Investigational New Drug

Investigational New Drug

An Investigational New Drug (IND) is a pharmaceutical compound that has been approved by the Food and Drug Administration (FDA) to be tested in humans. The IND application is a critical step in the drug development process, allowing researchers to begin clinical trials to assess the safety and efficacy of a new drug.

The drug evaluation process involves several stages, including preclinical testing and clinical trials.

Purpose of an IND

The primary purpose of an IND is to ensure that a new drug is safe for human testing. Before a drug can be tested in humans, it must undergo extensive preclinical research in laboratories and animal studies to gather preliminary data on its safety and biological activity. The IND application provides the FDA with comprehensive information about the drug, including its composition, manufacturing process, and the results of preclinical studies.

Types of INDs

There are three main types of INDs:

• Commercial IND: Submitted by companies that intend to market the drug after approval.
• Research IND: Submitted by researchers or institutions for experimental purposes, often without the intent to market the drug.
• Emergency Use IND: Allows the FDA to authorize the use of an experimental drug in an emergency situation that does not allow time for submission of a standard IND.

IND Application Process

The IND application process involves several key components:

• Pre-IND Consultation: Sponsors can meet with the FDA to discuss the development plan and receive guidance on the design of preclinical and clinical studies.
• IND Submission: The application must include detailed information about the drug's composition, manufacturing, and control, as well as the proposed clinical trial protocols.
• FDA Review: The FDA reviews the IND to ensure that the proposed studies do not pose unreasonable risks to participants. This review process typically takes 30 days.

Clinical Trials

Once an IND is approved, the drug can enter the clinical trial phase, which is divided into three main phases:

• Phase I: Tests the drug's safety, dosage range, and side effects in a small group of healthy volunteers or patients.
• Phase II: Focuses on the drug's efficacy and further evaluates its safety in a larger group of patients.
• Phase III: Confirms the drug's effectiveness, monitors side effects, and compares it to commonly used treatments in a large group of patients.

IND Amendments

During the course of clinical trials, sponsors may need to make changes to the IND. These changes can include protocol amendments, new investigator information, or changes in the manufacturing process. Such amendments must be submitted to the FDA for review.

IND Safety Reporting

Sponsors are required to report any adverse events or safety concerns that arise during clinical trials. This ensures ongoing monitoring of the drug's safety profile and allows the FDA to take action if necessary.

Related Pages

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