NSG6021
Pre-Clinical Evaluation
Midterm Assessment Review
(With Solutions)
2026
1
,2. Which animal model is most appropriate for evaluating the
cardiotoxicity of a new chemotherapeutic agent?
a) Zebrafish
b) Rabbit
c) Rat
d) Dog
Answer: d) Dog
Rationale: Dogs have cardiovascular physiology closer to humans and are
commonly used for cardiotoxicity studies.
3. During ADME (Absorption, Distribution, Metabolism, Excretion)
evaluation, which phase I metabolic reaction typically introduces a polar
group?
a) Glucuronidation
b) Sulfation
c) Oxidation
d) Acetylation
Answer: c) Oxidation
Rationale: Oxidation (e.g., via cytochrome P450 enzymes) introduces or
exposes polar functional groups, increasing solubility.
4. What is the primary purpose of a dose-ranging study in pre-clinical
evaluation?
a) To establish the therapeutic window
b) To evaluate the drug's molecular structure
c) To analyze drug solubility
d) To screen for carcinogenicity
Answer: a) To establish the therapeutic window
Rationale: Dose-ranging studies identify the minimum effective dose and
maximum tolerated dose.
2
, 5. Which parameter best describes the lethal dose required to kill 50% of
test animals?
a) NOAEL
b) LC50
c) LD50
d) ED50
Answer: c) LD50
Rationale: LD50 (lethal dose 50%) is a standard toxicology metric
indicating acute toxicity.
True/False
True or False: The use of in vitro cytotoxicity assays can replace all in vivo
pre-clinical toxicity studies.
Answer: False
Rationale: In vitro assays reduce animal use but cannot fully replicate
systemic effects and metabolism occurring in vivo.
True or False: A drug with high plasma protein binding typically has a
longer half-life.
Answer: True
Rationale: High protein binding reduces free drug clearance, prolonging
half-life.
True or False: Pre-clinical evaluation of immunogenicity is only necessary
for biologic drugs.
Answer: True
Rationale: Immunogenicity mainly concerns biologics which can elicit
immune responses.
True or False: The Ames test is used to assess a drug’s mutagenic
potential.
Answer: True
3
Pre-Clinical Evaluation
Midterm Assessment Review
(With Solutions)
2026
1
,2. Which animal model is most appropriate for evaluating the
cardiotoxicity of a new chemotherapeutic agent?
a) Zebrafish
b) Rabbit
c) Rat
d) Dog
Answer: d) Dog
Rationale: Dogs have cardiovascular physiology closer to humans and are
commonly used for cardiotoxicity studies.
3. During ADME (Absorption, Distribution, Metabolism, Excretion)
evaluation, which phase I metabolic reaction typically introduces a polar
group?
a) Glucuronidation
b) Sulfation
c) Oxidation
d) Acetylation
Answer: c) Oxidation
Rationale: Oxidation (e.g., via cytochrome P450 enzymes) introduces or
exposes polar functional groups, increasing solubility.
4. What is the primary purpose of a dose-ranging study in pre-clinical
evaluation?
a) To establish the therapeutic window
b) To evaluate the drug's molecular structure
c) To analyze drug solubility
d) To screen for carcinogenicity
Answer: a) To establish the therapeutic window
Rationale: Dose-ranging studies identify the minimum effective dose and
maximum tolerated dose.
2
, 5. Which parameter best describes the lethal dose required to kill 50% of
test animals?
a) NOAEL
b) LC50
c) LD50
d) ED50
Answer: c) LD50
Rationale: LD50 (lethal dose 50%) is a standard toxicology metric
indicating acute toxicity.
True/False
True or False: The use of in vitro cytotoxicity assays can replace all in vivo
pre-clinical toxicity studies.
Answer: False
Rationale: In vitro assays reduce animal use but cannot fully replicate
systemic effects and metabolism occurring in vivo.
True or False: A drug with high plasma protein binding typically has a
longer half-life.
Answer: True
Rationale: High protein binding reduces free drug clearance, prolonging
half-life.
True or False: Pre-clinical evaluation of immunogenicity is only necessary
for biologic drugs.
Answer: True
Rationale: Immunogenicity mainly concerns biologics which can elicit
immune responses.
True or False: The Ames test is used to assess a drug’s mutagenic
potential.
Answer: True
3
