FACULTY OF PHARMACY
Pharm. D I-Year (Post Baccalaureate) (Main Backlog) Examination,
August 2016
Subject Bio Pharmaceutics Pharmacokinetics
Time 3 Hours Max. Marks: 70
Note: Answer all questions from Part A and answer any five questions from Part-B.
PART A (10 x 2 20 Marks)
1 With examples, Name the various drug binding sites on HSA.
2 Explain, Greater the free drug concentration of drug in plasma, larger its volume of
distribution.
3 Estimate the creatinine clearance of a 20 years old, 70 kg man with serum creatinine value
of 2.0 mg What is the renal function of a such patient?
4 What are the different sites of presystemic metabolism of orally administered drugs?
5 Define Drug Accumulation and list the factors influencing renal clearance of drugs.
6 List out the reasons for failure of IVIVC.
7 Layout a Latin square cross over design for bioequivalence study on three formulations-A, B
and C in six volunteers.
8 Define orange book objectives of bioequivalence studies.
9 Significance and determination of MRT and t1/2.
10 Define the terms absolute bioavailability and relative bioavailability and derive the
relationship.
PART B x 10 50 Marks)
11 Write note on
pH-Partition Theory
Physiological barriers to distribution of drugs
12 How do you calculate KE from urinary excretion data by using Sigma-Minus method.
Following a 500 mg I.V. bolus dose of a drug to a 50 kg subject, the plasma drug
concentration was found to decline biexponentially. The equation that best described the
drug kinetic was C 57e-14t+43e-3t. Calculate the following parameters Vc, Vp, Vd.ss,
Vd.area, k12, k21 and KE etc.
13 What is linear and Non-Linear pharamcokinetics Explain the role of Michaelis Menton
kinetics in Non-Linear pharamacokinetics.
14 Explain the pharmacokinetic parameters of a drug which follows two compartment open
model when given by intravenous bolus with relevant mathematical equations.
Estimate the Ka by Loo-Riegelman method.
15 Explain details about Phase-I reactions of biotransformation with suitable examples.
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Library
G.Pulla Reddy College of Pharmacy
HyderabadOU 1705 OU 1705
Code No. 6135 PB
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16 Mention in details about Bioequivalence study protocol for Extended Release dosage
forms.
17 Explain the design of dosage regimen. Add a note an assumption made in
design of dosage regimen.
The equation best fits the plasma level time curve after I.V. bolus dose of a drug
100 mg is C=7.14e-0.173t. Calculate Vd, AUC and Total systemic clearance.
18 A 50 kg male received 2mg/kg of a drug orally. The following plasma concentration
vs time data is obtained. Assume the drug follows one compartment open model
and it is completely absorbed. Calculate all possible pharmacokinetic parameters.