Nonclinical Data Requirements for IND Filing
Nonclinical Data Requirements for IND Filing What Nonclinical Studies Are Required for an IND Submission? Purpose of Nonclinical Data in the IND Process Nonclinical (also known as preclinical) data are a critical component of any Investigational New Drug (IND) application. These studies establish the safety profile of a new drug before it is administered to…