NAPSRx FINAL EXAM COMPLETE QUESTIONS WITH ANSWERS
100% VERIFIED 2025 LATEST UPDATED ALREADY GRADED A+
Question 1
According to the Federal Food, Drug, and Cosmetic Act, what is the primary definition of a
"drug"?
A) Any substance that provides nutritional value to the body.
B) Any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of
disease in man or other animals.
C) Any chemical compound that alters the mind.
D) A substance used solely for cosmetic enhancement.
E) A supplement derived from herbal sources.
Correct Answer: B) Any article intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man or other animals.
Rationale: The FDA defines a drug broadly not just by its chemical nature, but by
its intended use. If a product is intended to diagnose, cure, mitigate, treat, or prevent
disease, or to affect the structure or function of the body, it is classified as a drug.
Question 2
What does the acronym "ADME" stand for in the context of Pharmacokinetics?
A) Administration, Dosage, Monitoring, Evaluation.
B) Absorption, Distribution, Metabolism, Excretion.
C) Activation, Delivery, Modification, Elimination.
D) Analysis, Design, Manufacturing, Efficacy.
E) Affinity, Dissociation, Migration, Effect.
Correct Answer: B) Absorption, Distribution, Metabolism, Excretion.
Rationale: ADME describes the four stages of a drug's life cycle within the body:
Absorption (getting into the blood), Distribution (moving to tissues), Metabolism (breaking
down, usually in the liver), and Excretion (leaving the body, usually via kidneys).
Question 3
Which phase of a clinical trial is primarily concerned with assessing the safety of a drug in
a small number (20–100) of healthy volunteers?
A) Pre-clinical Phase
B) Phase I
C) Phase II
D) Phase III
E) Phase IV
, [Type here]
Correct Answer: B) Phase I
Rationale: Phase I trials are the first human tests. They are small-scale and focus on safety,
tolerability, and pharmacokinetics, usually in healthy volunteers. Phase II focuses on
efficacy in patients; Phase III is large-scale confirmation; Phase IV is post-market.
Question 4
What is the "First-Pass Effect"?
A) The immediate therapeutic effect felt by the patient.
B) The filtering of the drug by the kidneys before it enters the blood.
C) The rapid uptake of a drug by the brain.
D) The metabolism of a drug by the liver before it reaches systemic circulation.
E) The initial rejection of a drug by the body's immune system.
Correct Answer: D) The metabolism of a drug by the liver before it reaches systemic
circulation.
Rationale: When a drug is taken orally, it is absorbed from the GI tract into the portal vein
and travels directly to the liver. The liver may metabolize a significant portion of the drug
before it ever enters the systemic circulation to reach target tissues. This reduces the
bioavailability of oral medications.
Question 5
Under the Prescription Drug Marketing Act (PDMA), which of the following practices
regarding drug samples is strictly prohibited?
A) Distributing samples to a licensed practitioner upon written request.
B) Storing samples in a locked cabinet.
C) The sale, purchase, or trade of drug samples.
D) Using a common carrier to ship samples.
E) Keeping an inventory log of samples.
Correct Answer: C) The sale, purchase, or trade of drug samples.
Rationale: The PDMA was enacted to prevent the diversion of sub-potent or counterfeit
drugs. It specifically bans the sale, purchase, or trade (or the offer to sell, purchase, or
trade) of drug samples and drug coupons.
Question 6
What is "Bioavailability"?
A) The total amount of drug in the pill.
B) The rate and extent to which the active ingredient is absorbed from a drug product and
100% VERIFIED 2025 LATEST UPDATED ALREADY GRADED A+
Question 1
According to the Federal Food, Drug, and Cosmetic Act, what is the primary definition of a
"drug"?
A) Any substance that provides nutritional value to the body.
B) Any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of
disease in man or other animals.
C) Any chemical compound that alters the mind.
D) A substance used solely for cosmetic enhancement.
E) A supplement derived from herbal sources.
Correct Answer: B) Any article intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man or other animals.
Rationale: The FDA defines a drug broadly not just by its chemical nature, but by
its intended use. If a product is intended to diagnose, cure, mitigate, treat, or prevent
disease, or to affect the structure or function of the body, it is classified as a drug.
Question 2
What does the acronym "ADME" stand for in the context of Pharmacokinetics?
A) Administration, Dosage, Monitoring, Evaluation.
B) Absorption, Distribution, Metabolism, Excretion.
C) Activation, Delivery, Modification, Elimination.
D) Analysis, Design, Manufacturing, Efficacy.
E) Affinity, Dissociation, Migration, Effect.
Correct Answer: B) Absorption, Distribution, Metabolism, Excretion.
Rationale: ADME describes the four stages of a drug's life cycle within the body:
Absorption (getting into the blood), Distribution (moving to tissues), Metabolism (breaking
down, usually in the liver), and Excretion (leaving the body, usually via kidneys).
Question 3
Which phase of a clinical trial is primarily concerned with assessing the safety of a drug in
a small number (20–100) of healthy volunteers?
A) Pre-clinical Phase
B) Phase I
C) Phase II
D) Phase III
E) Phase IV
, [Type here]
Correct Answer: B) Phase I
Rationale: Phase I trials are the first human tests. They are small-scale and focus on safety,
tolerability, and pharmacokinetics, usually in healthy volunteers. Phase II focuses on
efficacy in patients; Phase III is large-scale confirmation; Phase IV is post-market.
Question 4
What is the "First-Pass Effect"?
A) The immediate therapeutic effect felt by the patient.
B) The filtering of the drug by the kidneys before it enters the blood.
C) The rapid uptake of a drug by the brain.
D) The metabolism of a drug by the liver before it reaches systemic circulation.
E) The initial rejection of a drug by the body's immune system.
Correct Answer: D) The metabolism of a drug by the liver before it reaches systemic
circulation.
Rationale: When a drug is taken orally, it is absorbed from the GI tract into the portal vein
and travels directly to the liver. The liver may metabolize a significant portion of the drug
before it ever enters the systemic circulation to reach target tissues. This reduces the
bioavailability of oral medications.
Question 5
Under the Prescription Drug Marketing Act (PDMA), which of the following practices
regarding drug samples is strictly prohibited?
A) Distributing samples to a licensed practitioner upon written request.
B) Storing samples in a locked cabinet.
C) The sale, purchase, or trade of drug samples.
D) Using a common carrier to ship samples.
E) Keeping an inventory log of samples.
Correct Answer: C) The sale, purchase, or trade of drug samples.
Rationale: The PDMA was enacted to prevent the diversion of sub-potent or counterfeit
drugs. It specifically bans the sale, purchase, or trade (or the offer to sell, purchase, or
trade) of drug samples and drug coupons.
Question 6
What is "Bioavailability"?
A) The total amount of drug in the pill.
B) The rate and extent to which the active ingredient is absorbed from a drug product and
