M Pharm Il semester Regular & Supplementary Examinations, December 2013
BIOPHARMACEUTICS & PHARMACOKINETICS
(Common to Pharmaceutics, Pharmacology, Pharmacy Practice, Industrial Pharmacy, Pharmaceutical Technology, Pharmaceutics & Drug Regulatory Affairs and Hospital & Clinical Pharmacy)
Max Marks: 60 Time: 3 hours
Answer any FIVE questions
All questions carry equal marks
All questions carry equal marks
1. (a) What is the need of bioavailability studies? Discuss the criteria for establishing a bioequivalence requirement.
(b) Give design of single dose bioequivalent study with suitable example.
2. Define dissolution. Explain various theories of dissolution. Discuss the parameters that influence the rate of dissolution of drug.
3. (a) Explain methods of assessing bioavailability
(b) Briefly describe the formulation factors affecting bioavailability of drugs in dosage forms like liquid oral, topical and parenteral preparations.
4. Describe Wagner-Nelson method for determination of Ka. What are the advantages of Wagner-Nelson method over method of residuals?
5. (a) Define renal clearance and clearance ratio. Explain methods to determine renal Clearance
(b) How do you adjust the dose for renal impairment patient?
6. Write short note on
(a) Saturation Pharmacokinetics
(b) AUMc
(c) Absolute bioavailability.
(d) Two compartmental models.
(a) Saturation Pharmacokinetics
(b) AUMc
(c) Absolute bioavailability.
(d) Two compartmental models.
7. With the help of neat scheme, derive an equation that describes the urinary excretion rate-time data following iv. bolus administration of a drug
8. (a) Explain the term chronopharmacokinetics,
(b) How do you correlate in vitro drug dissolution with in vivo bioavailability?
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