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Pharmacology Ch 2
questions from IBC pharmacology ch 2
| Question | Answer |
|---|---|
| When a new drug is developed for use, who mandates tests required to evaluate its effects on animals? | FDA |
| How long does it typically take to bring a new veterinary drug to market? | 7 years |
| What are the 4 major steps in drug development? | 1. Synthesis/discovery of a new compound 2. Safety/effectiveness evaluation 3. Submission and review of the new animal drug 4. Postmarketing surveilance stage |
| What are the first tests performed on a newly-discovered substance? | Primary studies |
| What do primary studies determine? | If the drug produces the intended effect, whether or not the drug produces harmful side effects |
| How are primary tests performed? | via computer models, laboratory media, or on simple organisms. |
| What are preclinical studies, and when are they performed? | Tests done on lab animals after drug recieves satisfactory results in primary studies. |
| What do preclinical studies determine? | The safety and effectivness of the drug |
| What is a drug's carcinogenicity? | its ability or tendency to cause cancer |
| What is a drug's teratogenicity? | its capacity to cause birth defects |
| What is an INAD? | Investigational New Animal Drug |
| To whom is an INAD submitted? | FDA |
| What are clinical trials? When and on who are they performed? What do they evaluate? | Tests done on the target species when the FDA approves the application. Evaluates the drug's safety and effectivenes. |
| What do clinical trials determine? | A drug's toxic or adverse side effects, tissue residue, and withdrawl time information. |
| What is a NADA and who is it submitted to? | New Animal Drug Application, submitted to FDA, USDA, and EPA |
| What are short-term tests and what do they detect? | tests done hours after administration of a test dose, detects adverse reactions |
| What are long-term tests and what do they determine? | tests that run from 3 months to two years of repeat doses, checks for toxicity damage in organ systems |
| What do special tests determine? | reproductive effects, carcinogenicity, and teratogenicity (both long-term and short-term) |
| What is a toxicity evaluation and what does it determine? | an evaluation to see if a drug causes convulsions, seizures, or changes in blood pressure, heart rate, respiratory rate,sleep or muscle tension. Determines the dose at which a drug induces organ or tissue damage |
| What is ED50 and what does it mean? | Effective Dose-50, means that 50% of animals that recieve the drug have a desired effect |
| What is a "lethal dose?" | the amount of a drug that kills the patient |
| What is LD50 and what does it mean? | Lethal Dose-50, means that it kills 50% of the patients that recieve the dosage |
| What is a drug's therapeutic index and how is it determined? | its the margin of safety, or the dosage that produces the desired effect with minimal or no signs of toxicity |
| What does it mean if Drug A has a therapeutic index of "20"? | patient will have to take 20X the normal dose to reach toxicity levels |
| Is a wide or narrow therapeutic index more preferred? | wide, the larger the index, the safer the drug |
| What does a systems-oriented screen evaluate? | the drug's effect of a physiological exam, and its toxicity levels |
| How long are long-term tests usually done? | 3-24months |
| What do reproductive tests determine? | If drug prevents egg prevention If drug prevents fertilization If drug prevents uterine growth of fertilized egg If drug causes early expulsion of embryo |
| How is the teratogenicity of a drug determined? | with special tests |
| What is direct marketing? | Purchasing straight from the manufacturers |
| What are distributors or wholesalers? | Agencies that purchase from the manufacturer to resell them to veterinarians |
| What are generic companies? | Companies that sell drugs, under their own name, that are no longer under patent protection. |
| What must an applicant do for an ANDA demonstrate about the drug? | the drug's bioequivalency |
| What must companies that advertise prescription products for sale to non-veterinarians require before they will allow purchase? | a prescription |
Created by:
aburris
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