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OFFICE OF NEW DRUGS MODULE

Drug Study Progression

Drug development usually proceeds in an orderly and logical progression. Each step builds on prior experience. Studies follow this general outline:

  • Lab studies, animal studies, human studies. Lab studies are performed to understand the characteristics of the drug or the monoclonal antibody or another biologic. Animal studies are designed to obtain adequate information about the likelihood of toxicity if the drug is used in humans. For a drug, CDER usually wants pharmacology and toxicology studies done in two species, a rodent and a nonrodent. For a biological product, such as a monoclonal antibody, CDER will request that studies be done in a monkey, with additional immunogenicity studies done in the appropriate model. Once data are reviewed from animal studies, the sponsor will typically perform human studies; the study protocol will be part of the IND.
a lab mouse sitting on a table next to a beaker
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