Quiznetik

Biopharmaceutics and Pharmacokinetics | Set 5

1. What is the driving force for glomerular filtration?

A. Concentration gradient

B. Hydrostatic pressure of plasma

C. High amount of aqueous pores

D. Hydrostatic pressure of blood flow

Correct : D. Hydrostatic pressure of blood flow

2. Which of the following compounds are used as agents to determine Glomerular Filtration Rate?

A. Calcium ion

B. Albumin

C. Creatinine

D. Calcium carbonate

Correct : C. Creatinine

3. 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

Correct : B. Low solubility /High permeability

4. ………………is the ratio of the mean residence time to the absorption time

A. Absorption number

B. Dissolution number

C. Dose number

D. Intrinsic dissolution

Correct : A. Absorption number

5. USP Apparatus 5 is

A. Flow-through- cell

B. paddle over disk

C. Cylinder

D. Paddle

Correct : B. paddle over disk

6. 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

Correct : D. In vivo studies in human

7. 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

Correct : A. Not more than 2.5 m in thickness

8. 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

Correct : B. Disintegration

9. Under the concept biopharmaceutics, hydrophobic drugs are

A. Permeation rate limited

B. Dissolution rate limited

C. Both

D. Initially permeation then dissolution rate limited

Correct : B. Dissolution rate limited

10. When a drug is administered by the intravenous route then an absolute bioavailability will be

A. 1

B. 0

C. 2

D. 3

Correct : A. 1

11. 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

Correct : D. All of the above

12. Apparatus 5 of dissolution apparatus is known as

A. Paddle over disk

B. Flow-through- cell

C. Reciprocating disk

D. Basket

Correct : A. Paddle over disk

13. 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

Correct : C. Is incompletely absorbed

14. 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

Correct : A. AUC IV / AUC oral

15. The comparison of bioavailability between two dosage forms.

A. Bioequivalence

B. Bioavailability

C. Biopharmaceutics

D. Biological

Correct : A. Bioequivalence

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

A. Biological

B. Bioavailability

C. Biopharmaceutics

D. Bioequivalency

Correct : B. Bioavailability

17. 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.

Correct : D. Intravenous administration gets the drug into your bloodstream the fastest.

18. 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:

A. Biopharmaceutics

B. Relative bioavailability

C. Absolute bioavailability

D. Bioavailability

Correct : C. Absolute bioavailability

19. 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

Correct : A. Bioavailability of dosage form of one drug is same as that of the other dosage form

20. 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

Correct : B. Intravenous > oral > rectal > topical

21. …………decreases bioavailability of tetracycline.

A. Lactose

B. DCP

C. Starch

D. MCC

Correct : B. DCP

22. 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

Correct : B. measurement of the rate and amount of therapeutically active drug that reaches the systemic circulation

23. 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

Correct : C. Extent of absorption and hepatic first-pass effect

24. Bioavailability is defined as…..

A. Rate of drug absorption

B. Rate of drug distribution

C. Rate of drug elimination

D. Rate and extent of absorption

Correct : D. Rate and extent of absorption

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

A. controlled released product

B. hard gelatin capsule

C. tablet

D. solution

Correct : D. solution

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

A. Therapeutic Index

B. Therapeutic range

C. Therapeutic outcome

D. Therapeutic ratio

Correct : B. Therapeutic range

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

A. Paddle

B. Basket

C. Rotating basket

D. Rotating paddle

Correct : A. Paddle

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

A. hair

B. urine

C. saliva

D. All of the above

Correct : D. All of the above

29. Ex-vivo models refer to…….

A. in the body

B. in the computer

C. outside the body

D. none of the above

Correct : C. outside the body

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

A. Hansen paddle type

B. paddle over disc

C. Rotating basket type

D. none of the above

Correct : A. Hansen paddle type

31. Bioavailability from IV route is……%

A. 10

B. 100

C. 1000

D. 10000

Correct : B. 100

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

A. Skin condition

B. Topical vehicle

C. Application condition

D. all of the above

Correct : D. all of the above

33. 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

Correct : B. The rate of absorption of the unchanged drug from its dosage form

34. 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

Correct : C. Bioavailable dose/Administered dose

35. 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

Correct : D. Control the quantity of the drug to be administered

36. Single-dose bioavailability studies are simple and common.

A. True

B. False

C. none

D. all

Correct : A. True

37. Multiple dose study is better since we can understand the peak, valley, drug blood levels, etc.

A. True

B. False

C. none

D. all

Correct : A. True

38. 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

Correct : A. Acute pharmacologic response

39. 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

Correct : D. Steady state level

40. 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

Correct : C. [AUC]test Dstd τtest / [AUC]std Dtest τstd

41. The urinary excretion of the unchanged drug is directly proportional to the plasma concentration of a drug.

A. True

B. False

C. none

D. all

Correct : A. True

42. 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

Correct : D. Cmax

43. Which of the following is not measured in acute pharmacological response study?

A. ECG

B. EEG

C. Pupil diameter

D. Serum drug level

Correct : D. Serum drug level

44. Therapeutic response is based on observing the clinical response to a drug formulation.

A. True

B. False

C. none

D. all

Correct : A. True

45. In vitro determination of bioavailability by dissolution rate is not the best way to determine therapeutic efficacy.

A. True

B. False

C. none

D. all

Correct : B. False

46. 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

Correct : C. Duration of drug of action

47. Poor bioavailability means poor aqueous solubility.

A. True

B. False

C. none

D. all

Correct : A. True

48. A drug with poor stability means higher bioavailability.

A. True

B. False

C. none

D. all

Correct : B. False

49. 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

Correct : D. Partition coefficient approach

50. 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

Correct : A. 1-10 micron

51. 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

Correct : B. Enhancing the dissolution rate by promoting wetting

52. Salts improve solubility and dissolution characteristics.

A. True

B. False

C. none

D. all

Correct : A. True

53. 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

Correct : B. In situ salt formation

54. 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

Correct : C. Inorganic clays like bentonite

55. 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

Correct : B. Organic solvent

56. 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

Correct : A. Highly water-soluble compound

57. 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

Correct : B. Cyclodextrin

58. 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

Correct : C. Comparison between a drug’s specific characteristics to a defined set of standards

59. 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

D. Two or more drug products contain the same labeled chemical substance giving a different therapeutic effect

Correct : A. Two or more drug products contain the same labeled chemical substance in the same amount

60. What is pharmaceutic equivalence?

A. Two or more drug products contain the same labeled chemical substance in the same amount

B. Two or more drug products are identical in quality, purity, uniformity, disintegration, dissolution

C. Two or more drug products contain different labeled chemical substance giving the same therapeutic effect

D. Two or more drug products contain the same labeled chemical substance giving a different therapeutic effect

Correct : B. Two or more drug products are identical in quality, purity, uniformity, disintegration, dissolution

61. What is bioequivalence?

A. Drug substance reaches the systemic circulation at the same rate in two or more identical dosage

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

D. Two or more drug products contain the same labeled chemical substance giving a different therapeutic effect

Correct : A. Drug substance reaches the systemic circulation at the same rate in two or more identical dosage

62. What is therapeutic 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 the same labeled chemical substance giving the same therapeutic effect

D. Two or more drug products contain the same labeled chemical substance giving a different therapeutic effect

Correct : C. Two or more drug products contain the same labeled chemical substance giving the same therapeutic effect

63. On which individuals study of newly invented medicines are not done?

A. Pregnant and elderly

B. Fasting person

C. Healthy person

D. Adult male

Correct : A. Pregnant and elderly

64. 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

Correct : D. Takes a lot of time to get the result of the study

65. 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

C. none

D. all

Correct : B. False

66. If the bioavailability of test formulation is 80-120% of the reference standard, it is considered to be bioequivalent.

A. True

B. False

C. none

D. all

Correct : A. True

67. 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

C. none

D. all

Correct : B. False

68. The concentration of drug in plasma above which toxic effects are precipitated is known as

A. Maximum safe concentration

B. Minimum Effective Concentration

C. Intensity of Action

D. Duration of Action

Correct : A. Maximum safe concentration

69. When rate is independent of the reactant concentration, then it is called

A. zero order reaction

B. Pseudo zero order reaction

C. First order reaction

D. Second order reaction

Correct : A. zero order reaction

70. Which of the following is the half life of zero order reaction?

A. t1/2 = A0 /2k

B. t1/2 = 0.693/2k

C. t1/2 = A0 /2

D. t1/2 = 2k/ A0

Correct : A. t1/2 = A0 /2k

71. The unit of k for zero order reaction is

A. moles/litre/second

B. moles

C. moles/second

D. moles/litre

Correct : A. moles/litre/second

72. Which of the following is the half life of first order reaction?

A. t1/2 = A0 / 2k

B. t1/2 = 0.693 / 2k

C. tl/2 = 2k

D. tl/2 = 0.693 / k

Correct : D. tl/2 = 0.693 / k

73. Which of the following is not a pharmacokinetic parameters that describe the plasma level time curve?

A. tmax

B. cmax

C. Area under Curve

D. Minimum Effective Concentration

Correct : D. Minimum Effective Concentration

74. The drug concentration between Minimum Effective Concentration and Maximum Safe Concentration is called

A. Therapeutic range

B. Area under curve

C. Peak response

D. Pharmacological response

Correct : A. Therapeutic range

75. tmax indicates

A. drug absorption rate

B. drug elimination rate

C. drug distribution rate

D. drug metabolism rate

Correct : A. drug absorption rate

76. What Will be the approximate Tmax of a drug exhibiting Ka of 2 hr-1 and K of 0.2 hr-1 ?

A. 1.2 hr

B. 2.4 hr

C. 4.8 hr

D. 2.0 hr

Correct : A. 1.2 hr

77. A drug solution has half life of 21 days. Assuming that drug undergoes first order kinetics, how long will it take for the potency to drop to 90% of initial potency?

A. 3.2 days

B. 9.6 days

C. 16 days

D. 6.2 days

Correct : A. 3.2 days

78. A suspension shows zero-order kinetic with a rate constant 2mg/ml.month. The dose of suspension is 20mg/ml. The biological half life of the above dosage form is

A. 5 months

B. 1 month

C. 3 months

D. 2 months

Correct : A. 5 months

79. Drug showing zero order kinetic of elimination

A. Are more common than those showing first order kinetic

B. Show plot of drug concentration vs time (linear Plot)

C. Decrease in concentration exponentially with time

D. Have half life independent of dose

Correct : B. Show plot of drug concentration vs time (linear Plot)

80. Elimination after 4 half lives in first order kinetics is

A. 84%

B. 93%

C. 80%

D. 4%

Correct : B. 93%

81. Which one is irrational statement for first order kinetics?

A. Half life is a function of concentration of reactants

B. Reaction rate is not a function of concentration of reactants

C. Both a & b

D. All of these

Correct : D. All of these

82. T % (Half life time) of a drug can determine all of the following except

A. Closing interval

B. Therapeutic dose

C. Elimination time

D. Steady plasma concentration

Correct : B. Therapeutic dose

83. The area under serum concentration time curve of drug represents

A. The biological half life of the drug

B. Amount of drug biotransformed

C. The amount of drug absorbed

D. The amount of drug excreted in urine

Correct : D. The amount of drug excreted in urine

84. Under non compartment analysis the following formula is used for calculation

A. MRT = AUMC / AUC

B. AUMC = MRT / AUC

C. MRT = AUC / AUMC

D. AUC = AUMC / MRT

Correct : A. MRT = AUMC / AUC

85. Under compartment modeling, Wegner-Nelson-Method involves

A. Determination of absorption rate constant (Ka) from %ARA Vs time curve

B. Determination of elimination rate constant (Ka) from % ARA Vs time curve

C. Determination of absorption rate constant (Ke) from %ARA •Vs Concentration curve

D. Determination of plasma half life

Correct : A. Determination of absorption rate constant (Ka) from %ARA Vs time curve

86. The steady-state concentration of a drug can be double by:

A. Doubling the both rate of infusion and concentration of drug.

B. Doubling the rate of infusion only.

C. Doubling the loading dose but maintaining the infusion rate.

D. Tripling the rate of infusion.

Correct : B. Doubling the rate of infusion only.

87. In compartment modeling the term "Open" indicates

A. Unidirectional input and output

B. All compartments are open

C. Body is open

D. None of the above

Correct : A. Unidirectional input and output

88. Select the formula to calculate steady state concentration follows IV infusion

A. Css= Infusion Rate/ Clearance

B. Css= Clearance / Infusion Rate

C. Css= Infusion Rate X Clearance

D. Css = Infusion Rate - Clearance

Correct : A. Css= Infusion Rate/ Clearance

89. IV infusion model follows

A. Zero order absorption and first order elimination kinetic

B. No absorption and first order elimination kinetic

C. No absorption and Zero order elimination kinetic

D. First order absorption and first order elimination kinetic

Correct : A. Zero order absorption and first order elimination kinetic

90. Select the formula to calculate elimination half life

A. t1/2 = 0.693 + Ke

B. t1/2 = 0.693 / Ke

C. t1/2 = 0.693 × Ke

D. t1/2 = 0.693 – Ke

Correct : B. t1/2 = 0.693 / Ke

91. The constants that represent reversible transfer of drug between compartments are called as

A. microconstants

B. macroconstant

C. Infusion

D. Lag time

Correct : A. microconstants

92. In two compartment model, extravascular route of drug administration, there are ……phases

A. absorption phase,

B. Distribution phase

C. elimination phase,

D. All of the above

Correct : D. All of the above

93. Ka is estimated by

A. Method of Residuals

B. Loo Riegelman method

C. Both a and b

D. None of the above

Correct : C. Both a and b

94. The central compartment consist of

A. Highly perfused tissues

B. Slowly equilibrate tissues

C. Both a and b

D. Reproductive org

Correct : A. Highly perfused tissues

95. What does "pharmacokinetics" includes?

A. Mechanisms of drug action

B. Localization of drug action

C. Interaction of substances

D. Excretion of substances

Correct : D. Excretion of substances

96. Pharmacokinetics is:

A. The study of absorption, distribution, metabolism and excretion of drugs

B. The study of biological and therapeutic effects of drugs

C. The study of methods of new drug development

D. The study of mechanisms of drug action

Correct : A. The study of absorption, distribution, metabolism and excretion of drugs

97. What does "pharmacokinetics" includes?

A. Drug biotransformation in the organism

B. Influence of drugs on metabolism processes

C. Influence of drugs on genes

D. Complications of drug therapy

Correct : A. Drug biotransformation in the organism

98. Parenteral administration:

A. Is too slow for emergency use

B. Cannot be used with unconsciousness patients

C. Generally results in a less accurate dosage than oral administration

D. Usually produces a more rapid response than oral administration

Correct : D. Usually produces a more rapid response than oral administration

99. The volume of distribution (Vd) relates:

A. The amount of a drug in the body to the concentration of a drug in plasma

B. An uncharged drug reaching the systemic circulation

C. Single to a daily dose of an administrated drug

D. An administrated dose to a body weight

Correct : A. The amount of a drug in the body to the concentration of a drug in plasma

100. For the calculation of the volume of distribution (Vd) one must take into account:

A. Concentration of substance in urine

B. Therapeutical width of drug action

C. A daily dose of drug

D. Concentration of a substance in plasma

Correct : D. Concentration of a substance in plasma