A critical aspect of a drug involves how a drug is dosed and circulates throughout the body of a patient. These qualities are aspects of a drug’s pharmacokinetics or PK. Pharmacokinetics encompasses how a drug is absorbed and flows through a patient until it is ultimately eliminated. While pharmacokinetics covers drug behavior in a living organism, PK properties can often be predicted through laboratory tests for a compound’s ADME properties. ADME stands for absorption, distribution, metabolism, and excretion. The PK and ADME properties of potential drug are closely monitored throughout the discovery and early development stages of a drug campaign.
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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
