Bioavailability and Bioequivalence: Master the Concepts for Pharmacy Practice

Question 1

Which of the following is NOT a factor that affects drug bioavailability?

Accepted Answer

Patient's age

Answer

Route of administration

Answer

Dosage form

Answer

Physicochemical properties of the drug

Question 2

The fraction of an administered drug that reaches systemic circulation is known as its:

Accepted Answer

Bioavailability

Answer

Bioequivalence

Answer

Absorption

Answer

Distribution

Question 3

The concept of bioequivalence ensures that:

Accepted Answer

Different formulations of the same drug have comparable therapeutic effects

Answer

Drug manufacturers meet quality standards

Answer

Patients receive the correct dosage of medication

Answer

Drugs are safe for long-term use

Question 4

The primary site for drug metabolism is the:

Accepted Answer

Liver

Answer

Kidneys

Answer

Intestines

Answer

Lungs

Question 5

In the United Kingdom, what is the primary regulatory requirement for demonstrating bioequivalence between two drug products?

Accepted Answer

A 90% confidence interval for the ratio of the test to reference product within 80-125%

Answer

A single-dose, two-treatment, crossover study design involving healthy volunteers

Answer

Bioequivalence studies conducted across multiple doses

Answer

Bioequivalence studies conducted in patients with the target disease

Question 6

Which of the following factors does NOT affect drug bioavailability?

Accepted Answer

Patient's weight

Answer

Dosage form

Answer

Food intake

Answer

pH of the gastrointestinal tract

Question 7

What is the measure of the similarity between the rate and extent of drug absorption from two different formulations?

Accepted Answer

Bioequivalence

Answer

Bioavailability

Answer

Pharmacokinetic equivalence

Answer

Therapeutic equivalence

Question 8

Which of the following is NOT a criterion for establishing bioequivalence according to regulatory guidelines?

Accepted Answer

Study participants are healthy volunteers between 18-55 years of age

Answer

90% confidence interval of AUC lies within 80-125%

Answer

90% confidence interval of Cmax lies within 75-133%

Answer

Randomized, crossover study design

Question 9

What is the primary purpose of a dissolution test?

Accepted Answer

To evaluate the release rate of a drug from a dosage form

Answer

To predict the bioavailability of a drug

Answer

To assess the stability of a drug product

Answer

To identify impurities in a drug product

Question 10

What is the primary purpose of a bioequivalence study?

Accepted Answer

To demonstrate that two drug formulations are equivalent in terms of bioavailability

Answer

To compare the safety and efficacy of two different drug formulations

Answer

To determine the optimal dosage regimen for a new drug

Answer

To investigate the effects of food on drug absorption

Question 11

Which of the following is a potential limitation of using in vitro dissolution testing to predict bioavailability?

Accepted Answer

It does not account for the effects of gastrointestinal physiology

Answer

It is not suitable for drugs with poor solubility

Answer

It is expensive and time-consuming

Answer

It is not validated for all drug formulations

Question 12

What is the significance of the therapeutic index in assessing bioequivalence?

Accepted Answer

It indicates the range of drug concentrations that are both safe and effective

Answer

It helps determine the variability of drug response between individuals

Answer

It predicts the potential for drug-drug interactions

Answer

It is used to calculate the bioavailability of a drug

Question 13

What is the primary goal of bioavailability enhancement strategies?

Accepted Answer

To increase the rate and extent of drug absorption

Answer

To reduce the side effects of the drug

Answer

To improve patient compliance

Answer

To lower the cost of the drug

Question 14

Which of the following factors primarily determines the extent to which a drug reaches its target site in the body?

Accepted Answer

Drug bioavailability

Answer

Drug solubility

Answer

Drug stability

Answer

Drug release from the formulation

Question 15

What is the primary objective of conducting dissolution testing for an oral dosage form?

Accepted Answer

To simulate the release of the drug from the dosage form in the gastrointestinal tract

Answer

To assess the drug's solubility and stability in the gastrointestinal environment

Answer

To determine the amount of drug present in the formulation

Answer

To compare the dissolution profiles of different formulations

Question 16

Which of the following organs serves as a major site for drug distribution?

Accepted Answer

Liver

Answer

Brain

Answer

Heart

Answer

Lungs

Question 17

What is the term used to describe the similarity in the rate and extent of absorption of two drug products?

Accepted Answer

Bioequivalence

Answer

Pharmacokinetic equivalence

Answer

Therapeutic equivalence

Answer

Generic equivalence

Question 18

Which of the following formulations would be expected to have the highest absolute bioavailability?

Accepted Answer

Intravenous injection

Answer

Transdermal patch

Answer

Oral solution

Answer

Sustained-release tablet

Question 19

What is the main purpose of conducting bioequivalence studies?

Accepted Answer

To demonstrate that two different formulations of a drug have similar bioavailability and can be used interchangeably.

Answer

To compare the safety and efficacy of two different drugs.

Answer

To determine the minimum effective dose of a drug

Question 20

Which of the following statistical methods is commonly used to assess bioequivalence?

Accepted Answer

Two one-sided t-tests

Answer

Analysis of variance

Answer

Chi-square test

Answer

Log-rank test

Question 21

What is the significance of the 'bioequivalence window' in bioequivalence studies?

Accepted Answer

It defines the acceptable range of bioavailability between two formulations to be considered bioequivalent, typically within 80-125%.

Answer

It represents the time window within which a drug is absorbed into the body.

Question 22

What is the key difference between absolute and relative bioavailability?

Accepted Answer

Absolute bioavailability compares the amount of drug reaching systemic circulation to the amount administered (usually intravenous injection), while relative bioavailability compares the bioavailability of two different formulations of the same drug.

Answer

Relative bioavailability is always higher than absolute bioavailability.

Question 23

Which of the following is a common strategy to improve the oral bioavailability of a drug?

Accepted Answer

Formulating the drug in a lipid-based delivery system

Answer

Increasing the dose of the drug

Answer

Reducing the frequency of administration

Question 24

What is the role of regulatory agencies, such as the Food and Drug Administration (FDA), in regulating bioequivalence studies?

Accepted Answer

To establish guidelines and standards for the design, conduct, and analysis of bioequivalence studies, ensuring their validity and reliability.

Answer

To approve all new drug formulations that are bioequivalent to existing formulations.