What are the Key Components of an IND Application?
An IND application typically includes:
1. Preclinical Data: This involves laboratory and animal studies that show the compound is reasonably safe for initial human testing. 2. Manufacturing Information: Details on how the drug is manufactured to ensure it can be consistently produced at a high quality. 3. Clinical Protocols and Investigator Information: The design of the proposed human trials, including objectives, methodology, and qualifications of the clinical investigators.