Introduction to Pharmacokinetics: From ADME to PK/PD (edX)

In this course about ADME and PK, students will learn how the PK properties of drug candidate are analyzed to guide decisions by the entire drug discovery team. The three-week course starts with the use of drug concentration-time data points to determine the key pharmacokinetic parameters of a compound. The second week focuses on the types of laboratory and animal studies that assist in the prediction of the human PK properties of a compound. In the final week, students will learn how the PK properties are used with efficacy data to predict the human efficacious dose and assist in drug formulation.

Students in the course should understand human anatomy and cell structure. Students should also be comfortable with algebraic expressions, including logarithmic and exponential functions. A fundamental understanding of the structure of organic molecules and their functional groups will also be helpful. The course is designed in modules. Each module opens with a short video on a selected topic. The module continues with a short reading or exercise with an assessment activity. Each module will require approximately 1 hour to complete, and the course includes 15 modules. Two approaches to the course are recommended. One, a student might spend an hour per day on the course and complete all 15 modules in approximately three weeks. Two, a student with additional available time may be able to work through the entire course in just a single week or over an extended weekend.

Students signed up for the Audit Track have access to the instructional video materials. Students enrolled through the Verified Track have access to the instructional videos, the readings and activities, the assessments, as well as selected additional videos related to the primary instructional videos.

What you'll learn

- methods for determining the key PK properties from drug concentration-time data points

- distinctions between common routes of administration of various drugs

- laboratory techniques for studying ADME properties of compounds in vitro

- common in vivo PK studies for early prediction of human PK properties

- differences in PK properties between small molecule drugs and biologics

- models for understanding how PK and efficacy together can help determine the dosing regimen of a drug

Syllabus

week 1

Cp-time curves

Blood, plasma, and plasma protein binding

ADME and pharmacokinetics

intravenous dosing and PK parameters

oral dosing and PK parameters

week 2

other routes of administration

solubility and permeability assays

metabolic stability assays

in vivo PK studies

hepatic drug metabolism

week 3

renal and biliary drug excretion

PK of biologics

PK-PD relationships

anticipated human dose

drug formulation