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 In this section:

                The Drug Development Process

The Drug Development Process

                        Step 1: Discovery and Development
          Step 2: Preclinical Research
          Step 3: Clinical Research
          Step 4: FDA Drug Review
          Step 5: FDA Post-Market Drug Safety Monitoring Home
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          The Drug Development Process
          Step 2: Preclinical ResearchThe Drug Development Process Step 2: Preclinical Research
  
  	
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    PrintBefore 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:
In Vitro
    GLP
  In VivoFDA 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 productUsually, 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.

                                                                                  Content current as of:
      01/04/2018The Drug Development Process

          
                        Step 1: Discovery and Development
          Step 2: Preclinical Research
          Step 3: Clinical Research
          Step 4: FDA Drug Review
          Step 5: FDA Post-Market Drug Safety Monitoring
 
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