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Introduction to Pharmacokinetics

From ADME to PK/PD

Erland Stevens

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.

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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's inside

Learning objectives

  • 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
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intravenous dosing and PK parameters
oral dosing and PK parameters
other routes of administration
solubility and permeability assays
metabolic stability assays
in vivo PK studies
hepatic drug metabolism
renal and biliary drug excretion
PK of biologics
PK-PD relationships
anticipated human dose
drug formulation
week 2
week 3

Good to know

Know what's good
, what to watch for
, and possible dealbreakers
Useful for students seeking to learn about the analysis of PK properties of drugs to make informed decisions in drug discovery and development
Suitable for students with fundamental knowledge of anatomy, cell structure, algebraic equations, and organic chemistry
Designed for students with an interest in drug discovery and development, particularly those involved in pharmacology, medicinal chemistry, and pharmaceutical sciences
Taught by instructor Erland Stevens, who is known for their expertise in ADME and PK
Provides a comprehensive overview of methods used for determining key PK properties, understanding ADME properties, and predicting human PK properties
Students can choose between an Audit Track or Verified Track based on their learning preferences and needs

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Activities

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Career center

Learners who complete Introduction to Pharmacokinetics: From ADME to PK/PD will develop knowledge and skills that may be useful to these careers:
Pharmacokineticist
Pharmacokineticists research drug metabolism and biochemical processes in living things to determine safe and effective dosages and to aid in the development of new drugs. Understanding the principles of pharmacokinetics is an important first step to starting a successful career as a Pharmacokineticist. This course can help you build a foundation in the principles of pharmacokinetics, so you can determine routes of administration and anticipate dosing regimens.
Medicinal Chemist
Research and develop pharmaceuticals to improve human health through a deep understanding of drug metabolism, bioavailability, and chemical properties of drug candidates.
Clinical Research Associate
Clinical Research Associates manage clinical trials which are essential to testing the safety and efficacy of new drugs and medical devices.
Pharmaceutical Scientist
Pharmaceutical Scientists work in the pharmaceutical industry to develop, formulate, and test medications. This course may be useful to those who wish to enter this field. The course's focus on developing new drugs and dosage regimens would be relevant in this role.
Regulatory Affairs Specialist
Regulatory Affairs Specialists ensure that pharmaceutical products meet safety and efficacy standards and comply with regulations.
Toxicologist
Toxicologists conduct research to assess the potential health effects of chemicals and other substances on humans and the environment. Understanding human anatomy, cell structure, and pharmacokinetics are key to a career in Toxicology. This course can help build these foundations, while also teaching you about the development of new drugs and dosage regimens.
Medical Writer
Medical Writers create scientific and educational materials about medical products and treatments, and a solid understanding of pharmacokinetics can help you succeed in this career.
Health Policy Analyst
Health Policy Analysts develop and evaluate policies and programs related to public health. Understanding pharmacokinetics can help you evaluate the safety and efficacy of new drugs and treatments.
Biostatistician
Biostatisticians design and analyze studies to assess the safety and efficacy of new drugs and treatments.
Pharmacist
Pharmacists dispense medications and provide patient counseling, and a strong understanding of pharmacokinetics can help you ensure that medications are used safely and effectively.
Epidemiologist
Epidemiologists investigate the causes and patterns of disease, and a strong understanding of pharmacokinetics can help you understand how drugs and other exposures can affect health.
Science Writer
Science Writers communicate complex scientific information to a variety of audiences, and a solid understanding of pharmacokinetics can help you accurately and effectively report on drug development and use.
Patent Attorney
Patent Attorneys help clients obtain and protect patents for new inventions, including pharmaceuticals, and a strong understanding of pharmacokinetics can help you understand the technical aspects of these inventions.
Nurse
Nurses administer medications and provide patient education, and a solid understanding of pharmacokinetics can help you perform these tasks safely and effectively.
Physician
Physicians prescribe and administer medications, and a strong understanding of pharmacokinetics can help you make informed decisions about medication choices and dosages.

Reading list

We've selected seven books that we think will supplement your learning. Use these to develop background knowledge, enrich your coursework, and gain a deeper understanding of the topics covered in Introduction to Pharmacokinetics: From ADME to PK/PD.
This textbook classic work in the field of pharmacokinetics and provides a thorough grounding in the fundamental principles of the discipline. It is written in a clear and concise style, and is well-illustrated with examples and case studies.
This textbook provides a comprehensive and up-to-date overview of the field of biopharmaceutics and pharmacokinetics, with a focus on the application of these principles to drug development.
This textbook provides a comprehensive and up-to-date overview of the field of pharmacokinetics, with a focus on the theoretical and practical aspects of this discipline.
This textbook provides a comprehensive and up-to-date overview of the field of pharmacokinetics, with a focus on the application of these principles to the health sciences.
Classic textbook that provides a rigorous and detailed treatment of pharmacokinetic principles. Covers advanced topics such as compartmental modeling, nonlinear kinetics, and population pharmacokinetics, making it suitable for advanced learners and researchers.
Practical guide that focuses on the clinical applications of pharmacokinetics and pharmacodynamics. Provides essential information for healthcare professionals involved in drug therapy management.

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