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Preclinical Safety

From In Vitro Assays to Human Dose Predictions

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.

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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.

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-suited for life science professionals looking to understand the preclinical safety of potential drugs
Instructors Erland Stevens are recognized for their expertise in the preclinical safety of drugs
Course explores the practical aspects of preclinical safety, making it relevant to industry professionals
May require some background knowledge in pharmacology and pharmacokinetics
Offers a comprehensive overview of preclinical safety studies and their role in drug development
Designed in modules with video lessons, readings, and assessments, providing a structured learning experience

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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:
Clinical Research Associate
Clinical Research Associates (CRAs) are responsible for managing clinical trials. They ensure that trials are conducted according to Good Clinical Practice (GCP) guidelines and that data is collected and reported accurately. This course can help CRAs to better understand the safety of drugs and how to design and conduct clinical trials. It can also help them to communicate with investigators and other stakeholders about the safety of drugs.
Medical Science Liaison
Medical Science Liaisons (MSLs) are responsible for providing medical information to healthcare professionals. They work with physicians, pharmacists, and other healthcare providers to educate them about the safety and efficacy of drugs. This course can help MSLs to better understand the safety of drugs and how to communicate this information to healthcare professionals.
Regulatory Affairs Specialist
Regulatory Affairs Specialists are responsible for ensuring that drugs are safe and effective before they are marketed. They work with regulatory agencies to review and approve drugs. This course can help Regulatory Affairs Specialists to better understand the safety of drugs and how to prepare regulatory submissions.
Toxicologist
Toxicologists are responsible for assessing the safety of drugs and other chemicals. They conduct studies to identify the potential risks of these substances and to develop ways to mitigate these risks. This course can help Toxicologists to better understand the safety of drugs and to develop new methods for assessing the safety of new drugs and chemicals.
Pharmacovigilance Scientist
Pharmacovigilance Scientists are responsible for monitoring the safety of drugs after they have been marketed. They collect and analyze data on adverse events and other safety concerns. This course can help Pharmacovigilance Scientists to better understand the safety of drugs and to identify and mitigate potential risks.
Drug Safety Physician
Drug Safety Physicians are responsible for overseeing the safety of drugs. They work with other healthcare professionals to identify and manage adverse events. This course can help Drug Safety Physicians to better understand the safety of drugs and to develop strategies for mitigating risks.
Clinical Pharmacologist
Clinical Pharmacologists are responsible for studying the effects of drugs in humans. They conduct clinical trials to assess the safety and efficacy of drugs. This course can help Clinical Pharmacologists to better understand the safety of drugs and to design and conduct clinical trials.
Medical Writer
Medical Writers are responsible for writing medical documents, such as clinical trial protocols, regulatory submissions, and patient education materials. This course can help Medical Writers to better understand the safety of drugs and to communicate this information to healthcare professionals and patients.
Pharmaceutical Sales Representative
Pharmaceutical Sales Representatives are responsible for selling drugs to healthcare professionals. They work with physicians, pharmacists, and other healthcare providers to educate them about the safety and efficacy of drugs. This course can help Pharmaceutical Sales Representatives to better understand the safety of drugs and to communicate this information to healthcare professionals.
Biostatistician
Biostatisticians are responsible for designing and analyzing statistical studies. They work with other healthcare professionals to collect and interpret data on the safety and efficacy of drugs. This course can help Biostatisticians to better understand the safety of drugs and to design and conduct statistical studies.
Research Scientist
Research Scientists are responsible for conducting research on the safety and efficacy of drugs. They may work in academia, industry, or government. This course can help Research Scientists to better understand the safety of drugs and to develop new methods for assessing the safety of new drugs.
Laboratory Technician
Laboratory Technicians are responsible for conducting laboratory tests on drugs and other chemicals. They may work in a variety of settings, such as pharmaceutical companies, hospitals, and research institutions. This course can help Laboratory Technicians to better understand the safety of drugs and to conduct laboratory tests accurately and efficiently.
Quality Assurance Auditor
Quality Assurance Auditors are responsible for ensuring that drugs are manufactured and distributed in accordance with Good Manufacturing Practices (GMPs). They conduct audits of manufacturing facilities and review quality control data. This course can help Quality Assurance Auditors to better understand the safety of drugs and to ensure that they are manufactured and distributed in a safe and effective manner.
Healthcare Consultant
Healthcare Consultants provide advice to healthcare providers on a variety of topics, including the safety and efficacy of drugs. This course can help Healthcare Consultants to better understand the safety of drugs and to provide informed advice to their clients.
Patent Attorney
Patent Attorneys are responsible for drafting and prosecuting patent applications for new drugs. This course can help Patent Attorneys to better understand the safety of drugs and to draft and prosecute patent applications that protect the intellectual property of their clients.

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.
The most complete and current guide to toxicology, focusing on mechanisms of toxicity, drug interactions, and toxic effects on different organ systems. is useful for in-depth, authoritative information on the subject.
Provides a comprehensive overview of the principles and methods of toxicology, covering the different types of toxicants, their effects on the body, and the methods used to assess toxicity. It valuable reference for researchers and students in the field of toxicology.
Covers the use of different animal models in toxicology studies, including rodents, non-rodents, and in vitro models. It provides guidance on selecting the appropriate model for specific toxicity studies.
This textbook provides a comprehensive overview of toxicology, including chapters on preclinical safety assessment. It valuable resource for individuals who want to gain a broad understanding of toxicology and its role in drug development.
A textbook that provides a comprehensive overview of veterinary toxicology, covering the diagnosis and treatment of poisoning in animals.

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