BIOPHARMACEUTICS AND PHARMACOKINETICS

CATEGORY: UNIT – WISE QUESTION BANK

S. NO UNIT & TITLE OF THE CHAPTER

I CHAPTER – I : Introduction to Biopharmaceutics and Drug Absorption

Short Answer Questions

Define the following terms:

a. Biopharmaceutics
b. Drug Absorption process
c. Bioavailability
d. Pharmacokinetics
e. Pharmacokinetic parameters – Peak plasma concentration (Cmax)
Time of peak plasma concentration (Tmax)
Area under curve (AUC)
f. Pharmacodynamic
g. Pharmacodynamic parameters – Minimum effective concentration (MEC)
Maximum Safe Concentration (MSC)
Onset of Action
Onset of time
Duration of time and Intensity of action
Therapeutic Range/Therapeutic Window
Therapeutic Index
h. Clinical Pharmacokinetics
Long Answer Questions

Draw a neat labeled diagram of Cell membrane and emphasize a brief note on its
structure and physiology that effects drug absorption process.

Illustrate the various mechanisms involved in drug absorption process with a neat
labeled diagram.

Explain in detail about passive diffusion process, ion pair transport and pore transport
involved in drug absorption process.

Explain in detail about carrier mediated transport, facilitated diffusion, active transport
and endocytosis involved in drug absorption process with neat labeled diagrams.

Recall various phases and routes involved in drug transfer from GI absorption site in
to systemic circulation
 Classify various factors affecting drug absorption process and summarize a brief note
how physicochemical properties of drug such as polymorphism, amorphism and
pseudopolymorphism affect drug absorption process.

Summarize a brief note how physicochemical properties of drug such as Particle size
and effective surface area, Salt form of drug affect drug absorption process with neat
labeled diagram.

Recall and relate how pH partition hypothesis affects drug absorption process. Outline
the limitations of pH partition hypothesis.

Define Drug Solubility and dissolution rate. Demonstrate various dissolution theories
involved in drug absorption process.

How disintegration time , dissolution time, nature and type of dosage form
(pharmacotechnical factors) affects drug absorption process

How manufacturing variables and pharmaceutical ingredients as pharmacotechnical

factors affects drug absorption process

Outline a brief note on age, Gastric emptying time, Intestinal transit time, G.I pH and
disease state as a patient related factors affects drug absorption process

Outline a brief note on blood flow to GIT, Gastrointestinal contents and pre-systemic
metabolism as a patient related factors affects drug absorption process

2 Short Answer Questions

Chapter – II Distribution of Drugs

Define the following

a. Drug distribution
b. Pre-systemic Metabolism/First pass effect
c. Apparent volume of distribution
d. Protein binding of drugs
e. Significance of protein binding
f. Drug interactions
Long Answer Questions
Explain in detail about various miscellaneous factors affecting drug distribution

Enlist and explain in detail with neatly labeled diagrams of various physiological
barriers involved in distribution of drugs

Explain in detail about binding of drugs to blood components

Explain in detail about binding of drugs to Extravascular tissue components

 Explain briefly about various factors affecting protein – drug binding

Outline in detail about significance of protein/tissue binding of drugs

Illustrate in detail the kinetics of protein – drug binding with help of different plots

Explain in detail the concept of clearance.

Illustrate the mechanism involved in renal excretion of drugs with a neat labeled
diagram.

Explain in detail about factors affecting Renal clearance.

Explain in detail about Non-renal route of drug excretion (Entero-hepatic cyling &
Salivary Excretion).

3 Short Answer Questions

Chapter – III: Biotransformation/Metabolism of Drugs & Excretion of Drugs

Define the following

a. Define Biotransformation/ Metabolism

b. Drug Disposition
c. Excretion
d. Clearance
e. Pre-systemic Metabolism
f. Elimination
g. Soft drugs
h. Drug induced metabolism
i. Drug inhibited metabolism
j. Xenobiotics

Long Answer Questions

Enlist various pathways involved in Phase – I reactions and write in detail about how
oxidative reactions involved in biotransformation of drugs.

Enlist various pathways involved in Phase – I reactions and write in detail about how
Reductive reactions involved in biotransformation of drugs.

Enlist various pathways involved in Phase – I reactions and write in detail about how
Hydrolytic reactions involved in biotransformation of drugs.

Enlist various pathways involved in Phase – II reactions and write in detail about how
conjugation with glucuronic acid reactions involved in biotransformation of drugs.
 Enlist various pathways involved in Phase – II reactions and write in detail about how
conjugation with sulphate meioties and with alpha amino acids reactions involved in
biotransformation of drugs.

Enlist various pathways involved in Phase – II reactions and write in detail about how
conjugation with glutathione and mercapturic acids reactions involved in
biotransformation of drugs.

Enlist various pathways involved in Phase – II reactions and write in detail about how
acetylation and methylation reactions involved in biotransformation of drugs.

Explain various physicochemical properties and chemical factors affecting drug

biotransformation.

Explain various biological factors affecting drug biotransformation.

Outline a brief note on Apparent Volume of Distribution

4 Short Answer Questions

Chapter – IV: BIOAVAILABILITY & BIOEQUIVALENCE

Define the following:

a. Bioavailability and Bioequivalence

b. Differentiate Absolute bioavailability with Relative bioavailability

c. Merits and demerits of Single dose studies over Multiple Dose

d. Merits and demerits of subject selection

e. BIBD

f. Dosage Regimen

Long Answer Questions

Define Bioavailability. Emphasize a note on measurement of bioavailability.

Enlist various In-vitro dissolution testing models.

Define Bioequivalence Study and various types bioequivalence studies

Emphasize a detail note on Bioequivalence experimental study design

Enlist various methods used to enhance bioavailability of poorly soluble drugs and
write few methods adopted to enhance bioavailability by enhancing solubility.
 Enlist various methods used to enhance bioavailability of poor permeation of drugs
and write few methods adopted to enhance bioavailability by enhancing permeability.

Enlist various methods used to enhance bioavailability of poor permeation of drugs

and write few methods adopted to enhance bioavailability by enhancing drug stability.

4 Short Answer Questions

Chapter – V: PHARMACOKINETICS

Define the following:

a. What is meant by Mixed Order/ Non – linear Kinetics

b. Emphasize a note on Zero – order Kinetics
c. Define Order Process/ Order of Reaction
d. Emphasize a note on First – order Kinetics
e. What are Pharmacokinetic Parameters/ Variables? Classify their types
f. What is a pharmacokinetic Model
g. What is meant by compartmental modeling? Classify them.
h. Differentiate central compartment with peripheral compartment.
i. Define Mean Residence time
j. Define Excretion
Long Answer Questions

Emphasize a note on Rate, Rate Constants and orders of reaction.

What are Pharmacokinetic Models? Emphasize a note on Compartmental model along

with caternary model and mamillary model.

Explain in detail about physiological model and distributed parameter model along
with their advantages and disadvantages.

Emphasize a note on Non-compartmental analysis, its applications, advantages and

disadvantages.

Derive the mathematical equations to compute pharmacokinetics parameters when the

drug is administered as I.V bolus injection and drug disposition follows first order
kinetics.

Derive the mathematical equations to compute pharmacokinetics parameters when the

drug is administered as Extra vascular route of administration and drug disposition
follows first order kinetics.

Derive the mathematical equations to compute pharmacokinetics parameters when the

drug is administered as constant rate of infusion and drug disposition follows first
order kinetics.
Derive the mathematical equations to compute pharmacokinetics parameters when the
drug is administered as I.V bolus injection and drug disposition follows first order
kinetics from urinary data by Rate of Excretion Method, its advantages and criteria to
validate urinary data.

Derive the mathematical equations to compute pharmacokinetics parameters when the

drug is administered as I.V bolus injection and drug disposition follows first order
kinetics by Sigma-minus method, its advantages and criteria to validate urinary data.

Derive the mathematical equations to compute pharmacokinetics parameters when the

drug is administered by constant rate of infusion and drug disposition follows first
order kinetics from urinary excretion data, its advantages and criteria to validate
urinary data

Derive the mathematical equations to compute pharmacokinetics parameters when the

drug is administered by extra vascular route of administration and drug disposition
follows first order kinetics from urinary excretion data, its advantages and criteria to
validate urinary data

Derive the mathematical equations to compute pharmacokinetics parameters when the

drug is administered as Extra vascular route of administration and drug disposition
follows first order kinetics by Wagner-Nelson method

Define Non-linear pharmacokinetics. Explain briefly about various causes of Non-

linear pharmacokinetics.

Derive Michaelis Menten equation in relation to Non-linear pharmacokinetics.