Pharmacokinetics and Biopharmaceutics
PHAR 7632 Syllabus

PHAR 7632 Course Outline

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1. Introduction to the Course
• Online Resources
2. Background Mathematical Material
• Exponents
• Logarithms
• Graphing Data on Linear and Semi-Log Graph Paper
• Using Spreadsheets
• Calculus
• Writing Differential Equations
• Area under the plasma concentration time curve (AUC)
3. Pharmacokinetic Introduction
• An Introduction to Pharmacokinetics
• Complex Interactions
• Drug Transport
• One, Two and Three Compartment Models
• IV Bolus Dose - One Compartment
• Absorption and Elimination
• IV Bolus Two Compartment Model
• Two Compartment Model
• Drug Effect versus Time
• Drug Product Performance Parameters
• A(bsorption) D(istribution) M(etabolism) E(xcretion)
• Routes of Drug Administration
• Tablet Dissolution
• Absorption versus Particle Size
• Absorption of Different Salt Forms
• Drug Effect and Absorption
• Effect of Absorption Rate Constant
• Distribution
• ADME
• Drug Elimination
• Elimination and Multiple Dose
• Dosing Kanamycin
• Renal Disease and Drug Elimination
• Absorption and First-Pass Effect
• Aspirin Elimination
• Multiphasic Drug Elimination?
• Tissue Concentration versus Time
• Distribution
• Individualized Dosage Regimen
4. One Compartment IV Bolus
• Assumptions
• Linear Model - First Order Kinetics
• One Compartment Model
• Integrated Equations
• Apparent volume of distribution, V
• Area under the plasma concentration time curve, AUC
• Total Body Clearance, CL
• Elimination Rate Constant, kel
• Half-life of Elimination, t_1/2
• IV Bolus - Example 1
• IV Bolus - Example 2
• IV Bolus - Example 3
• IV Bolus - Example 4
5. Analysis of Urine Data
• Metabolism and Excretion - Parallel Pathways
• Plotting and Analyzing Urine Data
• Fraction Excreted or Metabolized, fe or fm
• Clearance
• Example Calculation of Urine Analysis Plots
6. Intravenous Infusion
• Continuous IV Infusion - Steady State
• Continuous IV Infusion - Time to Reach Steady State
• Combined Infusion and bolus administration
• Combined Slow and Fast Infusion
• Post Infusion
7. Routes of Drug Administration
• Oral (PO)
• Buccal and Sublingual (SL)
• Rectal (PR)
• Intravenous (IV)
• Subcutaneous (SC)
• Intramuscular (IM)
• Inhalation
• Topical or Transdermal
• Other ROA's
8. Pharmacokinetics of Oral Administration
• Scheme or diagram
• Integrated equation
• Bioavailability Parameters, ka and F
9. Calculation of Bioavailability Parameters
• Method of Residuals
• Wagner-Nelson Method
• Method of Inspection
• Calculation of F
10. Bioavailability Studies
• Definitions
• Past Bioavailability Problems
• Bioavailability study characteristics
11. Physiological Factors Affecting Oral Absorption
• Membrane physiology
• Gastrointestinal (GI) Physiology
12. Physical-Chemical Factors Affecting Oral Absorption
• pH - Partition Theory
• Drug Dissolution
13. Formulation Factors
• Solution Dosage Forms
• Suspension Dosage Forms
• Capsule Dosage Forms
• Tablet Dosage Forms
• Sustained Release Dosage Forms
• In Vitro Testing
14. Multiple IV Bolus Dose Administration
• Single Dose Review
• Multiple Dose
• Drug Accumulation
• Development of General Equation
• Cp_max and Cp_min
15. Multiple Oral Dose Administration
• Multiple Oral Dose Administration
• Cp_min Equation
• Cp_average Equation
• Superposition Principle
16. Routes of Excretion
• Renal Excretion
• Hemodialysis
• Biliary Excretion
• Pulmonary Excretion
• Salivary Excretion
• Renal Disease Considerations
• Cp_average Calculations
• Cp_max/Cp_min Calculations
17. Metabolism
• Metabolic Reactions
• Induction and Inhibition
• Hepatic Clearance
• Systemic Availability
18. Drug Distribution
• Drug Distribution Patterns
• Factors Affecting Drug Distribution
• Extent of Distribution
• Other Distribution Considerations
19. Multi-Compartment Pharmacokinetic Models
• Intravenous Administration
• Parameter Determination
• Effect of k12 and k21
• Apparent Volumes of Distribution
• Dosage Calculations
• Oral Administration
20. Non Compartmental Analysis
• Non Compartmental Analysis
21. Non-Linear Pharmacokinetic Models
• Scheme or Diagram
• Differential Equation
• Parallel Pathway
• Dosing Approaches
22. Non-Linear Regression Analysis of Pharmacokinetic Data
• Why Model Data
• Analysis using a Non-linear Regression Program
• Bayesian Analysis of Clinical Data
• Analysis using of Population Data using NONMEM
23. Pharmacodynamic Models and Physiologically Based Pharmacokinetic Models
• Pharmacodynamic Models
• Physiologically Based Pharmacokinetic Models
24. Pharmaceutical Analysis
• Sample Preparation
• Drug Quantitation
• Chromatographic Separation
• High Performance (Pressure) Liquid Chromatography (HPLC)
• Gas Liquid Chromatography (GLC)
• Radioimmunoassay (RIA)
• Enzyme Multiplied Immunoassay (EMIT)
• Fluorescence Polarization Immunoassay (FPIA)
• Comparison of Clinical Assay Methods
25. Clinical Applications of Pharmacokinetics
• Therapeutic Drug Monitoring
• Pediatric Considerations
• Geriatric Considerations