RT Book, Section A1 Graham, Thomas J. SR Print(0) ID 1150321276 T1 The Road to Drug Approval T2 Innovation the Cleveland Clinic Way: Powering Transformation by Putting Ideas to Work YR 2018 FD 2018 PB McGraw-Hill Education PP New York, NY SN 9781259582950 LK accessmedicine.mhmedical.com/content.aspx?aid=1150321276 RD 2024/03/29 AB The U.S. Food and Drug Administration (FDA) drug approval process has nine stages (fda.gov). They are organic research; target identification and validation; determination of a lead compound; ADME/tox testing; compound optimization; preclinical testing; investigational new drug (IND) application; clinical trials (Phases 1, 2, and 3); new drug application (NDA); manufacture and scaling; and Phase 4 testing. Each step is described in detail in this appendix, with an eye to how it contributes to the ultimate expense of drug development (see fda.gov).