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Investigational New Drug (IND)

Similar or Alternative Terms Meaning the Same Thing New Molecular Entity (NME)
Related Term(s) New Drug Application (NDA)

Definition

The process of getting a drug approved by the FDA -- the investigational new drug ("IND") process -- is costly and time-consuming. The IND process typically has three separate phases.

  1. "Phase I" trials, evaluate the safety of the medication by studying the effect of the drug and are designed to determine the metabolic and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.
  2. "Phase II" trials are designed to obtain preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition.
  3. "Phase III" trials, are intended to gather additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.

Many drugs, like chemotherapy for an example, have deeply deleterious -- sometimes even fatal -- side effects, and part of the FDA approval process is weighing the potentiality for those side effects against the disease process the drug is designed to treat. The sponsor's goal at the end of the IND process is an approved New Drug Application ("NDA").

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