JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objective

This course is designed to enable students to understand the basics principles

and applications of pharmacokinetics in designing the individualized dosage regimen, to interpret the plasma drug concentration profile in pharmacokinetics, drug interactions and in therapeutic drug monitoring processes to optimize the drug dosage regimen. Also, it enables students to understand the basic concepts of HPLC, Immunoassays and TDM of selected drugs.

Course Outcome

Upon completion of this course it is expected that students shall be able to:

• Design the drug dosage regimen for individual patients
• Interpret and correlate the plasma drug concentrations with patients' therapeutic outcomes Recommend dosage adjustment for patients IV Infusion to Oral dosing Recommend dosage adjustment for depening on patients response
• Manage TDM of selected drugs
• Apply pharmacokinetic parameters in analytical determination

UNIT - I

Introduction to pharmacokinetics: Compartmental and Non-compartmental models, Renal and non- renal clearance, Organ extraction and models of hepatic clearance, Estimation and determinants of bioavailability, Multiple dosing, Calculation of loading and maintenance doses.

UNIT - II

Therapeutic Drug Monitoring Introduction, Necessity of TDM, Criteria for valid TDM, Essentials for effective TDM, Organization of a TDM service, information requirements for TDM, effectiveness of TDM.

UNIT - III

Drug selection, Dosage regimen design, Pharmacokinetics of the Drug, Patient compliance, Evaluation of pateint’s response, Measurement of serum drug concentrations, Monitoring serum drug concentrations, Design of dose regimens. Conversion from i.v. infusion to oral dosing. Determination of dose frequently, dosing of drugs in elderly.

UNIT - IV

Analytical aspects of TDM, Uses of HPLC and Immunoassays in TDM

UNIT - V

TDM of selected individual drugs - Aminoglycosides, Carbamazepine, Theophulline Digoxin, Methotrexate, Phenytoin, Aspirin, Lithium, Valproic acid.

TEXT BOOKS:

• 1. Applied Biopharmaceutics and Pharmacokinetics by Leon Shargel and B.C. Andrew
• 2. Therapeutic Drug Monitoring and Clinical Biochemistry by Mike Halworth and Nigel Capps.
• 3. Biopharmaceutics and Pharmacokinetics by Robert E. Notari.
• 4. Therapeutic Drug Monitoring by Gerald E Schumacher, Pharmamed Press
• 5. Principles and Prescriptives in Drug Bioavailability by S.Karger.
• 6. Pharmaceutics and Pharmacy Practice by Gilbert S.Banker
• 7. Remington’s Pharmaceutical Sciences
• 8. Dissolution, bio-availability and bio-equivalence by Abdou
• 9. Pharma Review by Leon Shargel
• 10. Current concepts in Pharmaceutical Sciences by James Swarbrick
• 11. Drug Disposition and Pharmacokientics by Stephen H. Curry
• 12. Pharmacokinetics by MiloGilbaldi and Donald Perrier 2nded Marcel Dekker Inc. New York 1982.
• 13. Drug Level monitoring, Analghical Techniques, metabolism and pharmacokinetics.
• 14. Simkin: Handbook of TDM.
• 15. Goodman & Gilman's The pharmacological Basis of Therapeutics Ed. J.G. Hardman, L.E. Limbird,
• 16. P.B. Molinoff and R.W. Ruddon. International Edition. McGraw Hill.
• 17. Principles of drug action the basis of pharmacology by goldstein A., Arrow L. and Kalman S.M. 2nd ed. John Wiley & sons. Inc.New York 1974.
• 18. Clinical pharmacokinetics. Concepts and Applications by rowland M and Tozert.N. 3rd ed. Lea and Febiger Philadelphia, 1995.
• 19. Pharmacokinetics for pharmaceutical scientists Wagner J.G. Technomic. Inc. Lancaster PA 1993.
• 20. Integration of pharmacokinetics, pharmacodynamics and Toxico kinetics in Rational Drug Development Plenum, New York, 1993.
• 21. Applied Pharmacokinetics, Principles of Therapeutic Drug monitoring, by Evans W.E., Schentag J.J. and Jusko W.J. (Eds). 3rd ed. Applied Therapeutics Inc. Vancouvers HA. 1992. M.Pharm I Year II Sem (Pharmacology)