Introduction: Unacceptable failure rates in clinical trials are largely responsible for the high costs of bringing successful drugs to market - costs that are passed on to patients, insurers or healthcare providers. Furthermore, failures in clinical trials deny patients much-needed new drugs and potentially expose them to unnecessary risk. With so many medicines reaching their patent expiry date, pressure is on the pharmaceutical industry to not only increase its output of effective medicines but also improve its ability to minimise safety issues.
Areas covered: This review focuses on the availability and use of human tissues and their derivatives to explore potential toxicity problems of new drugs. The growth in the number and quality of human material-based assays and enabling technologies is reviewed, followed by a discussion of the application of such assays to identify specific toxicities, using specific examples.
Expert opinion: Although human tissues are now beginning to be seen as playing an important role in evaluating the potential for toxicity of new drugs in the clinic, their importance deserves to be more widely recognised and their use in the identification of toxicity issues as early as possible in the drug development life cycle should be significantly increased.