NURS 1140 Ch. 1 & 2 EAQs Exam
Questions and answers
Which .stage .of .new .drug .development .involves .giving .the .medication .to .large .numbers .of .individual
s .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 .- .(correct .answer) .-C. .Developmental .stage .- .phase .3
Which .legislation .was .enacted .to .stimulate .development .and .availability .of .drugs .to .treat .rare .disea
ses?
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 .- .(correct .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 .- .(correct .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 .- .(correct .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 .Authoriti
es .(NAPRA) .of .Canada?
A. .I
B. .II
C. .III
D. .Unscheduled .- .(correct .answer) .-B. .II
In .which .clinical .phase .of .new .drug .development .studies .are .a .drug's .pharmacological .properties .de
termined?
A. .1
B. .2
C. .3
D. .4 .- .(correct .answer) .-A. .1
Phase .3 .studies .determine .which .aspect .in .the .new .drug .development .process? .- .(correct .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
Questions and answers
Which .stage .of .new .drug .development .involves .giving .the .medication .to .large .numbers .of .individual
s .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 .- .(correct .answer) .-C. .Developmental .stage .- .phase .3
Which .legislation .was .enacted .to .stimulate .development .and .availability .of .drugs .to .treat .rare .disea
ses?
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 .- .(correct .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 .- .(correct .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 .- .(correct .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 .Authoriti
es .(NAPRA) .of .Canada?
A. .I
B. .II
C. .III
D. .Unscheduled .- .(correct .answer) .-B. .II
In .which .clinical .phase .of .new .drug .development .studies .are .a .drug's .pharmacological .properties .de
termined?
A. .1
B. .2
C. .3
D. .4 .- .(correct .answer) .-A. .1
Phase .3 .studies .determine .which .aspect .in .the .new .drug .development .process? .- .(correct .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
