Non-clinical research-based product assessment

Abstract

According to a long history of sanitary accidents, a large number of guidelines and rules governing the market access process have been introduced, including the requirement for non-clinical evaluations before human use. Drugs and other medicines probably undergo the strictest non-clinical assessments using not only animal models but also in vitro and in silico approaches. These approaches and methods are also used to assess non-drug products, such as foodstuffs, cosmetics and consumer products containing chemicals. However, these non-clinical approaches do not always guarantee the future users’ safety. In addition to new biotechnological approaches, the development of Phase 0 clinical trials may be a key element in product testing and approval. In fact, we should try to develop integrated approaches that take account of the potential risks to the individual and to the environment as a whole.