breathing, depressed heart rate, and death) post drug administration
Short-term Toxicity Test tests ran within hours after drug administration to determine toxicity levels
Special Tests determine reproductive effects, carcinogenicity, and teratogenicity
Systems-oriented Screen a test of the drug's effects on a particular physiological system
Teratogenicity the capacity to cause birth defects
Therapeutic Index drug's dosage or dose that produces the desired effect with minimal or no signs of toxicity
Toxicity Evaluation determine the dose at which a drug induces organ or tissue damage that may, at a high-enough dose, result in permanent injury or death
Created by: KTHindsCC