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Erland Stevens
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.
Read more
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.
Read more
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
Register for this course and see more details by visiting:
OpenCourser.com/course/yiww21/preclinical
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Explores by teaching the origins of preclinical safety programs as well as preliminary safety testing for promising compounds in a drug program
Covers important methods and topics such as distinctions between pharmacology and toxicology among other critical topics
Applicable and relevant to those working in or interested in healthcare, medicine, pharmaceuticals, and the drug industry
Involves industry experts, as Erland Stevens is the course instructor
Provides comprehensive information and a blended learning approach with videos, readings, exercises, and assessments
Recommended for professionals with a foundational understanding of human anatomy, pharmacodynamics, and pharmacokinetics
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Save Preclinical Safety: From In Vitro Assays to Human Dose Predictions to your list so you can find it easily later:
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Activities
Be better prepared
before
your course. Deepen your understanding
during
and
after
it. Supplement your coursework and achieve mastery of the topics covered
in Preclinical Safety: From In Vitro Assays to Human Dose Predictions with these
activities:
Safety Evaluation Software Training
Show steps
Completing guided tutorials on safety evaluation software will equip you with the technical skills necessary to effectively analyze and interpret safety data.
Browse courses on
Data Analysis Tools
Show steps
-
Identify a software program relevant to preclinical safety
-
Enroll in or access online tutorials
-
Follow the instructions and complete the exercises
Review general toxicology
Show steps
Refreshing your knowledge of general toxicology will help you better understand the concepts covered in this course, especially in the earlier modules.
Browse courses on
Toxicology
Show steps
-
Read through your old notes and textbooks on general toxicology.
-
Take practice quizzes or answer end-of-chapter questions from your old textbooks.
Review of Basic Pharmacology
Show steps
By reviewing basic pharmacology concepts, you can fill in any gaps in your knowledge and ensure a solid foundation for the more advanced topics covered in this course.
Browse courses on
Pharmacology
Show steps
-
Revisit notes from previous pharmacology courses or textbooks
-
Review online resources or attend a refresher workshop
-
Take practice quizzes or solve problems
Seven other activities
Expand to see all activities and additional details
Show all ten activities
Annotated Bibliography
Show steps
Creating an annotated bibliography will help you stay organized and identify key resources for future reference.
Show steps
-
Search for relevant scientific literature
-
Read and summarize the key findings of each paper
-
Organize the summaries into a structured bibliography
Data Interpretation Discussion Group
Show steps
Engaging in discussions with peers will provide diverse perspectives and foster a deeper understanding of the complexities involved in interpreting preclinical safety data.
Browse courses on
Risk Assessment
Show steps
-
Form a study group with classmates
-
Select a safety data set for analysis
-
Discuss the data, identify potential risks, and propose mitigation strategies
Practice calculating doses
Show steps
Practicing dose calculations will help you understand the relationship between drug concentration and effect, which is essential for preclinical safety studies.
Browse courses on
Pharmacokinetics
Show steps
-
Find practice problems online or in textbooks.
-
Solve the problems and check your answers.
In Silico Toxicity Prediction
Show steps
Undertaking an in silico toxicity prediction project allows you to apply your knowledge and develop practical skills in using computational tools for safety assessment.
Show steps
-
Select a drug compound and gather its structural information
-
Use computational software to predict potential toxic effects
-
Validate the predictions using experimental data
-
Write a report on the findings and implications for drug development
Learn about in vivo safety studies
Show steps
In vivo safety studies are an important part of preclinical safety assessment. This tutorial will help you understand the different types of studies, their purpose, and how to interpret the results.
Browse courses on
In Vivo Safety Studies
Show steps
-
Find a tutorial on in vivo safety studies.
-
Watch the tutorial and take notes.
-
Complete any exercises or assignments that are included with the tutorial.
Safety Assessment Report
Show steps
Creating a safety assessment report provides an opportunity to synthesize your knowledge and demonstrate your ability to communicate complex scientific information.
Show steps
-
Gather data on a hypothetical drug compound
-
Design and conduct in vitro and in vivo safety studies
-
Analyze and interpret the safety data
-
Write a comprehensive safety assessment report
Preclinical Safety Case Competition
Show steps
Participating in a preclinical safety case competition will challenge you to apply your knowledge and skills in a competitive environment, fostering critical thinking and problem-solving abilities.
Browse courses on
Regulatory Compliance
Show steps
-
Form a team and identify a case study
-
Research and analyze the safety data
-
Develop and present a comprehensive safety assessment plan
-
Compete against other teams and receive feedback from industry experts
Safety Evaluation Software Training
Show steps
Completing guided tutorials on safety evaluation software will equip you with the technical skills necessary to effectively analyze and interpret safety data.
Browse courses on
Data Analysis Tools
Show steps
Show steps
Show steps
- Identify a software program relevant to preclinical safety
- Enroll in or access online tutorials
- Follow the instructions and complete the exercises
Review general toxicology
Show steps
Refreshing your knowledge of general toxicology will help you better understand the concepts covered in this course, especially in the earlier modules.
Browse courses on
Toxicology
Show steps
Show steps
Show steps
- Read through your old notes and textbooks on general toxicology.
- Take practice quizzes or answer end-of-chapter questions from your old textbooks.
Review of Basic Pharmacology
Show steps
By reviewing basic pharmacology concepts, you can fill in any gaps in your knowledge and ensure a solid foundation for the more advanced topics covered in this course.
Browse courses on
Pharmacology
Show steps
Show steps
Show steps
- Revisit notes from previous pharmacology courses or textbooks
- Review online resources or attend a refresher workshop
- Take practice quizzes or solve problems
Seven other activities
Expand to see all activities and additional details
Show all ten activities
Annotated Bibliography
Show steps
Creating an annotated bibliography will help you stay organized and identify key resources for future reference.
Show steps
Show steps
Show steps
- Search for relevant scientific literature
- Read and summarize the key findings of each paper
- Organize the summaries into a structured bibliography
Data Interpretation Discussion Group
Show steps
Engaging in discussions with peers will provide diverse perspectives and foster a deeper understanding of the complexities involved in interpreting preclinical safety data.
Browse courses on
Risk Assessment
Show steps
Show steps
Show steps
- Form a study group with classmates
- Select a safety data set for analysis
- Discuss the data, identify potential risks, and propose mitigation strategies
Practice calculating doses
Show steps
Practicing dose calculations will help you understand the relationship between drug concentration and effect, which is essential for preclinical safety studies.
Browse courses on
Pharmacokinetics
Show steps
Show steps
Show steps
- Find practice problems online or in textbooks.
- Solve the problems and check your answers.
In Silico Toxicity Prediction
Show steps
Undertaking an in silico toxicity prediction project allows you to apply your knowledge and develop practical skills in using computational tools for safety assessment.
Show steps
Show steps
Show steps
- Select a drug compound and gather its structural information
- Use computational software to predict potential toxic effects
- Validate the predictions using experimental data
- Write a report on the findings and implications for drug development
Learn about in vivo safety studies
Show steps
In vivo safety studies are an important part of preclinical safety assessment. This tutorial will help you understand the different types of studies, their purpose, and how to interpret the results.
Browse courses on
In Vivo Safety Studies
Show steps
Show steps
Show steps
- Find a tutorial on in vivo safety studies.
- Watch the tutorial and take notes.
- Complete any exercises or assignments that are included with the tutorial.
Safety Assessment Report
Show steps
Creating a safety assessment report provides an opportunity to synthesize your knowledge and demonstrate your ability to communicate complex scientific information.
Show steps
Show steps
Show steps
- Gather data on a hypothetical drug compound
- Design and conduct in vitro and in vivo safety studies
- Analyze and interpret the safety data
- Write a comprehensive safety assessment report
Preclinical Safety Case Competition
Show steps
Participating in a preclinical safety case competition will challenge you to apply your knowledge and skills in a competitive environment, fostering critical thinking and problem-solving abilities.
Browse courses on
Regulatory Compliance
Show steps
Show steps
Show steps
- Form a team and identify a case study
- Research and analyze the safety data
- Develop and present a comprehensive safety assessment plan
- Compete against other teams and receive feedback from industry experts
Career center
Learners who complete Preclinical Safety: From In Vitro Assays to Human Dose Predictions will develop knowledge and skills
that may be useful to these careers:
Toxicologist
Toxicologist
Toxicologists design and conduct studies to assess the safety of chemicals, drugs, and other substances. This course provides a strong foundation in preclinical safety testing, which is essential for toxicologists who want to evaluate the potential risks of new compounds. The course covers topics such as in vitro and in vivo safety studies, dose prediction, and safety monitoring, all of which are critical for toxicologists to understand.
Pharmacologist
Pharmacologist
Pharmacologists study the effects of drugs on living organisms. This course provides a strong foundation in preclinical safety testing, which is essential for pharmacologists who want to develop and test new drugs. The course covers topics such as in vitro and in vivo safety studies, dose prediction, and safety monitoring, all of which are critical for pharmacologists to understand.
Regulatory Affairs Specialist
Regulatory Affairs Specialist
Regulatory Affairs Specialists ensure that drugs and other products meet safety and efficacy standards. This course provides a strong foundation in preclinical safety testing, which is essential for Regulatory Affairs Specialists who want to review and approve new drugs. The course covers topics such as in vitro and in vivo safety studies, dose prediction, and safety monitoring, all of which are critical for Regulatory Affairs Specialists to understand.
Clinical Research Scientist
Clinical Research Scientist
Clinical Research Scientists design and conduct clinical trials to test the safety and efficacy of new drugs. This course provides a strong foundation in preclinical safety testing, which is essential for Clinical Research Scientists who want to design and conduct safe and effective clinical trials. The course covers topics such as in vitro and in vivo safety studies, dose prediction, and safety monitoring, all of which are critical for Clinical Research Scientists to understand.
Drug Safety Scientist
Drug Safety Scientist
Drug Safety Scientists monitor the safety of drugs after they have been approved for use. This course provides a strong foundation in preclinical safety testing, which is essential for Drug Safety Scientists who want to identify and mitigate the risks associated with new drugs. The course covers topics such as in vitro and in vivo safety studies, dose prediction, and safety monitoring, all of which are critical for Drug Safety Scientists to understand.
Data Scientist
Data Scientist
Data Scientists use data to solve problems and make predictions. This course provides a strong foundation in preclinical safety testing, which can be used by Data Scientists to develop new methods for predicting the safety of new drugs. The course covers topics such as in vitro and in vivo safety studies, dose prediction, and safety monitoring, all of which are critical for Data Scientists to understand.
Biostatistician
Biostatistician
Biostatisticians use statistics to design and analyze clinical trials. This course provides a strong foundation in preclinical safety testing, which can be used by Biostatisticians to design and analyze more effective clinical trials. The course covers topics such as in vitro and in vivo safety studies, dose prediction, and safety monitoring, all of which are critical for Biostatisticians to understand.
Quality Assurance Manager
Quality Assurance Manager
Quality Assurance Managers ensure that drugs and other products meet quality standards. This course provides a strong foundation in preclinical safety testing, which is essential for Quality Assurance Managers who want to ensure the safety of new drugs. The course covers topics such as in vitro and in vivo safety studies, dose prediction, and safety monitoring, all of which are critical for Quality Assurance Managers to understand.
Medical Writer
Medical Writer
Medical Writers create documents that communicate medical information to a variety of audiences. This course provides a strong foundation in preclinical safety testing, which can be used by Medical Writers to create more accurate and informative documents. The course covers topics such as in vitro and in vivo safety studies, dose prediction, and safety monitoring, all of which are critical for Medical Writers to understand.
Patent Attorney
Patent Attorney
Patent Attorneys help inventors to obtain patents for their inventions. This course provides a strong foundation in preclinical safety testing, which can be used by Patent Attorneys to understand the safety and efficacy of new inventions. The course covers topics such as in vitro and in vivo safety studies, dose prediction, and safety monitoring, all of which are critical for Patent Attorneys to understand.
Healthcare Consultant
Healthcare Consultant
Healthcare Consultants advise healthcare providers on how to improve the quality and efficiency of their services. This course provides a strong foundation in preclinical safety testing, which can be used by Healthcare Consultants to understand the safety and efficacy of new drugs and treatments. The course covers topics such as in vitro and in vivo safety studies, dose prediction, and safety monitoring, all of which are critical for Healthcare Consultants to understand.
Science Writer
Science Writer
Science Writers communicate scientific information to a variety of audiences. This course provides a strong foundation in preclinical safety testing, which can be used by Science Writers to create more accurate and informative articles and reports. The course covers topics such as in vitro and in vivo safety studies, dose prediction, and safety monitoring, all of which are critical for Science Writers to understand.
Teacher
Teacher
Teachers educate students in a variety of subjects. This course provides a strong foundation in preclinical safety testing, which can be used by Teachers to teach students about the safety of drugs and other substances. The course covers topics such as in vitro and in vivo safety studies, dose prediction, and safety monitoring, all of which are critical for Teachers to understand.
Pharmacist
Pharmacist
Pharmacists dispense and advise on the use of medications. This course provides a strong foundation in preclinical safety testing, which can be used by Pharmacists to understand the safety and efficacy of new drugs. The course covers topics such as in vitro and in vivo safety studies, dose prediction, and safety monitoring, all of which are critical for Pharmacists to understand.
Chemist
Chemist
Chemist study the composition, structure, and properties of matter. This course provides a strong foundation in preclinical safety testing, which can be used by Chemists to develop new drugs and other products. The course covers topics such as in vitro and in vivo safety studies, dose prediction, and safety monitoring, all of which are critical for Chemists to understand.
For more career information including salaries, visit:
OpenCourser.com/course/yiww21/preclinical
Reading list
We've selected five 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
Preclinical Safety: From In Vitro Assays to Human Dose Predictions.
This classic text in toxicology provides a comprehensive overview of the field, including chapters on preclinical safety testing
Provides a comprehensive overview of toxicology, including chapters on preclinical safety testing.
A comprehensive reference work that covers all aspects of toxicology and valuable resource for anyone involved in this field.
Provides a detailed overview of the use of animal models in toxicology, including the design and interpretation of safety studies. It valuable resource for those who want to learn more about the role of animal models in preclinical safety testing.
Provides a comprehensive overview of the toxicology of the liver, including the effects of hepatotoxicants. It valuable resource for those who want to learn more about the safety of drugs that are metabolized by the liver.
For more information about how these books relate to this course, visit:
OpenCourser.com/course/yiww21/preclinical
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Effort
5 to 10 hours per week for 3 weeks
Level
Introductory
Via
edX
Institution
Davidson College
Instructor
Erland Stevens
Good to know
Explores by teaching the origins of preclinical safety programs as well as preliminary safety testing for promising compounds in a drug program
Covers important methods and topics such as distinctions between pharmacology and toxicology among other critical topics
Applicable and relevant to those working in or interested in healthcare, medicine, pharmaceuticals, and the drug industry
Involves industry experts, as Erland Stevens is the course instructor
Provides comprehensive information and a blended learning approach with videos, readings, exercises, and assessments
Recommended for professionals with a foundational understanding of human anatomy, pharmacodynamics, and pharmacokinetics
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