PTU B-Pharma 5th Semester May 2019 70431 PHARMACEUTICS VII Question Paper

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Roll No.                                                     Total No. of Pages : 02

Total No. of Questions : 10

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B.Pharma (2011 to 2016) (Sem.-5)

PHARMACEUTICS-VII

(Biopharmaceutics & Pharmacokinetics)

Subject Code : BPHM-505 M.Code: 70431

Time: 3 Hrs.                                                                                           Max. Marks : 80

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INSTRUCTION TO CANDIDATES :

1. SECTION-A is COMPULSORY consisting of FIFTEEN questions carrying TWO marks each.
2. SECTION-B contains FIVE questions carrying FIVE marks each and students have to attempt any FOUR questions.
3. SECTION-C contains FOUR questions carrying TEN marks each and students have to attempt any THREE questions.

SECTION-A

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1. Answer briefly :
   1. What is meant by K and Ke?
   2. What is absolute bioavailability? Which dosage form will ideally have 100% absolute availability?
   3. What is facilitated transport?
   4. Give two examples of plasma proteins.
   5. What is pinocytosis?

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   6. What is renal clearance and how is it calculated?
   7. What is MDT?
   8. Mention the formula for calculating T_1/2 of drug for first order kinetics.
   9. Define volume of distribution and its units.
   10. What is MRT and what does it represent?

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   11. What is extra hepatic clearance?
   12. What is meant by biopharmaceutical studies?
   13. What is extraction ratio?
   14. Define Phase I and II trials and their purpose.
   15. What is active secretion in renal tubules?

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SECTION-B

2. Enumerate various pharmaceutical factors influencing drug absorption.
3. Comment on factors affecting drug distribution in the body.
4. What is meant by Vd? Discuss the significance of Vd.

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5. Explain with the help of suitable equations the pharmacokinetics of a drug in plasma after IV administration that follows one compartment open model.
6. A dose of 300 mg was given to a patient by IV bolus injection. After 30 days the serum drug concentration was found to be 75 mg/ml. Calculate K and T_1/2 of the drug assuming first order kinetics.

SECTION-C

7. What is bioequivalence? Mention the criteria for declaring two products bioequivalent and discuss the regulatory considerations pertaining to bioequivalence studies in India.
8. Explain how Ka is determined by Wagner-Nelson method.

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9. What is Sigma-Minus method? Explain the method of calculating elimination rate constant by this method with the help of suitable equations.
10. IV bolus dose (4 mg/kg) was administered to a patient of 75 kg weight. Following equation represented the drug kinetics :
    Cp = 78 e^-0.46t Calculate :
    1. T_1/2;
    2. Vd;
    3. Plasma concentration after 4 hr

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NOTE : Disclosure of Identity by writing Mobile No. or Making of passing request on any page of Answer Sheet will lead to UMC against the Student.

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