Drug discovery phases pdf

The discovery process includes the early phases of research, which are designed to identify an investigational drug and perform initial tests in the lab. This first stage of the process takes approximately three to six years. By the end, researchers hope to identify a promising drug candidate to further study in Setting up drug discovery and development programs in academic, non-profit and other life science research companies requires careful planning. This chapter contains guidelines to develop therapeutic hypotheses, target and pathway validation, proof of concept criteria and generalized cost analyses at various stages of early drug discovery. Various decision points in developing a New Chemical The scope of drug discovery and early drug development within the scope of these guidelines spans Target Identification through Human (Phase I) and/or Clinical (Phase IIa) Proof of Concept. This document describes an approach to Drug Discovery and Development for Treatment, Prevention, and Control of Cancer. f Discovery involves following: 1. Prediscovery- Understanding the disease 2. Target Identification- Choose a molecule to target with a drug 3. Target Validation- Test the target and Confirm its role in disease 4. Drug Discovery- Find a promising lead compound that could become a drug 5. Early Safety tests- Perform initial tests on Leads 6. This process involves the identification of candidates, synthesis, characterization, validation, optimization, screening and assays for therapeutic efficacy. Once a compound has shown its significance in these investigations, it will initiate the process of drug development earlier to clinical trials. Edited by Jie Jack Li and Nobel laureate E. J. Corey, two leading pioneers in drug discovery and medicinal chemistry, this book synthesizes great moments in history, the current state of the science, and future directions of drug discovery into one expertly written and organized work. Exploring all major therapeutic areas, the book introduces … Biopharmaceutical Drug Development: Attrition Drug Discovery Pre-Clinical 5 years 1.5 years 6 years 2 years 2 years Clinical Trials FDA Review Large Scale Manufacturing/ Phase IV 250 Compounds ed 5 Compounds ed 10,000 Com-pounds 1 FDA Approved Drug Quelle: Burrell Report Biotechnology Industry 2006 Phase I 20-100 Volunteers Phase II 100-500 1. Discovery: Phases of drug discovery are as follows: (a) Target Identification: Identification of Target for the Drug: Drug can be therapeutically efficient after it binds to the body proteins. Hence, it is essential to determine the binding target of the drug. These targets include gene or a protein that is responsible for the particular Early stages of the drug discovery process contain hurdles that must be cleared before more robust drug development can commence. Once a molecular target is selected, drug discovery begins with identification of a hit and progresses toward a lead candidate through a series of structural optimizations. The Drug Discovery Process. Introducing a new drug to market is a complex and time-consuming process that can cost pharmaceutical companies an average $2.6 billion and ten years of research and development. There are multiple defined stages for this process, each with their own associated challenges, timelines, and costs. Drug discovery is a flexible process, as opposed to drug development that operates in a highly regulated environment. There are many ways to discover new