U.S. flag An official website of the United States government
  1. Home
  2. For Patients
  3. Learn About Drug and Device Approvals
  4. The Drug Development Process
  5. Step 2: Preclinical Research
  1. The Drug Development Process

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 (GLP), defined in medical product development regulations, for preclinical laboratory studies.  The GLP regulations are found in 21 CFR Part 58.1: Good Laboratory Practice for Nonclinical Laboratory Studies. These regulations set the minimum basic requirements for:

  • study conduct

  • personnel

  • facilities

  • equipment

  • written protocols

  • operating procedures

  • study reports

  • and a system of quality assurance oversight for each study to help assure the safety of FDA-regulated product

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.

Back to Top