Patient safety is of paramount importance for any drug discovery program. This course looks at some of the lessons learned which have influenced how promising molecules are currently evaluated for safety risks. In vitro and in vivo toxicology and safety studies are discussed, why they are performed, and how the data they provide guide a safety risk assessment, including determining a therapeutic index or safety window for a drug. Finally, the course will look at how safety data guide human dose selection, and some of the studies performed during clinical development.
Preclinical Safety
This course is part of Drug Hunting: The Science of Making New Medicines Specialization
Instructors: Erland Stevens, PhD
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There are 3 modules in this course
Welcome, by the end of the course students will be able to: Recognize the role of toxicology in drug development and its differentiation from pharmacology. List and describe representative preclinical toxicology studies conducted to identify and quantify risks a small molecule may pose to a patient. Explain how preclinical safety assessments contribute to early human dose selection.
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5 videos2 readings3 assignments
What's included
3 videos1 reading3 assignments
What's included
4 videos1 reading4 assignments
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Reviewed on Aug 6, 2024
excellent overview, very concise yet full of practical and useful information
Reviewed on Aug 3, 2024
The Course is very useful to those interested in understanding the principles of Pre-clinical Safety. I completed the course quickly in three sittings due to my prior exposure to this area.
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