Designing safe drugs: what to consider?

Toxicity continues to be a primary source of attrition at all stages of drug development. Attention to a few key considerations has the potential to move safety-related attrition earlier, before the expenditure of significant resources on a compound with a low chance of successfully reaching the market. The use of predictive in vitro toxicity assays, early in vivo signal generation studies, and application of new technologies will significantly reduce time spent and money lost owing to failures during development. In addition, more deliberate and informed application of assays for reducing the risk of human-specific toxicity holds promise for improving drug development success rates and reducing late-stage failures and post-approval withdrawals.