The number and proportion of elderly people continue to increase worldwide. The majority of the elderly have multiple medical conditions, often the result of changes in biological processes associated with aging. This leads to the use of multiple medications and increased risk for drug–drug interactions, drug–disease interactions, medication errors, and adverse drug reactions. This chapter highlights several important factors to consider when conducting safety evaluations for medicinal products used by elderly patients. These include age-related changes in pharmacokinetic and pharmacodynamic effects and the need for specialized data collection and analysis of elderly patient cohorts throughout the product life cycle. This chapter also addresses the importance of communicating risks and measures to minimize the risks to the growing elderly population.
