NAPLEX LICENSURE REVIEW SHEET
2026 FULL QUESTIONS AND
ACCURATE ANSWERS
◉ phase 1 studies. Answer: 20-100 healthy volunteers; assess safety,
PK/PD, MTD
(first in-human trial of a new anticoagulant in healthy adults)
◉ phase 2 studies. Answer: hundreds of patients; evaluate efficacy,
dose-ranging
(a new asthma medication tested in 150 patients for FEV1 improvement)
◉ phase 3 studies. Answer: large trials (100-1,000's) confirms efficacy,
monitor adverse effects
(A GLP-1 receptor agonist compared with insulin in 2500 patients with
T2DM)
◉ phase 4 studies. Answer: post-marketing studies for long-term safety,
new indications
(Statin registry tracking adverse liver events over 10 years)
, ◉ Emergency use authorization (EUA). Answer: allow temporary use of
unapproved drugs in public health emergencies
benefits > risks early evidence
◉ Fast track designation. Answer: accelerate development for drug
treating serious conditions with unmet needs
◉ accelerated approval. Answer: early approval based on surrogate
endpoints for serious diseases
◉ Breakthrough Therapy Designation. Answer: expedite drugs showing
substantial improvement over current therapies
◉ orphan drug designation. Answer: encourage developments of drugs
for rare diseases (< 2,000 patients in the U.S)
◉ parallel trial design. Answer: compare treatments in separate groups
◉ crossover trial design. Answer: each subject gets multiple treatments
◉ factorial trial design. Answer: evaluate multiple interventions
simultaneously
2026 FULL QUESTIONS AND
ACCURATE ANSWERS
◉ phase 1 studies. Answer: 20-100 healthy volunteers; assess safety,
PK/PD, MTD
(first in-human trial of a new anticoagulant in healthy adults)
◉ phase 2 studies. Answer: hundreds of patients; evaluate efficacy,
dose-ranging
(a new asthma medication tested in 150 patients for FEV1 improvement)
◉ phase 3 studies. Answer: large trials (100-1,000's) confirms efficacy,
monitor adverse effects
(A GLP-1 receptor agonist compared with insulin in 2500 patients with
T2DM)
◉ phase 4 studies. Answer: post-marketing studies for long-term safety,
new indications
(Statin registry tracking adverse liver events over 10 years)
, ◉ Emergency use authorization (EUA). Answer: allow temporary use of
unapproved drugs in public health emergencies
benefits > risks early evidence
◉ Fast track designation. Answer: accelerate development for drug
treating serious conditions with unmet needs
◉ accelerated approval. Answer: early approval based on surrogate
endpoints for serious diseases
◉ Breakthrough Therapy Designation. Answer: expedite drugs showing
substantial improvement over current therapies
◉ orphan drug designation. Answer: encourage developments of drugs
for rare diseases (< 2,000 patients in the U.S)
◉ parallel trial design. Answer: compare treatments in separate groups
◉ crossover trial design. Answer: each subject gets multiple treatments
◉ factorial trial design. Answer: evaluate multiple interventions
simultaneously
