NURS 1140 CH. 1 & 2 EAQS QUESTIONS AND ANSWERS 100% CORRECT.
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 - (answer)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 - (answer)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 - (answer)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 - (answer)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
, NURS 1140 CH. 1 & 2 EAQS QUESTIONS AND ANSWERS 100% CORRECT.
B. II
C. III
D. Unscheduled - (answer)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 - (answer)A. 1
Phase 3 studies determine which aspect in the new drug development process? - (answer)A. Safe
therapeutic dose
B. Safety at different dosing levels
C. Statistical significance of earlier results
D. Pharmacologic properties of the drug
Why was the Orphan Drug Act passed?
A. To regulate the dispensing of abused drugs
B. To determine the safety of drugs before marketing
C. To stimulate the development of drugs for rare diseases
D. To make investigational new drugs available to patients - (answer)C. To stimulate the development of
drugs for rare diseases
Which drug information source gives information regarding nutritional supplements?
A. LactMed Database
B. Natural Medicines Comprehensive Database
C. United States Pharmacopeia (USP)/National Formulary (NF)
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 - (answer)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 - (answer)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 - (answer)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 - (answer)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
, NURS 1140 CH. 1 & 2 EAQS QUESTIONS AND ANSWERS 100% CORRECT.
B. II
C. III
D. Unscheduled - (answer)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 - (answer)A. 1
Phase 3 studies determine which aspect in the new drug development process? - (answer)A. Safe
therapeutic dose
B. Safety at different dosing levels
C. Statistical significance of earlier results
D. Pharmacologic properties of the drug
Why was the Orphan Drug Act passed?
A. To regulate the dispensing of abused drugs
B. To determine the safety of drugs before marketing
C. To stimulate the development of drugs for rare diseases
D. To make investigational new drugs available to patients - (answer)C. To stimulate the development of
drugs for rare diseases
Which drug information source gives information regarding nutritional supplements?
A. LactMed Database
B. Natural Medicines Comprehensive Database
C. United States Pharmacopeia (USP)/National Formulary (NF)
