Download OU M.Pharma Pharmaceutics 2nd Sem 2020 6107PCI Advanced Biopharmaceutics And Pharmacokinetics Question Paper

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Code. No: 6107/PClI

FACULTY OF PHARMACY

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M. Pharmacy (Pharmaceutics) II-Semester (PCI) (Suppl.) Examination, January 2020

Subject : Advanced Biopharmaceutics and Pharmacokinetics

Time: 3 Hrs Max. Marks: 75

Note: Answer any Five Questions. All Questions Carry Equal Marks.

1. (a) Discuss about the theories proposed for the dissolution process and the factors affecting dissolution. 10
   

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   (b) What is in-vitro-in-vivo correlations (IVIVC) and explain in brief 5
2. (a) Write in details about factor affecting dosage forms in drug absorption 10
   (b) State and Explain the Noyes-Whitney equation 5
3. Write notes on
   (a) pH-partition hypothesis and its limitations 8
   

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   (b) Explain the biopharmaceutical factor affecting drug bioavailability 7
4. (a) Explain the pharmacokinetic parameters of a drug which follows one compartment open model when given by intravenous bolus with relevant mathematical equations. 8
   (b) Explain the various methods for assessment of bioavailability. 7
5. (a) Define Non-Linear pharmacokinetics. How do you estimate the pharmacokinetics parameters (Kmax and Vmax) by using Michaelis-Menten equation 10
   (b) Explain the biopharmaceutical classification system (BCS) with examples and what are its application. 5

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6. (a) Write a note on various study designs used for bioequivalence studies 8
   (b) Write the application of pharmacokinetics in monoclonal antibodies and gene therapies 7
7. (a) Explain the various methods for determining absorption of drugs in-vitro, in-situ and in-vivo and their correlation with examples. 10
   (b) Following a 650 mg I.V. bolus dose of a drug to a 65kg subject, the plasma drug concentration was found to decline biexponentially. The equation, that best described the drug kinetic was; C=76e^-4t + 33e^-3t Calculate the following parameters Ve, Vp, Vd.ss, Vd. area and Ke etc.
8. A dose of cirprofloxaction 250 mg I.V. bolus was administered to a patient and the plasma concentration vs time data is obtained. Assume the drug follows two compartment open model. Calculate all possible pharmacokinetic parameters.
   

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   Time (hrs) 0.25 0.5 0.75 1.5 2 2.25 3 5 6 7
   Plasma Conc. (µg/ml) 5.38 4.33 3.5 2.99 2.12 1.70 1.43 1.05 0.80 0.70

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