FIFTH YEAR

1.  Introduction to Clinical pharmacokinetics . 2. Design of dosage regimens:       Nomograms and Tabulations in designing dosage regimen,   Conversion from  intravenous to oral dosing,  Determination of dose and dosing intervals ,  Drug dosing in the elderly and pediatrics and obese patients . 3. Pharmacokinetics of Drug Interaction:          a. Pharmacokinetic drug interactions  b. Inhibition and Induction  of Drug metabolism  c. Inhibition of Biliary Excretion . 4. Therapeutic Drug monitoring :      a. Introduction   b. Individualization of drug dosage regimen         (Variability  Weight , disease, Interacting drugs) .   c. Indications for TDM.  Protocol for TDM.   d. Pharmacokinetic/Pharmacodynamic Correlation in drug therapy .   e. TDM of drugs used in the following disease conditions:    ...

PHARMACOEPIDEMIOLOGY   Definition and scope:   Origin and evaluation of pharmacoepidemiology  Need for  pharmacoepidemiology Aims and applications. Measurement of outcomes in pharmacoepidemiology     Outcome measure and drug use measures,  Prevalence,  Incidence and incidence rate.  Monetary units,  Number of prescriptions, Units of drugs dispensed,  Defined daily doses and prescribed daily doses, Medication adherence measurement      Concept of risk in pharmacoepidemiology                                                                             Measurement of risk, Attributable risk and relative risk Time-risk relationship and odds ratio Pharmacoepidemiological methods:           Includes ...

"Click on Orange colour titles for notes" 1. Drug development process:   Introduction Various Approaches to drug discovery      1. Pharmacological      2. Toxicological      3. IND Application      4. Drug characterization      5. Dosage form   2.   Clinical development of drug :      1.  Introduction to Clinical trials      2.   Various phases of clinical trial .      3.   Methods of post marketing surveillance           4.  Abbreviated New Drug Application submission .      5. Good Clinical Practice                 - ICH  guidelines               - GCP  guidelines               - Central drug standard control organisation (...