Preclinical Safety
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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:
