is being presented by Lorraine S. DeCesare, President, with LS Drug Development, Inc. and airs on Tuesday, August 17th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Phase I clinical trials are a critical step in the development program for an investigational product. First-in-man studies are the first step in the development program, but bioequivalency studies and food effect studies can also make or break the life cycle of an investigational product. Phase I studies are very different from Phase II-IV studies; all subjects in a Phase I study participate at the same time and at the time scheduled by the site, whereas in Phase III studies each subject participates on his own schedule. All activities in a Phase I study are conducted relative to the time of dosing and are usually minutes rather than days or even weeks apart as in Phase III studies.
This audio conference discusses the critical areas in selection of a clinical trial site for the conduct of Phase I studies, be they complex first-in-man studies or more routine bioequivalence studies.
