Bioavailability & Bioequivalence MCQs with Answers

Biopharmaceutics & Pharmacokinetics (BP604TT)

Chapter 5 BIOAVAILABILITY & BIOEQUIVALENCE

1. According to Biopharmaceutics Classification System (BCS), Class II drugs have
a. High solubility/High permeability
b. Low solubility /High permeability
c. High solubility /Low permeability
d. Low solubility /Low permeability
Answer: b

2………………is the ratio of the mean residence time to the absorption time
a. Absorption number
b. Dissolution number
c. Dose number
d. Intrinsic dissolution
Answer: a

3. USP Apparatus 5 is
a. Flow-through- cell
b. paddle over disk
c. Cylinder
d. Paddle
Answer: b

4. In vitro dissolution rate studies on drug product are useful in bioavailability evaluation if they are correlated with
a. Disintegration rate
b. In vivo studies in at least 3 species of animals
c. Chemical stability of drugs
d. In vivo studies in human
Answer: d

5, The gold coating on a USP Dissolution apparatus – I basket should be:
a. Not more than 2.5 m in thickness

b. Not more than 0.1 mm in thickness
c. Not more than 0.025 m in thickness
d. Not more than 0.22 mm in thickness
Answer: a

6. Which of the following is initial step for drug absorption in case of tablet dosage form?
a. Friability
b. Disintegration
c. Dissolution
d. None of these
Answer: b

7. Under the concept biopharmaceutics, hydrophobic drugs are
a. Permeation rate limited
b. Dissolution rate limited
c. Both
d. Initially permeation then dissolution rate limited
Answer: b

8. When a drug is administered by the intravenous route then an absolute bioavailability will be
a. 1 b. 0
c. 2 d. 3
Answer: a

9. Which of the following methods are used to determine Area Under curve?
a. Cut and weigh method
b. Trapezoidal method
c. Integration method
d. All of the above
Answer: d

10. Apparatus 5 of dissolution apparatus is known as
a. Paddle over disk
b. Flow-through- cell
c. Reciprocating disk
d. Basket
Answer: a

11. Bioavailability differences among oral formulations of a drug are most likely to occur if the drug
a. Is freely water soluble
b. Is completely absorbed
c. Is incompletely absorbed
d. Undergoes little first-pass metabolism
Answer: c

12. Bioavailability is expressed by formula
a. AUC IV / AUC oral
b. AUC ora1 X AUC IV
c. AUC ora1 / AUC IV
d. None of the above
Answer: a

13. The comparison of bioavailability between two dosage forms.

1. A. Bioequivalence
2. B. Bioavailability
3. C. Biopharmaceutics
4. D. Biological

Answer: a

14. The relative amount of an administered dose that reaches the general circulation and the rate at which this occurs.

1. A. Biological
2. B. Bioavailability
3. C. Biopharmaceutics
4. D. Bioequivalency

Answer: b

15. Bioavailability of an intravenous drug is always 100% by definition because:
A. Bioavailability measures the amount of substance that reaches the bloodstream.
B. Absolute bioavailability is 50%, for any drug taken intravenously
C. Absolute bioavailability is a much more important measure than relative bioavailability
D. Intravenous administration gets the drug into your bloodstream the fastest.

Answer: d

16. Comparison of the rate and extent of the absorption of drug from the formulation under study to the data of a reference standard that is given intravenously is known as:

1. A. Biopharmaceutics
2. B. Relative bioavailability
3. C. Absolute bioavailability
4. D. Bioavailability

Answer: c

17. If the Relative Bioavailability is 1, it indicates:
A. Bioavailability of dosage form of one drug is same as that of the other dosage form
B. Complete binding of the drugs to the proteins as compared to the standard drug
C. Complete bioavailability of the drug
D. Complete distribution of the drug
Answer: a

18. What would be the order of greater or lesser bioavailability of the dosage forms?
A. Intravenous > rectal > oral > topical
B. Intravenous > oral > rectal > topical
C. Intravenous > topical > rectal > oral
D. Oral > intravenous > rectal > topical
Answer: b

19. …………decreases bioavailability of tetracycline.

1. (a) Lactose
2. (b) DCP
3. (c) Starch
4. (d) MCC

Answer: b

20. The term bioavailability refers to the………….
(a) relationship between the physical and chemical properties of a drug and the systemic absorption of the drug
(b) measurement of the rate and amount of therapeutically active drug that reaches the systemic circulation
(c) movement of drug into the body tissues over time
(d) dissolution of a drug in the gastrointestinal tract

Answer: b

21. The reasons determining bioavailability are…..
(a) Rheological parameters of blood
(b) Amount of a substance obtained orally and quantity of intakes
(c) Extent of absorption and hepatic first-pass effect
(d) Glomerular filtration rate
Answer: c

22. Bioavailability is defined as…..

1. (a) Rate of drug absorption
2. (b) Rate of drug distribution
3. (c) Rate of drug elimination
4. (d) Rate and extent of absorption

Answer: d

23. The rate of drug bioavailability is most rapid when the drug is formulated as a…..

1. (a) controlled released product
2. (b) hard gelatin capsule
3. (c) tablet
4. (d) solution

Answer: d

24. The drug concentration between MEC and MSC represents the….

1. (a) Therapeutic Index
2. (b) Therapeutic range
3. (c) Therapeutic outcome
4. (d) Therapeutic ratio

Answer: b

25. Dissolution test apparatus I as per IP is…..

1. (a) Paddle
2. (b) Basket
3. (c) Rotating basket
4. (d) Rotating paddle

Answer: a

26. Non-invasive measurement of drug concentration includes ……….sampling.

1. (a) hair
2. (b) urine
3. (c) saliva
4. (d) All of the above

Answer: d

27. Ex-vivo models refer to…….

1. (a) in the body
2. (b) in the computer
3. (c) outside the body
4. (d) none of the above

Answer: c

28. USP dissolution test apparatus type-II is also called as…..

1. (a) Hansen paddle type
2. (b) paddle over disc
3. (c) Rotating basket type
4. (d) none of the above

Answer: a

29. Bioavailability from IV route is……%

1. (a) 10
2. (b) 100
3. (c) 1000
4. (d) 10000

Answer: b

30. Bioavailability of drug from topical administration is affected by…..

1. (a) Skin condition
2. (b) Topical vehicle
3. (c) Application condition
4. (d) all of the above

Answer: d

31. Which of the following forms inclusion complex and improves aqueous solubility and dissolution rate?

1. (a) Cyclodextrins
2. (b) PEG
3. (c) PVT
4. (d) Poloxamer

Answer: a

32. What is bioavailability?
a) The time of absorption of the drug from its dosage form
b) The rate of absorption of the unchanged drug from its dosage form
c) The time of absorption of the unchanged drug from its dosage form
d) The rate of absorption of the drug from its dosage form
Answer: b

33. What is the equation of bioavailable fraction?
a) 1/Bioavailable dose
b) 1/Administered dose
c) Bioavailable dose/Administered dose
d) Administered dose/Bioavailable dose
Answer: c

34. Which of the following is not an objective of bioavailability studies?
a) Primary stages of development of suitable dosage form for new drug
b) Determination of the influence of excipients, patient-related factors, etc
c) Development of new formulations of the existing drugs
d) Control the quantity of the drug to be administered
Answer: d

35. Single-dose bioavailability studies are simple and common.
a) True
b) False
Answer: a

36. Multiple dose study is better since we can understand the peak, valley, drug blood levels, etc.
a) True
b) False
Answer: a

37. Which of the following is the pharmacodynamics method of studying bioavailability?
a) Acute pharmacologic response
b) Plasma-level time studies
c) Urinary excretion studies
d) Stool excretion studies
Answer: a

38. Which of the following is not an important parameter of plasma level time studies?
a) Cmax
b) Tax

c) The area under the plasma level-time curve
d) Steady state level
Answer: d

39. What is the equation for bioavailability?
a) [AUC]std Dstd τtest / [AUC]test Dtest τstd
b) [AUC]test Dtest τstd / [AUC]std Dstd τtest
c) [AUC]test Dstd τtest / [AUC]std Dtest τstd
d) 1 / [AUC]std Dtest τstd
Answer: c

40. The urinary excretion of the unchanged drug is directly proportional to the plasma concentration of a drug.
a) True
b) False
Answer: a

41. Which of the following will not be a parameter that should be examined for urinary excretion data?
a) (dXu/dt) max
b) (tu)max
c) Xu
d) Cmax
Answer: d

42. Which of the following is not measured in acute pharmacological response study?
a) ECG
b) EEG
c) Pupil diameter
d) Serum drug level
Answer: d

43. Therapeutic response is based on observing the clinical response to a drug formulation.
a) True
b) False

Answer: a

44. In vitro determination of bioavailability by dissolution rate is not the best way to determine therapeutic efficacy.
a) True
b) False
Answer: b

45. The time period for which the plasma concentration of drug remains above minimum effective concentration is known as ______________
a) Onset of time
b) Onset of action
c) Duration of drug of action
d) Therapeutic range
Answer: c

46. Poor bioavailability means poor aqueous solubility.
a) True
b) False
Answer: a

47. A drug with poor stability means higher bioavailability.
a) True
b) False
Answer: b

48. Which of the following is not an approach for overcoming bioavailability problems?
a) Pharmaceutic approach
b) Pharmacokinetic approach
c) Biologic approach
d) Partition coefficient approach
Answer: d

49. What will be the particle size after micronization of drugs?
a) 1-10 micron
b) 10-20 micron
c) 20-30 micron
d) 1-5 micron
Answer: a

50. What is the principle behind the use of surfactants?
a) Reducing the size of solid drug particles
b) Enhancing the dissolution rate by promoting wetting
c) Improving solubility
d) Alter the pH of the microenvironment
Answer: b

51. Salts improve solubility and dissolution characteristics.
a) True
b) False
Answer: a

52. How pH alteration of the drug microenvironment is done?
a) Altering the pH while the administration
b) In situ salt formation
c) Altering the pH of the tissue
d) Formulating the drug in such a way that it gets activated only when it reaches the tissue pH
Answer: b

53. Which one of the following is used for selective adsorption on insoluble carriers of the drugs?
a) Freeze drying
b) Organic solvent
c) Inorganic clays like bentonite
d) Creating metastable polymorphs
Answer: c

54. Which of the following is used in solvent deposition method of enhancing bioavailability?
a) Freeze drying
b) Organic solvent
c) Inorganic clays like bentonite
d) Creating metastable polymorphs
Answer: b

55. Which of the following is used in solid solutions method of enhancing bioavailability?
a) Highly water-soluble compound
b) Organic solvent
c) Inorganic clays like bentonite
d) Creating metastable polymorphs
Answer: a

56. Which of the following is used in molecular encapsulation of drugs for enhancing bioavailability?
a) Highly water-soluble compound
b) Cyclodextrin
c) Inorganic clays like bentonite
d) Creating metastable polymorphs
Answer: b

Bioequivalence Studies

57. What is bioequivalence?
a) Comparison between 3-year-old drugs to the same new drug
b) Comparison between a drugs to another drug
c) Comparison between a drug’s specific characteristics to a defined set of standards
d) Comparison between two or 3 characteristics of a drug to the same characteristics of a different drug
Answer: c

58. What is the chemical equivalence?
a) Two or more drug products contain the same labeled chemical substance in the same amount
b) Two or more drug products contain the same labeled chemical substance in different quantity
c) Two or more drug products contain different labeled chemical substance giving the same therapeutic effect

c) Healthy person
d) Adult male
Answer: a

63. What should be the disadvantage of cross over study on volunteers?
a) Minimize the intersubject variability in plasma drug levels
b) Minimize the carry-over effect
c) Minimizes variations due to time effect
d) Takes a lot of time to get the result of the study
Answer: d

64. Two or more drugs contain the same therapeutically active ingredient which elicits same pharmacological effects and can control the disease to the same extent are known to be pharmaceutic equivalent.
a) True
b) False
Answer: b

65. If the bioavailability of test formulation is 80-120% of the reference standard, it is considered to be bioequivalent.
a) True
b) False
Answer: a

66. Bioequivalence is a relative term which denotes that the drug substance reaches the systemic circulation at the same relative rate or time.
a) True
b) False
Answer: b