Preclinical Safety: From In Vitro Assays to Human Dose Predictions from edX

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

Know what's good

, what to watch for

, and possible dealbreakers

Well designed for pre-clinical safety research scientists looking to advance their careers

Includes in vivo safety studies in rodents and non-rodents, a common aspect of safety research

Provides a strong foundation in preclinical safety, which can benefit early-career scientists and those in regulatory affairs

Taught by Erland Stevens, an experienced instructor recognized for their expertise in toxicology

Examines the origins of preclinical safety programs and their relevance in drug development

Can be completed flexibly, allowing learners to balance the course with other responsibilities

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:

Recall general toxicology concepts

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Refreshes general toxicology concepts, enhancing the ability to grasp preclinical safety methods and their applications.

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Review notes or textbooks from previous toxicology courses.
Attend a webinar or seminar on basic toxicology principles.

Review the fundamentals of pharmacology

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Refreshes the fundamentals of pharmacology, providing a strong foundation for understanding preclinical safety concepts.

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Review textbook chapters or online resources on basic pharmacology principles.
Solve practice problems or quizzes to test understanding of pharmacological concepts.

Review the fundamentals of preclinical safety testing

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Understand the principles of nonclinical safety assessment before starting the course.

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Review course syllabus and introductory materials
Complete any assigned pre-course readings
Attend the first lecture or orientation session

Nine other activities

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Review 'Casarett and Doull's Toxicology: The Basic Science of Poisons'

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Gain a comprehensive understanding of the field of toxicology.

View Casarett & Doull's Toxicology: The Basic... on Amazon

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Read selected chapters relevant to preclinical safety
Take notes and summarize key concepts
Discuss the book with classmates or colleagues

Participate in online discussion forums or study groups

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Provides opportunities for students to engage in discussions, share perspectives, and enhance their understanding of preclinical safety concepts.

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Join online discussion forums or study groups related to preclinical safety.
Actively participate in discussions by asking questions, sharing insights, and providing feedback.
Collaborate with peers on projects or assignments.

Explore online tutorials on preclinical drug development

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Supplements course materials by providing additional insights and practical guidance on preclinical drug development processes.

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Identify reputable online platforms or resources offering tutorials on preclinical drug development.
Follow tutorials that cover topics relevant to the course, such as study design, data analysis, and regulatory requirements.
Take notes or complete exercises to reinforce learning.

Solve practice problems on preclinical safety assessment

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Provides hands-on practice in applying preclinical safety assessment methods, reinforcing understanding of course concepts.

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Access online platforms or textbooks that offer practice problems in preclinical safety.
Solve problems covering topics such as in vitro and in vivo toxicity testing, and safety pharmacology.
Review solutions and identify areas for improvement.

Calculate doses for in vivo safety studies

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Practice applying the principles of dose selection for non-clinical safety studies.

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Review the course materials on dose calculations
Complete the practice exercises provided in the course
Seek additional practice problems online or in textbooks

Attend a workshop on preclinical safety assessment

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Supplement the course materials with interactive learning and networking opportunities.

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Attend the workshop and participate actively
Research and identify relevant workshops
Register for the workshop

Develop a case study on a preclinical safety assessment

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Enhances critical thinking and problem-solving skills by applying preclinical safety concepts to a real-world scenario.

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Select a specific drug or therapeutic area of interest.
Research and gather data on preclinical safety studies conducted on the selected drug.
Analyze the data and identify key safety findings.
Develop a comprehensive case study report outlining the safety assessment process and its implications.

Develop a case study on a preclinical safety finding

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Apply the knowledge gained in the course to a real-world scenario.

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Choose a specific preclinical safety finding
Gather relevant data and information
Analyze the data and develop a hypothesis
Write a report summarizing your findings

Design and conduct a mock in vivo safety study

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Gain hands-on experience in the design and execution of non-clinical safety studies.

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Develop a study protocol
Obtain necessary approvals and resources
Conduct the study according to the protocol
Analyze the data and prepare a study report

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:

Pharmacologist

Pharmacologists study the effects of drugs on living organisms, including humans. This course would be helpful for students interested in a career as a pharmacologist by providing an understanding of the methods used to quantify the safety of potential drugs. The course covers topics such as in vitro and in vivo safety studies, the design of preclinical safety studies, and the calculation of an investigational drug’s first-in-human dose.

See salaries and explore the career path for Pharmacologist

Research Scientist

Research Scientists conduct scientific research in a variety of fields, including pharmacology and toxicology. This course would be helpful for students interested in a career as a Research Scientist by providing an understanding of the methods used to quantify the safety of potential drugs. The course covers topics such as in vitro and in vivo safety studies, the design of preclinical safety studies, and the calculation of an investigational drug’s first-in-human dose.

See salaries and explore the career path for Research Scientist

Clinical Research Associate

Clinical Research Associates (CRAs) manage and coordinate clinical trials, ensuring that they are conducted in accordance with Good Clinical Practice (GCP) guidelines. This course would be helpful for students interested in a career as a CRA by providing an understanding of the methods used to quantify the safety of potential drugs. The course covers topics such as in vitro and in vivo safety studies, the design of preclinical safety studies, and the calculation of an investigational drug’s first-in-human dose.

See salaries and explore the career path for Clinical Research Associate

Toxicologist

Toxicologists identify, assess, and control risks to human health and the environment posed by chemicals, drugs, biological agents, and other substances. This course would help build a foundation for a career as a toxicologist by providing an understanding of the methods used to quantify the safety of potential drugs. The course covers topics such as in vitro and in vivo safety studies, the design of preclinical safety studies, and the calculation of an investigational drug’s first-in-human dose.

See salaries and explore the career path for Toxicologist

Regulatory Affairs Specialist

Regulatory Affairs Specialists ensure that drugs and medical devices are safe and effective before they are marketed. This course would be helpful for students interested in a career as a Regulatory Affairs Specialist by providing an understanding of the methods used to quantify the safety of potential drugs. The course covers topics such as in vitro and in vivo safety studies, the design of preclinical safety studies, and the calculation of an investigational drug’s first-in-human dose.

See salaries and explore the career path for Regulatory Affairs Specialist

Biostatistician

Biostatisticians design and analyze statistical studies in the biomedical field. This course would be helpful for students interested in a career as a Biostatistician by providing an understanding of the methods used to quantify the safety of potential drugs. The course covers topics such as in vitro and in vivo safety studies, the design of preclinical safety studies, and the calculation of an investigational drug’s first-in-human dose.

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Toxicology Consultant

Toxicology Consultants provide advice to businesses and individuals on a variety of topics related to toxicology, including the safety of potential drugs. This course would be helpful for students interested in a career as a Toxicology Consultant by providing an understanding of the methods used to quantify the safety of potential drugs. The course covers topics such as in vitro and in vivo safety studies, the design of preclinical safety studies, and the calculation of an investigational drug’s first-in-human dose.

See salaries and explore the career path for Toxicology Consultant

Pharmaceutical Sales Representative

Pharmaceutical Sales Representatives sell drugs and medical devices to healthcare professionals. This course would be helpful for students interested in a career as a Pharmaceutical Sales Representative by providing an understanding of the methods used to quantify the safety of potential drugs. The course covers topics such as in vitro and in vivo safety studies, the design of preclinical safety studies, and the calculation of an investigational drug’s first-in-human dose.

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Healthcare Consultant

Healthcare Consultants provide advice to healthcare organizations on a variety of topics, including drug safety. This course would be helpful for students interested in a career as a Healthcare Consultant by providing an understanding of the methods used to quantify the safety of potential drugs. The course covers topics such as in vitro and in vivo safety studies, the design of preclinical safety studies, and the calculation of an investigational drug’s first-in-human dose.

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Medical Writer

Medical Writers communicate complex medical information to a variety of audiences. This course would be helpful for students interested in a career as a Medical Writer by providing an understanding of the methods used to quantify the safety of potential drugs. The course covers topics such as in vitro and in vivo safety studies, the design of preclinical safety studies, and the calculation of an investigational drug’s first-in-human dose.

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Laboratory Technician

Laboratory Technicians conduct experiments and tests in a variety of settings, including pharmaceutical companies and research institutions. This course may be helpful for students interested in a career as a Laboratory Technician by providing an understanding of the methods used to quantify the safety of potential drugs. The course covers topics such as in vitro and in vivo safety studies, the design of preclinical safety studies, and the calculation of an investigational drug’s first-in-human dose.

See salaries and explore the career path for Laboratory Technician

Science Writer

Science Writers communicate complex scientific information to a variety of audiences. This course may be helpful for students interested in a career as a Science Writer by providing an understanding of the methods used to quantify the safety of potential drugs. The course covers topics such as in vitro and in vivo safety studies, the design of preclinical safety studies, and the calculation of an investigational drug’s first-in-human dose.

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Epidemiologist

Epidemiologists investigate the causes and distribution of diseases in populations. This course may be helpful for students interested in a career as an Epidemiologist by providing an understanding of the methods used to quantify the safety of potential drugs. The course covers topics such as in vitro and in vivo safety studies, the design of preclinical safety studies, and the calculation of an investigational drug’s first-in-human dose.

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Quality Assurance Specialist

Quality Assurance Specialists ensure that products and services meet quality standards. This course may be helpful for students interested in a career as a Quality Assurance Specialist by providing an understanding of the methods used to quantify the safety of potential drugs. The course covers topics such as in vitro and in vivo safety studies, the design of preclinical safety studies, and the calculation of an investigational drug’s first-in-human dose.

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Forensic Scientist

Forensic Scientists analyze evidence in criminal cases. This course may be helpful for students interested in a career as a Forensic Scientist by providing an understanding of the methods used to quantify the safety of potential drugs. The course covers topics such as in vitro and in vivo safety studies, the design of preclinical safety studies, and the calculation of an investigational drug’s first-in-human dose.

See salaries and explore the career path for Forensic Scientist