Fresh, functional human tissues and the prediction of drug safety

Preclinical human tissue assays can be successfully used to help predict clinical adverse effects. Data generated may contribute to the determination of therapeutic index by correlating a measured biological effect with drug concentration in target or surrogate tissue. Whilst assays such as these do not completely replace existing safety tests, they can contribute to a platform of evidence that increases the probability of clinical success and reduces the risk that species differences will go undetected. The considerable untapped resource of residual tissues has the potential to contribute significantly to the 3Rs. Strategy