Investigational New Drug

Investigational New Drug (IND) is a term used in the pharmaceutical industry to describe a new drug that is under investigation but has not yet been approved by the Food and Drug Administration (FDA) for general use. The IND application is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines before a marketing application for the drug has been approved.

Overview

The IND application is part of the FDA's drug approval process, in which the agency reviews the proposed testing protocol and evaluates data from animal testing and manufacturing information to ensure that the company can adequately produce and supply the drug. The FDA also reviews the drug's safety data and the proposed clinical study protocols to determine whether the drug's potential benefits outweigh its risks.

Process

The IND application process involves several steps. First, the pharmaceutical company must conduct preclinical testing, which includes laboratory and animal testing, to evaluate the drug's safety and effectiveness. The results of these tests are then submitted to the FDA in the IND application.

Once the IND application is submitted, the FDA has 30 days to review the application. If the FDA does not object within this time, the pharmaceutical company can begin clinical trials. These trials are conducted in three phases, each with a different purpose and number of participants.

Phase I trials involve a small group of healthy volunteers and are designed to evaluate the drug's safety, dosage range, and side effects. Phase II trials involve a larger group of patients and are designed to evaluate the drug's effectiveness and further assess its safety. Phase III trials involve a large group of patients and are designed to confirm the drug's effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug to be used safely.

See also

• Clinical trial
• Drug development
• Food and Drug Administration
• Pharmaceutical industry

References

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