Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MPT202T Date: 17/11/2018
Subject Name: Principles of biopharmaceutics& pharmacokinetics
Time 02:30 PM TO 05:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make Suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1

What physical or chemical properties of a drug substance are important in designing a drug for oral administration?
06

Explain the reasons to use a multi-compartment model instead of a physiologic model?
05

Define Cmax Tmax. What is the significance of the apparent volume of distribution?
05
Q.2

Describe the statistical methods for comparing two dissolution profiles for similarity.
06

What is the usual rate-limiting step for a poorly soluble and highly permeable drug?
05

Write a note on Latin-square crossover designs.
05
Q.3

What is meant by the rate-limiting step in drug bioavailability from a solid oral drug product?
06

Write a note on Michaelis Menten equation
05

Write a note on Biopharmaceutics classification system.
05
Q.4

What is GRDDS? What are the mechanisms of drug absorption from this dosage form?
06

Explain the effect of cytochrome p450-based drug interactions.
05

Explain the role of Suspension as a dosage form in Gastrointestinal absorption.
05
Q.5

Enlist different pharmacokinetic models. What is compartment model? Mention advantages and disadvantages of the same.
06

Define in vitro-in vivo correlation (IVIVC) and explain why a Level A correlation is the most important correlation for IVIVC.
05

Write a note on Bioequivalence studies for extended-release drug products.
05
Q. 6

Define the term "rate-limiting step" and discuss how the rate-limiting step relates to the bioavailability of a drug.
06

How could the manufacturing process affect drug product performance?
05

What are the advantages and disadvantages of a zero-order rate design for drug absorption?
05
Q.7

Define Dissolution. Enlist the theories of dissolution. Explain in detail Film Theory.
06

Write a note on Factors Affecting Drug Absorption in the Gastrointestinal Tract.
05

Describe the methods of prediction of in vivo profile from in vitro drug dissolution
05