Drug Activity, Disposition, and Safety

Davidson College via edX Professional Certificate

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Provider

edX Professional Certificate
Pricing

$297.00
Languages

English
Certificate

Certificate Available
Level

Intermediate

Found in

Overview

Explore the essential early stages of drug development in this three-course online certificate program. The Professional Certificate in Drug Activity, Disposition, and Safety is designed to introduce learners to the key scientific concepts behind pharmacokinetics, pharmacodynamics, and preclinical safety—three interconnected disciplines that determine whether a drug candidate is suitable for clinical testing.

Through engaging instructional videos, practical examples, and case-based applications, you’ll build a strong conceptual framework for how a compound's activity is evaluated, how it moves through the body, and how safety risks are identified and mitigated. Each course builds upon the next, offering a modular yet integrated approach suitable for scientists, regulatory professionals, and curious learners looking to expand their expertise in drug development.

Whether you're preparing for a new role in pharmaceutical research or looking to deepen your understanding of preclinical science, this program equips you with the skills and insights to navigate early-stage drug development with confidence.

No prior industry experience is required. Learners from scientific, clinical, or regulatory backgrounds—or anyone curious about how safe and effective medicines are developed—are encouraged to enroll.

Syllabus

Courses under this program:
Course 1: Measuring Pharmacodynamics: From Ligand Binding to Clinical Outcomes

Drugs are biologically active compounds. Drug discovery and drug development rely on methods for measuring biological activity. The term “activity” is quite general. In practice, a substance’s biological activity can refer to how a substance affects a biological pathway, cell-level responses, safety risks, how long a substance resides within in a system, as well as a substance’s effects in an organism (called pharmacodynamics). The design of methods for measuring activity is a critical aspect of drug discovery. The design of robust and informative methods can accelerate the drug discovery and development process.

Course 2: Introduction to Pharmacokinetics: From ADME to PK/PD

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.

Course 3: Preclinical Safety: From In Vitro Assays to Human Dose Predictions

Drugs are approved based on their “safety and efficacy”. Determining the safety of a drug occurs through studies that are largely completely separate from efficacy studies. The safety studies fall under the umbrella of preclinical safety. While a drug’s therapeutic benefit is typically narrow and well-defined, the potential safety risks of a compound can be very broad. Preclinical studies therefore search broadly in order to reveal any possible safety issues in a compound. Safety studies ultimately determine dosing limits for clinical trials as well as the final approved drug product.

Courses

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3 weeks, 5-10 hours a week, 5-10 hours a week
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In this course about measuring biological activity, students will learn different methods of activity measurement encountered at different stages of a drug program. The three-week course starts with an introduction to drug targets, which are biological molecules affected by drugs. The second week emphasizes biochemical, cellular, and computational methods for determining the extent to which a drug can affect the action of its target and associated signal pathways. In the final week, students will transition to in vivo studies and the interpretation of dose-response curves.

Students in the course should understand the concepts of proteins and biological pathways. Students should also be comfortable with algebraic expressions, including logarithmic functions. 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.
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3 weeks, 5-10 hours a week, 5-10 hours a week
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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.
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3 weeks, 5-10 hours a week, 5-10 hours a week
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In this course about preclinical safety, students will learn methods for quantifying the safety of a potential drug. The three-week course starts with the origins of preclinical safety programs as well as preliminary safety testing for promising compounds in a drug program. The second week emphasizes in vivo safety studies in representative rodent and non-rodent preclinical animal species. 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. An understanding of both pharmacodynamics and pharmacokinetics 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.