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, which includes three phases of clinical trials designed to test the safety, effectiveness, and side effects of new drugs. The IND application must include data from preclinical testing and animal studies, as well as a plan for testing the drug in humans.

Preclinical Testing

Before a company can submit an IND application, it must conduct extensive preclinical testing. This includes laboratory and animal studies to evaluate the safety and effectiveness of the drug. The results of these studies are used to justify the proposed clinical trials in humans.

Clinical Trials

Once the IND application is approved, the company can begin clinical trials. These are divided into three phases:

• Phase I trials test the drug in a small group of healthy volunteers to evaluate its safety and dosage.
• Phase II trials involve a larger group of patients and are designed to assess the drug's effectiveness and further evaluate its safety.
• Phase III trials are conducted in large groups of patients 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 long-term effects of the drug in the general population.

See Also

• Clinical trial
• Food and Drug Administration
• Pharmaceutical industry

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