Biopharmaceutics and Pharmacokinetics (Theory)

Introduction to various Pharmacokinetic parameters (using Plasma drug Concentration vs Time curve) and Pharmacodynamic parameters and drug 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.

Drug metabolism and basic understanding of metabolic pathways renal excretion of drugs, factors affecting renal excretion of drugs, renal clearance, non renal routes of drug excretion of drugs Bioavailability and Bioequivalence: Definition and Objectives of bioavailability, absolute and relative bioavailability, Introduction to BCS and biopharmaceutical drug disposition classification system, methods of measurement of bioavailability (Plasma data, Urinary excretion data), Protocol for assessment of bioavailability and bioequivalence studies. in-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.

Compartment Models: Definition, Basis of classification, Properties of compartment, Advantages and disadvantages of compartment modelling. Kinetic considerations of One compartment open model. (a). Intravenous Injection (Bolus/rapid) (b). Intravenous infusion and (c) Extra-vascular administration. (with emphasis on Curve Fitting, Wagner Nelson, Loo Riegelman) Introduction to non - compartment model: Principles, estimation of PK parameters (AUC, AUMC, MRT, MAT statistical moment theory).

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 drug products.

Introduction, Reasons for Non-linearity, Michaelis-menton method of estimating parameters, Explanation with example of drugs. Application of PK software: Introduction of various in -silico methods for calculating various PK parameters.