Few acute studies are conducted today as the value of these data for predicting human adverse reactions is very limited. A battery of mutagenicity tests to evaluate the potential for genetic problems in animal models are performed to meet regulatory requirements worldwide. Carcinogenicity tests are usually conducted in two animal species for a period of two years. The ability of the offspring to grow normally and reproduce is also tested in most cases. C. Human Studies Human safety is evaluated primarily from results obtained in clinical trials.
Every clinical study evaluates safety, regardless of whether safety is a stated objective.
During all studies, including quality of life or pharmacoeconomic studies, patients are observed for adverse events. Those that are observed are reported to FDA and when appropriate, are incorporated in the package labeling. Because safety information is cumulative, the more patients studied, the greater is the data base of safety information. Phase I - Most drugs are initially evaluated for safety in healthy male volunteers in small Phase I trials. First, a single dose trial is conducted, beginning with small doses.