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's inside

Learning objectives

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

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

Syllabus

week 1

pharmacology & toxicology

preclinical safety timeline

tragedies in drug safety

in vitro safety assays

risks from hERG channel inhibition

on-target toxicity

in vivo toxicology studies

drug-drug interactions

intra-family target selectivity

drug purity and safety

efficacy vs. safety risks

maximum recommended starting dose

safety in oncology drugs

preclinical safety concurrent with clinical trials

post-approval surveillance

week 2

week 3

Good to know

Know what's good

, what to watch for

, and possible dealbreakers

Covers traditional pharmacology and toxicology, providing foundational knowledge for clinical drug development

In-depth exploration of in vitro and in vivo safety testing methodologies used in preclinical drug development

Taught by Erland Stevens, recognized for his expertise in preclinical safety

Strong focus on efficacy and safety considerations, helping learners understand the balance between drug effectiveness and potential risks

Covers topics relevant for professionals involved in drug development

Provides comprehensive insights into preclinical safety assessment, suitable for individuals seeking a strong foundation in this field

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:

Watch video tutorials on toxicology

Show steps

Supplement your learning by watching video tutorials on specific toxicology topics.

Browse courses on Toxicology

Show steps

Search for video tutorials on toxicology topics
Watch the tutorials and take notes

Compile a toxicology resource list

Show steps

Gather and organize a list of valuable toxicology resources, including websites, books, and articles.

Browse courses on Toxicology

Show steps

Search for toxicology resources online and in libraries
Evaluate the resources for quality and relevance
Organize the resources into a list or database

Review Casarett & Doull's Toxicology

Show steps

Review this comprehensive textbook to gain a deep understanding of the principles of toxicology.

View Casarett & Doull's Essentials of Toxicology,... on Amazon

Show steps

Read the assigned chapters and take notes
Summarize the key points of each chapter
Complete the end-of-chapter questions

Five other activities

Expand to see all activities and additional details

Show all eight activities

Solve toxicology practice problems

Show steps

Practice solving toxicology problems to reinforce your understanding of concepts and prepare for exams.

Browse courses on Toxicology

Show steps

Identify the key concepts and principles of toxicology
Practice solving problems related to toxicology
Review your solutions and identify areas where you need improvement

Participate in a toxicology study group

Show steps

Join a study group to discuss course material, solve problems, and quiz each other.

Browse courses on Toxicology

Show steps

Find a group of classmates who are interested in forming a study group
Set regular meeting times and locations
Prepare for each meeting by reviewing the assigned material

Tutor a classmate in toxicology

Show steps

Help a classmate understand toxicology concepts by tutoring them.

Browse courses on Toxicology

Show steps

Offer to tutor a classmate who is struggling with toxicology
Meet with your tutee regularly to review material and answer questions
Create practice problems and quizzes to help your tutee prepare for exams

Create a toxicology infographic

Show steps

Design an infographic that visually communicates a toxicology concept or topic.

Browse courses on Toxicology

Show steps

Choose a toxicology topic to focus on
Research the topic and gather data
Design the infographic using a visual design tool

Volunteer at a toxicology lab

Show steps

Gain hands-on experience in toxicology by volunteering at a lab.

Browse courses on Toxicology

Show steps

Research toxicology labs in your area
Contact the labs and inquire about volunteer opportunities
Attend the volunteer training program

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:

Safety Pharmacologist

Safety Pharmacologists are responsible for evaluating the safety of drugs and medical devices. This course will provide you with a solid foundation in preclinical safety, including the principles of preclinical testing, the design and conduct of preclinical safety studies, and the interpretation of preclinical safety data. This course may be particularly helpful if you are interested in a research career in the pharmaceutical industry, as it will provide you with a deeper understanding of the preclinical safety aspects of drug development.

See salaries and explore the career path for Safety Pharmacologist

Clinical Pharmacologist

Clinical Pharmacologists are responsible for evaluating the safety and efficacy of drugs in humans. By taking this course, you will supplement your knowledge in understanding the principles of preclinical safety, including the design and conduct of preclinical safety studies, and the interpretation of preclinical safety data. This course will help you to better understand the preclinical safety aspects of drug development, which can be valuable in your role as a Clinical Pharmacologist.

See salaries and explore the career path for Clinical Pharmacologist

Toxicologist

Toxicologists evaluate the potential risks and hazards of drugs and chemicals. This course may help build a foundation in preclinical safety and provide you with the skills to perform toxicity studies, interpret results, and make recommendations for safe use of drugs and chemicals. It can also help prepare you for a career in regulatory affairs, where you will apply your knowledge of preclinical safety to assess the safety of drugs and medical devices for regulatory approval.

See salaries and explore the career path for Toxicologist

Regulatory Affairs Specialist

Regulatory Affairs Specialists work to ensure that drugs and medical devices meet regulatory requirements and are safe and effective for use. This course can be particularly helpful for Regulatory Affairs professionals who want to build a foundation in preclinical safety, as it provides an overview of the principles of preclinical testing, as well as the design and conduct of preclinical safety studies. It can also provide you with a deeper understanding of the regulatory requirements for preclinical safety studies, which can be valuable in your role.

See salaries and explore the career path for Regulatory Affairs Specialist

Research Scientist

Research Scientists with an interest in preclinical safety and pharmacology can benefit from this course. It will help you understand the principles of preclinical safety, including the design and conduct of preclinical safety studies, and the interpretation of preclinical safety data. This course may be particularly helpful if you are interested in a research career in the pharmaceutical industry, as it can provide you with a deeper understanding of the preclinical safety aspects of drug development.

See salaries and explore the career path for Research Scientist

Clinical Research Associate

Clinical Research Associates (CRAs) play a crucial role in the clinical research process by ensuring that studies are conducted ethically and in accordance with good clinical practices (GCPs). This course can be helpful for CRAs who wish to expand their knowledge of preclinical safety, as it provides an understanding of the principles of preclinical testing, as well as the design and conduct of preclinical safety studies.

See salaries and explore the career path for Clinical Research Associate

Pharmacovigilance Scientist

Pharmacovigilance Scientists play a key role in identifying, evaluating, and mitigating the risks associated with drugs and medical devices. This course may be helpful for Pharmacovigilance Scientists who want to expand their knowledge of preclinical safety, as it provides an overview of the principles of preclinical testing, as well as the design and conduct of preclinical safety studies. This knowledge can help you to better understand the potential risks associated with drugs and medical devices, and to develop and implement effective risk management strategies.

See salaries and explore the career path for Pharmacovigilance Scientist

Medical Writer

A Medical Writer creates and edits a variety of documents, including scientific, educational, marketing, and regulatory materials used by healthcare professionals and patients. In this role, you will write about preclinical safety and clinical trial data, as well as safety issues and risks associated with the use of drugs or devices. This course can be particularly helpful for understanding the underlying science and principles of preclinical safety, drug efficacy, and risks. It may also help you if you need to stay up-to-date on the latest advances in drug development, clinical trials, and regulatory compliance.

See salaries and explore the career path for Medical Writer

Regulatory Compliance Manager

Regulatory Compliance Managers in the pharmaceutical industry may find this course helpful for understanding the principles of preclinical safety, including the design and conduct of preclinical safety studies, the interpretation of preclinical safety data, and the regulatory requirements for preclinical safety studies.

See salaries and explore the career path for Regulatory Compliance Manager

Chemist

Chemists working in the pharmaceutical industry may find this course helpful for understanding the principles of preclinical safety, including the design and conduct of preclinical safety studies, the interpretation of preclinical safety data, and the regulatory requirements for preclinical safety studies.

See salaries and explore the career path for Chemist

Biostatistician

Biostatisticians in the pharmaceutical industry may find this course helpful for understanding the principles of preclinical safety, including the design and conduct of preclinical safety studies, the interpretation of preclinical safety data, and the regulatory requirements for preclinical safety studies.

See salaries and explore the career path for Biostatistician

Quality Assurance Specialist

Quality Assurance Specialists in the pharmaceutical industry may find this course helpful for understanding the principles of preclinical safety, including the design and conduct of preclinical safety studies, the interpretation of preclinical safety data, and the regulatory requirements for preclinical safety studies.

See salaries and explore the career path for Quality Assurance Specialist

Healthcare Consultant

Healthcare Consultants may find this course helpful for understanding the principles of preclinical safety, including the design and conduct of preclinical safety studies, the interpretation of preclinical safety data, and the regulatory requirements for preclinical safety studies.

See salaries and explore the career path for Healthcare Consultant

Medical Science Liaison

Medical Science Liaisons may find this course helpful for understanding the principles of preclinical safety, including the design and conduct of preclinical safety studies, the interpretation of preclinical safety data, and the regulatory requirements for preclinical safety studies.

See salaries and explore the career path for Medical Science Liaison

Pharmaceutical Sales Representative

Pharmaceutical Sales Representatives may find this course helpful for understanding the principles of preclinical safety, including the design and conduct of preclinical safety studies, the interpretation of preclinical safety data, and the regulatory requirements for preclinical safety studies.

See salaries and explore the career path for Pharmaceutical Sales Representative