PharmD Fifth Year Notes

Unit 1: Overview of drug development—from discovery approaches, pharmacological/toxicological testing, IND filing, drug characterization to dosage form selection.

Unit 2: Fundamentals and phases of clinical trials.

Unit 3: Methods of post-marketing surveillance and ANDA submission process.

Unit 4: GCP principles (ICH, CDSCO), implementation challenges, and ethical research guidelines.

Unit 5: IRB/IEC composition, roles, procedures, and regulatory environments (USA, EU, India).

Unit 6: ICH GCP-defined roles of sponsors, investigators, CRAs, auditors, coordinators, and regulators.

Unit 7: Clinical study document design (protocol, CRF, ICF, PIC) and informed consent process.

Unit 8: Clinical trial data management and safety monitoring.

Unit 1: Pharmacoepidemiology—definition, scope, origin, evolution, need, aims, and applications.

Unit 2: Measurement of outcomes—drug use measures, prevalence, incidence, incidence rate, monetary units, prescriptions count, DDD, PDD, and medication adherence.

Unit 3: Risk concepts—measurement of risk, attributable and relative risk, time-risk relationship, and odds ratio.

Unit 4: Pharmacoepidemiological methods—case reports, case series, DUE, surveys, cross-sectional, cohort, case-control, case-cohort, meta-analysis, spontaneous reporting, prescription event monitoring, and record linkage systems.

Unit 5: Data sources—ad hoc data sources and automated data systems.

Unit 6: Special applications—vaccine safety studies, hospital pharmacoepidemiology, risk management, and drug-induced birth defects.

Unit 7: Pharmacoeconomics—definition, history, need, role in formulary decisions, and methods (cost-minimization, cost-benefit, cost-effectiveness, cost-utility) with case studies.

Unit 8: Applications of pharmacoeconomic software with case studies.

Unit-1: Introduction to Clinical Pharmacokinetics – Covers principles of absorption, distribution, metabolism, and excretion with focus on their clinical applications in drug therapy.

Unit-2: Design of Dosage Regimens – Includes nomograms, IV-to-oral conversion, determining dose and intervals, and adjustments for elderly, pediatric, and obese patients.

Unit-3: Pharmacokinetics of Drug Interactions – Explores pharmacokinetic interactions, enzyme inhibition/induction, and inhibition of biliary excretion.

Unit-4: Therapeutic Drug Monitoring (TDM) – Involves dosage individualization based on genetic, age, weight, disease, and drug interactions, TDM protocols, PK/PD correlations, and TDM in cardiovascular, seizure, psychiatric, and transplant cases.

Unit-5: Dosage Adjustment in Renal and Hepatic Disease – Discusses renal impairment, GFR/creatinine clearance measurement, dosage adjustment in uremia, extracorporeal drug removal, and hepatic disease effects on PK.

Unit-6: Population Pharmacokinetics – Introduces Bayesian theory, adaptive dosing with feedback, and analysis of population PK data.

Unit-7: Pharmacogenetics – Covers genetic polymorphisms in drug metabolism (CYP450), transport, and targets, with PK/PD considerations.