Pharm D Revised Regulations 2008 - Rajiv Gandhi University of ...

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764.5 BIOPHARMACEUTICS AND PHARMACOKINETICS (THEORY)Theory : 3 Hrs. /Week1. Biopharmaceutics1. Introduction to Biopharmaceuticsa. Absorption of drugs from gastrointestinal tract.b. Drug Distribution.c. Drug Elimination.2. Pharmacokinetics2. Introduction to Pharmacokinetics.a. Mathematical modelb. Drug levels in blood.c. Pharmacokinetic modeld. Compartment modelse. Pharmacokinetic study.3. One compartment open model.a. Intravenous Injection (Bolus)b. Intravenous infusion.4. Multicompartment models.a. Two compartment open model.b. IV bolus, IV infusion and oral administration5. Multiple – Dosage Regimens.a. Repititive Intravenous injections – One Compartment Open Modelb. Repititive Extravascular dosing – One Compartment Open modelc. Multiple Dose Regimen – Two Compartment Open Model6. Nonlinear Pharmacokinetics.a. Introductionb. Factors causing Non-linearity.c. Michaelis-menton method of estimating parameters.7. Noncompartmental Pharmacokinetics.a. Statistical Moment Theory.b. MRT for various compartment models.c. Physiological Pharmacokinetic model.8. Bioavailability and Bioequivalence.a. Introduction.b. Bioavailability study protocol.c. Methods of Assessment of Bioavailability
774.5 BIOPHARMACEUTICS AND PHARMACOKINETICS (PRACTICAL)Practical : 3 Hrs./Week1. Improvement of dissolution characteristics of slightly soluble drugs by some methods.2. Comparison of dissolution studies of two different marketed products of same drug.3. Influence of polymorphism on solubility and dissolution.4. Protein binding studies of a highly protein bound drug and poorly protein bound drug.5. Extent of plasma-protein binding studies on the same drug (i.e. highly and poorlyprotein bound drug) at different concentrations in respect of constant time.6. Bioavailability studies of some commonly used drugs on animal/human model.7. Calculation of Ka, Ke, t 1 /2, Cmax, AUC, AUMC, MRT etc. from blood profile data.8. Calculation of bioavailability from urinary excretion data for two drugs.9. Calculation of AUC and bioequivalence from the given data for two drugs.10. In vitro absorption studies.11. Bioequivalency studies on the different drugs marketed.(eg) Tetracyclin e,Sulphamethoxzole, Trimethoprim, Aspirin etc., on animals and human volunteers.12. Absorption studies in animal inverted intestine using various drugs.13. Effect on contact time on the plasma protein binding of drugs.14. Studying metabolic pathways for different drugs based on elimination kinetics data.15. Calculation of elimination half-life for different drugs by using urinary eliminationdata and blood level data.16. Determination of renal clearance.References:a. Biopharmaceutics and Clinical Pharmacokinetics by, Milo Gibaldib. Remington’s Pharmaceutical Sciences, By Mack Publishing Company, Pennsylvnia.c. Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker Inc.d. Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie Prescott byADIS Health Science Press.e. Biopharmaceutics and Pharmacokinetics; By Robert F Notarif. Biopharmaceutics; By Swarbrickg. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and SunilB.Jaiswal, Vallabh Prakashan Pitampura, Delhih. Cilincal Pharmacokinetics, Concepts and Applications: By Malcolm Rowland andThomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.i. Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack, PublishingCompany, Pennsylvania 1989.j. Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4 th edition Revisedand expanded by Rebort F Notari Marcel Dekker Inn, New York and Basel, 1987.k. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, James, C.Roylan, Marcel Dekker Inc, New York 1996.
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