Department of Health and Human Services

Patient Network

Bringing Your Voice to Drug and Device Approval and Safety

Step 2 Preclinical Research

Before testing a drug in people, researchers must find out whether it has the potential to cause serious harm, also called toxicity. The two types of preclinical research are:

FDA requires researchers to use good laboratory practices, defined in medical product development regulations, for preclinical laboratory studies. This ensures that researchers meet minimum standards for animal testing.

Usually, preclinical studies are not very large. However, these studies must provide detailed information on dosing and toxicity levels. After preclinical testing, researchers review their findings and decide whether the drug should be tested in people.

Next Step Clinical Research