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Regulations for Drug Development 08403500 1. Given the

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Regulations for Drug Development 08403500

1. Given the following information for three new drugs, which
drug has the greatest margin of safety?
LD50 (milligrams) ED50 (milligrams)
Drug A 200 60
Drug B 120 10
Drug C 240 2
A. Drug A
B. Drug B
C. Drug C
D. They all have the same margin of safety.
2. The majority of new chemical molecules that are tested as
new drugs come from
A. the synthesis of new chemicals by chemists.
B. bacteria found in the soil.
C. the leaves of plants.
D. the bark of trees.
3. The “treatment use” of investigational drugs usually occurs at which stage of drug
A. During Phase 1 clinical testing
B. During FDA review of the investigational new drug application
C. During long-term animal toxicity testing
D. During FDA review of a new drug application (NDA)
4. The law that prohibited the marketing of new drugs unless they were adequately
tested to demonstrate safety was the
A. Controlled Substances Act of 1970.
B. Federal Pure Food and Drug Act of 1906.
C. Poison Prevention Packaging Act of 1970.
D. Federal Food, Drug, and Cosmetic Act of 1938.
5. The dose of a test drug that causes death in the animal during short-term toxicity
testing is referred to as the
A. control. C. placebo.
B. lethal dose. D. effective dose.
6. The Federal Pure Food and Drug Act of 1906 was concerned with
A. establishing guidelines for dispensing controlled substances.
B. establishing guidelines for drug labeling and interstate transport of certain foods
and drugs.
C. placing regulations on drug manufacturers and pharmacists.
D. safety issues regarding botanicals and adulterated drugs.
7. A tragedy with which drug was responsible for the passage of the Kefauver-Harris
Amendment in 1962 that called for more drug safety?
A. Thalidomide C. Ergot
B. Sulfanilamide D. Strychnine
8. Phase ________ of clinical testing is required by the FDA before drug approval and
uses the greatest number of subjects.
A. 1 C. 3
B. 2 D. 4
9. A tragedy with which drug was responsible for the passage of the Federal Food, Drug,
and Cosmetic Act of 1938 that required the establishment of drug safety standards?
A. Thalidomide C. Ergot
B. Sulfanilamide D. Strychnine
10. The Federal Pure Food and Drug Act of 1906 defined an adulterated drug as a
drug that
A. has false or misleading labeling.
B. was prepared with alcohol or similar substances.
C. contains a decomposed substance or whose strength, quality, or purity is different
from what’s indicated on the label.
D. contains ergot, digitalis, or quinine.
11. The investigational new drug (IND) application contains which of the following
A. Effectiveness of the test drug in humans
B. Toxicity of the test drug in humans
C. Toxicity of the test drug in animals
D. Safety and effectiveness of the test drug after FDA approval
12. Quinine, which is found in the bark of the cinchona tree, is effective in
A. reducing fever and other symptoms associated with malaria.
B. reducing the burning sensations of St. Anthony’s Fire.
C. treating serious bacterial infections.
D. reducing convulsions caused by the use of strychnine.
13. The approval of a new drug application (NDA) by the FDA allows for which of the
A. The manufacturer is allowed to sell the drug in the United States.
B. The drug is allowed to be tested in animals for safety.
C. The drug is allowed to be tested in humans for the first time.
D. The drug is allowed to be shipped for the first time through interstate commerce.
14. Phase ________ of clinical testing uses the fewest number of subjects and establishes
the dose at which signs of toxicity appear.
A. 1 C. 3
B. 2 D. 4
15. The post-marketing surveillance phase of drug development
A. reports previously discovered toxic reactions.
B. depends solely on the reports of prescribers of the drug.
C. includes surveys and reports of adverse reactions as well as consumer watchdog
D. reports only short-term toxicity test results.
16. The Kefauver-Harris Amendment of 1962 required that a drug be
A. labeled as either an over-the-counter (OTC) or prescription drug.
B. not only safe but effective.
C. used prior to proof of effectiveness, if necessary.
D. inventoried by the pharmacist every two years.
17. The Controlled Substances Act of 1970 categorized drugs such as morphine and
meperidine as Schedule ________ drugs.
18. The OTC monograph for a specific class of ingredients was codified in an official,
legally binding
A. FDA journal.
B. amendment to the Orphan Drug Act of 1983.
C. Treatment IND Program.
D. Code of Federal Regulations (CFR).
19. The application for approval of a generic equivalent of an existing proprietary drug
must show that the drug is absorbed from the _______ into the bloodstream at the
same rate as the proprietary drug.
A. liver C. small intestine
B. stomach D. skin
20. How long does it take for the average new drug to be tested and approved for sale in
the United States?
A. 30 days C. 3 to 5 years
B. 2 years D. 11 years

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Customer: replied 6 years ago.
thanks now all i need is 08403400 that i posted. always glad to see you
Hi again, and you're most welcome!

Glad to see you, as well, and thanks very much for your accept.

I'll check to see if I have 08403400.

Customer: replied 6 years ago.
k thanks
Hi again,

Sorry, I don't seem to have that one.

Good luck on your other exams!

Customer: replied 6 years ago.
no problen, thanks for trying