May 2, 2024
3 minute read
Preclinical Safety is a field of study that deals with the assessment of the safety of new drugs and other chemical substances before they are tested in humans. Preclinical safety studies are essential to identify any potential risks associated with a new drug or substance, and to determine the safe dosage and administration route for human testing.
Types of Preclinical Safety Studies
Preclinical safety studies can be divided into two main types: in vitro studies and in vivo studies. In vitro studies are conducted in the laboratory, using cells or tissues from animals or humans. In vivo studies are conducted in live animals, and are used to assess the safety and efficacy of a new drug or substance in a whole organism.
Preclinical safety studies typically include a battery of tests to assess the following:
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Find a path to becoming a Preclinical Safety. Learn more at:
OpenCourser.com/topic/bsdzi8/preclinical
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.
A textbook providing insight into the fundamentals of toxicology and discussing the principles underlying the science of toxicology.
An in-depth look at the ADME aspects of drug development covering such areas as absorption, distribution, metabolism, and excretion.
An overview of pharmaceutical preclinical development covering such topics as study designs, risk assessment, species selection, and timelines.
An exploration of regulatory toxicology and its applications in drug development and other areas.
An exploration of genetic toxicology from an agricultural perspective, discussing such topics as genotoxicity testing, risk assessment, and regulatory aspects.
For more information about how these books relate to this course, visit:
OpenCourser.com/topic/bsdzi8/preclinical
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