Analyzing Safety Data

Abstract

The safety of a drug is assessed at all stages of its life cycle, from drug discovery through nonclinical development, preapproval clinical development, and all the time it is subsequently on the market. The focus of this chapter is safety assessment during later-stage clinical trials. When a drug is granted marketing approval by a regulatory agency and therefore becomes available to prescribing physicians and their patients, the best available information upon which the doctor and patient can form answers to questions concerning the drug’s safety profile is the safety information gathered during clinical trials. This information is provided to the clinician and all patients receiving the drug in the drug’s package insert, or label. The content of the label will have been agreed upon by the Sponsor and the regulatory agency granting marketing approval, and it summarizes the best available data about the drug’s safety at that point in time.