SEMESTER- VI
Biopharmaceutics and Pharmacokintetics (BP604TT)
1. Define absolute and relative bioavailability. Classify the methods for bioavailability measurement. Discuss the method based on plasma data.
2. Explain various types of equivalence. How Latin square cross over design works?
3. Discuss the regulatory requirements for conduction of bio-equivalence studies.
4. Volunteer selection for bioavailability studies is a critical issue. Discuss the statement with examples.
5. Discuss criteria for waiver of in vivo bioavailability study with reference to drug product.
6. Explain various methods used for enhancement of bioavailability.
7. Write a note on IVIVC & Explain in brief different in-vitro dissolution testing models.
8. Define clearance and renal clearance ratio of drug. Discuss the role of active tubular secretion and tubular re-absorption on renal drug excretion.
9. Describe factors influencing renal excretion of drug.
10. Write a note on: Biotransformation.
11. Describe Noyes-Whitney theory for drug dissolution.
12. Discuss plasma protein drug binding and explain kinetics of protein binding.
13. What is gastric emptying? Describe its role in drug absorption.
14. Enumerate the factors affecting drug absorption from GIT. Discuss the effect of drug pKa and GI pH and Log P on drug absorption
15. Enumerate the drug transport mechanisms. Discuss passive diffusion or active transport in detail.
16. What are the physiologic barriers to distribution of drugs? Discuss BBB in detail
17. Discuss the apparent volume of distribution. Describe the factor affecting protein binding
18. Define pharmacokinetics & explain pharmacokinetic parameters that describe atypical plasma level time curve
19. Enlist various approaches for pharmacokinetic analysis of experimental data and explain compartmental models in detail
20. Differentiate compartment and physiological model
21. Explain non-compartmental analysis for assessment of pharmacokinetic parameters
22. What is extraction ratio? Explain hepatic clearance and organ clearance
23. Explain one compartment open model for continuous iv infusion
24. Explain the method of residuals for the calculation of absorption rate constant form oral data
25. Discuss Wagner- Nelson and Loo-Riegelman method
26. Enlist criteria to obtain valid urinary excretion data. Explain any one method in detail to obtain excretion rate constant from urinary excretion data
27. What is nonlinear pharmacokinetics? Explain Michaelis-Mentan equation for the same.
28. Explain assumption for multi-compartment model.
29. Define non-linearity and Give causes of non-linearity.
