AppendixB
The Road to Drug Approval
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).
Organic Research
The initial step is a characterization of the disease or disorder that is in need of a new therapeutic approach. Academic medical centers (AMCs) ...
Get Innovation the Cleveland Clinic Way: Powering Transformation by Putting Ideas to Work now with the O’Reilly learning platform.
O’Reilly members experience books, live events, courses curated by job role, and more from O’Reilly and nearly 200 top publishers.
