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Semester VI · PCI syllabus 2026
Biopharmaceutics and Pharmacokinetics
BP602T
3 credits
Theory
Coming soon
Unit 1: Introduction to Biopharmaceutics and pharmacokinetics:
- Introduction to various Pharmacokinetic parameters (using Plasma Concentration vs Time curve) and Pharmacodynamic parameters and delivery index. Absorption; Mechanisms of drug absorption through GIT, Physicochemical, Biological and Dosage form related factors influencing drug absorption though GIT, methods of Assessment of GIT absorption, Distribution Tissue permeability of drugs, binding of drugs, apparent volume of drug distribution, plasma and tissue protein binding of drugs, factors affecting protein-drug binding. Kinetics of protein binding, Clinical significance of protein binding of drugs
Unit 2: Elimination (Metabolism and Elimination): Drug metabolism and basic
- understanding of metabolic pathways renal excretion of drugs, factors affecting renal excretion of drugs, renal clearance, non renal routes of excretion of drugs Bioavailability and Bioequivalence: Definition and Objectives bioavailability, absolute and relative bioavailability, Introduction to BCS biopharmaceutical drug disposition classification system, methods measurement of bioavailability (Plasma data, Urinary excretion data), Protocol for assessment of bioavailability and bioequivalence studies. vitro drug dissolution methods (test apparatus I-VII), biorelevant dissolution mediums, in-vitro in-vivo correlations: Concept and Applications, Biowaivers, Methods of enhancement of bioavailability
Unit 3: Pharmacokinetic Models: Compartment Models: Definition, Basis of
- classification, Properties of compartment, Advantages and disadvantages compartment modelling. Kinetic considerations of One compartment model. (a). Intravenous Injection (Bolus/rapid) (b). Intravenous infusion (c) Extra-vascular administration. (with emphasis on Curve Fitting, Wagner –Nelson, Loo Riegelman) Introduction to non - compartment model: Principles, estimation of parameters (AUC, AUMC, MRT, MAT statistical moment theory)
Unit 4: Multicompartment models: Multiple dosage regimen: dosing interval, drug
- accumulation, loading dose, maintenance dose, PK Parameters Kinetic consideration of two compartment open model (a) Intravenous Injection (Bolus/rapid) and (b) Extra vascular administrations (oral administration). Kinetics of multiple dosing, steady state drug levels, calculation of loading and maintenance doses and their clinical significance. Multiple dosage regimen. Introduction to pharmacokinetic consideration of Modified release products
Unit 5: Nonlinear Pharmacokinetics: Introduction, Reasons for Non-linearity,
- Michaelis-menton method of estimating parameters, Explanation example of drugs. Application of PK software: Introduction of various in -silico methods calculating various PK parameters
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