ABSTRACT
The goal of this chapter is to discuss the general principles of risk assessment and risk communication as they relate to the use of excipients in drug products. A vital need of the user of any product is to understand its "safety," to know when and under what conditions its employment will not be harmful, and correspondingly when it may carry some risk. Safety, in this sense, is the complement of toxicity, and it represents the best judgment of the circumstances when any hazard of the product will not be realized as a risk.
