1. In Vitro and animal studies are rarely sufficient to anticipate safety problems that may result in the development of pharmaceuticals.
Preclinical studies, including both in vitro and animal studies provide valuable information and are the foundation for designing for “First in Man” phase 1 studies, but the results are rarely directly transferrable for humans. Subject safety is paramount in carefully controlled phase 1 clinical trials, which typically use healthy volunteers. Subjects are dosed and observed in clinical trial units where medical personnel are available immediately to avert any untoward events unanticipated from the previous work done in animals.