Credits
This is a 3-credit course
Description
This course consists of a series of lectures and active learning/hands on sessions (ALS) structured in 8 different modules focused on general principles of drug pharmacology. Major topics are principles of drug pharmacokinetics (PK) (including drug absorption, distribution, metabolism and elimination, ADME) and pharmacodynamics and the interpretation of pharmacology in a quantitative fashion. This course is aimed to expose students to different tools and comprehensive case examples to apply principles and concepts.
Terms Offered: Fall
Upon completion of this course, students will be able to understand and apply the concepts and principles of pharmacokinetics and pharmacodynamics and its role in designing optimal dosing regimens. Specifically:
- Visualize the drug development process, familiarize with the information required to build the drug label and understand how PK and PD studies help to inform it.
- Understand and explain the following concepts: first-order elimination, zero-order elimination, half-life, volume of distribution, and clearance.
- Understand and explain the following concepts: first-order absorption, flip-flop kinetics, and drug absorption.
- Predict the effect of some physiological processes, as blood flow, intrinsic clearance or protein binding affect PK processes.
- Identify whether a drug is predominately reabsorbed or secreted based on renal clearance and protein binding.
- Predict the relationship between pH (and urine flow) and renal clearance.
- Apply pharmacokinetic equations to derive pharmacokinetic parameters, and pharmacokinetic parameters to predict plasma concentration over time, maximum plasma concentrations and area under the curve.
- Recommend dosing regimens in different clinical situations.
- Understand the basic pharmacodynamics principles and models.
- Understand how growth, aging and disease affect drug’s PK and PD, and the considerations behind selecting dosing regimens for special populations.
- Access different case examples on the application of pharmacokinetic and pharmacodynamics principles for dose selection.
Topics
| Module | Topics |
|---|---|
| Module 1: Generalities | Overview of the drug development process. Importance of PK/PD; Fundamental concepts and basic PK (and PD) parameters |
| Module 2 a: ADME Processes | Clearance: Renal and hepatic |
| Module 2b: ADME processes | Protein Binding and Drug Distribution |
| Module 2c: ADME processes | Absorption |
| Module 3: Non-compartmental PK | Non-compartmental PK |
| Module 4a: Intravenous Pharmacokinetics | One-compartment Model |
| Module 4b: Intravenous Pharmacokinetics | Multi-compartment Model |
| Module 4c: Intravenous Pharmacokinetics | Zero-order infusion and steady state |
| Module 5a: Extravascular PK | Modeling absorption related processes |
| Module 5b: Extravascular PK | In vitro – in vivo correlations |
| Module 5c: Extravascular PK | Bioavailability and bioequivalence |
| Module 6: Pharmacokinetics of large molecules | PK of Protein Therapeutics ; Nonlinear PK: Michaelis Menten kinetics and target mediated drug disposition (TMDD) |
| Module 7: Pharmacodynamics | Introduction to Pharmacodynamics; PK/PD Applications |
| Module 8: PBPK | Introduction to PBPK |
| Module 9a: PK/PD Special Populations | Pediatrics; Geriatrics |
| Module 9b: PK/PD Special Populations | Renal and hepatic impairment |
Please see the downloadable syllabus for a full week to week breakdown of the course topics.
Prerequisites
There are no pre-requisites for this course.
Suggested Textbooks/Readings
- Rowland and Tozer. Clinical Pharmacokinetics: Concepts and Applications. Philadelphia: Lea & Febiger, 2019. 5th edition.
- Pharmacokinetic & Pharmacodynamic Data Analysis Johan Gabrielsson and Dan Weiner. 4th edition. Swedish Pharmaceutical Press 2006
- Basic Pharmacokinetics by David Bourne: https://itunes.apple.com/us/book/basic- pharmacokinetics/id505553540?mt=11
- Leon Shargel, Susanna WuPong, Andrew Yu, Applied Biopharmaceutics and Pharmacokinetics, 6th ed. McGraw Hill (This text is available via the UF library/Pharmacy Access)
- Larry A. Bauer, Applied Clinical Pharmacokinetics, 2nd ed. (This text is available via the UF library/Pharmacy Access)
Other reading material will be provided during the course.