TY - CHAP M1 - Book, Section TI - The Road to Drug Approval A1 - Graham, Thomas J. PY - 2018 T2 - Innovation the Cleveland Clinic Way: Powering Transformation by Putting Ideas to Work 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). SN - PB - McGraw-Hill Education CY - New York, NY Y2 - 2024/11/01 UR - accessmedicine.mhmedical.com/content.aspx?aid=1150321276 ER -