Description

Navigating the Investigational New Drug (IND) Applications: A Comprehensive Guide is a detailed resource for professionals involved in drug development, regulatory affairs, and clinical research. This guide offers a step-by-step approach to understanding the intricacies of the IND application process, providing insight into the regulatory requirements set by the U.S. Food and Drug Administration (FDA). Covering everything from preclinical studies and clinical trial design to safety reporting and FDA interactions, this book equips readers with the knowledge to successfully navigate the IND submission journey. With practical tips, real-world examples, and a focus on compliance, this comprehensive guide is an essential tool for ensuring the smooth progression of investigational drugs from the lab to human trials.