TY - CHAP M1 - Book, Section TI - Chapter 7. Phase II Clinical Trials A1 - Guptill, Jeffrey T. A1 - Chiswell, Karen A2 - Lopes, Renato D. A2 - Harrington, Robert A. Y1 - 2013 N1 - T2 - Understanding Clinical Research AB - Following preclinical and first-in-human (Phase I) studies, an investigational drug or device is studied in subjects who have the disorder of interest. This phase of development is commonly called Phase II or exploratory therapeutic development. Major goals of Phase II studies are to support the proof of concept or proof of mechanism identified during preclinical development and to show evidence of efficacy that will support future confirmatory trials (Table 7–1). Other objectives include defining the target population, exploring the pharmacodynamic relationship between dosing regimens and the effects on disease, determining the proposed dosing regimen for future trials, and providing preliminary estimates of drug effect to be used in calculating sample sizes for Phase III trials. SN - PB - The McGraw-Hill Companies CY - New York, NY Y2 - 2024/03/28 UR - accessmedicine.mhmedical.com/content.aspx?aid=57835879 ER -