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NIH Principals of Clinical Pharmacology questions and answers

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NIH Principals of Clinical Pharmacology questions and answers

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  • June 23, 2024
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  • 2023/2024
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NIH Principals of Clinical Pharmacology
2021-2022
A patient is receiving an aminoglycoside antibiotic for the treatment of a serious infection. PK
samples today revealed a peak within acceptable limits but a trough much lower than the
target concentration. What is the best approach to increase the trough concentration? -
correct answer-Reduce the dosing interval (i.e. shorten the time between doses)
Extend the dosing interval (i.e. lengthen the time between doses)
Increase the dose
Decrease the dose

A patient with depression diagnosed 2 years ago presents to your office for follow-up.
Although he states his mood is "pretty good most days," he started St. John's Wort 3 weeks
ago based on a recommendation from a friend. He is currently taking an antidepressant that
is a CYP3A4 substrate. What is your assessment regarding the drug-herbal interaction? -
correct answer-The antidepressant can increase the metabolism of the St. John's Wort,
possibly causing loss of clinical efficacy of St. John's Wort
The antidepressant can decrease the metabolism of the St. John's Wort, possibly increasing
the risk of toxicities associated with St. John's Wort
St. John's Wort can increase metabolism of the antidepressant, possibly causing loss of
clinical efficacy of the antidepressant
St. John's Wort can decrease metabolism of the antidepressant, possibly increasing the risk
of toxicities associated with the antidepressant

A patient with intermediate TPMT activity is planning to initiate mercaptopurine. Which of the
following is the most reasonable approach? - correct answer-Use of mercaptopurine is
contraindicated in this population so therapy should not be initiated
TPMT activity is not relevant in mercaptopurine dosing so no dose adjustment is required
Increase the initial dose by 30-60%
Decrease the initial dose by 30-60%

According to Lipinski's Rule of 5, which of the following characteristics is flagged as likely to
have poor oral absorption? - correct answer-Less than 5 H-bond donors
Molecular weight < 500
c log P < 5
Sum of Ns and Os (H-bond acceptors) > 10

All of the following are expedited programs at the FDA except: - correct answer-Accelerated
Approval
Special Protocol Review
Fast Track
Breakthrough Therapy Designation

An 14 kg child is prescribed azithromycin for community-acquired pneumonia. The
prescription is for 10 mg/kg on day 1, followed by 5 mg/kg/dose once daily on days 2-5.

, Azithromycin is available as a 100 mg/5mL suspension. How many mLs will be required to
complete the course? - correct answer-10 mL
12 mL
21 mL
26 mL

An investigator would like to open a clinical trial using a topical medication in the infant
population. Which of the following most accurately characterizes a factor that impacts
systemic absorption of topical agents in infants compared to adults? - correct
answer-Epidermal thickness is the same in preterm infants, full-term infants, and adults
The extent of skin hydration increases from infancy to adulthood
The extent of perfusion diminishes from infancy to adulthood
P-glycoprotein is the primary determinant of systemic absorption in both infants and adults

Drug G is administered in an active form and converted to an inactive metabolite by
CYP2D6. If Drug G is administered to a patient who is a poor metabolizer, what is the likely
outcome? - correct answer-The efficacy will be reduced
The metabolism will be increased
The toxicity will be increased
The metabolism will be as expected

Drug X is given at a dose of 100 mg by mouth every 12 hours. If the half-life is 11.1 hours,
approximately when will steady-state be reached? - correct answer-At 23 hours
At 56 hours
At 80 hours
At 133 hours

Drug Z is given at a dose of 100 mg by mouth once daily and exhibits nonlinear
pharmacokinetics. If the dose is doubled (i.e. to 200 mg/day), how would the average steady
state concentration be impacted? - correct answer-The average steady state concentration
would remain unchanged
The average steady state concentration would decrease by 50%
The average steady state concentration would double
The average steady state concentration would increase unpredictably

During the third trimester of pregnancy, the percent protein binding of Drug C has been
shown to be 22%. Typical fluid volumes for such patients are 21 L for extracellular fluid
space and 40 L for total body water. Based on this data, what would be the expected
distribution volume of Drug C?
Hint: Vd = ECF + fu (TBW-ECF) - correct answer-26 L
28 L
39 L
36 L

Factors that determine drug transport across the blood brain barrier include all of the
following except: - correct answer-Renal function
Charge at physiological pH
Presence of efflux transporters

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