Pharmaceutics Final Exam Part I questions With answers

Pharmaceutics Final Exam Part I || || || || ||




questions With answers || || ||




National Formulary (NF) and USP - CORRECT || || || || || || ||



ANSWER(S)✔✔- organized sets of monographs or books || || || || || || ||



of standards
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- adopts standards for drugs, pharmaceutical ingredients
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and dosage forms
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- reflects the best current practices of medicine
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- provides info on rests and assay procedures for
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demonstrating compliance w/ these standards || || || ||




- for individual components, not combinations
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CDER - CORRECT ANSWER(S)✔✔Center for Drug
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Evaluation and Research || ||




- considers if a drug is safe enough to approve
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- approves drugs faster
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- drugs benefit to risk ratio is higher but risks are high
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What is the difference between FDA 1906 and 1938 -
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CORRECT ANSWER(S)✔✔1906 - 1st federal law, || || || || || ||



required that drugs marketed interstate comply w/
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claimed standards for strength, purity, & quality
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,1938 - all new drugs tested for safety, NDA, label w/
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adequate directions & FDA to conduct unauthorized
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inspections


Sulfanilamide Tragedy - CORRECT || || || ||



ANSWER(S)✔✔Diethylene glycol ||




finished mixture intended to treat infectious
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diseases/antibiotic
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could have been prevented with testing
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Thalidomide Tragedy - CORRECT || || || ||



ANSWER(S)✔✔prescribed to pregnant woman w/ || || || || ||



morning sickness, stopped formation of limbs
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Kefauver Harris Amendment of 1962 - CORRECT
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ANSWER(S)✔✔inspired by Thalidomide Tragedy || || ||




required manufacture to prove safety & efficacy of drug
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before granting FDA approval for manufacturing
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Durham-Humphrey Amendment of 1952 - CORRECT || || || || || ||



ANSWER(S)✔✔no refills w/o valid Rx, clarified || || || || || ||



dispensing obligations of pharmacist defined OTC
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Prescription Drug Marketing Act of 1987 - CORRECT
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ANSWER(S)✔✔Dingell Bill ||

, Prohibits reimportation of drugs; sales, trading, and
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purchasing of drugs || ||




prohibits repackaging and mislabeling || || ||




Drug product recall - CORRECT ANSWER(S)✔✔initiated
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by mfr or FDA if product presents threat to public
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Class I - serious/death
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Class II - temporary/medically reversibly
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Class III - not likely to do harm
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Natural Plant sources - CORRECT
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ANSWER(S)✔✔morphine - opium poppy || || ||




quinine - cinchona bark|| || ||




digitalis - foxglove || ||




belladonna - deadly night shade || || || ||




Goal drug - CORRECT ANSWER(S)✔✔can produce
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desired effects ||




administer at most desirable route (orally) || || || || ||




administer at minimum dosage and frequency || || || || ||




should be eliminated from the body efficiently and w/o
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negative side effects || ||