...Thank you. <3? NOTE: MY ANSWERES ARE AT THE BOTTOM!
LD50(milligrams) ED50(milligrams)
DRUG A 200 60
DRUG B 120 10
DRUG C 240 2
1. Given the above information for three new drugs, which drug has the greatest margin of safety?
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 testing?
A. During Phase 1 clinical testing
B. During FDA review of the investigational new drug application (IND)
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.
B. lethal dose.
C. placebo.
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
B. Sulfanilamide
C. Ergot
D. Strychnine
8. Phase ________ of clinical testing is required by the FDA before drug approval and uses the greatest number of subjects.
A. 1
B. 2
C. 3
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
B. Sulfanilamide
C. Ergot
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 application (IND) contains which of the following information?
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 following?
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
B. 2
C. 3
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 information.
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.
A. I
B. II
C. III
D. IV
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
19. The application for approval of a generic equivalent of an existing proprietary drug must show that the drug
A. doesn't cause birth defects.
B. is safe in humans.
C. is absorbed from the stomach into the bloodstream at the same rate as the proprietary drug.
D. is effective in humans.
20. How long does it take for the average new drug to be tested and approved for sale in the United States?
A. 2 years
B. 30 days
C. 3 to 5 years
D. 11 years
1(C) 2(A) 3(D) 4(D) 5(B) 6(B) 7(A) 8(C) 9(B) 10(C) 11(D) 12(A) 13(A) 14(A) 15(C) 16(B) 17(C) 18(D) 19(C) 20(D)
Thank you for your time, I will reward the best answer.
LD50(milligrams) ED50(milligrams)
DRUG A 200 60
DRUG B 120 10
DRUG C 240 2
1. Given the above information for three new drugs, which drug has the greatest margin of safety?
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 testing?
A. During Phase 1 clinical testing
B. During FDA review of the investigational new drug application (IND)
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.
B. lethal dose.
C. placebo.
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
B. Sulfanilamide
C. Ergot
D. Strychnine
8. Phase ________ of clinical testing is required by the FDA before drug approval and uses the greatest number of subjects.
A. 1
B. 2
C. 3
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
B. Sulfanilamide
C. Ergot
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 application (IND) contains which of the following information?
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 following?
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
B. 2
C. 3
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 information.
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.
A. I
B. II
C. III
D. IV
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
19. The application for approval of a generic equivalent of an existing proprietary drug must show that the drug
A. doesn't cause birth defects.
B. is safe in humans.
C. is absorbed from the stomach into the bloodstream at the same rate as the proprietary drug.
D. is effective in humans.
20. How long does it take for the average new drug to be tested and approved for sale in the United States?
A. 2 years
B. 30 days
C. 3 to 5 years
D. 11 years
1(C) 2(A) 3(D) 4(D) 5(B) 6(B) 7(A) 8(C) 9(B) 10(C) 11(D) 12(A) 13(A) 14(A) 15(C) 16(B) 17(C) 18(D) 19(C) 20(D)
Thank you for your time, I will reward the best answer.