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Pharmacology Ch.2
Romich 2nd edition "Veterinary Drug Development and Control"
| Term | Definition | Question | Answer |
|---|---|---|---|
| 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 |
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KTHindsCC
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