NUR 642 Pharm: Pharmacodynamics &
Pharmacokinetics questions with correct answers
What are the phases of a clinical trial Correct Answer-Preclinincal
phase 1
phase 2
phase 3
phase 4
Who ensures drug safety in the USA Correct Answer-FDA
Who sets the guidelines for prescribers of drug therapy? Correct
Answer-set by both the sate and federal governments and the licensing
bodies in each state
Preclinical Phase Correct Answer-Lab and animal studies. No human
subjects. Looking at the efficacy. toxic effects, and untoward effects on
animals
Phase 1 Correct Answer-Safety study
20-80 people
pharmacokinetics such as absorption, distribution, metabolism and
elimination. Dose ranges are determined
Phase 2 Correct Answer-Safety study.
,identify side effects
measure effectiveness
100-300 people
used on individuals with the disease process
Phase 3 Correct Answer-measure effectiveness
monitor side effects
1,000-3,000 people
make sure its causing no significant effects. Effectiveness and adverse
events (double-blind studies). true evidence of how it is effective.
Phase 4 Correct Answer-Monitor long term side effects
approval means it can be marketed after phase 3 only by the company
seeking its approval. May see its not as effective, issue black box
warnings. Compared to other drugs on the market. Can still be taken off
the market
How long can the clinical trial process last Correct Answer-up to 9 years
How many categories of scheduled drugs are there Correct Answer-5
Schedule 1 drugs Correct Answer-high potential for abuse, no routine
therapeutic use
investigational only
heroin, etc.
, Schedule 2 drugs Correct Answer-valid medical use, high potential for
abuse
written prescription needed, can be called in but need the written
prescription within 72 hours.
Amphetamines, barbiturates. Cannot be refilled
Schedule 3 drugs Correct Answer-Potential for abuse is lower than drugs
on schedule 2, prescriptions cannot be refilled
combined controlled and noncontrolled in them.
Codiene, non-barbiturate sedatives
Schedule 4 drugs Correct Answer-Low potential for abuse, limited
physical dependency
non narcotic analgesics, benzo
Schedule 5 drugs Correct Answer-Least potential for abuse, moderate
amount of opioids
Antitussives, lomotil, etc.
What is the NPI number Correct Answer-Identify all healthcare
providers by a unique number in standard transactions such as your
healthcare claims
Assists with the efficiency and effectiveness of electronically
transmitted health information.
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