Seat No.: _____ Enrolment No.
_____________
GUJARAT TECHNOLOGICAL UNIVERSITY
Pharm D – 5th Year • EXAMINATION – WINTER - 2022
Subject Code: 858803 Date: 27/01/2023
Subject Name: Clinical Pharmacokinetics and Pharmacotherapeutic Drug Monitoring
Time: 10:30 AM TO 01:30 PM Total Marks: 70
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Define: Clinical Pharmacokinetics. Write a short note on pharmacokinetic 06
parameters affecting drug action.
(b) Explain: Therapeutic Drug Monitoring (TDM) necessity and process in patients 04
receiving Cyclosporine and Carbamazepine.
(c) Explain the sampling design used in population pharmacokinetic study. 04
Q.2 (a) Discuss the importance of genetic polymorphism of cytochrome P-450 isozymes 06
on drug metabolism with suitable examples.
(b) What is Bayesian theory? Explain adaptive method in detail. 04
(c) Explain the influence of drug interaction in metabolism phase of drug with 04
examples.
Q.3 (a) Define: Population Pharmacokinetics. Explain population pharmacokinetic 06
analysis using NONMEM method.
(b) What is Biliary excretion? Explain the effect of inhibition of Biliary excretion of 04
drugs with suitable examples.
(c) What are the indications of TDM? Explain the protocol of TDM for a drug. 04
Q.4 (a) Classify and explain pharmacokinetic drug-drug interactions with examples. 06
(b) What is Clearance? Explain the relationship between Clearance, Drug dose and 04
AUC.
(c) Explain: Determination of dose and dosing interval of a drug. 04
Q.5 (a) Explain the process and clinical significance of conversion from intravenous to 06
oral dosing.
(b) Describe the role of genetic polymorphism in drug transports and drug targets. 04
(c) Enlist various factors for hepatic impairment. Discuss in detail the 04
pharmacokinetic considerations in the hepatic disease patients.
Q. 6 (a) Discuss various markers used to measure GFR and their advantages and 06
disadvantages. Write various formulae used for the measurement of Creatinine
clearance.
(b) What are Nomograms and Tabulations? Explain their applications in 04
pharmacokinetic studies with examples and their advantages and disadvantages.
(c) Write in detail: TDM of Sodium valproate and Lithium. 04
Q.7 (a) Short Note on: Designing the dosage regimen for Obese and Geriatric patients. 06
(b) Write a note on: Giusti-Hayton method for the dosage adjustment in uremic 04
patients.
(c) Write in detail: Different methods of extracorporeal removal of drugs. 04
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