ABSTRACT
Strictly speaking, no medical product has zero risk; there are always safety concerns associated with the use of any medical product in a population of users under certain conditions. “A safe product is one that has acceptable risks, given the magnitude of the benefit expected in a specific population and within the context of alternatives available” (FDA, 2008b). A product may be relatively safe for short-term use by oral administration in adult patients with certain disorders. However, it may do more harm, as compared to the benefit of the product, for long-term use by different routes of administration in the same group of patients. In Section 1.1, we consider the probabilities of observing certain adverse events with various incidence rates, and give an overview of safety evaluation in product development that includes clinical trials and post-licensure observational studies. In this connection, we also provide a concise review of US medical product safety regulation. Section 1.2 briefly describes the concepts of adverse events and adverse drug reactions which are frequently encountered in the analysis, reporting, and dissemination of safety data. Section 1.3 describes commonly used coding standards for medical products (primarily drugs) and Section 1.4 reviews some widely used dictionaries for medical terminology. Section 1.5 gives an introduction to safety signals and serious adverse events. We discuss in Section 1.6 statistical strategies for medical product safety evaluation, and in this connection also give an overview of the other chapters of the book and provide suggestions on how the book can be used by different groups of readers. Supplements and problems are given in Section 1.7.
