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This document provides an overview of investigational new drugs (INDs) in 3 parts: 1. It defines an IND and describes when an IND is and is not required. It also outlines the different types of INDs. 2. It discusses the key requirements for an IND application including animal studies, manufacturing information, and clinical protocols. It also lists resources for IND applications. 3. It describes the three phases of clinical investigations and the general principles and format for IND submissions inclu

Author

Sejal khumam

Language

EN