GUJARAT TECHNOLOGICAL UNIVERSITY

Bachelor of Pharmacy
Subject Code: BP604TT
SEMESTER: VI
Subject Name: Biopharmaceutics and Pharmacokintetics

Scope: This subject is designed to impart knowledge and skills of Biopharmaceutics and pharmacokinetics
and their applications in pharmaceutical development, design of dose and dosage regimen and in solving
the problems arised therein

Objectives: Upon completion of the course the student shall be able to

1. Understand the basic concepts in biopharmaceutics and pharmacokinetics and their significance.
2. Use of plasma drug concentration-time data to calculate the pharmacokinetic parameters to
describe the kinetics of drug absorption, distribution, metabolism, excretion, elimination.
3. To understand the concepts of bioavailability and bioequivalence of drug products and their
significance.
4. Understand various pharmacokinetic parameters, their significance & applications.

Teaching scheme and examination scheme:

Teaching Scheme Evaluation Scheme

Theory Tutorial Practical Total Theory Practical
External Internal External Internal
3 1 0 4 80 20 0 0

Sr No Topics %
weightage
1. Introduction 10
Biopharmaceutics To Absorption; Mechanisms of drug absorption through
GIT, factors influencing drug absorption though GIT, absorption of drug from
Non per oral extra-vascular routes,
Distribution Tissue permeability of drugs, binding of drugs, apparent, volume
of drug distribution, plasma and tissue protein binding of drugs, factors affecting
protein-drug binding. Kinetics of protein binding, Clinical significance of
protein binding of drugs
2. Elimination: Drug metabolism and basic understanding metabolic pathways 10
renal excretion of drugs, factors affecting renal excretion of drugs, renal
clearance, Non renal routes of drug excretion of drugs
Bioavailability and Bioequivalence: Definition and Objectives of
bioavailability, absolute and relative bioavailability, measurement of
bioavailability, in-vitro drug dissolution models, in-vitro-in-vivo correlations,
bioequivalence studies, methods to enhance the dissolution rates and
bioavailability of poorly soluble drugs.
3. Pharmacokinetics: Definition and introduction to Pharmacokinetics, 10
Compartment models, Non compartment models, physiological models, One
compartment open model. (a). Intravenous Injection (Bolus) (b). Intravenous
infusion and (c) Extra vascular administrations. Pharmacokinetics parameters -
KE ,t1/2,Vd,AUC,Ka, Clt and CLR- definitions methods of eliminations,
understanding of their significance and Application
Multicompartment models: Two compartment open model. IV bolus Kinetics 8
4. of multiple dosing, steady state drug levels, calculation of loading and
mainetnance doses and their significance in clinical settins
5. Nonlinear Pharmacokinetics: a. Introduction, b. Factors causing Non- 7
linearity. c. Michaelis-menton method of estimating parameters, Explanation
with example of drugs.

Page 1 of 2
w.e.f. AY 2017-18
 GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP604TT
Recommended Books (Latest Editions)
1. Biopharmaceutics and Clinical Pharmacokinetics by, Milo Gibaldi.
2. Biopharmaceutics and Pharmacokinetics; By Robert F Notari
3. Applied biopharmaceutics and pharmacokinetics, Leon Shargel and Andrew B.C.YU 4th
edition,Prentice-Hall Inernational edition.USA
4. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and Sunil
B.Jaiswal,Vallabh Prakashan Pitampura, Delhi
5. Pharmacokinetics: ByMilo Glbaldi Donald, R. Mercel Dekker Inc.
6. Hand Book of Clinical Pharmacokinetics, ByMilo Gibaldi and Laurie Prescott by ADIS Health
Science Press.
7. Biopharmaceutics; By Swarbrick
8. Clinical Pharmacokinetics, Concepts and Applications: ByMalcolm Rowland and
9. Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.
10. Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack, Publishing
Company,Pennsylvania 1989.
11. Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edition Revised and
expanded by Rebort F Notari Marcel Dekker Inn, New York and Basel, 1987.
12. Remington’s Pharmaceutical Sciences, ByMack Publishing Company, Pennsylvnia

Page 2 of 2
w.e.f. AY 2017-18
Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B.PHARM - SEMESTER– 6 EXAMINATION – SUMMER -2020

Subject Code: BP604TT Date:29-10-2020

Subject Name: Biopharmaceutics and Pharmacokintetics
Time: 10:30 AM TO 1:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B.Pharm - SEMESTER–VI • EXAMINATION – WINTER -2020

Subject Code: BP604TT Date: 11/01/2021

Subject Name: Biopharmaceutics And Pharmacokinetics
Time: 2:00 PM TO 4:00 PM Total Marks: 54
Instructions:
1. Attempt any THREE questions from Q-1 to Q-6.
2. Q.7 is compulsory to attempt.
3. Make suitable assumptions wherever necessary.
4. Figures to the right indicate full marks.

Q.1 Answer the following questions. (1 mark each) 16

I) Discuss the mechanism of intracellular transport.
II) Differentiate pinocytosis and phagocytosis.
III) Define apparent volume of distribution.
IV) What do you mean by renal clearance?
V) How many types of compartment models are there? Name them.
VI) Draw a schematic diagram of three compartment open model, extra-vascular
administration.
VII) What is the meaning of the term open in a compartment model?
VIII) What is a flip-flop phenomenon?
IX) Define extraction ratio.
X) If steady-state plasma concentration is not directly proportional to dose then
it detects non-linearity in pharmacokinetics. State whether the statement is
true or false.
XI) What is pharmaceutical equivalence?
XII) How is dissolution of a drug different from its solubility parameter?
XIII) Explain IVIVC
XIV) What is the difference between relative and absolute bioavailability?
XV) How AUC is calculated by trapezoidal rule?
XVI) Which law governs the passive diffusion process of absorption?

Q.2 (a) Write short note on carrier mediated transport mechanism of drug absorption 06
(b) Discuss physicochemical factors of drug substance affecting its GI 05
absorption.
(c) Explain physiological barriers to drug distribution in body. 05
Q.3 (a) Explain the processes involved in the urinary excretion of drug with a 06
schematic diagram.
(b) Explain plasma-level time curve along with its pharmacokinetic parameters. 05
(c) Explain the concept of loading dose and maintenance dose. 05
Q.4 (a) Enlist methods to determine the Ke value from urinary excretion data and 06
discuss any one in detail.
(b) Discuss applications of pharmacokinetic models. 05
(c) Write a note on PBPK models. 05
Q.5 (a) Discuss Michaelis-Menten Equation. 06
(b) What are the assumptions made from multi-compartment model? 05
(c) List out the causes of non-linearity in pharmacokinetics and discuss any one 05
cause in detail.
Q. 6 (a) Enumerate different methods to improve the dissolution rate of poorly 06
soluble drug. Discuss any one in detail.
(b) Describe different dissolution apparatus according to USP 05
(c) Explain Latin Square Design for bioequivalence study. 05
Q.7 (a) Discuss Wagner-Nelson method for estimation of Ka. 06
OR
(a) Differentiate between plasma-protein drug binding and tissue-drug binding 06
OR
(a) Enlist different non-renal routes of drug excretion with example of drug 06
excreted through each route.

***************
Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B.Pharm - SEMESTER– VI• EXAMINATION – SUMMER -2021

Subject Code: BP604TT Date: 09/08/2021

Subject Name: Biopharmaceutics and Pharmacokinetics
Time: 02:30PM to 05:30pm Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1 (a) Enlist various mechanism of drug transport. Write a detailed note on active 06
transport process.
(b) Describe the Pharmaceutical factors affecting drug absorption from GI tract. 05
(c) Write a short note on kinetics of protein-drug binding. 05
Q.2 (a) Define clearance and write about renal clearance in detail. 06
(b) Discuss tissue permeability of drug distribution. 05
(c) Discuss the influence of BBB and CSF barriers on distribution of drugs. 05
Q.3 (a) Differentiate absolute and relative bioavailability. Discuss the pharmacokinetic 06
methods for the bioavailability measurement.
(b) Explain various methods used for enhancement of bioavailability. 05
(c) Define bioequivalence. Explain Latin crossover design in BE studies. 05
Q.4 (a) What is IVIVC? Write a note on Levels of IVIVC. 06
(b) Explain the dissolution apparatus type I and type II as per USP. 05
(c) Explain Wagner nelson method in detail. 05
Q.5 (a) Describe the method of residuals for determination of absorption rate constant 06
(b) Explain Catenary and Mammillary compartment models in detail. 05
(c) Describe assumption to be considered in developing equation for two 05
compartment model with suitable diagram.
Q. 6 (a) Compare and contrast excretion rate method and Sigma-Minus method. Explain 06
Sigma-Minus method in detail.
(b) Discuss about significance of different volume of distribution in two 05
compartment model based on IV bolus administration.
(c) Enlist the causes for non-linearity. Explain Michaelis Menton Equation for the 05
same.
Q.7 (a) Discuss the regulatory requirements for conduction of bioequivalence study. 06
(b) Write a short note on Plasma Protein Binding. 05
(c) Hydrophilicity and lipophylicity property of a drug decide its absorption. 05
Comment with justification.

***************
Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B. Pharm. SEMESTER– VI EXAMINATION – WINTER -2021

Subject Code: BP604TT Date:01/12/2021

Subject Name: Biopharmaceutics and Pharmacokinetics
Time: 02:30pm to 05:30pm Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1 (a) Discuss the kinetics of protein binding. 06

(b) Enlist various factors responsible for protein binding and explain any one in 05
detail.
(c) Explain binding of drug to blood components giving suitable examples 05
Q.2 (a) Comment on passive diffusion is one of the important mechanisms of drug 06
absorption.
(b) Enlist various factors influencing GI absorption of a drug from its dosage form 05
and explain physicochemical factors affecting drug absorption in detail.
(c) Discuss the absorption of drugs from non-oral extra vascular routes 05
Q.3 (a) Discuss various methods used for the measurement of bioavailability 06
(b) What are the problems faced in formulation of BCS Class II drugs? Discuss 05
suitable strategies to overcome them.
(c) Define the following terms first pass metabolism, active diffusion, 05
bioavailability and bioequivalence
Q.4 (a) Discuss USP dissolution apparatus with specific uses 06
(b) Explain In-vitro - In-vivo correlations 05
(c) Describe Latin Square cross over design for bioequivalence study 05
Q.5 (a) Write a note on renal excretion of drugs 06
(b) Define biotransformation and discuss in brief phase I and Phase II 05
biotransformation
(c) Explain the following terms Clearance, Total body clearance, Hepatic clearance 05
and Renal clearance
Q. 6 (a) Explain the method of residuals for the calculation of absorption rate constant 06
on administration of drug by Extra vascular route.
(b) Write Note on Non compartmental Analysis 05
(c) Write a note on Wagner Nelson Method 05
Q.7 (a) What process of drug ADME are known to show non linearity? Explain giving 06
suitable examples.
(b) Explain Michaelis Menten equation for capacity limited process 05
(c) What are pharmacokinetic models? Explain in detail compartment models 05

***************
Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B.Ph. – SEMESTER VI • EXAMINATION – SUMMER -2022

Subject Code:BP604TT Date:09/06/2022

Subject Name: Biopharmaceutics and Pharmacokinetics
Time: 10:30AM TO 01:30PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1 (a) Discuss the physicochemical factors affecting the GI absorption of drugs. 06
(b) Explain barriers to drug distribution. 05
(c) Describe Noyes-Whitney equation. 05
Q.2 (a) Discuss the clinical significance of the Protein binding of drugs. 06
(b) Write note on physicochemical properties influencing tissue permeability of 05
drugs.
(c) Write short notes on BCS. 05
Q.3 (a) Discuss the importance of in vitro and in vivo correlation in the bioavailability 06
studies.
(b) Discuss the significance of non renal excretion of drugs. 05
(c) Write short notes on Pharmaceutical equivalence. 05
Q.4 (a) Explain method of residuals to calculate absorption rate constant of a drug 06
following one compartment kinetics.
(b) Discuss pharmacokinetic variables in disease states. 05
(c) Write short notes on Volume of distribution. 05
Q.5 (a) List out the various pharmacokinetic parameters and define. 06
(b) Write concept of Loading dose and Maintenance dose. 05
(c) Write short notes on Phase I reactions. 05
Q. 6 (a) What are the causes of Non linearity? How will you determine the non 06
linearity?
(b) Explain Michaelis Menten equation. 05
(c) How Blood brain barrier influence pharmacokinetic pattern of drug? 05
Q.7 (a) Give the criteria for obtaining valid urinary excretion data. 06
(b) Explain sigma minus method to calculate Ke for a drug given by IV bolus by 05
following open compartment kinetics.
(c) Discuss the various factors affecting distribution of drugs. 05

***************
Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B.Ph. - SEMESTER–VI • EXAMINATION – WINTER -2022

Subject Code: BP604TT Date: 10/01/2023

Subject Name: Biopharmaceutics and Pharmacokinetics
Time: 02:30pm to 05:30pm Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1 (a) Define following terms: 1) Absorption 2) Total clearance 3) Biopharmaceutics 06

4) Compartment model 5) Bioequivalence 6) Therapeutic index
(b) Enlist different types of Passive transport mechanisms. Write characteristics of 05
passive diffusion.
(c) Discuss patient related factors that influence GI absorption of drug. 05
Q.2 (a) How does route of administration and type of dosage form influence rate of 06
drug absorption?
(b) Define drug distribution. Write a short note on volume of distribution. 05
(c) Explain effect of Particle size, Polymorphism and lipophilicity of drug on GI 05
absorption.
Q.3 (a) Discuss active transport mechanism in drug absorption. 06
(b) Write a note on pH Partition theory with its limitation. 05
(c) Compare protein drug binding and tissue drug binding. 05
Q.4 (a) Write significance of drug dissolution in bioavailability. Write use of different 06
dissolution apparatus with respect to dosage forms.
(b) What do you mean by nonlinear pharmacokinetics? Discuss factors causing 05
nonlinearity.
(c) Define absolute and relative bioavailability. Discuss methods of measurement 05
of bioavailability.
Q.5 (a) What are pharmacokinetic models? What are applications of such models? 06
Discuss any one pharmacokinetic model.
(b) Derive equation in determination of absorption rate constant (Ka) using 05
Wegner Nelson Method.
(c) What criteria must be considered in calculation of pharmacokinetic parameters 05
from urinary excretion data?
Q. 6 (a) Define pharmacokinetics. Draw a well labeled diagram of plasma drug 06
concentration versus time plot and explain pharmacokinetic parameters.
(b) Define bioequivalence. Explain Latin crossover design in BE studies. 05
(c) What are loading and maintenance dose? How are they calculated? 05
Q.7 (a) Discuss clinical effect of protein/Tissue drug binding on absorption, 06
distribution and elimination of drug.
(b) Write on methods to enhance dissolution rate of poorly soluble drugs. 05
(c) Explain dosage adjustment in patients with hepatic failure. 05

***************
Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B.PHARM - SEMESTER– 6 EXAMINATION – SUMMER -2023

Subject Code: BP604TP Date: 27/06/2023

Subject Name: Biopharmaceutics and Pharmacokintetics
Time:10.30 a.m. to 1.30 p.m. Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1 (a) Define: Biopharmaceutics, Pharmacokinetics, Mean residence time, Non renal 06
excretion, Therapeutic window, Biotransformation.
(b) Enumerate the various factors influencing GI absorption of drug. Explain 05
particle size and surface area of the drug.
(c) Explain the dissolution apparatus type I and type II as per USP 05
Q.2 (a) Enlist the various mechanism of drug transport. Explain Passive diffusion. 06
(b) Discuss the kinetics of protein binding. 05
(c) Differentiate plasma-protein drug binding and tissue-drug binding 05
Q.3 (a) Why glucuronidation is the common and most important phase II reaction? 06
Explain it.
(b) Enlist the non renal routes of drug excretion and explain mammary excretion. 05
(c) Enlist the methods for enhancement of bioavailability. Differentiate Absolute 05
bioavailability & Relative bioavailability
Q.4 (a) Define bioequivalence. Explain Latin crossover design in BE studies. 06
(b) Discuss Wagner Nelson Method. 05
(c) Write a note on volume of distribution. 05
Q.5 (a) Discuss plasma drug concentration-time profile curve in detail. 06
(b) Explain the terms Clearance, Total body clearance, Hepatic clearance and 05
Renal clearance
(c) Describe two compartment open model for IV bolus administration in brief. 05
Q. 6 (a) Describe the methods of residuals for one compartment kinetics. 06
(b) Enumerate the various pharmacokinetic models and explain mammillary 05
model.
(c) Give difference between linear & non linear pharmacokinetics 05
Q.7 (a) Explain Michaelis Menten equation in detail. 06
(b) Discuss in brief about loading dose and maintenance dose. 05
(c) Write causes of non linearity. 05

***************
 Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B.PHARM - SEMESTER–6 EXAMINATION – WINTER -2023

Subject Code: BP604TT Date: 12/12/2023

Subject Name: Biopharmaceutics and Pharmacokintetics
Time: 02.30 p.m. to 5.30 p.m. Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1 (a) Discuss the objectives and factors affecting drug absorption through oral route. 06
(b) What is apparent volume of distribution. Discuss the influence of protein 05
binding on apparent volume of distribution.
(c) Discuss Michaelis-Menten Equation. 05
Q.2 (a) Define following terms: Absolute bioavailability, Relative Bioavailability, 06
Bioequivalence.
(b) Write a short note on kinetics of protein-drug binding. 05
(c) Briefly describe factors affecting distribution of drug. 05
Q.3 (a) Introduce the concept of IVIVC. Discuss BCS based biowaivers in IVIVC 06
briefly.
(b) Write a short note on non-renal excretion of drugs. 05
(c) Define high soluble and high permeable as per BCS classification. Enumerate 05
various methods for improvement of dissolution rates of poorly soluble drug.
Q.4 (a) Explain Latin crossover design in bioequivalence studies. 06
(b) Explain briefly what is compartmental model. Explain Catenary and 05
Mammillary compartment models in detail
(c) Describe the method of residuals for determination of absorption rate constant. 05
Q.5 (a) Write a note on PBPK models. 06
(b) Enumerate USP dissolution apparatus along with examples of relevant dosage 05
forms evaluated in each dissolution apparatus.
(c) Explain Wagner nelson method in detail. 05
Q. 6 (a) Discuss briefly the concept of loading dose and maintenance dose. 06
(b) Write a brief note on two compartment open model. 05
(c) Write a note on factors affecting protein binding with suitable examples. 05
Q.7 (a) Explain the factors causing non linearity in pharmacokinetics in drugs. 06
(b) Explain merits and demerits of non-compartmental pharmacokinetics. 05
(c) Differentiate between plasma-protein drug binding and tissue-drug binding. 05

***************
Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY

B.PHARM - SEMESTER– 6 EXAMINATION – SUMMER-2024

Subject Code:BP604TT Date: 14/05/2024

Subject Name: Biopharmaceutics and Pharmacokintetics
Time: 10.30 a.m. to 1.30 p.m. Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1 (a) Describe USP dissolution apparatus with their application. 06

(b) Explain physicochemical factors affecting GI absorption of drug. 05
(c) Write a note on Passive diffusion. 05
Q.2 (a) Define: Pharmacokinetics, Clearance, Peak plasma concentration, Time of peak 06
concentration, Area under curve, Therapeutic index.
(b) Enlist extravascular routes for drug absorption. Discuss Topical route of 05
administration.
(c) Discuss physiological barriers for distribution of drugs. 05
Q.3 (a) Discuss significance of protein binding of drugs. 06
(b) Discuss Wagner-Nelson method for estimation of Ka. 05
(c) Enumerate different method for measurement of bioavailability. Discuss 05
Pharmacokinetic methods for measurement of bioavailability.
Q.4 (a) Differentiate: compartment model and physiological model. 06
(b) Describe factors affecting drug protein binding. 05
(c) Write a note on Loading and maintenance dose. 05
Q.5 (a) Explain Michaelis-Menten Equation. 06
(b) Discuss factors affecting renal clearance of drug. 05
(c) Write a note on In-vitro - In-vivo correlations. 05
Q. 6 (a) Define bioequivalence. Describe Latin square design for bioequivalence study. 06
(b) Discuss Phase I biotransformation process. 05
(c) Discuss causes of non-linearity with examples. 05
Q.7 (a) Explain methods for solubility enhancement of the drug. 06
(b) Write note on Non compartmental Analysis. 05
(c) Discuss open compartment model IV bolus administration 05

***************