Pharm D 5th Year Syllabus Pdf Download

Pharm D 5th Year Syllabus Pdf

Pharm D 5th Year Syllabus Exam Pattern

Sr No	Name of Subjects	I<–	Maximum Marks for Theory	–>I	I<–	Maximum Marks for Practicals	–>I
–	–	Examination	Sessional	Total	Examination	Sessional	Total
1.1	Clinical Research	70	30	100	–	–	–
1.2	Pharmacoepidemiology and Pharmacoeconomics	70	30	100	–	–	–
1.3	Clinical Pharmacokinetics and Pharmacotherapeutic Drug Monitoring	70	30	100	–	–	–
1.4	Clerkship	–	–	–	70	30	100
1.5	Project work (Six Months)	–	–	–	100**	–	100
–	–	–	–	300	–	–	200=500

Clinical Research

Theory (Topic-wise Lecture)

I. Drug Development Process:

1. Introduction
2. Various Approaches to Drug Discovery

II. Clinical Development of Drugs:

1. Introduction to Clinical Trials
2. Various Phases of Clinical Trials
   2.1 Phase I
   2.2 Phase II
   2.3 Phase III
   2.4 Phase IV (Post-Marketing Surveillance)
3. Methods of Post-Marketing Surveillance
4. Abbreviated New Drug Application (ANDA) Submission
5. Good Clinical Practice (GCP) Guidelines
   5.1 ICH Guidelines
   5.2 GCP Guidelines
   5.3 Central Drug Standard Control Organization (CDSCO) Guidelines
6. Challenges in Implementing Guidelines
7. Ethical Guidelines in Clinical Research
8. Composition, Responsibilities, and Procedures of Institutional Review Board (IRB) / Independent Ethics Committee (IEC)
9. Overview of Regulatory Environment in the USA, Europe, and India
10. Role and Responsibilities of Clinical Trial Personnel as per ICH GCP
    a. Sponsor
    b. Investigators
    c. Clinical Research Associates
    d. Auditors
    e. Contract Research Coordinators
    f. Regulatory Authority
11. Designing of Clinical Study Documents
    • Protocol
    • Case Report Form (CRF)
    • Informed Consent Form (ICF)
    • Participant Information Sheet (PIS) with Assignment
12. Informed Consent Process
13. Data Management and its Components
14. Safety Monitoring in Clinical Trials

Reference Text Books

1. Central Drugs Standard Control Organization. Good Clinical Practices-Guidelines for Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health; 2001.
2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice. E6; May 1996.
3. Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council of Medical Research, New Delhi.
4. Textbook of Clinical Trials edited by David Machin, Simon Day, and Sylvan Green, March 2005, John Wiley and Sons.

Pharmacoepidemiology and Pharmacoeconomics

Theory (Topic-wise Lecture)

I. Pharmacoepidemiology:

1. Definition and Scope
   • Origin and Evaluation of Pharmacoepidemiology
   • Need for Pharmacoepidemiology
   • Aims and Applications
2. 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
3. Concept of Risk in Pharmacoepidemiology
   • Measurement of Risk, Attributable Risk, and Relative Risk
   • Time-Risk Relationship and Odds Ratio
4. Pharmacoepidemiological Methods
   • Theoretical Aspects of Various Methods
   • Practical Study of Various Methods with the Help of Case Studies for Individual Methods
   • Drug Utilization Review
   • Case Reports
   • Case Series
   • Surveys of Drug Use
   • Cross-Sectional Studies
   • Cohort Studies
   • Case-Control Studies
   • Case-Cohort Studies
   • Meta-Analysis Studies
   • Spontaneous Reporting
   • Prescription Event Monitoring
   • Record Linkage System
5. Sources of Data for Pharmacoepidemiological Studies
   • Ad Hoc Data Sources
   • Automated Data Systems
6. Selected Special Applications of Pharmacoepidemiology
   • Studies of Vaccine Safety
   • Hospital Pharmacoepidemiology
   • Pharmacoepidemiology and Risk Management
   • Drug-Induced Birth Defects

II. Pharmacoeconomics:

1. Definition, History, and Needs of Pharmacoeconomic Evaluations
2. Role in Formulary Management Decisions
3. Pharmacoeconomic Evaluation
   • Outcome Assessment and Types of Evaluation
   • Theoretical Aspects of Various Methods
   • Practical Study of Various Methods with the Help of Case Studies for Individual Methods
   • Cost-Minimization
   • Cost-Benefit
   • Cost-Effectiveness
   • Cost-Utility

III. Applications of Pharmacoeconomics:

• Software and Case Studies

Clinical Pharmacokinetics and Pharmacotherapeutic Drug Monitoring

Theory (Topic-wise Lecture)

I. Introduction to Clinical Pharmacokinetics.

II. Design of Dosage Regimens:

1. Nomograms and Tabulations in Designing Dosage Regimen
2. Conversion from Intravenous to Oral Dosing
3. Determination of Dose and Dosing Intervals
4. Drug Dosing in the Elderly, Pediatrics, and Obese Patients

III. Pharmacokinetics of Drug Interaction:

1. Pharmacokinetic Drug Interactions
2. Inhibition and Induction of Drug Metabolism
3. Inhibition of Biliary Excretion

IV. Therapeutic Drug Monitoring:

1. Introduction
2. Individualization of Drug Dosage Regimen
   • Variability (Genetic, Age, Weight, Disease, Interacting Drugs)
3. Indications for TDM. Protocol for TDM
4. Pharmacokinetic/Pharmacodynamic Correlation in Drug Therapy
5. TDM of Drugs Used in the Following Disease Conditions:
   • Cardiovascular Disease
   • Seizure Disorders
   • Psychiatric Conditions
   • Organ Transplantations

V. Dosage Adjustment in Renal and Hepatic Disease:

1. Renal Impairment
2. Pharmacokinetic Considerations
3. General Approach for Dosage Adjustment in Renal Disease
4. Measurement of Glomerular Filtration Rate and Creatinine Clearance
5. Dosage Adjustment for Uremic Patients
6. Extracorporeal Removal of Drugs
7. Effect of Hepatic Disease on Pharmacokinetics

VI. Population Pharmacokinetics:

1. Introduction to Bayesian Theory
2. Adaptive Method or Dosing with Feedback
3. Analysis of Population Pharmacokinetic Data

VII. Pharmacogenetics:

1. Genetic Polymorphism in Drug Metabolism: Cytochrome P-450 Isoenzymes
2. Genetic Polymorphism in Drug Transport and Drug Targets
3. Pharmacogenetics and Pharmacokinetics/Pharmacodynamic Considerations

Clerkship

Clerkship examination – Oral examination shall be conducted after the completion of the clerkship of students. An external and an internal examiner will evaluate the student. Students may be asked to present the allotted medical cases followed by discussion. Students’ capabilities in delivering clinical pharmacy services, pharmaceutical care planning, and knowledge of therapeutics shall be assessed.

Project work (Six Months)

(1) To allow the student to develop data collection and reporting Skills in the field of community, hospital, and clinical pharmacy, there will be a project work Should be done under the supervision of a teacher.

The project topic must be approved By the head of the department or head of the institution. it will be like that The announcement was made to students within a month of the start of fifth-year classes.
The project work will be presented in the form of a written report and a seminar at the end Year. External and internal examiners will evaluate the project work.

(2) Project work will include objectives, methodology, and results of the work, Discussions, and Conclusions.