Pharmaceutics Final Exam Part I || || || || ||
questions With answers || || ||
National Formulary (NF) and USP - CORRECT || || || || || || ||
ANSWER(S)✔✔- organized sets of monographs or books || || || || || || ||
of standards
||
- adopts standards for drugs, pharmaceutical ingredients
|| || || || || ||
and dosage forms
|| || ||
- reflects the best current practices of medicine
|| || || || || || ||
- provides info on rests and assay procedures for
|| || || || || || || || ||
demonstrating compliance w/ these standards || || || ||
- for individual components, not combinations
|| || || || ||
CDER - CORRECT ANSWER(S)✔✔Center for Drug
|| || || || || ||
Evaluation and Research || ||
- considers if a drug is safe enough to approve
|| || || || || || || || ||
- approves drugs faster
|| || ||
- drugs benefit to risk ratio is higher but risks are high
|| || || || || || || || || || ||
What is the difference between FDA 1906 and 1938 -
|| || || || || || || || || ||
CORRECT ANSWER(S)✔✔1906 - 1st federal law, || || || || || ||
required that drugs marketed interstate comply w/
|| || || || || || ||
claimed standards for strength, purity, & quality
|| || || || || ||
,1938 - all new drugs tested for safety, NDA, label w/
|| || || || || || || || || || ||
adequate directions & FDA to conduct unauthorized
|| || || || || || ||
inspections
Sulfanilamide Tragedy - CORRECT || || || ||
ANSWER(S)✔✔Diethylene glycol ||
finished mixture intended to treat infectious
|| || || || ||
diseases/antibiotic
||
could have been prevented with testing
|| || || || ||
Thalidomide Tragedy - CORRECT || || || ||
ANSWER(S)✔✔prescribed to pregnant woman w/ || || || || ||
morning sickness, stopped formation of limbs
|| || || || ||
Kefauver Harris Amendment of 1962 - CORRECT
|| || || || || || ||
ANSWER(S)✔✔inspired by Thalidomide Tragedy || || ||
required manufacture to prove safety & efficacy of drug
|| || || || || || || || ||
before granting FDA approval for manufacturing
|| || || || ||
Durham-Humphrey Amendment of 1952 - CORRECT || || || || || ||
ANSWER(S)✔✔no refills w/o valid Rx, clarified || || || || || ||
dispensing obligations of pharmacist defined OTC
|| || || || ||
Prescription Drug Marketing Act of 1987 - CORRECT
|| || || || || || || ||
ANSWER(S)✔✔Dingell Bill ||
, Prohibits reimportation of drugs; sales, trading, and
|| || || || || || ||
purchasing of drugs || ||
prohibits repackaging and mislabeling || || ||
Drug product recall - CORRECT ANSWER(S)✔✔initiated
|| || || || || ||
by mfr or FDA if product presents threat to public
|| || || || || || || || ||
Class I - serious/death
|| || ||
Class II - temporary/medically reversibly
|| || || ||
Class III - not likely to do harm
|| || || || || || ||
Natural Plant sources - CORRECT
|| || || || ||
ANSWER(S)✔✔morphine - opium poppy || || ||
quinine - cinchona bark|| || ||
digitalis - foxglove || ||
belladonna - deadly night shade || || || ||
Goal drug - CORRECT ANSWER(S)✔✔can produce
|| || || || || ||
desired effects ||
administer at most desirable route (orally) || || || || ||
administer at minimum dosage and frequency || || || || ||
should be eliminated from the body efficiently and w/o
|| || || || || || || || ||
negative side effects || ||
questions With answers || || ||
National Formulary (NF) and USP - CORRECT || || || || || || ||
ANSWER(S)✔✔- organized sets of monographs or books || || || || || || ||
of standards
||
- adopts standards for drugs, pharmaceutical ingredients
|| || || || || ||
and dosage forms
|| || ||
- reflects the best current practices of medicine
|| || || || || || ||
- provides info on rests and assay procedures for
|| || || || || || || || ||
demonstrating compliance w/ these standards || || || ||
- for individual components, not combinations
|| || || || ||
CDER - CORRECT ANSWER(S)✔✔Center for Drug
|| || || || || ||
Evaluation and Research || ||
- considers if a drug is safe enough to approve
|| || || || || || || || ||
- approves drugs faster
|| || ||
- drugs benefit to risk ratio is higher but risks are high
|| || || || || || || || || || ||
What is the difference between FDA 1906 and 1938 -
|| || || || || || || || || ||
CORRECT ANSWER(S)✔✔1906 - 1st federal law, || || || || || ||
required that drugs marketed interstate comply w/
|| || || || || || ||
claimed standards for strength, purity, & quality
|| || || || || ||
,1938 - all new drugs tested for safety, NDA, label w/
|| || || || || || || || || || ||
adequate directions & FDA to conduct unauthorized
|| || || || || || ||
inspections
Sulfanilamide Tragedy - CORRECT || || || ||
ANSWER(S)✔✔Diethylene glycol ||
finished mixture intended to treat infectious
|| || || || ||
diseases/antibiotic
||
could have been prevented with testing
|| || || || ||
Thalidomide Tragedy - CORRECT || || || ||
ANSWER(S)✔✔prescribed to pregnant woman w/ || || || || ||
morning sickness, stopped formation of limbs
|| || || || ||
Kefauver Harris Amendment of 1962 - CORRECT
|| || || || || || ||
ANSWER(S)✔✔inspired by Thalidomide Tragedy || || ||
required manufacture to prove safety & efficacy of drug
|| || || || || || || || ||
before granting FDA approval for manufacturing
|| || || || ||
Durham-Humphrey Amendment of 1952 - CORRECT || || || || || ||
ANSWER(S)✔✔no refills w/o valid Rx, clarified || || || || || ||
dispensing obligations of pharmacist defined OTC
|| || || || ||
Prescription Drug Marketing Act of 1987 - CORRECT
|| || || || || || || ||
ANSWER(S)✔✔Dingell Bill ||
, Prohibits reimportation of drugs; sales, trading, and
|| || || || || || ||
purchasing of drugs || ||
prohibits repackaging and mislabeling || || ||
Drug product recall - CORRECT ANSWER(S)✔✔initiated
|| || || || || ||
by mfr or FDA if product presents threat to public
|| || || || || || || || ||
Class I - serious/death
|| || ||
Class II - temporary/medically reversibly
|| || || ||
Class III - not likely to do harm
|| || || || || || ||
Natural Plant sources - CORRECT
|| || || || ||
ANSWER(S)✔✔morphine - opium poppy || || ||
quinine - cinchona bark|| || ||
digitalis - foxglove || ||
belladonna - deadly night shade || || || ||
Goal drug - CORRECT ANSWER(S)✔✔can produce
|| || || || || ||
desired effects ||
administer at most desirable route (orally) || || || || ||
administer at minimum dosage and frequency || || || || ||
should be eliminated from the body efficiently and w/o
|| || || || || || || || ||
negative side effects || ||
