Risk predicted from animal studies

Abstract

The concept that the first use of a new drug in man must always be preceded by safety studies in laboratory animals, and that additional toxicological experiments are performed before a marketing licence is requested, came into force almost 50 years ago. During this time, toxicological testing has developed into an enormously laborious effort, whose cost-effectiveness is now seriously disputed. Moreover, a third party, the drug regulatory agencies, is increasingly using safety and consumer protection as arguments to tighten its control over the drug development process. Therefore, it is understandable that medicinal chemists and pharmacologists on the one hand, and clinical pharmacologists on the other, regard pre-clinical safety investigations as a mixed blessing and, at best, as a costly insurance policy with limited coverage.