BIOPHARMACEUTICS and CLINICAL PHARMACY

Transcription

1 11 years papers covered BIOPHARMACEUTICS and CLINICAL PHARMACY IV B.Pharm II Semester, Andhra University Topics: Absorption Distribution Protein binding Metabolism Excretion Bioavailability Drug Interactions Pharmacokinetics Clinical Pharmacy 1

2 BIOPHARMACEUTICS and CLINICAL PHARMACY IV B.Pharm II Semester, Andhra University 11 years papers covered Topic: Absorption 1. Explain the influence of route of administration on drug absorption in the blood. What are the physicochemical and physiological factors that affect absorption of drug from a subcutaneous injection dosage form? (8) 2. Between tablets and hard gelatin capsules, which dosage form produces more prompt onset of drug action? Is it always true? Cite examples (8) 3. Discuss with the help of Noyes-whitney equation the factors which alter the distribution of drugs. (8) 4. What is the effect of gastro intestinal ph on the solubility and dissolution rate of a weak acid and a weak base? (8) 5. How is a drug absorbed through the rectal route? What is first pass effect? Explain. How does it influence bioavailability of a drug? (8) 6. Explain Noye s whitney equation and drug absorption (4) 7. Explain in detail various factors affecting drug absorption through GIT (any two in each) (16) 8. Discuss the salient features of passive diffusion (8) 9. Write a note on ph partition theory. Mention its importance (8) 10. What are the formulation factors that effect the absorption of drugs from tablets (8) 11. Mention the advantages and disadvantages of rectal route. Write a note on the factors affecting rectal route (8) 12. Explain the following in detail: Percutaneous adsorption (8), ph partition theory (8) 13. Discuss: First pass effect (4), Buccal and sub-lingual route of drug administration (4) 14. Explain the characteristics and kinetics of active and passive transport of drugs? (16) 15. Distinguish between solubility and dissolution rate. Explain the factors that influence the dissolution of drug from tablets (16) 16. What is the role of ph-partition theory in the absorption of drugs from GIT? Discuss in detail the effects of drug pk a and GI ph on the absorption of the drug from GIT? (8) 17. How does lipid solubility of a drug influence its absorption from the G.I? Explain with examples? (8) 18. Discuss the biopharmaceutical factors which influence absorption of drug from a tablet dosage form influence absorption of drug from a tablet dosage form (8) 19. Biological factors affecting drug absorption (8) 20. Explain all the factors that affect oral absorption (16) 21. Discuss the different factors involved in percutaneous and rectal absorption (16) 22. What is sink condition in dissolution testing? What is its importance (7) 23. What is the influence of particle size on absorption of drugs (8) 24. Discuss the salient features of active transport (8) 25. Enumerate the formulation factors affecting drug absorption from capsules (8) 26. Discuss the factors affecting percutaneous absorption (8) 27. Adsorption and complexation in drug absorption (6) 28. First pass effect (5) 2

3 Topic: Distribution 1. Explain permeability rate limited and perfusion rate limited drug distribution (8) 2. Apparent volume of distribution (5) 3. Volume of distribution at steady state (5) 4. Volume of Distribution (5) Topic: Protein binding 1. Explain protein binding of drugs with suitable examples (8) 2. How do you determine binding constants and binding sites by graphical methods (8) 3. Write a note on plasma protein binding (5) 4. Explain the significance of protein binding (8) 5. Explain with examples how protein binding takes place. Write about the factors affecting protein binding (16) Topic: Metabolism/ Bio-Transformation 1. Mixed function oxidases in drug metabolism (4) 2. Define the term biotransformation. List out Phase I and Phase II reactions. Explain any four (8) 3. Discuss the significance of enzyme induction and inhibition (8) 4. Discuss: First pass metabolism (5), Saturable metabolism (5), Extra hepatic metabolism (5) 5. Microsomal drug metabolism (5) 6. Enzyme induction and inhibition (8) 7. Explain how biotransformation takes place and discuss the factors affecting biotransformation (16) 8. Phase I metabolism (8) Topic: Excretion 1. Define renal clearance. Explain the principle process involved n the urinary excretion of drug (8) 2. Write a note on the significance and determination of creatinine clearance rate (8) 3. Explain the pharmacokinetic property - renal clearance (5) 4. Enterohepatic cycling (8), (5) 5. Discuss renal clearance (4) 6. How general clearance and renal clearance are defined mathematically. Briefly explain the factors on which renal clearance of a drug is dependent? (8) 7. Intrinsic clearance (5) 8. Biliary transport (5) 9. Draw a diagram showing the enterohepatic cycling of drug (4) 10. Explain Enterohepatic cycling (6) 11. Discuss Enterohepatic cycling (5) Topic: Bioavailability 1. What is the effect of absorption rate on drug bioavailability? How does patient to patient variability affect bioavailability? (8) 2. What are the differences between active transport and passive transport process? (8) 3. Bioequivalence studies and their significance (4) 3

4 4. Explain what is bioavailability? Discuss different methods of determining bioavailability comparing their merits and demerits? (16) 5. Define and explain the terms bioavailability and bioequivalence. How will you determine the bioavailability of a drug given orally (16) 6. Explain the terms, Bioequivalence, Therapeutic equivalence, Generic equivalence. Discuss the reported generic inequivalences of digoxin (8) 7. What do you understand by the term bioavailability? How is it determined using blood/plasma drug concentration or urinary excretion of drug data? (8) 8. Describe the official apparatus and method used for the determination of dissolution (8) 9. Discuss the statistical designs used in the conduct of bioavailability studies (8) 10. Explain what is bio-equivalence? How do you establish bio-equivalence of a new drug formulation? (16) 11. Mean Residence Time (5) 12. Describe in detail how you plan the conduct of a bioavailability study (9) Topic: Drug Interactions 1. Giving examples discuss the drug-drug interactions at absorption (8) 2. Write a note on drug-food interactions (8) 3. Write briefly on food-drug interactions (8) 4. Food drug administration (5) 5. Drug-food interactions (4) 6. Define drug interactions with examples. Explain in detail the pharmacokinetic interactions (16) 7. Drug interactions at distribution sites (8) 8. Explain with examples pharmacokinetic interactions (16) 9. Explain with examples pharmacodynamic drug interactions (8) 10. Write some food drug interactions (8) 11. Discuss the drug interactions occurring involving metabolism. Give examples (8) 12. Write a note on pharmacodynamic interactions (8) 13. Drug interactions at metabolism pathway (4) Topic: Pharmacokinetics 1. Describe the kinetics of one compartment and two compartment models. How these are mathematically expressed? How do you determine the overall elimination rate constants for one compartment and two compartments models? (8) 2. What is the significance of blood stream level curves of a drug? What do you understand by the terms C max, t max, MEC and Therapeutic index? (8) 3. Define apparent volume of distribution of a drug. How is it obtained for a drug conferring the kinetics of one compartment and two compartment on the body? (8) 4. What is compartment and model? The following plasma data is obtained after an i.v bolus dose of 184 mg of drug. Estimate all possible pharmacokinetic parameters (8) Time (hrs) Conc. mg/ml How do you calculate the half life of a drug in a patient by i.v infusion method? What are the advantages of administering drug by constant rate of i.v infusion? (8) 4

5 6. Explain how you can determine the absorption rate constant by method of residuals (8) 7. Discuss the methods of determination of Area under the curve (8) 8. Define and explain the significance of biological half-life. How will you determine it? (8) 9. Define and explain the significance of Volume of distribution. How will you determine it? (8) 10. Plasma concentrations following oral administration of 500mg of an antibiotic to a subject are given below: Calculate all possible pharmacokinetics parameters (8) Time (Hrs) Plasma conc. (mg/l) Time (Hrs) Plasma conc. (mg/l) What are the advantages of the Wagner-Nelson method over method of residuals? (8) 12. Discuss Non-linear pharmacokinetics (5) and AUC (5) 13. How do you determine absorption rate of a drug by the method of feathering or stripping and by Wagner nelson method. Discuss their limitation (16) 14. Explain the significance of half life of a drug (8) 15. A drug has a half life of 6 hours. If it has a volume of distribution of 72 liters in an 85 kg individual. What is its clearance? If its clearance is decreased by 50% due to renal failure what will be its new half life? (Assume V d remains constant) (8) 16. What is zero-order kinetics? What order of kinetics is associated with active transport? Explain first order kinetics in active transport process (8) 17. What are the mathematical characteristics of a drug conferring two compartment kinetics of the body? How many exponential phases exist? (8) 18. Discuss the differences between the half lives of a zero- order and a 1 st order process. Define biological half life. How is it determined? (8) 19. How do you obtain different pharmacokinetic parameters following oral administration of a drug that confers one compartment open model characteristics? (16) 20. A patient weighing 70 kgs received a drug i.v bolus at a dose of 500 mg. The initial concentration was 37.5 mg/l. What is the V d of the drug? If the half life of the drug is 3 hrs, what is clearance? (8) 21. Differentiate between one compartment and two compartment models (8) 22. Define and explain C max, MSC, MEC, Therapeutic range and volume of distribution (8) 23. Comment on the kinetics of blood vessels following iv bolus and oral single administration (8) 24. Discuss the determination of various pharmacokinetic parameters from urine data (8) 25. Discuss the determination of absorption rate constant by any one method (8) 26. Write a note on renal clearance and area under the curve (8) Topic: Clinical Pharmacy 1. What is patient counseling? Write in detail the role of the pharmacists in patient counseling regarding approach and various other aspects? (8) 2. Define adverse drug reactions discuss the different types of adverse drug reactions. Explain their significance (16) 5

6 3. What are the specific antidotes of the following poisons? Why should you use them? 4x4=16 (a) Arsenic (b) Heavy metals (c) Organic phosphorus type (d) Barbiturates 4. Pharmacodynamic drug interactions in polypharmacy (4) 5. What is therapeutic drug monitoring? Write briefly on TDM in paediatric patients. (8) 6. Write briefly on: (2x4=8) a) Patient counseling b) Scope of Clinical pharmacy 7. Write a note on the dose adjustment in pediatrics (8) 8. What is the importance and use of therapeutic drug level monitoring? (8) 9. Discuss: Modern dispensing practices (5) 10. Explain Unit dose dispensing (5) 11. Describe the following: a) Patient counseling (8) b) Precautions in pediatric medication (8) c) Repeated administration of drugs (5) 12. Write notes on the following: a) Objectives and scope of clinical pharmacy (8), b) Dosage regimens (8) 13. Discuss with the help of equations, the influence of the intravenous, oral & intramuscular routes of administration on drug absorption, distribution & elimination (8) 14. Define the term clinical pharmacy. Give in detail various functions of clinical pharmacy? (16) 15. What is patient counseling? (5) 16. Write a note on pharmacist and patient counseling? (5) 17. What is the modern scope of clinical pharmacy in India? (5) 18. Write short notes on: a) Idiosyncrasy (5), b) Anaphylaxis (5), c) Teratogencity (8) 19. Drug therapy in geriatrics (5) 20. What is clinical pharmacy? What are its objectives and scope in India? (8) 21. What is the significance of patient counseling? How does it improve treatment out comes? (8) 22. Therapeutic drug monitoring (8) 23. Write a note on the duties of a clinical pharmacist (8) 24. How are the physiological factors affecting drug ADME altered in geriatric patients? (8) 25. Write a note on patient counseling (8) 26. What precautions are necessary in paediatric medication? (8) 27. Write a note on patient counseling and its importance (8) 28. What are the precautions to be taken in the therapy of geriatric patients (8) * * * GOOD LUCK * * * RCP Vizag 11 years papers covered 6