Investigational New Drug (IND)

Definition

An Investigational New Drug (IND) is a pharmaceutical compound that has received approval from the FDA to begin clinical trials in humans. This status allows the drug to be tested for safety and efficacy, providing a critical step before it can be considered for full market approval. The IND application must include preclinical data, manufacturing information, and a detailed clinical trial plan, ensuring that the drug can be safely administered to human subjects.

5 Must Know Facts For Your Next Test

1. The IND application must demonstrate sufficient evidence from preclinical studies that the drug is likely to be safe for human use.
2. There are three main phases of clinical trials (Phase I, II, III) that an IND must go through to evaluate safety, efficacy, and side effects.
3. Once an IND is granted, the sponsor can begin recruiting participants for clinical trials while adhering to strict regulations and oversight.
4. The FDA can place a clinical hold on an IND if there are concerns about the safety of the drug or if the trial protocol is inadequate.
5. Transitioning from IND status to NDA status is crucial for bringing a drug to market; only after successful completion of all trial phases can a drug be marketed.

Review Questions

• What key components must be included in an IND application to ensure it meets FDA requirements?
  • An IND application must include comprehensive preclinical data demonstrating safety, a description of the manufacturing process for the drug, and a detailed clinical trial protocol outlining how the drug will be tested in humans. This ensures that the FDA has sufficient information to assess whether the investigational drug can proceed to human testing safely. By fulfilling these requirements, sponsors can begin to evaluate the drug's effects in clinical settings.
• Discuss how Phase I clinical trials contribute to the overall drug development process following an IND approval.
  • Phase I clinical trials are critical as they represent the first time an investigational new drug is tested in humans. The primary focus during this phase is to assess safety and identify any potential side effects. By enrolling a small group of healthy volunteers, researchers gather important data on how the body processes the drug, helping inform subsequent phases of testing. The insights gained here are foundational for understanding dosage and safety before moving on to larger populations in later phases.
• Evaluate the impact of regulatory holds on INDs and how they affect the timeline of drug development.
  • Regulatory holds on INDs can significantly delay the timeline of drug development by halting clinical trials until concerns raised by the FDA are addressed. These holds may occur due to safety issues or inadequate trial designs, requiring sponsors to provide additional information or make modifications. This not only prolongs the development process but also increases costs and resource allocation challenges for pharmaceutical companies. Consequently, delays in advancing from IND status may hinder timely access to potentially life-saving treatments for patients.

Related terms

New Drug Application (NDA): A formal request submitted to the FDA for approval to market a new drug after completing clinical trials and demonstrating its safety and efficacy.

Phase I Trials: The initial stage of clinical trials that primarily focuses on assessing the safety, tolerability, and pharmacokinetics of a drug in a small group of healthy volunteers.

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