NURS 1140 Ch. 1 & 2 EAQs Exam #1 Questions with Correct
Answers
Which stage of new drug development involves giving the medication to large
numbers of individuals with the disorder that the medication intends to treat?
A. Developmental stage - phase 1
B. Developmental stage - phase 2
C. Developmental stage - phase 3
D. Postmarketing surveillance stage - ✔✔C. Developmental stage - phase 3
Which legislation was enacted to stimulate development and availability of drugs
to treat rare diseases?
A. The Food and Drug Act of 1979
B. The Fast Tracking rules
C. The Orphan Drug Act
D. The Controlled Drugs and Substance Act of 1997 - ✔✔C. The Orphan Drug Act
Which source of drug information discusses more than 3000 therapeutic agents?
A. LactMed
B. Physicians' Desk Reference
C. Martindale: The Complete Drug Reference
D. Natural Medicines Comprehensive Database - ✔✔B. Physicians' Desk
Reference
Which legislation was written to require companies to determine the safety of
medications before marketing?
, A. The Federal Food, Drug, and Cosmetic Act of 1938
B. Durham Humphrey Amendment of 1952
C. The Kefauver Harris Drug Amendment of 1962
D. Controlled Substance Act of 1970 - ✔✔A. The Federal Food, Drug, and
Cosmetic Act of 1938
Which drug schedule includes restricted-access nonprescription drugs according
to the National Association of Pharmacy Regulatory Authorities (NAPRA) of
Canada?
A. I
B. II
C. III
D. Unscheduled - ✔✔B. II
In which clinical phase of new drug development studies are a drug's
pharmacological properties determined?
A. 1
B. 2
C. 3
D. 4 - ✔✔A. 1
Phase 3 studies determine which aspect in the new drug development process? -
✔✔A. Safe therapeutic dose
B. Safety at different dosing levels
C. Statistical significance of earlier results
D. Pharmacologic properties of the drug
Answers
Which stage of new drug development involves giving the medication to large
numbers of individuals with the disorder that the medication intends to treat?
A. Developmental stage - phase 1
B. Developmental stage - phase 2
C. Developmental stage - phase 3
D. Postmarketing surveillance stage - ✔✔C. Developmental stage - phase 3
Which legislation was enacted to stimulate development and availability of drugs
to treat rare diseases?
A. The Food and Drug Act of 1979
B. The Fast Tracking rules
C. The Orphan Drug Act
D. The Controlled Drugs and Substance Act of 1997 - ✔✔C. The Orphan Drug Act
Which source of drug information discusses more than 3000 therapeutic agents?
A. LactMed
B. Physicians' Desk Reference
C. Martindale: The Complete Drug Reference
D. Natural Medicines Comprehensive Database - ✔✔B. Physicians' Desk
Reference
Which legislation was written to require companies to determine the safety of
medications before marketing?
, A. The Federal Food, Drug, and Cosmetic Act of 1938
B. Durham Humphrey Amendment of 1952
C. The Kefauver Harris Drug Amendment of 1962
D. Controlled Substance Act of 1970 - ✔✔A. The Federal Food, Drug, and
Cosmetic Act of 1938
Which drug schedule includes restricted-access nonprescription drugs according
to the National Association of Pharmacy Regulatory Authorities (NAPRA) of
Canada?
A. I
B. II
C. III
D. Unscheduled - ✔✔B. II
In which clinical phase of new drug development studies are a drug's
pharmacological properties determined?
A. 1
B. 2
C. 3
D. 4 - ✔✔A. 1
Phase 3 studies determine which aspect in the new drug development process? -
✔✔A. Safe therapeutic dose
B. Safety at different dosing levels
C. Statistical significance of earlier results
D. Pharmacologic properties of the drug
