Proper preparation of an Investigational New Drug (IND) application is a carefully orchestrated process that requires many disciplines to collaborate in delivering a consistent message regarding the safety of an investigative compound.
Proactively identifying and avoiding common IND submission pitfalls can help ensure that your application is clear, concise, and error-free.
Preparation of an Investigational New Drug (IND) application is a critical early step in clinical trial development as it enables sponsors to obtain an exemption to the federal law that prohibits the transport of drugs across state lines prior to marketing approval. The process of preparing an IND requires careful coordination of many players with different specialties who must work together to demonstrate the safety of the investigative compound.
The IND application must contain three areas of information:
- Animal pharmacology and toxicology studies
- Manufacturing information
- Clinical protocols and investigator information
While there are different types of IND submission, there are errors that are commonplace amongst all application types. In this paper, we look at common submission pitfalls and strategies for avoiding them.