Preclinical Toxicology: Points to Consider in Program Design - Sponsored Whitepaper

Drug development is a high-risk enterprise. The typical new drug takes 10-12 years to get to market and costs up to $500 million. Pharmaceutical companies face continually increasing challenges in drug development— shorter product life cycles, global competition, as well as daunting technical and regulatory hurdles. Meanwhile, as a result of the Human Genome Project and high throughput drug development methods, there are many more drug candidates to test. Thus, there is growing pressure on pharmaceutical and biopharmaceutical companies to be efficient in their drug discovery and development programs.

Roughly 80% of candidate drugs will fail during the preclinical phase of their development. A well thought out nonclinical pharmacology/ toxicology program is critical for the long-term effectiveness of a drug development effort. Because they help drug developers avoid clinical trials that are destined to fail, nonclinical studies can be a major tool for reducing drug development costs.