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Preclinical Studies

What are preclinical studies?

Preclinical studies are completed on a new drug before it is tested on people. These studies include laboratory and animal testing, and their goal is to determine the drug’s toxicity or if it has the potential to cause serious harm.

The two types of preclinical studies are in vitro (outside of an organism; laboratory) and in vivo (animal testing).

The FDA requires that researchers use good laboratory practices (GLP) for preclinical laboratory studies, which set basic requirements for study conduct, facilities, personnel, study reports, equipment, written protocols, and a system of quality assurance oversight.

Why are preclinical studies important to healthcare?

Preclinical studies allow researchers to gather basic information about a drug’s safety and biological efficacy before it is tested on humans.

It is crucial for any treatment that reaches human trials to be vetted using quality preclinical research because human clinical trials require not only a significant amount of time and money but also a great commitment from the participants. Preclinical studies ensure that any drug that makes it to clinical trials deserves to be there because of solid evidence regarding its potential for efficacy in humans.