TY - CHAP M1 - Book, Section TI - Chapter 6. Phase I Trials: First in Human A1 - Watt, Kevin M. A1 - Chiswell, Karen A1 - Cohen-Wolkowiez, Michael A2 - Lopes, Renato D. A2 - Harrington, Robert A. PY - 2013 T2 - Understanding Clinical Research AB - The development process for a new molecular entity (NME) in humans proceeds over several phases of clinical trials (I through III) before it can be approved for marketing by national regulatory authorities (Figure 6–1). Once regulatory approval has been obtained, after undergoing all required trials over many years, NMEs translate into drugs that are used to treat specific conditions. SN - PB - The McGraw-Hill Companies CY - New York, NY Y2 - 2024/03/28 UR - accessmedicine.mhmedical.com/content.aspx?aid=57835652 ER -