4.5 Biopharmaceutics and Pharmacokinetics

1. Biopharmaceutics

a. Introduction to Biopharmaceutics

i. Absorption of Drugs from Gastrointestinal Tract

ii. Drug Distribution

iii. Drug Elimination

2. Pharmacokinetics

a. Introduction to Pharmacokinetics

i. Mathematical Model

ii. Drug Levels in Blood

iii. Pharmacokinetic Model

iv. Compartment Models

v. Pharmacokinetic Study

b. One Compartment Open Model

i. Intravenous Injection (Bolus)

ii. Intravenous Infusion

c. Multi-Compartment Models

i. Two Compartment Open Model

ii. IV Bolus

iii. IV Infusion

iv. Oral Administration

d. Multiple-Dosage Regimens

i. Repetitive Intravenous Injections – One Compartment Open Model

ii. Repetitive Extravascular Dosing – One Compartment Open model

iii. Multiple Dose Regimen – Two Compartment Open Model

e. Nonlinear Pharmacokinetics

i. Introduction

ii. Factors causing Non-Linearity

iii. Michaelis-Menton method of Estimating Parameters

f. Non-Compartmental Pharmacokinetics

i. Statistical Moment Theory

ii. MRT for various Compartment Models

iii. Physiological Pharmacokinetic Model

g. Bioavailability and Bioequivalence

i. Introduction

ii. Bioavailability Study Protocol

iii. Methods of Assessment of Bioavailability