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BP604T. BIOPHARMACEUTICS AND PHARMACOKINETICS Books
“Biopharmaceutics and Pharmacokinetics: Study of the physical and chemical properties of drugs, their absorption, distribution, metabolism, and excretion (ADME), and the factors influencing drug bioavailability and pharmacological effects.”
Course Content
Unit Title
Content
UNIT-I
Biopharmaceutics
Absorption; Mechanisms of drug absorption through GIT, factors influencing drug absorption though GIT, absorption of drug from Non per oral extra-vascular routes, 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-II
- Elimination: Drug metabolism and basic understanding 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, measurement of bioavailability, in-vitro drug dissolution models, in-vitro-in-vivo correlations, bioequivalence studies, methods to
enhance the dissolution rates and bioavailability of poorly soluble drugs.
UNIT-III
- Pharmacokinetics: Definition and introduction to Pharmacokinetics, Compartment models, Non compartment models, physiological models, One compartment open model.
- (a). Intravenous Injection (Bolus)
- (b). Intravenous infusion
- (c) Extravascular administrations. Pharmacokinetics parameters – KE ,t1/2,Vd,AUC,Ka, Clt and CLR- definitions methods of eliminations, understanding of their significance and application
UNIT-IV
- Multicompartment models: Two compartment open model. IV bolus
Kinetics of multiple dosing, steady state drug levels, calculation of loading and mainetnance doses and their significance in clinical settins.
UNIT-V
- Nonlinear Pharmacokinetics: a. Introduction, b. Factors causing Non-linearity. c. Michaelis-menton method of estimating parameters, Explanation with example of
drugs.
Learning Objectives
- Understand the basic concepts in biopharmaceutics and pharmacokinetics and their significance.
- Use of plasma drug concentration-time data to calculate the pharmacokinetic parameters to describe the kinetics of drug absorption, distribution, metabolism, excretion, elimination
- To understand the concepts of bioavailability and bioequivalence of drug products and their significance