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What is phase two of drug development? - CORRECT ANSWERClinical research
in humans primarily for medication safety usually in a population for which
treatment is inteded
What is phase three of drug development? - CORRECT ANSWERClinical
research in humans comparing the new drug to accepted medications or placebo
for efficacy and safety
,What does pharmacokinetics involve? - CORRECT ANSWERabsorption,
distribution, metabolism, excretion
What is absorption? - CORRECT ANSWERfrom the administration site either
directly or indirectly into the blood plasma
What is distribution? - CORRECT ANSWERreversibly or irreversibly move from
the bloodstream into the interstitial and intracellular fluid
What is metabolism? - CORRECT ANSWERBiotransformed via hepatic
metabolism or by other tissues
What is elimination? - CORRECT ANSWERThe drug and it metabolites are
eliminated from the body
What route of administration has the highest bioavailability? - CORRECT
ANSWERintravenous
Which route of administration avoid first-pass metabolism in the liver? -
CORRECT ANSWERintravenous route
,What administration route has variable and erractic absorption? - CORRECT
ANSWERrectal
When is a steady state of a drug reached? - CORRECT ANSWERwithin 4-5 half-
lives of a drug
What is important to know in regards to half-life? - CORRECT
ANSWERdetermines how frequently the drug must be administered
Predicts how long toxic effects last
What does first-order (linear) pharmacoknetics mean? - CORRECT ANSWERthe
metabolism is directly proportional to the free concentration of the drug
What does zero-order (nonlinear) pharmacokinetics? - CORRECT ANSWERa
drug is metabolized at a constant rate per unit time
What does the drug development proccess involve according to the FDA? -
CORRECT ANSWERdiscovery
preclinical research with animal testing
Phase 1
, Phase 2
Phase 3
FDA review of the results to determine approval
Phase 4
What is phase one of drug development? - CORRECT ANSWERClinical research
on healthy human subjects to assess medication pharmacokinetics
What is phase four of drug development? - CORRECT ANSWERPostmarketing
study to identify adverse effects not found in earlier clinical studies
What are the medication safety organizations? - CORRECT ANSWERFDA
Institute for safe medication practices (ISMP)
JCAHO
What is the institute for safe medication practices? - CORRECT ANSWERnon-
profit organization that focuses on preventing medication errors and promoting
safe medication practices