Clinical Pharmacokinetics and Therapeutic Drug Monitoring Detailed Syllabus for Pharmacy Practice M.Pharm first year second sem is covered here. This gives the details about credits, number of hours and other details along with reference books for the course.
The detailed syllabus for Clinical Pharmacokinetics and Therapeutic Drug Monitoring M.Pharm 2017-2018 (R17) first year second sem is as follows.
M.Pharm. I Year II Sem.
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 altered 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 pharmacogenetics, pharmacometrics for modeling and simulation of pharmacokinetic data.
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 with renal/ hepatic impairment
- Recommend dosage adjustment for paediatrics and geriatrics
- Manage pharmacokinetic drug interactions
- Apply pharmacokinetic parameters in clinical settings
- Interpret the impact of genetic polymorphisms of individuals on pharmacokinetics and or pharmacodynamics of drugs
- Do pharmacokinetic modeling for the given data using the principles of pharmacometrics
UNIT I : Introduction to Clinical 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. Designing of dosage regimens: Determination of dose and dosing intervals, Conversion from intravenous to oral dosing, Nomograms and Tabulations in designing dosage regimen.
UNIT II : Pharmacokinetics of Drug Interaction: Pharmacokinetic drug interactions, Inhibition and Induction of Drug metabolism, Inhibition of Biliary Excretion. Pharmacogenetics: Genetic polymorphism in Drug metabolism: Cytochrome P-450 Isoenzymes, Genetic Polymorphism in Drug Transport and Drug Targets, Pharmacogenetics and Pharmacokinetic/ Pharmacodynamic considerations. Introduction to Pharmacometrics: Introduction to Bayesian Theory, Adaptive method or Dosing with feedback, Analysis of Population pharmacokinetic Data.
UNIT III: Non Linier Mixed Effects Modelling: The Structural or Base Model, Modeling Random Effects, Modeling Covariate Relationships, Mixture Model, Estimation Methods, Model Building Techniques, Covariate Screening Methods, Testing the model assumptions, Precision of the parameter estimates and confidence intervals, Model misspecification and violation of the model assumptions, Model Validation, Simulation of dosing regimens and dosing recommendations, Pharmacometrics software.
UNIT IV : Altered Pharmacokinetics: Drug dosing in the elderly, Drug dosing in the paediatrics, Drug dosing in the obese patients, Drug dosing in the pregnancy and lactation, Drug dosing in the renal failure and extracorporeal removal of drugs, Drug dosing in the inhepatic failure.
UNIT V : Therapeutic Drug monitoring: Introduction, Individualization ofdrug dosage regimen (Variability – Genetic, age, weight, diseaseand Interacting drugs), Indications for TDM, Protocol for TDM, Pharmacokinetic/Pharmacodynamic Correlation in drug therapy, TDM of drugs used in the following conditions: Cardiovascular disease: Digoxin, Lidocaine, Amiodarone; Seizure disorders:Phenytoin, Carbamazepine, Sodium Valproate; Psychiatricconditions: Lithium, Fluoxetine, Amitriptyline; Organtransplantations: Cyclosporine; Cytotoxic Agents: Methotrexate, 5-FU, Cisplatin; Antibiotics: Vancomycin, Gentamicin, Meropenem.
REFERENCES
- Leon Shargel, Susanna Wu-Pong, Andrew Yu. Applied Biopharmaceutics & Pharmacokinetics. New York: McGraw Hill.
- Peter L. Bonate. Pharmacokinetic – Pharmacodynamic Modeling and Simulation. Springer Publications.
- Michael E. Burton, Leslie M. Shaw, Jerome J. Schentag, William E. Evans. Applied Pharmacokinetics & Pharmacodynamics: Principles of Therapeutic Drug Monitoring. Iippincott Williams & Wilkins.
- Steven How-Yan Wong, Irving Sunshine. Handbook of AnalyticalTherapeutic Drug Monitoring and Toxicology. CRC Press, USA.
- Soraya Dhillon, Andrzej Kostrzewski. Clinical pharmacokinetics. 1st edition. London: Pharmaceutical Press.
- Joseph T. Dipiro, William J. Spruill, William E. Wade, Robert A.Blouin and Jane M. Pruemer Concepts in Clinical Pharmacokinetics. AmericanSociety of Health-System Pharmacists, USA.
- Malcolm Rowland, Thomas N. Tozer .Clinical Pharmacokinetics and pharmacodynamics: concepts and applications. Iippincott Williams &Wilkins, USA.
- Evans, Schentag, Jusko. Applied pharmacokinetics. American Society of Health system Pharmacists, USA.
- Michael E. Winter. Basic Clinical Pharmacokinetics. Iippincott Williams &Wilkins, USA.
- Milo Gibaldi. Biopharmaceutics and Clinical Pharmacokinetics. Pharma Book Syndicate, USA.
- Dhillon and Kostrzewski. Clinical pharmacokinetics. Pharmaceutical Press, London.
- John E .Murphy. Clinical Pharmacokinetics. 5th edition. US: AmericanSociety of HealthSystem Pharmacist, USA.
- Relevant review articles from recent medical and pharmaceutical literature
For all other M.Pharm 1st Year 2nd Sem syllabus go to JNTUH M.Pharm Pharmacy Practice 1st Year 2nd Sem Course Structure for (R17) Batch.
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