Calicut University M.Com 2020 Important Questions (Question Bank) || (University of Calicut)
V Pharm D
Subject: Clinical Pharmacokinetics &Pharmacotherapeutic Drug Monitoring
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QUESTION BANK 2016-17
Note: Unit II, IV –Two Chapters are clubbed together
Unit I: Introduction to Clinical pharmacokinetics
3
No. of Hours:
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Short Answers 2 Marks
- Give the importance of clinical pharmacokinetics
- Define apparent volume of distribution and give the mathematical equation to calculate this parameter.
- Define non-linear pharmacokinetics
- Describe the difference between first and zero order elimination and how each order appears graphically.
- Define biological half-life and give it's equation with units.
- Give the relationship between half-life and elimination rate constant.
- What is clearance? Give the relationship between clearance, drug dose and AUC.
- Give the assumptions of compartment model.
- Define pharmacokinetics. Name and define three pharmacokinetic parameters that describe a typical plasma level time curve.
- Define loading dose and maintenance dose. Give equations to calculate the same.
- Give any four applications of clinical pharmacokinetics.
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Unit II: (A. Design of Dosage Regimen + Therapeutic Drug Monitoring)
A. Design of dosage regimens
7
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No. of Hours:
Long Answers 10 Marks
- Explain the various factors considered in the design of dosage regimen for geriatric and obese patients.
Short Essay 5 Marks
- Explain the process and clinical significance of conversion from intravenous to oral dosing.
- What are nomograms? Explain their applications in pharmacokinetic studies with examples. Give their advantages and disadvantages.
- Explain in detail the determination of dose and dosing interval of a drug.
- Describe the principle of superposition and how it applies to multiple drug dosing.
- Explain the role of nomograms and tabulations in the design of dosage regimen.
- Explain the different methods of conversion of intravenous to per oral dosing.
- Explain various factors considered in designing the dosage regimen for geriatric patients.
- Explain the factors considered in the design of dosage regimen for paediatric patients. Give any two formulae for the calculation of child dose.
- Explain various factors considered in the design of dosage regimen for obese patients.
- Why dosage adjustment is necessary in the obese patients. What are the pharmacokinetic parameters to be considered in the dosage adjustment for obese patients?
- The elimination half-life and Va of tobramycin was reported to be 2.15 hrs and 33.5% of body weight respectively. What is the dose for an 80 kg individual if a steady state level of 2.5 µg/ml is desired? Assume that the drug is given as iv bolus every 8 hrs.
- The elimination half-life of an antibiotic is 3 hrs with an apparent volume of distribution equivalent to 20% of bodyweight. The usual therapeutic range of this antibiotic is between 5-15 µg/ml. Calculate the dose and dosing interval that will just maintain the therapeutic concentration.
- Explain in detail determination of dose and dosing interval of a drug.
- Enumerate the factors involved in calculation of drug dose in peadiatric patients.
- Discuss the factors to be considered during the design of dosage regimen.
- Explain the reasons for converting IV dose to oral dose. Add a note on START and STOP criteria for drugs to be used in patients.
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Short Answers 2 Marks
- Add a note on START and STOP criteria for drugs to be used in geriatric patients.
- Write different formulae for calculating child dose.
- Add a note on BEER's criteria for drugs to be used in geriatric patients.
- Write the importance of loading dose in finding drug dosing intervals.
- Give the relationship between elimination half-life and drug dosing intervals
- Define nomograms and tabulations.
- Give any two advantages and disadvantages of nomograms.
- Enumerate the methods for conversion of IV to oral dosing.
- Give any four factors considered in dosing geriatric patients.
- What are the factors affecting the drug absorption in geriatric patients?
- Mention the factors affecting the drug distribution in obese patients.
- Based on which property of drug, the drug dosage is adjusted in the obese patients and why?
- Give any four factors considered in dosing obese patients.
- Mention any four factors considered in dosing paediatric patients.
- Give any two formulae for the calculation of paediatric dose.
- Write the formula for the calculation of geriatric dose.
- What are the factors considered in the conversion of IV to oral dosing?
- What is the BEER's criteria for drugs to be used in geriatric patients?
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B. Therapeutic Drug Monitoring
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15
No. of Hours:
Long Essay 10 marks
- Explain the necessity and process of TDM in patients receiving cyclosporine and carbamazepine.
- List out the indications for TDM. Explain the necessity and process of TDM in patients receiving digoxin and phenytoin.
- Explain the necessity and process of TDM in patients receiving lithium and methotrexate.
- Enumerate and explain various factors in individualizing drug dosage regimen.
- Explain in detail pharmacokinetic/pharmacodynamic correlation in drug therapy.
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Short Essay 5 Marks
- Explain effect of age and bodyweight in individualization of drug dosage regimen.
- Explain role of genetics and disease condition in the individualization of drug dosage regimen.
- Explain role of co-existing diseases and interacting drugs in the individualization of drug dosage regimen.
- Describe the protocol for TDM of a drug.
- Define TDM. Discuss the indications for TDM of drugs.
- Explain the role of clinical pharmacist in TDM.
- Explain the relationship between dose and pharmacological effect of a drug.
- Explain the relationship between dose and duration of activity of a drug.
- Explain with suitable examples how elimination half life of a drug influence the duration of activity.
- Write about Emax model
- Explain the sigmoidal Emax model in PK/PD correlation
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Short Answers 2 Marks
- Enlist various types of samples used for analysis in TDM
- What do you understand by drug tolerance and physical dependency?
- Define narrow therapeutic index with suitable examples.
- Define TDM. Name any four drugs that require TDM.
- Write the protocol for TDM of a drug.
- Give any four indications for TDM.
- Why is TDM necessary for digitoxin.
- Why is TDM necessary for methotrexate.
- Explain the necessity of monitoring cyclosporine.
- Give the necessity for TDM of lithium.
- Why is TDM necessary for phenytoin.
- Explain the reasons for monitoring drug levels.
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Unit III: Pharmacokinetics of drug interactions
5
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No. of Hours:
Short Essay 5 Marks
- Explain the various pharmacokinetic drug interactions with suitable examples*.
- Explain the influence of drug interaction on drug absorption with examples
- Discuss drug interactions related to protein binding and metabolism.
- Describe the role of cytochrome P-450 enzymes in drug interactions. Add a note with suitable examples and their clinical significance.
- Explain the influence of drug interaction on drug metabolism with respect to enzyme induction and enzyme inhibition.
- Explain the effect of inhibition of biliary excretion of drugs and list out the drug interactions which influence the biliary excretion.
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Unit IV: (A. Dosage adjustment in renal and hepatic disease + B. Pharmacogenetics)
A. Dosage adjustment in renal and hepatic disease
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10
No. of Hours:
Long Essay 10 Marks
- Explain in detail the general approaches for dosage adjustment in renal diseases.
- Explain in detail the different methods of extracorporeal removal of drugs.
- Discuss various markers used in the measurement of glomerular filtration rate along with their advantages and disadvantages. Enumerate the various formulae used for the measurement of creatinine clearance.
- Enumerate various causes for renal impairment. Discuss in detail the pharmacokinetic considerations in the renal failure patients.
- List out various factors for hepatic impairment. Discuss in detail the pharmacokinetic considerations in the hepatic disease patients.
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Short Essay 5 Marks
- List various formulae for measurement of glomerular filtration rate.
- Explain the various pharmacokinetic changes observed in the renally impaired patients.
- How do you adjust dosage regimen in renal failure patients based on elimination half life of drug?
- How do you adjust dosage regimen in renal failure patients based on total body clearance of drug?
- Give the ideal characteristics of a marker to be used in the measurement of GFR.
- Explain various markers used in the measurement of glomerular filtration rate along with their advantages and disadvantages.
- Define creatinine clearance. Enumerate various formulae used for the measurement of creatinine clearance.
- Explain the effect of hepatic disease on pharmacokinetics of drugs.
- Describe peritoneal dialysis with its advantages and disadvantages.
- Explain the Giusti-Hayton method for the dosage adjustment in uremic patients.
- Describe the Wagner method for the dose adjustment in uremic patients.
- The maintenance dose of gentamicin is 80mg every 6hrs for a patient with normal renal function. Calculate the maintenance dose for a uremic patient with creatinine clearance of 20ml/min. Assume a normal creatinine clearance of 100ml/min.
- What is the creatinine clearance for a 25 year old male patient with a serum creatinine of 1mg/dL? The patient is 5 ft, 4inches in height and weighs 103 Kg.
- An adult male patient (52 years old, 75 kg) whose serum creatinine is 2.4 mg/dL is to be given gentamicin sulphate. The usual dose of gentamicin in adult patients with normal renal function is 1 mg/kg every 8 hours by multiple IV bolus injections. Calculate the appropriate dosage regimen of gentamicin sulfate for this patient.
- Explain hemodialysis.
- Explain methods of determining creatinine clearance.
- Describe the methods of measurement of GFR and their significance.
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Short Answers 2 Marks
- Enumerate the factors influencing dialyzability of drugs.
- Enumerate the causes for renal failure
- Give any four pharmacokinetic parameter changes observed in the renal failure patients.
- List the markers used in the measurement of GFR.
- Give any four ideal characteristics of the marker drugs to be used for GFR measurement.
- Give two advantages and disadvantages of inulin as a marker for GFR measurement.
- Give the Jellife's equation for the measurement of creatinine clearance.
- Give the Cockraft and Gault's equation for the measurement of creatinine clearance.
- Give the formula for the calculation of creatinine clearance in children.
- Give the MDRD equation for the measurement of creatinine clearance.
- Name the methods for the extracorporeal removal of drugs.
- Give any two advantages and disadvantages of peritoneal dialysis.
- Give any two advantages and disadvantages of haemodialysis.
- Define intrinsic clearance of drugs with its clinical significance.
- Calculate creatinine clearance for a 30 year old female patient with a serum creatinine value of 0.8 mg/dl. The patient is 5 ft 1 inch tall and weighs 69 kgs.
- Name the metabolic markers used in liver function test with their normal values.
- Define hepatic clearance
- Give the importance of extra corporeal rem of drugs.
- Calculate creatinine clearance for a 23 year old male patient with a serum creatinine value of 1.2 mg/dl. The patient is 5 ft 5 inch tall and weighs 98 kgs.
- Using the method of Cockroft and Gault, Calculate creatinine clearance for a 36 year old female patient with a serum creatinine value of 1.8 mg/dl. The patient is 5 ft 5 inch tall and weighs 58 kgs.
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B. Pharmacogenetics
5
No. of Hours:
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Long Essay 10 Marks
- Discuss the role and clinical significance of genetic polymorphism in drug transports and drug targets with suitable examples.
- Discuss the importance of genetic polymorphism of cytochrome P-450 isozymes on drug metabolism with suitable examples.
Short Essay 5 Marks
- Describe the role of genetic polymorphism in drug targets.
- Describe the genetic polymorphism in CYP2D6 and 2C9 isozymes.
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Short Answers 2 Marks
- Define pharmacogenetics
- Describe genetic polymorphism in CYP2D6 isozymes
- Describe genetic polymorphism in CYP2C9 isozymes
- How do efflux transporters affect the bioavailability of the drugs
- Give any two examples for clinically important genetic polymorphism of drug targets.
- Give any two examples for clinically important genetic polymorphism of drug transporters.
- Describe the role of genetic polymorphism in drug targets.
- Define pharmacogentics and with suitable examples.
- With suitable examples, enumerate drug dosing in genetic dependent fast acetylators.
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Unit V: Population Pharmacokinetics
5
No. of Hours:
Short Essay 5 Marks
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- Describe Bayesian theory
- Explain dosing with feedback.
- Discuss population pharmacokinetic analysis using NONMEM method.
- Discuss analysis of population pharmacokinetic data.
- Discuss about the methods used to obtain the estimates of fixed effects and variability
- Describe the two-stage approach in population pharmacokinetic analysis
- Explain non-linear mixed effects modeling approach
- Give the applications of population pharmacokinetics.
- Explain the sampling design used in population pharmacokinetic study
- Describe how population pharmacokinetic data analysis is carried out.
- Give the reasons for conducting population pharmacokinetic study
- What are the limitations of population pharmacokinetic approach
- Explain the difference between population pharmacokinetics and population pharmacokinetics.
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Short Answers 2 Marks
- Define adaptive method in population pharmacokinetics study.
- Define population pharmacokinetics.
- Define adaptive method in population pharmacokinetics study.
- Define population pharmacokinetics.
- What are the advantages of population pharmacokinetic study over traditional pharmacokinetic study?
- Define interindividual variation
- Define within subject variation
- What is random error?
- What is residual error?
- What do you understand by typical value?
- Define theta, omega, sigma in NONMEM method of analysis
- List the methods used for the population pharmacokinetic model evaluation
- What is difference between observed and predicted concentrations?
- What do you understand by over-estimation?
- List various softwares used for conducting population pharmacokinetic analysis
- Give Bayesian equation.
- What do you understand by Goodness of Fit plot
- Define FO and FOCE.
- What do you understand by nested models?
- What is naïve pool data?
- Give the advantages of Bayesian method in population pharmacokinetic study
- What is interoccasion variation?
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