CA-6 UNIT-6

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1. Nonlinear pharmacokinetics refers to 2. Which of the following processes in

a situation where the following the body can contribute to non-
relationship between a drug and its linear pharmacokinetics?
plasma concentration does NOT A. Passive diffusion across cell
hold true: membranes.
A. The rate of drug elimination is constant. B. Saturation of plasma protein binding
B. Doubling the dose results in a doubling sites.
of the plasma concentration. C. Zero-order elimination by metabolism.
C. The drug exhibits dose-dependent D. Both A and B
changes in its pharmacokinetic
parameters.
D. The drug follows first-order elimination
kinetics.
3. A drug undergoes extensive first-pass 4. Which of the following statements
metabolism in the liver. At low about the implications of non-linear
doses, the elimination rate constant pharmacokinetics is MOST
(kel) remains relatively constant. accurate?
However, as the dose increases, kel
starts to decrease. This observation A. It simplifies the prediction of drug
suggests: effects at different doses
A. The drug follows zero-order elimination
kinetics. B. It necessitates complex
B. The metabolic pathway for the drug mathematical models for dose
becomes saturated at higher doses. adjustment in patients.
C. The drug exhibits time-dependent
elimination. C. It eliminates the need for
D. The liver becomes less efficient at therapeutic drug monitoring.
eliminating the drug at higher doses.
D. It has no significant impact on
clinical practice.

5. Compared to a healthy individual, 6. Which of the following dosage

an individual with severe liver forms is LEAST likely to exhibit
dysfunction might exhibit changes in non-linear pharmacokinetic
the pharmacokinetics of a drug that behavior?
is primarily eliminated by hepatic
metabolism. These changes could A. A sustained-release tablet with a
include: controlled release mechanism.
A. Increased volume of distribution.
B. An intravenous bolus injection of a
B. Decreased first-pass effect. highly water-soluble drug.

C. Prolonged elimination half-life. C. An oral suspension of a drug with low

aqueous solubility.
D. Both B and C
D. A chewable tablet containing a drug
with high protein binding affinity.
7. In a clinical trial, researchers observe a 8. Which of the following statements
disproportionately large increase in about therapeutic drug monitoring
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plasma concentration compared to the (TDM) is MOST relevant in the context

increase in dose for a new drug of non-linear pharmacokinetic drugs?
candidate. What is the MOST
appropriate initial step to investigate A. TDM becomes less important because
this observation? dose adjustments are predictable.

B. TDM plays a crucial role in ensuring

A. Repeat the study with a larger sample effective and safe drug therapy.
size.
B. Investigate potential drug interactions C. Blood sampling for TDM can be done at
with co-administered medications. any time point after drug administration.

C. Design in-vitro studies to assess the D. TDM is only necessary for patients with
drug's protein binding characteristics. severe renal impairment.

D. Modify the dosage regimen to administer

smaller doses more frequently.
9. A drug exhibits a non-linear relationship 10. Which of the following factors can
between dose and plasma concentration. contribute to non-linear drug
This most likely indicates saturation of metabolism, leading to a non-linear
which of the following processes? pharmacokinetic response?

A. Absorption from the gastrointestinal tract A. High water solubility of the drug

B. Distribution throughout body tissues B. Low protein binding in plasma

C. Elimination from the body C. Enzyme saturation at high drug

concentrations (Km)
D. All of the above
D. Presence of food in the gastrointestinal
tract
11. Michaelis-Menten kinetics is a 12. Compared to a drug with linear
commonly used model to describe non- pharmacokinetics, a drug exhibiting
linear drug metabolism. What parameter non-linear pharmacokinetic behavior
in this model represents the drug due to saturation of elimination
concentration at which the metabolic processes may require:
rate reaches half its maximum velocity A. A lower initial dose to achieve the same
(Vmax)? therapeutic effect.
A. Clearance (Cl) B. A higher frequency of dosing to
B. Volume of distribution (Vd) maintain therapeutic drug levels.
C. Less frequent monitoring of plasma
C. Michaelis constant (Km) drug concentrations.
D. A simpler dosage regimen for all
D. Elimination half-life (t½) patients.

13. When designing a clinical trial to 14. A drug exhibits a dose-dependent

evaluate the pharmacokinetics of a new decrease in oral bioavailability. This is
drug, why is it important to consider most likely due to saturation of which
potential non-linearity in its response? process?
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A. Non-linearity simplifies dose selection for A. Passive diffusion across the intestinal
the study. membrane
B. It allows for a smaller number of B. Enzymatic degradation in the gut wall
participants to be enrolled. C. Renal clearance
C. If non-linearity is present, the relationship D. Protein binding in plasma
between dose and plasma concentration
needs to be carefully evaluated to
establish safe and effective dosing
regimens.
D. Non-linearity is a rare phenomenon and
can be ignored in most cases.

15. A highly protein-bound drug exhibits a 16. A drug undergoes metabolism by the
non-linear increase in free drug CYP3A4 enzyme system. At high doses,
concentration with increasing dose. plasma concentrations of the drug
What is the most likely explanation? increase disproportionately compared
A. Increased blood flow to distribution to the increase in dose. This suggests:
tissues A. Increased activity of CYP3A4 at higher
B. Saturation of binding sites on plasma substrate (drug) concentrations
proteins B. Saturation of CYP3A4 enzyme capacity
C. Enhanced renal excretion at higher C. First-pass metabolism becoming less
doses significant
D. Faster metabolism at higher drug D. Competition for CYP3A4 by another
concentrations drug
17. A drug is primarily eliminated by renal 18. Which of the following statements
tubular secretion. At high doses, the about non-linear pharmacokinetics is
amount of drug excreted in the urine MOST accurate?
does not increase proportionally with A. It only affects the absorption of drugs.
the dose. This indicates saturation of: B. It can occur due to saturation of processes
A. Glomerular filtration in absorption, distribution, metabolism, and
B. Passive tubular reabsorption excretion.
C. Active tubular secretion C. It always leads to a decrease in drug
D. Hepatic metabolism exposure at higher doses.
D. It simplifies the prediction of drug effects at
different dose levels.
19. Why is it important to consider 20. Compared to a drug with linear
potential non-linear pharmacokinetics pharmacokinetics, a drug exhibiting
when designing a dosing regimen for a non-linear elimination due to
new drug? saturation of metabolic processes may
A. It may necessitate adjustments to the dose require
based on individual patient characteristics. A. A lower initial dose to achieve the same
B. It allows for a fixed dose regimen for all therapeutic effect.
patients. B. A higher frequency of dosing to maintain
therapeutic drug levels.
C. Non-linear drugs are less effective than
C. Less frequent monitoring of plasma drug
drugs with linear pharmacokinetics. concentrations
D. Blood concentration monitoring becomes
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unnecessary. D. A simpler dosage regimen for all patients.

21. Consider the following reaction scheme for 22. The Michaelis-Menten equation relates
enzymatic conversion of substrate (S) to the reaction rate (v) of an enzyme-
product (P) by an enzyme (E): catalyzed reaction to the substrate
………E + S <=> ES -> E + P concentration ([S]). Which of the
According to Michaelis-Menten kinetics, following terms in the equation
which of the following represents the represents the maximum reaction rate?
dissociation constant (Kd) for the enzyme-
A. Km B. v * [S]
substrate complex (ES)?
A. [E] * [P] / [ES] B. [E] * [S] / [ES] C. Vmax
C. [ES] / ([E] + [S]) D. [E] + [S] / [ES] D. [S] / (Km + [S])
23. The following diagram depicts the 24. A numerical representation of the
Michaelis-Menten equation is given
relationship between reaction rate (v)
below:
and substrate concentration ([S]) for an v = (Vmax * [S]) / (Km + [S])
enzyme-catalyzed reaction
If the Km value for a particular
enzyme-substrate pair is 1 mM, what
substrate concentration ([S]) would
result in a reaction rate equal to half
the Vmax?

1. 0.5 mM

The curve reaches a plateau at higher

2. 1 mM

substrate concentrations. What does this 3. 2 mM

plateau represent? 4. Cannot be determined without

A. The rate of substrate depletion knowing Vmax

B. The maximum rate of product 25. Compared to a scenario with a low Km
formation (Vmax)
C. The dissociation rate of the enzyme- value, a high Km value for an enzyme-
substrate complex substrate pair indicates:
D. The point of equal concentrations of
A. A higher affinity of the enzyme for the
substrate and product
substrate
B. A slower rate of product formation at low
substrate concentrations
C. A lower Vmax for the reaction
D. No change in the overall reaction rate

26. If the Vmax for a particular enzyme is 10 27. An experiment is conducted to measure
μmol/min and the Km is 2 μM, what is the initial reaction rates (v) at different
the reaction rate (v) when the substrate substrate concentrations ([S]). The data
concentration ([S]) is 4 μM? is plotted as 1/v vs 1/[S]. The slope (m)
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A. 2.5 μmol/min and y-intercept (b) of the resulting line

B. 5 μmol/min are determined. What does the y-
C. 7.5 μmol/min
D. 10 μmol/min intercept represent?
A. Km
B. 1/Vmax
C. Vmax
D. Km * Vmax

28. An enzyme exhibits a Km value of 5 mM 29. A scientist is studying a new drug that
for a particular substrate. In a acts as a non-competitive inhibitor of a
Lineweaver-Burk plot, a competitive specific enzyme. The Lineweaver-Burk
inhibitor binds to the enzyme and plot for the enzyme-substrate reaction
increases the Km to 10 mM. What can be shows a decrease in Vmax but no
concluded about not true the inhibitor's change in Km compared to the
effect? uninhibited reaction. What does this
A. The inhibitor increases the affinity of suggest about the inhibitor's
the enzyme for the substrate mechanism of action?
B. The inhibitor decreases the affinity of
the enzyme for the substrate A. The inhibitor binds to the same site as
the substrate on the enzyme
C. The inhibitor has no effect on the Vmax
B. The inhibitor binds to a different site on
of the reaction the enzyme, but it reduces the rate of
D. Both A and C are true product formation from the enzyme-
substrate complex
C. The inhibitor increases the Km value,
indicating a decrease in enzyme-
substrate affinity
D. The information provided is insufficient
to determine the inhibitor's mechanism
30. An enzyme reaction follows Michaelis-
Menten kinetics. At a particular
substrate concentration, the reaction
rate is measured to be 6 μmol/min. When
the substrate concentration is doubled,
the reaction rate increases to 9
μmol/min. The Km value for this
enzyme-substrate pair is likely to be:
A. Much lower than 3 μM
B. Around 3 μM
C. Much higher than 3 μM
D. Cannot be determined without
knowing Vmax

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