Course

Unit 1

UNIT IIntroduction to Clinical pharmacokinetics 5 hours

• Instantaneous and delayed distribution model for intravenous and extravascular administration of drugs-2hours
• Calculation of Half life, elimination rate constant, Volume of distribution,Renal and hepatic clearance-
• Non linear kinetics- 1 hour
• Time dependent and dose dependent kinetics – 1 hour
• Estimation and determinants of Bioavailability
• Multiple dosing, Calculation of loading dose and maintenance dose -1hour

Unit 2

UNIT II Design of dosage regimens 6 hours

• Nomograms and Tabulations in designing dosage regimen, Conversion from intravenous to oral dosing, Determination of dose and dosing intervals.-2hrs
• Metric measures – conversion factors -1hr
• Milligram to Milliequivalent calculations -1hr
• Drug dosing in the elderly, pediatrics and obese patients.
• Drug dosing in pregnancy and lactation -2hrs

Unit 3

UNIT III Pharmacokinetics of Drug Interaction 4 hours

• Pharmacokinetic drug interactions-2hrs
• Inhibition and Induction of Drug -1hr
• Inhibition of Biliary Excretion.-1hr

Unit 4

UNIT IVDosage adjustment in Renal and hepatic Disease 5 hours

• Renal impairment
• Pharmacokinetic considerations
• General approach for dosage adjustment in Renal
• Measurement of Glomerular Filtration rate and creatinine
• Dosage adjustment for uremic Extracorporeal removal of drugs.
• Effect of Hepatic disease on

Unit 5

UNIT V Therapeutic Drug monitoring 9 hours

• Introduction -1hr
• Individualization of drug dosage regimen (Variability – Genetic, Age and Weight, disease, Inter- acting drugs). -1hr
• Indications for -1hr
• Protocol for -1hr
• Pharmacokinetic/Pharmacodynamic Correlation in drug therapy. -1hr
• TDM of drugs used in the following disease conditions: cardiovascular disease, Seizure disorders, Psychiatric conditions, and Organ transplantations. -4hrs

Unit 6

UNIT VI Population Pharmacokinetics. 5 hours

• Introduction to Bayesian
• Adaptive method or Dosing with Analysis of Population Pharmacokinetic Data.
• Pharmacometrics software

Unit 7

UNIT VII Pharmacogenetics 5 hours

Introduction to Pharmacogenetics

• Ethical issues in genetics
• Is genetic information qualitatively different from other medical information?

Scientific background of Pharmacogenetics

• Introduction tothe scientific basis of pharmacogenetics
• Differentiating people Pharmacogenetics in different ethnic groups
• Changes in Pharmacogenetics in Different diseases
• Public perceptions of pharmacogenetics
• The application of pharmacogenetics in improving safety and increasing efficacy

PK/PD considerations in Pharmacogenetics 6 hours

• Genetic polymorphism in Drug metabolism: Cytochrome P-450
• Genetic Polymorphism in Drug Transport and Drug
• Pharmacogenetics and Pharmacokinetics/Pharmacodynamic considerations

This course is designed to enable students to understand the basic principles and applications of Pharmacokinetics in designing the individualized dosage regimens, to interpret the plasma drug concentration profile in altered pharmacokinetics, drug interactions and in therapeutic drug monitoring processes to optimize the drug dosage regimen. The subject enables students to understand the basic concepts of pharmacogenetics, pharmacometrics for calculation and interpretation of pharmacokinetic data.

Helps one apply kinetics in dosage individualization, dose calculation in renal and hepatic dysfunction. Student practices calculation of AUC, elimination rate constant, half life, clearance from the given plasma drug levels.One is able to correlate plasma drug levels from therapeutic drug monitoring with drug response to differentiate between non-adherence to therapy or patient inherent pharmacogenomics variation. Detect the pharmacokinetic interactions with co administered drugs and possible complications arising from Genomic SNP variants causing changes in drug levels and subsequent impact on response. Illustrates capability considering the criteria in fixing doses in paediatric and geriatric patients.

K1:Define the basic terms in Pharmacogenomics

K2: Quote the need for compartment kinetics model

K3: Describe the objectives and eligibility criteria of drugs requiring TDM

K4: State the factors to be considered in dose calculation for Geriatrics, Paediatrics and obese population Compose the design of Pharmacokinetic distribution models

K5: Realise the patterns of metabolic and elimination pathway for regularly used drugs

K6:Correlate drug kinetics with type of drug distribution

SKILL

S1:Link the drug concentration –time data in semilog graph paper and calculate Pharmacokinetic parameters

S2:Use Pharmacokinetic data to calculate maintenance dose and loading dose

S3:Recognise individual patient status , assess and prepare intravenous to oral conversion S4:Demonstrate expertise in metric measures conversions , Milliequivalent to milligram and vice versa

S5: calculate drug dosing in liver and renal failure

S6: Predict the sampling time for TDM to conduct TDM studies

S7:Apply Pharmacogenetic polymorphism principles in recognizing the variation in drug response in Patients and suggest for optimization of therapy

ATTITUDE

A1: Coordinate with other healthcare team to give best Patient care

A2:Relate discussions with colleagues to give best possible pharmaceutical care

A3: Articulate knowledge to the community

A4:Maximize sincerity, punctuality and integrity in the profession ventures.

A5: Value ethics in Pharmacogenetics

A6:Show compassion towards patients while providing Patient car

REFERENCE BOOKS

Leon Shargel, Susanna Wu-Pong, Andrew Yu. Applied Biopharmaceutics & Pharmacokinetics. ,7^th edition , Mc Graw Hill.,2021

• Peter L. Bonate. Pharmacokinetic – Pharmacodynamic Modeling and Simulation. SpringerPublications,2011
• Malcolm Rowland, Thomas N. Tozer .Clinical Pharmacokinetics and pharmacodynamics: concepts and applications,5^th edition, Lippincott Williams & Wilkins, USA,2019
• Michael E. Burton, Leslie M. Shaw, Jerome J. Schentag, William E.Evans. Applied Pharmacokinetics & Pharmacodynamics: Principles of Therapeutic Drug Monitoring., 3^rd edition, Iippincott Williams & Wilkins,2006
• Steven How-Yan Wong, Irving Sunshine. Handbook of Analytical Therapeutic Drug Monitoring and Toxicology. CRC Press, USA, 1996

• Soraya Dhillon, Andrzej Kostrzewski. Clinical pharmacokinetics. 1st edition. London: Pharmaceutical Press,2006
• Joseph T.Dipiro, William J.Spruill, William E.Wade, Robert A.Blouin and Jane M.Pruemer Concepts in Clinical Pharmacokinetics., 6^th edition, American Society of Health-System Pharmacists, USA,2014
• Evans, Schentag, Jusko. Applied pharmacokinetics, 4^th edition American Society of Health system Pharmacists, USA,2006
• Michael Winter. Basic Clinical Pharmacokinetics. Iippincott Williams & Wilkins, USA,2004
• Milo Biopharmaceutics and Clinical Pharmacokinetics. ,4^th edition,Pharma Book Syndicate, USA,2005
• Dhillon and Clinical pharmacokinetics., volume 13,Pharmaceutical Press, London.,2006
• John E .Murphy. Clinical Pharmacokinetics. 7th edition. US: American Society of Health- System Pharmacist, USA.,2022

JOURNALS

Journal of Pharmacy Practice- SAGE Publications Inc

New England journal of Medicine- Massachusetts Medical Society.

Journal of clinical trials- SAGE Publications Inc

ASSIGNMENTS

• Population Pharmacokinetics of Vancomycin in paediatric patients
• Relationship Between Antithymocyte Globulin Concentrations and Lymphocyte Sub- Populations in Kidney Transplant Patients
• Drug–Drug Interaction Potential with Once-Weekly Isoniazid/Rifapentine (3HP) for the Treatment of Latent Tuberculosis Infection
• Comparison of Pharmacokinetics and Pharmacodynamics of Inhaled Technosphere Insulin and Subcutaneous Insulin Lispro in the Treatment of Type 1 Diabetes Mellitus
• Systematic Review and Meta-analysis on the Association of Occupational Exposure to Free Crystalline Silica and Rheumatoid Arthritis
• Clinical Treatment Options in Scleroderma: Recommendations and Comprehensive Review
• Impact of Inflammation on Cytochromes P450 Activity in Pediatrics: A Systematic Review
• Influence of CYP2D6 Phenotypes on the Pharmacokinetics of Aripiprazole and Dehydro- Aripiprazole
• Inter-species geographic signatures for tracing horizontal gene transfer and long-term persistence of carbapenem resistance
• Population study of the gut microbiome: associations with diet, lifestyle, and cardiometabolic disease
• Determination of plasma drug concentration for digoxin/ Phenytoin/ aminoglycoside antibiotic/ immunosuppressant from a given patient Blood sample drawn at steady state by HPLC analysis (Shall be done in group of 5 or 6 students)
• Dosage adjustment in Renal and hepatic