Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M.Pharm SEMESTER III -EXAMINATION SUMMER 2017
Subject Code: 930103 Date: 29/04/2017
Subject Name: Clinical Research and Pharmacy Practice
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

Write a note on Investigator Brochure.
06

Classify adverse drug reactions. Describe the procedure for adverse drug reaction reporting.
05

Describe the process of Therapeutic Drug Monitoring (TDM). State the limitations of TDM in Indian scenario.
05
Q.2

What is the role and responsibilities of principal investigator and sponsor as per ICH GCP guidelines?
06

Describe examples of variations in CVS drugs response due to genetic polymorphism.
05

Discuss various parameters used to establish types of anemia with clinical significance.
05
Q.3

Define the term "pharmacoeconomics". State its types and write any one in detail.
06

Discuss factors affecting drug dosage adjustments in pediatric patients.
05

Write short note on informed consent.
05
Q.4

Explain essential drug. Describe properties and advantages of essential drugs.
06

Explain one compartment pharmacokinetic model.
05

Write short note on Transplantation.
05
Q.5

What is pharmacoepidemiology? Discuss the advantages and disadvantages of randomized controlled trials.
06

Discuss general measures for management of heavy metals and barbiturate poisoning.
05

Explain the clinical pharmacokinetic parameters and illustrate their significance in patient care.
05
Q. 6

Enlist the drugs frequently used in ICU. Write short note on role of pharmacists in critical care therapy.
06

Discuss various markers for cardiac disorders with clinical interpretation.
05

Write a note on IRB/IEC.
05
Q.7

What precautions are required while administering drugs to pregnant and lactating woman?
06

Write a note on pharmacodynamic drug-drug interactions with examples.
05

Enlist the laboratory tests done for infectious diseases along with their significance.
05