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.
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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.
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.
Target audience: This course is suitable for life scientists, clinicians, and individuals from fields that support drug discovery (e.g., patents, finance, licensing, etc.) interested in learning more about the pharmaceutical/biotechnology sector. Advanced undergraduate coursework or practical familiarity/working knowledge in biological sciences and organic chemistry is recommended.
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Syllabus
Preclinical Safety, part 1
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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Activities
Review Basic Pharmacology
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Review the basics of pharmacology to strengthen your understanding of drug development.
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Pharmacology
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Read a textbook chapter on basic pharmacology
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Review lecture notes from an introductory pharmacology course
Explore In Vitro Toxicology Techniques
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Follow online tutorials to gain practical insights into in vitro toxicology methods used in drug development.
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Find online tutorials on in vitro toxicology techniques
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Watch the tutorials and take notes on key concepts
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Practice applying the techniques through simulations or exercises
Organize and Review Course Content
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Compile and review lecture notes, assignments, and other course materials to reinforce your understanding of key concepts.
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-
Gather all relevant course materials
-
Organize the materials in a logical order
-
Review the materials regularly to reinforce your learning
Show all three activities
Review Basic Pharmacology
Show steps
Review the basics of pharmacology to strengthen your understanding of drug development.
Browse courses on
Pharmacology
Show steps
- Read a textbook chapter on basic pharmacology
- Review lecture notes from an introductory pharmacology course
Explore In Vitro Toxicology Techniques
Show steps
Follow online tutorials to gain practical insights into in vitro toxicology methods used in drug development.
Show steps
- Find online tutorials on in vitro toxicology techniques
- Watch the tutorials and take notes on key concepts
- Practice applying the techniques through simulations or exercises
Organize and Review Course Content
Show steps
Compile and review lecture notes, assignments, and other course materials to reinforce your understanding of key concepts.
Show steps
- Gather all relevant course materials
- Organize the materials in a logical order
- Review the materials regularly to reinforce your learning
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