IND

IND or Investigational New Drug is a term used in the pharmaceutical industry to describe a new drug that is in the process of being tested but has not yet been approved by the 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 must contain data from preclinical testing and animal studies that show it is safe to test the drug on humans. The application also includes a detailed plan for the proposed clinical trial, which is designed to answer specific questions about the drug's safety and effectiveness.

Preclinical Testing

Before an IND application is submitted, the drug must undergo extensive preclinical testing. This involves laboratory testing and animal studies to evaluate the drug's safety and effectiveness. The results of these tests are included in the IND application.

Clinical Trials

Once the IND application is approved, the drug can proceed to clinical trials. These are conducted in three phases:

• Phase I trials test the drug on a small group of healthy volunteers to evaluate its safety, determine a safe dosage range, and identify side effects.
• Phase II trials involve a larger group of people who have the condition the drug is intended to treat. This phase is designed to evaluate how well the drug works and to further evaluate its safety.
• Phase III trials are conducted on large groups of people 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.

Post-Marketing Surveillance

After a drug has been approved by the FDA and is on the market, it is subject to post-marketing surveillance. This is a phase IV clinical trial that monitors the drug's performance in the general population and detects any rare or long-term side effects.

See Also

• Clinical trial
• Food and Drug Administration
• Pharmaceutical industry
• Preclinical testing
• Post-marketing surveillance

IND Resources
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