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.
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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.
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.
What you'll learn
distinctions between pharmacology and toxicology
origins of preclinical safety studies required by regulatory agencies
common in vitro tests for safety risks
the design of different in vivo preclinical safety studies
the basis for calculating an investigational drug’s first-in-human dose
processes for monitoring the safety of drugs that are already approved and in the hands of patients
Good to know
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Activities
Practice PK property calculations
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Practice calculating PK properties to gain a strong foundation that applies directly to the coursework from the first week on.
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Pharmacokinetics
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Review principles behind PK calculations - including Cmax, tmax, AUC, etc.
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Solve practice problems using sample data to determine PK parameters
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Check answers and reconcile any errors found in the calculations
Compile a glossary of safety terms
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Safety regulations are written in technical language. Understanding the definitions and meanings of the terms will reduce the amount of effort required to understand safety regulations and apply them to drug development.
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Review primary source materials, including course lectures, textbooks, and online resources
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Extract safety-related terms and definitions
Review human anatomy
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Perform a quick review of the material, ensuring that you have the foundational knowledge to apply material in this course.
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Human Anatomy
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Six other activities
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Show all nine activities
Find a research mentor in pharmacology
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In this course, students will learn the basics of pharmacology, which is a broad field. Getting experience with a particular area of pharmacology will allow a student to apply their classroom learning to real-world practice.
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Research potential pharmacology research areas online and via library resources
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Reach out to potential mentors in those areas to discuss interests and research projects
Calculate drug dosages before quizzes
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Practice performing calculations on pharmacokinetic properties to prepare for assessments.
Browse courses on
Pharmacokinetics
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Review course notes
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Solve practice problems
Create a preclinical safety plan
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Apply the content covered in the course to create a safety plan for a new drug, which can help solidify understanding of the process.
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Preclinical Safety
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Draft potential hazards to the drug
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Research in vitro and in vivo testing methods
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Design a testing plan
Learn about in vivo safety study design
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Review different types of in vivo study designs to enhance understanding of how to test drug safety in animal models.
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Watch video tutorials on in vivo safety study design
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Review scientific articles on the topic
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Attend a webinar or workshop on the subject
Shadow a scientist in a preclinical safety lab
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Apply what is learned directly to a real world scenario to enhance the practical aspects of your knowledge.
Browse courses on
Preclinical Safety
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Contact a local university or research institute
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Inquire about volunteering opportunities in preclinical safety labs
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Attend and assist in the research process
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Learn about the preclinical safety testing procedures and regulations
Contribute to an open-source project on preclinical safety
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Apply knowledge of preclinical safety in a collaborative environment.
Browse courses on
Preclinical Safety
Show steps
-
Find an open-source project related to preclinical safety
-
Review the project documentation and codebase
-
Identify an area where you can contribute
-
Submit a pull request with your changes
Practice PK property calculations
Show steps
Practice calculating PK properties to gain a strong foundation that applies directly to the coursework from the first week on.
Browse courses on
Pharmacokinetics
Show steps
- Review principles behind PK calculations - including Cmax, tmax, AUC, etc.
- Solve practice problems using sample data to determine PK parameters
- Check answers and reconcile any errors found in the calculations
Compile a glossary of safety terms
Show steps
Safety regulations are written in technical language. Understanding the definitions and meanings of the terms will reduce the amount of effort required to understand safety regulations and apply them to drug development.
Show steps
- Review primary source materials, including course lectures, textbooks, and online resources
- Extract safety-related terms and definitions
Review human anatomy
Show steps
Perform a quick review of the material, ensuring that you have the foundational knowledge to apply material in this course.
Browse courses on
Human Anatomy
Show steps
Find a research mentor in pharmacology
Show steps
In this course, students will learn the basics of pharmacology, which is a broad field. Getting experience with a particular area of pharmacology will allow a student to apply their classroom learning to real-world practice.
Show steps
- Research potential pharmacology research areas online and via library resources
- Reach out to potential mentors in those areas to discuss interests and research projects
Calculate drug dosages before quizzes
Show steps
Practice performing calculations on pharmacokinetic properties to prepare for assessments.
Browse courses on
Pharmacokinetics
Show steps
- Review course notes
- Solve practice problems
Create a preclinical safety plan
Show steps
Apply the content covered in the course to create a safety plan for a new drug, which can help solidify understanding of the process.
Browse courses on
Preclinical Safety
Show steps
- Draft potential hazards to the drug
- Research in vitro and in vivo testing methods
- Design a testing plan
Learn about in vivo safety study design
Show steps
Review different types of in vivo study designs to enhance understanding of how to test drug safety in animal models.
Show steps
- Watch video tutorials on in vivo safety study design
- Review scientific articles on the topic
- Attend a webinar or workshop on the subject
Shadow a scientist in a preclinical safety lab
Show steps
Apply what is learned directly to a real world scenario to enhance the practical aspects of your knowledge.
Browse courses on
Preclinical Safety
Show steps
- Contact a local university or research institute
- Inquire about volunteering opportunities in preclinical safety labs
- Attend and assist in the research process
- Learn about the preclinical safety testing procedures and regulations
Contribute to an open-source project on preclinical safety
Show steps
Apply knowledge of preclinical safety in a collaborative environment.
Browse courses on
Preclinical Safety
Show steps
- Find an open-source project related to preclinical safety
- Review the project documentation and codebase
- Identify an area where you can contribute
- Submit a pull request with your changes
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