Investigational New Drug Application

Definition

An Investigational New Drug Application (IND) is a request submitted to the U.S. Food and Drug Administration (FDA) to obtain permission to start clinical trials on a new drug or biological product in humans. This application includes data from preclinical studies, plans for clinical trials, and information about the drug’s composition, manufacturing, and labeling, making it a critical step in the drug development process.

5 Must Know Facts For Your Next Test

1. The IND must demonstrate that there is enough evidence from preclinical research to support testing the drug in humans.
2. Once an IND is filed, the FDA has 30 days to review it before clinical trials can begin; if no objections are raised, trials can proceed.
3. The IND process is crucial for ensuring patient safety and gathering data on the drug’s effects before it can be marketed.
4. Different types of INDs exist, including commercial INDs for new drugs intended for sale and research INDs for investigational use without commercialization.
5. The IND application includes detailed information such as proposed trial protocols, investigator qualifications, and plans for monitoring safety.

Review Questions

• How does the IND process impact the timeline of drug development?
  • The IND process significantly influences the timeline of drug development by establishing a regulatory framework that must be followed before human testing can begin. Once an IND is submitted, the FDA has 30 days to review it, which can introduce delays if additional information or clarifications are requested. The time taken in obtaining IND approval is crucial as it directly affects how quickly a new drug can move into clinical trials and ultimately reach the market.
• Discuss the role of preclinical studies in supporting an IND application.
  • Preclinical studies are fundamental in supporting an IND application as they provide initial evidence of the drug's safety and efficacy through laboratory and animal testing. These studies help identify potential side effects, appropriate dosages, and mechanisms of action, forming the basis for determining whether a new drug is ready for human trials. A robust set of preclinical data is essential for convincing regulatory authorities that proceeding with clinical trials is justified.
• Evaluate the implications of an unsuccessful IND application on pharmaceutical research and development.
  • An unsuccessful IND application can have significant implications for pharmaceutical research and development by not only delaying or halting a particular drug’s progress but also influencing future investment decisions. Companies may reconsider funding for similar compounds or alter their research strategies based on feedback received during the IND review process. Additionally, failed INDs can highlight gaps in preclinical research methodologies or raise questions about a company's overall drug development approach, potentially impacting their reputation within the industry.

Related terms

Clinical Trials: Research studies conducted with human participants to evaluate the safety and efficacy of new drugs or treatments.

New Drug Application: A formal proposal submitted to the FDA for the approval of a new drug after clinical trials have been successfully completed.

Phase I Trials: The first phase of clinical trials, focusing on assessing the safety, tolerability, and pharmacokinetics of a drug in a small group of healthy volunteers.