Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect and, therefore, may present a hazard—particularly in individuals who already have one or more compromised or limited organ system functions. Unlike other nonclinical evaluations of a drug’s safety, these evaluations are usually conducted at doses close to the intended clinical dose. Recent International Conference on Harmonization (ICH) guidelines,
followed by versions by national regulatory authorities including those of the U.S. Food and Drug Administration (FDA), have made such evaluations mandatory before a potential drug is introduced into humans—while also failing to provide clear guidance as to how the requirements are to be met click here for download
