QUESTION BANK-

Subject: Biopharmaceutics and Pharmacokinetics

Year and Sem: Third Year B. Pharm. Sem-VI (Choice Based)

Q.1 Choose appropriate option for following multiple choice based questions.
1. Pharmacokinetics is: .....................
a. The study of biological and therapeutic effects of drugs
b. The study of absorption, distribution, metabolism and excretion of drugs
c. The study of methods of new drug development
d. The study of mechanisms of drug action
2. In the sequence of events in drug absorption from orally administered tablet, which one
comes
at first
a. Absorption
b. Dissolution
c. deaggregation
d. Disintegration
3. Volume of distribution refers to......................
a. Hypothetical volume in which drug is distributed
b. Volume of fluids in tissue in which drug is distributed
c. Total body water
d. Water in which the tablet disintegrates
4. The following IV administration, drugs are distributed fastest to:
a. The skin, kidney, and brain
b. The liver, adipose, and brain
c. The liver, kidney, and brain
d. The liver, kidney, and adipose
5. Induction of drug metabolism leads to ................... in half-life of drug.
a. Increase
b. Decrease
c. Remain constant
d. Unpredictable
6. What is the equation to find out renal clearance
a. Rate of elimination by kidney/plasma drug concentration
b. Plasma drug concentration/rate of elimination by the kidney
c. 1 / rate of elimination by the kidney
d. 1 / plasma drug concentration
7. Select the feature of class III Biopharmaceutics classification system.
a. Low solubility, low permeability
b. Low solubility, high permeability
c. High solubility, high permeability
d. High solubility, low permeability
8. Name the model in which compartments are joined in series
a. Distributed parameter model
b. Catenary model
c. Physiologic model
d. Mammillary model
9. Which of the following is pharmacodynamics method of studying bioavailability.
a. Acute pharmacologic response
b. Plasma-level time studies
c. Urinary excretion studies
d. Stool excretion studies
10. The onset of drug action depends on the rate of ....................
a. Drug absorption
b. Clearance
c. Pore transport
d. Binding of the drugs
11. The plasma protein to which maximum drugs bind is-
a. Albumin
b. Globulin
c. Haemoglobin
d. Plasmin
12. All of the following are examples of Phase I drug metabolizing reactions EXCEPT:
a. N-dealkylation of theophylline
b. Reductive dehalogenation of halothane
c. Hydrolysis of succinylcholine
d. Glucuronidation of acetaminophen
13. Which drug cannot be filtered through glomerulus?
a. Drugs bounds to plasma protein
b. Unbound
c. Free drug
d. Below molecular weight of 300 Dalton
14. Paddle over disc apparatus is used for dissolution testing of ....................
a. Soft gelatine Capsules
b. Transdermal drug delivery systems
c. Hard gelatine Capsules
d. Tablets
15. First order kinetics …………………..
a. Means rate of reaction is proportional to concentration
b. Are more common than zero order kinetics
c. Generally apply to high plasma concentrations
d. Result in steady state concentrations after multiple dosing
16. Absolute bioavailability is calculated with respect to
a. IV injection
b. Solution
c. Innovator product
d. Another dose
17. Select structure specific mechanism of drug absorption
a. Facilitated diffusion
b. Passive diffusion
c. Endocytosis
d. Pinocytosis
18. Hepatic clearance is said to be perfusion rate limited, if .......................
a. It undergoes high metabolism
b. It escapes metabolism
c. It is metabolized to poor extent
d. It shows intermediate metabolism rate
19. Rate of dissolution can be expected to increase by adopting one of the following method.
a. Increase in particle size
b. Decrease in surface area
c. Unionised form of drug
d. Ionised form of drug
20. An individual receives an i. v. bolus dose of 200mg of a drug. Blood samples drawn
immediately
after injection and found 0.5/ml. calculate the apparent Vd.
a. 250l
b. 400l
c. 200l
d. 100l
21. Class I features
a. Low permeability High solubility
b. High permeability High solubility
c. Low permeability Low solubility
d. High permeability low solubility
22. High circulating levels of active drug are seen for those drugs which have low rate is
a. Drug absorption
b. Clearance
c. Extensive binding to plasma protein
d. Distribution into total body water
23. ______________is also called as convective transport, bulk flow or filtration
a. Pore transport
b. Binding of the drugs
c. enzyme induction
d. enzyme inhibition
24. The characteristics of continuous release systems
a. Release the drug along the entire length of GIT
b. Prolonged their residence in the GIT and release
c. Release only at a specific drug
d. Release as soon as comes in contact to the saliva
25. Enzymes in Microsomal drug metabolism are typically associated with
a. smooth endoplasmic reticulum
b. Rough endoplasmic reticulum
c. endoplasmic reticulum
d. Nucleus
26. renal clearance ratio is
a. Renal clearance of creatinine / renal clearance of the drug
b. 1/renal clearance of the drug
c. Renal clearance of drug/ renal clearance of creatinine
d. 1/renal clearance of creatinine
27. Noyes and Whitney described
a. The quantitative analysis of the amount of drug dissolved from solid particles as a function
off of time
b. The qualitative analysis of the amount of drug dissolved from solid particles as a function of
time
c. The renal clearance of liquid dosage forms
d. The hrepaticclerance of the amount of drug absorbed from solid particles as a function of
time
28. organs associated with central compartment in a two-compartment model
a. Muscles
b. Skin
c. Adipose
d. Liver
29. Bioavailability fraction equation will be
a. 1/2 Bioavaliable dose
b. 1/Administered dose
c. Bioavailable dose/ Administered dose
d. Administered dose/ Bioavailable dose
30. To increase the time of gastric emptying
a. By drinking a lot of water
b. By taking a drug in empty stomach
c. By taking the drug after food
d. Cannot increase the time of gastric emptying at all
31. Once the drug diffuse through capillary to extracellular fluid
a. Its further entry in to cells of most tissue is more .
b. Its further entry in to cells of most tissue is limited.
c. Its further entry in to cells of most tissue is less.
d. Further distribution will not possible
32.Membrane is used in haemodialysis
a. Artificial Semipermeable membrane
b. Permeable membrane
c. Natural semipermeable membrane of the peritoneal cavity
d. Artificial permeable membrane
33. Phase II consists of
a. Drug bound by van der waals forces
b. Hydrogen bonding of polar groups molecules to render them water-soluble and allow renal
or biliary excretion
c. covalent bonding of polar groups to nonpolar molecules to render them water-soluble and
allow renal or biliary excretion
d. bonding of polar groups molecules
34. According to the USP, the axis of the stirring element should not deviate more than
a. 0.1 cm
b. 0.2 cm
c. 0.3 cm
d. 0.5 cm
35. In pharmacokinetics, the term rate refers to a change in which of the following
measurements over time.
a. drug dose
b. drug elimination
c. concentration of drug in plasma
d. drug absorption
36.A prodrug is a chemical derivative of a main drug, use to enhance
a. Bioavailability of drug to convert to active form
b. Dissolution time enhanced
c. Change in Drug distribution
d. Body converts active to inactive form of drug
37.Factors that cause variability in plasma drug concentrations after the same drug dose is
given to different patients include variations in the
a. drug absorption
b. drug distribution
c. pharmacokinetics
d. pharmacodynamics
38. By-product of phase I metabolism
a. Derivative, is pharmacologically inactive but more chemically reactive than the parent drug
b. Derivative, is pharmacologically active but more chemically Inactive than the parent drug
c. Too polar or hydrophilic for sufficient absorption
d. facilitated by active transport systems
39. The rate which drug reaches the systemic circulation is determined by the slowest of the
various steps
a. Dissolution time enhanced
b. Gastric emptying
c. Disintegration lowers
d. Rate limiting step
40. Cs is approximated by the
a. The solubility of the drug substance
b. The disintegration of the drug substance
c. solubility at pH 6.5
d. Enhanced the rate of excretion
41. What is bioavailability
a. The time of absorption of the drug from its dosage form
b. The rate and extent 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
42. What does interfacial barrier model state
a. Turbulence in the dissolution medium exists at the solid/liquid interface
b. Formation of a thin film or layer at the solid-liquid interface
c. An intermediate concentration exists at the interface
d. Solute passes easily through the interfaces
43. What will be the apparent volume of distribution of warfarin
a. There is no correlation between apparent and true volume of distribution
b. The apparent volume of distribution is more than the total body water
c. The apparent volume of distribution is equal to the total body water
d. The apparent volume of distribution is less than the total body water
44. What is true about tissue binding
a. Competition between drug for binding to plasma proteins can occur
b. Does not result in toxicity
c. Half-life of extravascular tissues bound drug is relatively long
d. Binding involve weak bonds and thus reversible
45. What is the end product of hydrolytic dehalogenation of DDT
a. 1- chloro diphenyl dichloroethylene
b. Dichloro diphenyl dichloroethylene
c. Trichloro triphenyl trichloroethylene
d. Dichloro diphenyl ethylene
46. The relationship between elimination rate constant & half life of drug is described by-
a. Ke= 0.693/t1/2
b. Ke= 2.303* t1/2
c. Ke= 2.303/t1/2
d. Ke= 0.105/t1/2
47. Dissolution is rate limiting step in absorption of BCS classified
a. Class I
b. Class II
c. Class III
d. Class IV
48. One compartment model assumes that-
a. The rate input> rate of output of
b. Drug circulates infinitely inside the body
c. Body is divided in various compartments
d. The processes follow second order kinetics
49. Relative bioavailability is calculated with respect to
a. IV injection
b. Oral standard of same drug
c. Innovator product
d. Another dose
49. Diffusion layer theory of drug dissolution is based on-
a. Noyce- Whitney equation
b. Henderson- Hekelbach equation
c. pH- partition hypothesis
d. distribution Law
50. Volume of distribution refers to-
a. Volume of fluids in tissue in which drug is distributed
b. Hypothetical volume in which drug is distributed
c. Total body water
d. Water in which the tablet disintegrates
51. Which of the following is a Phase II metabolism reaction?
a. Oxidation
b. Reduction
c. Acetylation
d. Hydrolysis
52. Drug X has molecular weight of 750 dalton, predict its route of excretion
a. biliary excretion
b. salivary excretion
c. renal excretion
d. Mammary Excretion
53. Which sentence will define dissolution rate
a. Amount of solid substrate that goes into solution under constant time
b. Amount of solid substrate that goes into solution under constant time under standard
temperature, pH, and pressure
c. Amount of solid substrate that goes into solution under constant time under standard
temperature, pH, solvent composition and constant surface area
d. Amount of solid substrate that goes into solution under constant time under standard
temperature
54. The compartment is also refered as
a. Realistic model
b. physiologic model
c. mammillary model
d. Empirical model
55. The bioavailability of a drug can be increased by-
a. Use of amorphous form
b. Use of crystalline form
c. Addition of a gelling polymer
d. Increase in hydrophobicity
56. Michaelis-Menten saturation is observed in following mechanisms of adsorption
a. Passive diffusion
b. Ion -pair transport
c. Carrier mediated Transport
d. Facilitated Diffusion
57. The drug which undergoes complete change in pharmacological active during metabolism
a. Iproniazid
b. Aspirin
c. Paracetamol
d. Codeine
58. The belonging to class III accordingly to BCS
a. Diltiazem
b. Insulin
c. Naproxen
d. Taxol
59. The half-life of propranolol in a 60kg patient is 4 hours and Vd is 5.5litre/Kg Determine
the total systemic clearance of the drug
a. 678ml/min
b. 953ml/min
c. 765ml/min
d. 924ml/min
61. Which of the following is a not mechanism of drug absorption through GIT
a. Pore transport
b. Active transport
c. Endocytosis
d. Metastasis
62. The process of engulfing of particulate material is called
a. Pinocytosis
b. Phagocytosis
c. Convective transport
d. Facilitated diffusion
63. The absorption of drugs like (quaternary ammonium compounds, sulphonic acid) are
explained by
a. Ion pair transport
b. convective transport
c. active transport
d. Facilitated diffusion
64. Maximum movement of drug across the membrane occurs by
a. Completely ionised
b.Unionised
c. Partially ionised
d. Ionised
65. The delivery of a drug through the skin is known as
a. Sublingual
b. Transdermal
C. Inhalation
D. Buccal
66. The process of engulfing of particulate material is called
a. Pinocytosis
b. Phagocytosis
c. Convective transport
d. Facilitated diffusion
67. What kind of substances can’t permeate membranes by passive diffusion?
a. Lipid-soluble
b. Non-ionized substances
c. Hydrophobic substances
d. Hydrophilic substances
68. Biotransformation of a medicinal substance results in:
a. Faster urinary excretion
b. Slower urinary excretion
c. Easier distribution in organism
d. Higher binding to membranes
69. Metabolic transformation (phase 1) is:
a. Acetylation and methylation of substances
b. Transformation of substances due to oxidation, reduction or hydrolysis
c. Glucuronide formation
d. Binding to plasma proteins
70. All of the following are examples of Phase I drug metabolizing reactions EXCEPT:
a. N-dealkylation of theophylline
b. Aliphatic oxidation of pentobarbital
c. Hydrolysis of succinylcholine
d. Glucuronidation of acetaminophen
Q. 2 Answer any one question.
1. Write a note on Sigma minus method.

2. An intravenously administered i.v. bolus dose of 300mg of a new drug to

a healthy volunteer and the following blood data were obtained:

Time (hr) 1 2 4 6 12
Plasma concentration (μ g/ml) 1.82 1.41 0.75 0.43 0.08

Assuming that the drug follows one compartment open model, calculate the
following pharmacokinetics parameters:
1. Elimination rate constant
2. Biological half life
3. Initial plasma drug concentration
4. Volume of distribution
5. Total systemic clearance
6. Area under the curve

3. Define fluctuation. Explain accumulation of drug in the body during

multiple dose regimen of i.v. bolus dosing with diagrammatic
representation.

4. What are the causes of Non-linearity? Differentiate between linear and

non-linear pharmacokinetics

5. Enlist various patient related factors affecting drug absorption. Elaborate

gastric emptying.

6. Discuss significance of protein binding with examples.

7. Enlist the non-renal routes of drug excretion. Discuss biliary excretion of

drug.

I8. Explain the study designs in bioequivalence studies.

9. Enlist various mechanisms of drug transport. Discus active transport in

detail.

10. Write a note on real and apparent volume of distribution.

11. What is clearance? Give the formula for the clearance. Explain organ
clearance and hepatic extraction ratio.

12. Discuss any three factors affecting renal excretion.

13. Enlist in vitro drug dissolution models. Explain type I and type II
apparatus.

14. Explain methods used for enhancement of bioavailability of poorly

soluble drugs.
15. Explain one compartment open model and its assumptions

16.What is optimal dosage regimen? For one compartment model state the
mathematical expressions for maximum,minimum and steady state
concentration of drugin the plasma

17. Explain and derive equation to estimate elimination rate constant,

elimination half-life and clearance following an IV Bolus administration

18.Explain Linear and non-linear kinetics and describe the factors resulting
in non- linear kinetics.

19. Explain Factors affecting drug absorption-Physicochemical properties

20. Enlist Physiological Barriers in Drug distribution and explain any two
in detail

21. Define excretion and elaborate on causes of non-linearity in excretion

22. Enlist the criteria necessary for BCS biowaiver for in vivo
bioavailability and bioequivalence studies

23. How does the solubility and dissolution rate of a drug affect its
metabolism

24. Define volume of distribution and clearance, explain trapezoidal rule

for estimation of AUC

25. What are effects of enzyme induction on drug metabolism. Discuss in

detail
26. What is Total renal clearance explain deceased renal function effect
drug excretion

27. Explain Film theory for drug dissolution, elaborate on type 2

dissolution apparatus

28. Enlist and explain the elements of Bioequivalence study protocol

29. Explain the equation use for calculation of non-linear kinetic behavior
of drug

30. Explain various parameters of plasma drug concentration profile with

its graph
31. The equation that best fits the plasma level time curve of
drug after an IV bolus dose of 2000mg is,(assuming one-
compartment kinetics) C=143 e-0.87t calculate,
a. Apparent volume of distribution,
b. Elimination Half life
c. Plasma Concentration of drug remaining after 6 hr.
 d. How much of drug will be left in body after 6 hours.

32. Describe the method of residuals for calculation of absorption rate

constant

33. In study of an unknown drug, micronization was carried in order to

enhance its
absorption but it lead to reduced dissolution rate. What may be the
reason behind this behaviour. Explain briefly about absorption
mechanism with mixed order kinetics.

34. Describe the Tissue permeability of drug affecting distribution of drug

in tissues

35. Enlist factors affecting renal clearance and explain effect of renal
disease state on
drug elimination

36. Explain pharmacokinetic methods of measurement of bioavailability

37. Enlist the difference between active and passive transport

38. What is effect of protein binding on the apparent volume of distribution

39. Explain glucuronidation as most important of all phase II reaction.

40. Explain Renal excretion Ratio. State and explain mechanism of Renal
excretion

41. Explain BCS class boundaries

42. Define Absolute bioavailability and write a note on IVIVC,

43. Define biotransformation, state different phases of biotransformation.

44. Explain why glucuronidation pathway is true biotransformation and

major method

45. Explain any one theory of dissolution in detail

46. Give various technique to enhance bioavailability

47. Write assumption of IVIVC and explain its various level in detail.

48. Give mechanism of USP apparatus to II

49. Explain BCS system of classification of drug.

50. Define Following: bioavailability, pharmacokinetics, biopharmaceutics,

pharmacodynamics, bioequivalence, clearance.