and 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 /.- /.(correct /.answer) /.-C. /.Developmental /.stage /.- /.phase /.3
Which /.legislation /.was /.enacted /.to /.stimulate /.development /.and /.availability /.of /.drugs /.to /.treat /.ra
re /.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 /.- /.(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 /.A
uthorities /.(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 /.prop
erties /.determined?
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?