## COURSE OBJECTIVES

This course presents the basic concepts and principles of biopharmaceutics and pharmacokinetics. The necessary mathematical expressions needed to characterize the absorption, distribution, metabolism, and excretion of drugs will be discussed with respect to routes of administration. Parameters that influence pharmacokinetic and therapeutic outcomes of the most common drug regimens will be emphasized. In addition, this course highlights some recent models i.e. compartmental models, their mathematical backbone and their relation to logical conclusions of drug time course in the body.

### COURSE LEARNING OUTCOMES (CLO)

CLO: 1. To describe the general principles of biopharmaceutics and pharmacokinetics
CLO: 2. To illustrate mechanism, methodologies and mathematical approaches described the fate of drug.
CLO: 3. To apply knowledge of biopharmaceutics in different compartmental models and multiple dosing regimen.

## COURSE CONTENTS

1. DEFINITIONS AND TERMINOLOGY:
• Biopharmaceutics, Generic Equivalence, Therapeutic Equivalents, Bioavailability, Bioequivalence, Drug Disposition, Pharmacokinetics (LADMER; Liberation, absorption, distribution, metabolism, elimination and response).
2. GASTRO-INTESTINAL ABSORPTION:
• Forces which help in transmembrane movements, Anatomical and physiological factors influencing absorption of drugs. Physicochemical properties of drugs affecting absorption. Absorption of different oral dosage forms.
3. BIOLOGICAL HALF LIFE AND VOLUME OF DISTRIBUTION:
• Introduction, types, methods of determination and application
4. DRUG CLEARANCE:
• Introduction, Mechanism, Models, determination and relationship of clearance with half-life.
5. PHARMACOKINETICS:
• Introduction, Linear and Non-linear Pharmacokinetics application of pharmacokinetics in clinical situations
6. MULTIPLE DOSAGE REGIMENS:
• Introduction, principles of superposition
• _persistent, accumulation and loss factors_
• Repetitive Intravenous injections – One Compartment Open Model
• Repetitive Extravascular dosing – One Compartment Open model
• Multiple Dose Regimen – Two Compartment Open Model
7. CONCEPT OF COMPARTMENT(S) MODELS:
• One compartment open model
• Intravenous Injection (Bolus)
• Intravenous infusion.
• Multi-compartment models
• Two compartment open model
• IV bolus, IV infusion and oral administration
• Non-compartmental Model
• Statistical Moment Theory
• MRT for various compartment models
• Physiological Pharmacokinetic model.