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Discovery to IND Filing, 2nd Edition
Drug and Market Development Publishing, Jan 2007, Pages: 96
The Discovery to IND process currently takes an average of 6.5 years and consumes over 40% of the total R&D budget for a new drug. This critical, initial phase yields a drug candidate that, with FDA approval of an IND, will enter Phase 1 clinical trials in healthy human volunteers. The stakes are high because the initiation of human clinical trials commits a company to significant additional R&D investment. Consequently, the process of drug candidate discovery through to IND submission which consists of a series linear and parallel, steps, procedures and outcomes critical to reducing the risk of further investment. This initial phase is also governed by the need to present a cogent case before the FDA in order to gain approval to move the candidate into clinical trials.
Overview
Discovery to IND Filing, 2nd Edition analyzes the discovery and drug candidate development process leading to the filing of a successful IND application. Get answers to crucial questions such as:
-Lead optimization, why is it so critical to get it right?
-What are the steps required for drug development required by FDA?
-What IND enabling studies are required by the FDA?
This publication provides a review of the major steps as well as the current techniques utilized in the discovery to IND filing phase of new product innovation. This report gives the reader a detailed breakdown of the steps involved in the different stages of therapeutic drug discovery and development. It also provides detailed analysis of identification of small molecules using HTS; the issues associated with target identification and validation; as well as the requirements related to lead optimization.
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